Briviact (in Italy: Nubriveo)

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg film-coated tablets 
Briviact 25 mg film-coated tablets 
Briviact 50 mg film-coated tablets 
Briviact 75 mg film-coated tablets 
Briviact 100 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Briviact 10 mg film-coated tablets 
Each film-coated tablet contains 10 mg brivaracetam. 
 
Briviact 25 mg film-coated tablets 
Each film-coated tablet contains 25 mg brivaracetam. 
 
Briviact 50 mg film-coated tablets 
Each film-coated tablet contains 50 mg brivaracetam. 
 
Briviact 75 mg film-coated tablets 
Each film-coated tablet contains 75 mg brivaracetam. 
 
Briviact 100 mg film-coated tablets 
Each film-coated tablet contains 100 mg brivaracetam. 
 
Excipient(s) with known effect: 
 
Briviact 10 mg film-coated tablets 
Each 10 mg film-coated tablet contains 88 mg lactose. 
 
Briviact 25 mg film-coated tablets 
Each 25 mg film-coated tablet contains 94 mg lactose.  
 
Briviact 50 mg film-coated tablets 
Each 50 mg film-coated tablet contains 189 mg lactose.  
 
Briviact 75 mg film-coated tablets 
Each 75 mg film-coated tablet contains 283 mg lactose.  
 
Briviact 100 mg film-coated tablets 
Each 100 mg film-coated tablet contains 377 mg lactose. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
 



 

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Briviact 10 mg film-coated tablets 
White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10’ on one 
side. 
 
Briviact 25 mg film-coated tablets 
Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one 
side. 
 
Briviact 50 mg film-coated tablets 
Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50’ on 
one side. 
 
Briviact 75 mg film-coated tablets 
Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75’ on one 
side.  
 
Briviact 100 mg film-coated tablets 
Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100’ 
on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without 
secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults 

The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of 
required seizure reduction versus potential side effects. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening. Based on individual patient 
response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.  
 
Missed doses 

If patients missed one dose or more, it is recommended that they take a single dose as soon as they 
remember and take the following dose at the usual morning or evening time. This may avoid the 
brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures 
from occurring. 
 
Discontinuation 

If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a 
weekly basis. After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 
20 mg/day is recommended. 
 
Special populations 
 

Elderly (65 years of age and above) 

No dose adjustment is needed in elderly patients (see section 5.2). 
The clinical experience in patients ≥ 65 years is limited. 
 



 

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Renal impairment 

No dose adjustment is needed in patients with impaired renal function (see section 5.2). Brivaracetam 
is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data. 
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal 
function. 
 

Hepatic impairment 

Exposure to brivaracetam was increased in adult patients with chronic liver disease. In adults, a 
50 mg/day starting dose should be considered. In children and adolescents weighing 50 kg or greater, a 
50 mg/day starting dose is recommended. A maximum daily dose of 150 mg administered in 2 divided 
doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2). 
In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended. 
The maximum dose should not exceed 3 mg/kg/day. No clinical data are available in paediatric 
patients with hepatic impairment. 
 
Paediatric population 

The physician should prescribe the most appropriate formulation and strength according to weight and 
dose.  
 
The following table summarises the recommended posology for children from 4 years of age and 
adolescents. More details are provided below the table. 
 
 Children (≥4 years) and 

adolescents ≥50 kg 
 

Administered in 2 equally divided 
doses 

Children (≥4 years) and 
adolescents <50 kg 

 
Administered in 2 equally divided 

doses 
Therapeutic dose range 50 - 200 mg/day 1 - 4 mg/kg/day 
Recommended starting dose 50 mg/day   

(or 100 mg/day)* 
1 mg/kg/day 
(or 2 mg/kg/day)* 

Recommended maintenance 
dose 

100 mg/day 2 mg/kg/day 

* Based on physician assessment of need for seizure control. 
 

Children (from 4 years of age) and adolescents weighing 50 kg or more  
The recommended starting dose is 50mg/day. Brivaracetam may also be initiated at 100 mg/day based 
on physician assessment of need for seizure control. The dose should be administered in two equally 
divided doses, once in the morning and once in the evening. The recommended maintenance dose is 
100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose 
range of 50 mg/day and 200 mg/day. 
 
Children (from 4 years of age) and adolescents weighing less than 50 kg 

The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at 2 mg/kg/day 
based on physician assessment of need for seizure control. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening.The recommended maintenance 
dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective 
dose range of 1 mg/kg/day and 4 mg/kg/day. 
 
Children less than 4 years 

The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been 
established. 
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a 
posology can be made. 
 



 

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Method of administration  
 
Brivaracetam film-coated tablets must be taken orally swallowed in whole with liquid and may be 
taken with or without food (see section 5.2). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients 
listed in section 6.1.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs 
(AEDs), including brivaracetam, in several indications. A meta-analysis of randomized placebo-
controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The 
mechanism of this risk is not known and the available data do not exclude the possibility of an 
increased risk for brivaracetam. 
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment 
should be considered. Patients (and caregivers of patients) should be advised to seek medical advice 
should any signs of suicidal ideation or behaviour emerge. See also section 4.8, paediatric data. 
 
Hepatic impairment 
 
There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic 
impairment. Dose adjustments are recommended for patients with hepatic impairment (see section 
4.2). 
 
Excipients 
 
Lactose intolerance 

Brivaracetam film-coated tablets contain lactose. Patients with rare heriditary problems of galactose 
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
 
Sodium content 

Brivaracetam film-coated tablets contain less than 1 mmol sodium (23mg) per tablet, that is to say 
essentially ‘sodium free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Formal interaction studies have only been performed in adults. 
 

Pharmacodynamic interactions 
 

Concomitant treatment with levetiracetam 

In the clinical studies, although the numbers were limited, there was no observed benefit of 
brivaracetam versus placebo in patients taking levetiracetam concurrently. No additional safety or 
tolerability concern was observed (see section 5.1). 
 
Interaction with alcohol 

In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single 
dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic 
interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, 
attention and memory. Intake of brivaracetam with alcohol is not recommended. 
 



 

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Pharmacokinetic interactions 
 
Effects of other agents on the pharmacokinetics of brivaracetam 

In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway 
of brivaracetam is by CYP-independent hydrolysis. A second disposition pathway involves 
hydroxylation mediated by CYP2C19 (see section 5.2).  
 
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong 
inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated 
interaction is considered to be low. 
 
Rifampicin 

In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 
5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 
45 %. Prescribers should consider adjusting the brivaracetam dose in patients starting or ending 
treatment with rifampicin.  
 
Strong enzyme inducing AEDs 

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing 
AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).  
 
Other enzyme inducers 

Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the 
systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John’s wort should 
be done with caution. 
 
Effects of brivaracetam on other medicinal products 
Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by 
CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low. 
 
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms 
except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products 
metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam). When tested in vitro 
brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6. No CYP3A4 induction 
was found in vivo (see midazolam above). CYP2B6 induction has not been investigated in vivo and 
brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. 
efavirenz). In vitro interaction studies to determine the potential inhibitory effects on transporters 
concluded that there were no clinically relevant effects, except for OAT3. In vitro, Brivaracetam 
inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest 
clinical dose. Brivaracetam 200mg/day may increase plasma concentrations of medicinal products 
transported by OAT3. 
 
Antiepileptic drugs 
 
Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were 
investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies, in a 
population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drug-
drug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and 
topiramate). The effect of the interactions on the plasma concentration is summarised in table 1 
(increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time 
curve as “AUC”, maximum observed concentration as Cmax).  
 



 

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Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs 
AED coadministered Influence of AED on brivaracetam 

plasma concentration 
Influence of brivaracetam on 
AED plasma concentration 

Carbamazepine AUC 29 % ↓ 
Cmax 13 % ↓ 
No dose adjustment required 

Carbamazepine - None 
Carbamazepine-epoxide ↑ 
(See below)  
No dose adjustment required. 

Clobazam No data available None 
Clonazepam No data available None 
Lacosamide No data available None  
Lamotrigine None  None  
Levetiracetam None  None  
Oxcarbazepine  None  None (monohydroxy derivative, 

MHD) 
Phenobarbital AUC 19 % ↓ 

No dose adjustment required 
None  

Phenytoin AUC 21 % ↓ 
No dose adjustment required 

None 
a AUC 20% ↑ 
a Cmax 20% ↑ 

Pregabalin No data available None  
Topiramate None  None  
Valproic acid None  None  
Zonisamide No data available None  

a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam. 
 
Carbamazepine  

Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased 
concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled studies, 
the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with 
little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively. No 
safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of 
carbamazepine epoxide. 
 
Oral contraceptives 
 
Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol 
(0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. 
When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum 
daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel 
(0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed 
without impact on suppression of ovulation. There was generally no change in the concentration-time 
profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle 
stimulating hormone (FSH), and sex hormone binding globulin (SHBG). 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential  
 
Physicians should discuss family planning and contraception with women of childbearing potential 
taking brivaracetam (see Pregnancy). 
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated. 
 
Pregnancy 
 

Risk related to epilepsy and antiepileptic medicinal products in general 

For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the 
prevalence of malformations is two to three times greater than the rate of approximately 3 % in the 



 

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general population. In the treated population, an increase in malformations has been noted with 
polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible 
has not been elucidated. Discontinuation of anti-epileptic treatments may result in exacerbation of the 
disease which could be harmful to the mother and the foetus. 
 
Risk related to brivaracetam 
There is a limited amount of data from the use of brivaracetam in pregnant women. There is no data on 
placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see 
section 5.3). The potential risk for humans is unknown. Animal studies did not detect any teratogenic 
potential of brivaracetam (see section 5.3). 
 
In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with 
carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, 
carbamazepine-epoxide (see section 4.5). There is insufficient data to determine the clinical 
significance of this effect in pregnancy. 
 
As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically 
necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus). 
 
Breast-feeding 
 
It is unknown whether brivaracetam is excreted in human breast milk. Studies in rats have shown 
excretion of brivaracetam in breast milk (see section 5.3). A decision should be made whether to 
discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the 
medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the 
amount of carbamazepine-epoxide excreted in breast milk could increase. There is insufficient data to 
determine the clinical significance. 
 
Fertility 
 
No human data on the effect of brivaracetam on fertility are available. In rats, there was no effect on 
fertility with brivaracetam (see section 5.3).  
 
4.7 Effects on ability to drive and use machines 
 
Brivaracetam has minor or moderate influence on the ability to drive and use machines. 
 
Due to possible differences in individual sensitivity some patients might experience somnolence, 
dizziness, and other central nervous system (CNS) related symptoms. Patients should be advised not to 
drive a car or to operate other potentially hazardous machines until they are familiar with the effects of 
brivaracetam on their ability to perform such activities.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received 
brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥24 
months and 569 for ≥ 60 months (5 years). 
 
The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: 
somnolence (14.3 %) and dizziness (11.0 %). They were usually mild to moderate in intensity. 
Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose. The types 
of adverse reactions reported during the first 7 days of treatment were similar to those reported for the 
overall treatment period. 
 



 

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The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized 
to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7 % for 
patients randomized to placebo. The adverse reactions most frequently resulting in discontinuation of 
brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %). 
 
Tabulated list of adverse reactions 
 
In the table below, adverse reactions, which were identified based on review of the three placebo-
controlled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ 
Class and frequency.  
The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), 
uncommon (≥ 1/1,000 to < 1/100). Within each frequency grouping, undesirable effects are presented 
in order of decreasing seriousness. 
 
System organ class Frequency Adverse reactions from clinical trials 
Infections and 
infestations 

Common Influenza 

Blood and lymphatic 
system disorders 

Uncommon Neutropenia 

Metabolism and nutrition 
disorders 

Common  Decreased appetite 

Immune system disorders Uncommon Type I hypersensitivity 
Psychiatric disorders Common Depression, anxiety, insomnia, irritability 

Uncommon Suicidal ideation, psychotic disorder, 
aggression, agitation 

Nervous system disorders Very common  Dizziness, somnolence 
Common 
 

Convulsion, vertigo 

Respiratory, thoracic and 
mediastinal disorders 

Common  
 

Upper respiratory tract infections, cough 

Gastrointestinal 
disorders 

Common  
 

Nausea, vomiting, constipation 

General disorders and 
administration site 
conditions 

Common  
 

Fatigue 

 
Description of selected adverse reactions 
 
Neutropenia has been reported in 0.5 % (6/1099) brivaracetam patients and 0 % (0/459) placebo 
patients. Four of these subjects had decreased neutrophil counts at baseline, and experienced 
additional decrease in neutrophil counts after initiation of brivaracetam treatment. None of the 6 cases 
of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam 
and none had associated infections. 
 
Suicidal ideation has been reported in 0.3 % (3/1099) brivaracetam patients and 0.7 % (3/459) placebo 
patients. In the short-term clinical studies of brivaracetam in epilepsy patients, there were no cases of 
completed suicide and suicide attempt, however both have been reported in open-label extension 
studies (see section 4.4). 
 
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of 
brivaracetam patients (9/3022) during clinical development. 
 
Open-label extension studies 
 
In patients who were followed up in the open-label extension studies for up to 8 years, the safety 
profile was similar to that observed in the short-term, placebo-controlled studies.  
 



 

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Paediatric population 
The safety profile of brivaracetam observed in children was consistent with the safety profile observed 
in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of 
paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural 
disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority 
of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of 
study drug. An additional adverse reaction reported in children was psychomotor hyperactivity 
(4.7 %).  
 
There are limited safety data from open-label studies in children from 1 month to <4 years of age. 
Limited data are available on neurodevelopment in children <4 years of age. No clinical data are 
available in neonates. 
 
Elderly  
 
Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with 
epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age. The safety profile in elderly 
patients appears to be similar to that observed in younger adult patients. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness 
have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. 
 
Management of overdose 
 
There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include 
general supportive measures. Since less than 10 % of brivaracetam is excreted in urine, haemodialysis 
is not expected to significantly enhance brivaracetam clearance (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23  
 
Mechanism of action 
 
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a 
transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although 
the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of 
neurotransmitters. Binding to SV2A is believed to be the primary mechanism for brivaracetam 
anticonvulsant activity. 
 



 

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Clinical efficacy and safety 
 
The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established 
in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 
16 years of age and older. The daily dose of brivaracetam ranged from 5 to 200 mg/day across these 
studies. All studies had an 8-week baseline period followed by a 12-week treatment period with no up-
titration. 1,558 patients received study drug of which 1,099 received brivaracetam. Study enrollment 
criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant 
AEDs. Patients were required to have at least 8 POS during the baseline period. The primary endpoints 
in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % 
responder rate based on 50 % reduction in POS frequency from baseline. 
The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine 
(25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and 
levetiracetam (9.8 %). The median baseline seizure frequency across the 3 studies was 9 seizures per 
28 days. Patients had a mean duration of epilepsy of approximately 23 years. 
The efficacy outcomes are summarized in Table 2. Overall, brivaracetam was efficacious for the 
adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day 
and 200 mg/day.  
 
Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days 

Study 
 

Placebo Brivaracetam  
* Statistically significant (p-value) 

50 mg/day 100 mg/day 200 mg/day 
Study N01253(1) 
 n= 96 n= 101   
50 % Responder rate 16.7 32.7*  

(p=0.008) 
~ ~ 

 
Percent reduction over placebo (%)  NA 22.0*  

(p=0.004) 
~ ~ 

Study N01252(1) 
 n = 100 n = 99 n = 100  
50 % Responder rate  20.0 27.3 

(p=0.372) 
36.0(2) 
(p=0.023) 

~ 
 

Percent reduction over placebo (%) NA 9.2 
(p=0.274) 

20.5(2)  
(p=0.010) 

~ 
 

Study N01358 
 n = 259  n = 252 n = 249 
50% Responder rate 21.6 ~ 38.9*  

(p<0.001) 
37.8*  

(p<0.001) 
Percent reduction over placebo (%) NA ~ 22.8*  

(p<0.001)  
23.2*  

(p<0.001) 
n = randomised patients who received at least 1 dose of study medication  
~ Dose not studied 
* Statistically significant 
(1) Approximately 20 % of the patients were on concomitant levetiracetam  
(2) The primary outcome for N01252 did not achieve statistical significance based on the sequential 
testing procedure. The 100 mg/day dose was nominally significant. 
 
In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 
100 mg/day than with 50 mg/day. Apart from dose-dependent increases in incidences of somnolence 
and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNS-
related AEs and with long-term use. 
 
Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by 
category of reduction from baseline in POS frequency per 28 days in all 3 studies. Patients with more 
than a 25 % increase in POS are shown at left as “worse”. Patients with an improvement in percent 
reduction in baseline POS frequency are shown in the 4 right-most categories. The percentages of 



 

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patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % 
for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.   
 

Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 

12 weeks across all three double-blind pivotal trials 

 
 
In a pooled analysis of the three pivotal trials, no differences in efficacy (measured as 50 % responder 
rate) was observed within the dose range of 50 mg/day to 200 mg/day when brivaracetam is combined 
with inducing or non-inducing AEDs. In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% 
(10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became 
seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.  
 
Improvement in the median percent reduction in seizure frequency per 28 days has been observed in 
patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with 
brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 
50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).  
 
The efficacy of brivaracetam in monotherapy has not been established. Brivaracetam is not 
recommended for use in monotherapy.  
 
Treatment with levetiracetam 
 
In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant 
AED in about 20 % of the patients. Although the number of subjects is limited, there was no observed 
benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect 
competition at the SV2A binding site. No additional safety or tolerability concerns were observed. 
 
In a third study, a pre-specified analysis demonstrated efficacy over placebo for 100 mg/day and 
200 mg/day in patients with prior exposure to levetiracetam. The lower efficacy observed in these 
patients compared to the leveticacetam-naïve patients was likely due to the higher number of prior 
AEDs used and higher baseline seizure frequency. 
 
Elderly (65 years of age and above) 

The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 
65 and 80 years. Although data are limited, the efficacy was comparable to younger subjects. 
 



 

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Open label extension studies 

Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the 
long-term open-label extension studies. From entry into the randomized studies,5.3 % of the subjects 
exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for 
subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively. However, as a high 
proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a 
selection bias may have occurred, as the subjects who stayed in the study responded better than those 
who have terminated prematurely. 
 
Paediatric population 
 
In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in 
adolescents and adults. Experience with epilepsy medicines suggests that the results of efficacy studies 
performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric 
dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8). Doses in 
patients from 4 years of age were defined by weight-based dose adaptations which have been 
established to achieve similar plasma concentrations to the ones observed in adults taking efficacious 
doses (section 5.2). 
  
A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 
years) who continued treatment after completing the PK study (see section 5.2) and children directly 
enrolled into the safety study. Children who directly enrolled received a brivaracetam starting dose of 
1 mg/kg/day and depending on response and tolerability, the dose was increased up to 5 mg/kg/day by 
doubling the dose at weekly intervals. No child received a dose greater than 200 mg/day. For children 
weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response 
and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 
50 mg/day.  
 
From the pooled open-label safety and PK studies in adjunctive therapy, 149 children  with POS have 
received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 
months, and 28 for ≥36 months. 
 
The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not 
been established (see section 4.2). Brivaracetam was evaluated in these patients in a short term open-
label pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month 
to <4 years of age (see section 5.2). 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset 
seizures. 
 
5.2 Pharmacokinetic properties 
 
Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same 
AUC, while the maximum plasma concentration is slightly higher after intravenous administration. 
Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject 
variability, and features complete absorption, very low protein binding, renal excretion following 
extensive biotransformation, and pharmacologically inactive metabolites.  
 
Absorption 
 
Brivaracetam is rapidly and completely absorbed after oral administration and the absolute 
bioavailablity is approximately 100 %. The median tmax for tablets taken without food is 1 hour (tmax 
range is 0.25 to 3 h).  
Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and 
decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of 
absorption remained unchanged. 



 

14 

 
Distribution 
 
Brivaracetam is weakly bound (≤ 20 %) to plasma proteins. The volume of distribution is 0.5 L/kg, a 
value close to that of the total body water. 
Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.  
 
Biotransformation 
 
Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding 
carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl 
side chain (approximately 30 % the elimination). The hydrolysis of the amide moiety leading to the 
carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic 
amidase. In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19. Both 
metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by 
hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). In vivo, 
in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy 
metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals 
with one or both mutated alleles. The three metabolites are not pharmacologically active. 
 
Elimination 
 
Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95 % of 
the dose, including metabolites, is excreted in the urine within 72 hours after intake. Less than 1 % of 
the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine. The 
terminal plasma half-life (t1/2) is approximately 9 hours. The total plasma clearance in patients was 
estimated to 3.6 L/h.  
 
Linearity 
 
Pharmacokinetics is dose-proportional from 10 to at least 600 mg. 
 
Interactions with medicinal products 
 
Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated 
hydrolysis and CYP-mediated oxidations. In vitro, brivaracetam is not a substrate of human P-
glycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion 
transporter polypeptide 1B1 (OATP1B1) and OATP1B3. 
In vitro assays showed that brivaracetam disposition should not be significantly affected by CYP (eg. 
CYP1A, 2C8, 2C9, 2D6 and 3A4) inhibitors. 
 
In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the 
transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and 
OCT1 at clinically relevant concentrations. In vitro, brivaracetam did not induce CYP1A2.  
 
Pharmacokinetics in special patient groups 
 
Elderly (65 years of age and above) 

In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) 
receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 
7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively. The steady-state plasma 
clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects 
(0.83 ml/min/kg) (see section 4.2). 
 



 

15 

Renal impairment 

A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not 
requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) 
relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were 
increased 3-, 4-, and 21-fold, respectively. The renal clearance of these non active metabolites was 
decreased 10-fold. The hydroxyacid metabolite did not reveal any safety concerns in non clinical 
studies. Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2). 
 
Hepatic impairment 

A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed 
similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), 
relative to matched healthy controls. (see section 4.2) 
 
Paediatric population 

In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using 
the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated. Brivaracetam 
was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 
4 mg/kg/day. All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 
100 mg/day, and 200 mg/day. At the end of the evaluation period, subjects may have been eligible for 
entry into a long-term follow-up study continuing on their last received dose (see section 4.8). Plasma 
concentrations were shown to be dose-proportional in all age groups. Population pharmacokinetics 
modeling indicated that the dose of 2.0 mg/kg twice a day provides the same steady-state average 
plasma concentration as in adults receiving 100 mg twice daily. The estimated plasma clearance was 
1.61 L/h, 2.18  L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively. In 
comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight). 
Currently, no clinical data are available in neonates. 
 
Body weight 

A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range 
from 46 kg to 115 kg. However, this is not considered to be a clinically relevant difference.  
 
Gender 

There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender. 
  
Race 

The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, Asian) in a 
population pharmacokinetic modeling from epilepsy patients. The number of patients with other ethnic 
background was limited. 
 
Pharmacokinetic/pharmacodynamics relationship 
 
The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was 
estimated to be 0.57 mg/L. This plasma concentration is slightly above the median exposure obtained 
after brivaracetam doses of 50 mg/day. Further seizure frequency reduction is obtained by increasing 
the dose to 100 mg/day and reaches a plateau at 200 mg/day. 
 
5.3 Preclinical safety data 
 
In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS 
depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of 
the pharmacologically active dose of brivaracetam, 2 mg/kg. Learning and memory function were not 
affected.  
 
Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at 
exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria). However, 
toxicological data accumulated on brivaracetam and on a structurally-related compound indicate that 
the dog liver changes have developed through mechanisms not relevant for humans. No adverse liver 



 

16 

changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42-
fold the clinical AUC exposure. In monkeys, CNS signs (prostrate, loss of balance, clumsy 
movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time. 
 
Genotoxicity studies have not detected any mutagenic or clastogenic activity. Carcinogenicity studies 
did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors 
in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitone-
like liver enzyme induction, which is a known rodent specific phenomenon.  
 
Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in 
either rat or rabbit. Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam 
with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose. In rats, 
brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with 
concentrations similar to maternal plasma levels. 
 
Brivaracetam did not show any dependence potential in rats. 
 
Juvenile animals studies 
 

In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum 
recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased 
body weight and lower brain weight). There were no adverse effects on CNS function, 
neuropathological and brain histopathological examination. In juvenile dogs, the brivaracetam-induced 
changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals. 
There were no adverse effects in any of the standard developmental or maturation endpoints. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Core 
 
Croscarmellose Sodium, 
Lactose monohydrate 
Betadex  
Lactose anhydrous 
Magnesium stearate  
 
Coating 
 
Briviact 10 mg film-coated tablets 
Polyvinyl alcohol 
Titanium dioxide (E171) 
Macrogol 3350 
Talc. 
 
Briviact 25 mg film-coated tablets 
Polyvinyl alcohol 
Titanium dioxide (E171) 
Macrogol 3350 
Talc 
Iron oxide yellow (E172) 
Iron oxide black (E172). 
 
Briviact 50 mg film-coated tablets 
Polyvinyl alcohol 



 

17 

Titanium dioxide (E171) 
Macrogol 3350 
Talc 
Iron oxide yellow (E172) 
Iron oxide red (E172). 
 
Briviact 75 mg film-coated tablets 
Polyvinyl alcohol 
Titanium dioxide (E171) 
Macrogol 3350 
Talc 
Iron oxide yellow (E172) 
Iron oxide red (E172) 
Iron oxide black (E172). 
 
Briviact 100 mg film-coated tablets 
Polyvinyl alcohol 
Titanium dioxide (E171) 
Macrogol 3350 
Talc 
Iron oxide yellow (E172) 
Iron oxide black (E172) 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
4 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Briviact 10 mg film-coated tablets 

• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film-
coated tablets in PVC/PCTFE - Aluminium blisters 

• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters 
 

Briviact 25 mg film-coated tablets 
• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film-

coated tablets in PVC/PCTFE - Aluminium blisters 
• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters 

 
Briviact 50 mg film-coated tablets 

• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film-
coated tablets in PVC/PCTFE - Aluminium blisters 

• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters 
 
Briviact 75 mg film-coated tablets 

• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film-
coated tablets in PVC/PCTFE - Aluminium blisters 

• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters 
 



 

18 

Briviact 100 mg film-coated tablets 
• Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film-

coated tablets in PVC/PCTFE - Aluminium blisters 
• Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters 

 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements.  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/001 
EU/1/15/1073/002 
EU/1/15/1073/003 
EU/1/15/1073/004 
EU/1/15/1073/005 
EU/1/15/1073/006 
EU/1/15/1073/007 
EU/1/15/1073/008 
EU/1/15/1073/009 
EU/1/15/1073/010 
EU/1/15/1073/011 
EU/1/15/1073/012 
EU/1/15/1073/013 
EU/1/15/1073/014 
EU/1/15/1073/015 
EU/1/15/1073/016 
EU/1/15/1073/017 
EU/1/15/1073/018 
EU/1/15/1073/019 
EU/1/15/1073/020 
EU/1/15/1073/023 
EU/1/15/1073/024 
EU/1/15/1073/025 
EU/1/15/1073/026 
EU/1/15/1073/027 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 January 2016 
 
 



 

19 

10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



 

20 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg/ml oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 10 mg brivaracetam. 
 
Excipient(s) with known effect: 
Each ml of oral solution contains 239.8 mg sorbitol (E420), 1 mg methyl parahydroxybenzoate 
(E218), 1.16 mg sodium and maximum 5.5 mg propylene glycol (E1520). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral solution 
Slightly viscous, clear colourless to yellowish liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without 
secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults  

The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of 
required seizure reduction versus potential side effects. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening. Based on individual patient 
response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.  
 
Missed doses 

If patients missed one dose or more, it is recommended that they take a single dose as soon as they 
remember and take the following dose at the usual morning or evening time. This may avoid the 
brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures 
from occurring. 
 
Discontinuation 

If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a 
weekly basis. After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 
20 mg/day is recommended. 
 



 

21 

Special populations 
 

Elderly (65 years of age and above) 

No dose adjustment is needed in elderly patients (see section 5.2). 
The clinical experience in patients ≥ 65 years is limited. 
 
Renal impairment 

No dose adjustment is needed in patients with impaired renal function (see section 5.2). Brivaracetam 
is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data. 
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal 
function. 
 
Hepatic impairment 

Exposure to brivaracetam was increased in adult patients with chronic liver disease. In adults, a 
50 mg/day starting dose should be considered. In children and adolescents weighing 50 kg or greater, a 
50 mg/day starting dose is recommended. A maximum daily dose of 150 mg administered in 2 divided 
doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2).  
In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended. 
The maximum dose should not exceed 3 mg/kg/day. No clinical data are available in paediatric 
patients with hepatic impairment. 
 
Paediatric population 

 
The physician should prescribe the most appropriate formulation and strength according to weight and 
dose.  It is recommended to parent and care giver to administer Briviact oral solution with the 
measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. 
 
The following table summarises the recommended posology for children from 4 years of age and 
adolescents. More details are provided below the table. 
 
 Children (≥4 years) and 

adolescents ≥50 kg 
 

Administered in 2 equally divided 
doses 

Children (≥4 years) and 
adolescents <50 kg 

 
Administered in 2 equally divided 

doses 
Therapeutic dose range 50 - 200 mg/day 1 - 4 mg/kg/day 
Recommended starting dose 50 mg/day   

(or 100 mg/day)* 
1 mg/kg/day 
(or 2 mg/kg/day)* 

Recommended maintenance 
dose 

100 mg/day 2 mg/kg/day 

* Based on physician assessment of need for seizure control. 
 
Children (from 4 years of age) and adolescents weighing 50 kg or more  
The recommended starting dose is 50mg/day. Brivaracetam may also be initiated at 100 mg/day based 
on physician assessment of need for seizure control. The dose should be administered in two equally 
divided doses, once in the morning and once in the evening.The recommended maintenance dose is 
100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose 
range of 50 mg/day and 200 mg/day. 
 
Children (from 4 years of age) and adolescents weighing less than 50 kg 

The recommended starting dose is 1mg/kg/day. Brivaracetam may also be initiated at 2 mg/kg/day 
based on physician assessment of need for seizure control. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening. The recommended maintenance 
dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective 
dose range of 1 mg/kg/day and 4 mg/kg/day. 
 



 

22 

The dose per intake for each patient should be calculated using the following formula: 
 

Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05 
 
The table below provides examples of volumes of oral solution per intake depending on prescribed 
dose and body weight. The precise volume of oral solution is to be calculated according to the exact 
body weight of the child. 
 Volumes of oral solution to be taken per administration 
Weight  

For a dose of 

1 mg/kg/day 

0.05 ml/kg/intake 

(corresponding to 
0.5 mg/kg/intake) 

For a dose of 

2 mg/kg/day 

0.1 ml/kg/intake 

(corresponding to 
1 mg/kg/intake) 

For a dose of 

3 mg/kg/day 

0.15 ml/kg/intake 

(corresponding to 
1.5 mg/kg/intake) 

For a dose of 

4 mg/kg/day 

0.2 ml/kg/intake 

(corresponding to 
2 mg/kg/intake) 

10 kg 0.5 ml  
(5 mg) 

1 ml 
(10 mg) 

1.5 ml 
(15 mg) 

2 ml 
(20 mg) 

15 kg 0.75 ml  
(7.5 mg) 

1.5 ml 
(15 mg) 

2.25 ml 
(22.5 mg) 

3 ml 
(30 mg) 

20 kg 1 ml 
(10 mg) 

2 ml 
(20 mg) 

3 ml 
(30 mg) 

4 ml 
(40 mg) 

25 kg 1.25 ml 
(12.5 mg) 

2.5 ml 
(25 mg) 

3.75 ml 
(37.5 mg) 

5 ml 
(50 mg) 

30 kg 1.5 ml 
(15 mg) 

3 ml 
(30 mg) 

4.5 ml 
(45 mg) 

6 ml 
(60 mg) 

35 kg 1.75 ml 
(17.5 mg) 

3.5 ml 
(35 mg) 

5.25 ml 
(52.5 mg) 

7 ml 
(70 mg) 

40 kg 2 ml 
(20 mg) 

4 ml 
(40 mg) 

6 ml 
(60 mg) 

8 ml 
(80 mg) 

45 kg 2.25 ml 
(22.5 mg) 

4.5 ml 
(45mg) 

6.75 ml 
(67.5 mg) 

9 ml 
(90 mg) 

50 kg 2.5 ml 
(25 mg) 

5 ml 
(50 mg) 

7.5 ml 
(75 mg) 

10 ml 
(100 mg) 

 
Children less than 4 years 

The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been 
established. 
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a 
posology can be made. 
 
Method of administration 
 
Brivaracetam oral solution can be diluted in water or juice shortly before swallowing and may be 
taken with or without food (see section 5.2). A nasogastric tube or a gastrostomy tube may be used 
when administering brivaracetam oral solution.  
 
Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.  
 
Oral dosing syringe (5 ml graduated every 0.1 ml) with an adaptor, recommended for use by patients 

weighing less than 20 kg or needing a maximum of 50 mg (5 ml) brivaracetam per administration. 

The 5 ml oral syringe must be used in patients weighing less than 20 kg to ensure accurate dosing as 
the 10 ml oral syringe does not allow accurate measurements of volumes <1 ml. 
One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam. The minimum extractible 
volume is 0.25 ml which is 2.5 mg of brivaracetam. As from the 0.1 ml graduation mark, each 
graduation corresponds to 0.1 ml which is 1 mg of brivaracetam. Additional graduations at 0.25 ml 
and 0.75 ml starting at 0.25 ml up to 5 ml are shown. 



 

23 

 
Oral dosing syringe (10 ml graduated every 0.25 ml) with an adaptor, recommended for use by 

patients weighing more than 20 kg or needing a dose between 50 mg and 100 mg (5 ml to 10 ml) 

brivaracetam per administration. 

One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam. The minimum extractible 
volume is 1 ml which is 10 mg of brivaracetam. As from the 1 ml graduation mark, each graduation 
corresponds to 0.25 ml which is 2.5 mg of brivaracetam. 
 
Instructions for use are provided in the package leaflet.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients 
listed in section 6.1.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs 
(AEDs), including brivaracetam, in several indications. A meta-analysis of randomized placebo-
controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The 
mechanism of this risk is not known and the available data do not exclude the possibility of an 
increased risk for brivaracetam. 
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment 
should be considered. Patients (and caregivers of patients) should be advised to seek medical advice 
should any signs of suicidal ideation or behaviour emerge. See also section 4.8, paediatric data. 
 
Hepatic impairment 
 
There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic 
impairment. Dose adjustments are recommended for patients with hepatic impairment (see section 
4.2). 
 
Excipients 
 
Sodium content 

Brivaracetam oral solution contains less than 1 mmol sodium (23mg) per ml, that is to say essentially 
‘sodium free’. 
 
Fructose intolerance 

The oral solution contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take this medicine. 
 
Excipients which may cause intolerance 

The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions 
(possibly delayed). 
Brivaracetam oral solution contains propylene glycol (E1520). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Formal interaction studies have only been performed in adults. 
 



 

24 

Pharmacodynamic interactions 
 

Concomitant treatment with levetiracetam 

In the clinical studies, although the numbers were limited, there was no observed benefit of 
brivaracetam versus placebo in patients taking levetiracetam concurrently. No additional safety or 
tolerability concern was observed (see section 5.1). 
 
Interaction with alcohol 

In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single 
dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic 
interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, 
attention and memory. Intake of brivaracetam with alcohol is not recommended. 
 
Pharmacokinetic interactions 
 
Effects of other agents on the pharmacokinetics of brivaracetam 

In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway 
of brivaracetam is by CYP-independent hydrolysis. A second disposition pathway involves 
hydroxylation mediated by CYP2C19 (see section 5.2).  
 
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong 
inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated 
interaction is considered to be low. 
 
Rifampicin 

In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 
5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 
45 %. Prescribers should consider adjusting the brivaracetam dose in patients starting or ending 
treatment with rifampicin.  
 
Strong enzyme inducing AEDs 

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing 
AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).  
 
Other enzyme inducers 

Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the 
systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John’s wort should 
be done with caution. 
 
Effects of brivaracetam on other medicinal products  
Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by 
CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low. 
 
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms 
except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products 
metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam). When tested in vitro 
brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6. No CYP3A4 induction 
was found in vivo (see midazolam above). CYP2B6 induction has not been investigated in vivo and 
brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 
(e.g. efavirenz). In vitro, interaction studies to determine the potential inhibitory effects on transporters 
concluded that there were no clinically relevant effects, except for OAT3. In vitro, brivaracetam 
inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest 
clinical dose. Brivaracetam 200mg/day may increase plasma concentrations of medicinal products 
transported by OAT3. 
 



 

25 

Antiepileptic drugs 
 
Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were 
investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a 
population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drug-
drug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and 
topiramate). The effect of the interactions on the plasma concentration is summarised in table 1 
(increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time 
curve as “AUC”, maximum observed concentration as Cmax).  
 
Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs 

AED coadministered Influence of AED on brivaracetam 
plasma concentration 

Influence of brivaracetam on 
AED plasma concentration 

Carbamazepine AUC 29 % ↓ 
Cmax 13 % ↓ 
No dose adjustment required 

Carbamazepine - None 
Carbamazepine-epoxide ↑ 
(See below)  
No dose adjustment required. 

Clobazam No data available None 
Clonazepam No data available None 
Lacosamide No data available None  
Lamotrigine None  None  
Levetiracetam None  None  
Oxcarbazepine  None  None (monohydroxy derivative, 

MHD) 
Phenobarbital AUC 19 % ↓ 

No dose adjustment required 
None  

Phenytoin AUC 21 % ↓ 
No dose adjustment required 

None 
a AUC 20% ↑ 
a Cmax 20% ↑ 

Pregabalin No data available None  
Topiramate None  None  
Valproic acid None  None  
Zonisamide No data available None  

a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam 
 

Carbamazepine  

Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased 
concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled studies, 
the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with 
little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively. No 
safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of 
carbamazepine epoxide. 
 
Oral contraceptives 
 
Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol 
(0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. 
When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum 
daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel 
(0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed 
without impact on suppression of ovulation. There was generally no change in the concentration-time 
profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle 
stimulating hormone (FSH), and sex hormone binding globulin (SHBG). 
 



 

26 

4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential  
 
Physicians should discuss family planning and contraception with women of childbearing potential 
taking brivaracetam (see Pregnancy). 
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated. 
 
Pregnancy 
 

Risk related to epilepsy and antiepileptic medicinal products in general 

For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the 
prevalence of malformations is two to three times greater than the rate of approximately 3 % in the 
general population. In the treated population, an increase in malformations has been noted with 
polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible 
has not been elucidated. Discontinuation of anti-epileptic treatments may result in exacerbation of the 
disease which could be harmful to the mother and the foetus. 
 
Risk related to brivaracetam 
There is a limited amount of data from the use of brivaracetam in pregnant women. There is no data on 
placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see 
section 5.3). The potential risk for humans is unknown. Animal studies did not detect any teratogenic 
potential of brivaracetam (see section 5.3). 
 
In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with 
carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, 
carbamazepine-epoxide (see section 4.5). There is insufficient data to determine the clinical 
significance of this effect in pregnancy. 
 
As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically 
necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus). 
 
Breast-feeding 
 
It is unknown whether brivaracetam is excreted in human breast milk. Studies in rats have shown 
excretion of brivaracetam in breast milk (see section 5.3). A decision should be made whether to 
discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the 
medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the 
amount of carbamazepine-epoxide excreted in breast milk could increase. There is insufficient data to 
determine the clinical significance. 
 
Fertility 
 
No human data on the effect of brivaracetam on fertility are available. In rats, there was no effect on 
fertility with brivaracetam (see section 5.3).  
 
4.7 Effects on ability to drive and use machines 
 
Brivaracetam has minor or moderate influence on the ability to drive and use machines. 
 
Due to possible differences in individual sensitivity some patients might experience somnolence, 
dizziness, and other central nervous system (CNS) related symptoms. Patients should be advised not to 
drive a car or to operate other potentially hazardous machines until they are familiar with the effects of 
brivaracetam on their ability to perform such activities.   
 



 

27 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received 
brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥ 
24 months and 569 for ≥ 60 months (5 years). 
 
The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: 
somnolence (14.3 %) and dizziness (11.0 %). They were usually mild to moderate in intensity. 
Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose. The types 
of adverse reactions reported during the first 7 days of treatment were similar to those reported for the 
overall treatment period. 
 
The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized 
to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for 
patients randomized to placebo. The adverse reactions most frequently resulting in discontinuation of 
brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %). 
 
Tabulated list of adverse reactions 
 
In the table below, adverse reactions, which were identified based on review of the three placebo-
controlled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ 
Class and frequency.  
The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon 
(≥ 1/1,000 to < 1/100). Within each frequency grouping, undesirable effects are presented in order of 
decreasing seriousness. 
 

System organ class Frequency Adverse reactions from clinical trials 
Infections and 
infestations 

Common Influenza 

Blood and lymphatic 
system disorders 

Uncommon Neutropenia 

Metabolism and nutrition 
disorders 

Common  Decreased appetite 

Immune system disorders Uncommon Type I hypersensitivity 
Psychiatric disorders Common Depression, anxiety, insomnia, irritability 

Uncommon Suicidal ideation, psychotic disorder, 
aggression, agitation 

Nervous system disorders Very common  Dizziness, somnolence 
Common 
 

Convulsion, vertigo 

Respiratory, thoracic and 
mediastinal disorders 

Common  
 

Upper respiratory tract infections, cough 

Gastrointestinal 
disorders 

Common  
 

Nausea, vomiting, constipation 

General disorders and 
administration site 
conditions 

Common  
 

Fatigue 

 
Description of selected adverse reactions 
 
Neutropenia has been reported in 0.5 % (6/1,099) brivaracetam patients and 0 % (0/459) placebo 
patients. Four of these subjects had decreased neutrophil counts at baseline, and experienced 
additional decrease in neutrophil counts after initiation of brivaracetam treatment. None of the 6 cases 
of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam 
and none had associated infections. 



 

28 

 
Suicidal ideation has been reported in 0.3 % (3/1,099) brivaracetam patients and 0.7 % (3/459) 
placebo patients. In the short-term clinical studies of brivaracetam in epilepsy patients, there were no 
cases of completed suicide and suicide attempt, however both have been reported in open-label 
extension studies (see section 4.4). 
 
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of 
brivaracetam patients (9/3022) during clinical development. 
 
Open-label extension studies 
 
In patients who were followed up in the open-label extension studies for up to 8 years, the safety 
profile was similar to that observed in the short-term, placebo-controlled studies.  
 
Paediatric population 
 
The safety profile of brivaracetam observed in children was consistent with the safety profile observed 
in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of 
paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural 
disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority 
of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of 
study drug. An additional adverse reaction reported in children was psychomotor hyperactivity 
(4.7 %).  
 
There are limited safety data from open-label studies in children from 1 month to <4 years of age. 
Limited data are available on neurodevelopment in children <4 years of age. No clinical data are 
available in neonates.  
 
Elderly  
 
Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with 
epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age. The safety profile in elderly 
patients appears to be similar to that observed in younger adult patients. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness 
have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. 
 
Management of overdose 
 
There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include 
general supportive measures. Since less than 10 % of brivaracetam is excreted in urine, haemodialysis 
is not expected to significantly enhance brivaracetam clearance (see section 5.2). 
 
 



 

29 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23  
 
Mechanism of action 
 
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a 
transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although 
the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of 
neurotransmitters. Binding to SV2A is believed to be the primary mechanism for brivaracetam 
anticonvulsant activity. 
 
Clinical efficacy and safety 
 
The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established 
in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 
16 years of age and older. The daily dose of brivaracetam ranged from 5 to 200 mg/day across these 
studies. All studies had an 8-week baseline period followed by a 12-week treatment period with no up-
titration. 1,558 patients received study drug of which 1,099 received brivaracetam. Study enrollment 
criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant 
AEDs. Patients were required to have at least 8 POS during the baseline period. The primary endpoints 
in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % 
responder rate based on 50 % reduction in POS frequency from baseline. 
The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine 
(25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and 
levetiracetam (9.8 %). The median baseline seizure frequency across the 3 studies was 9 seizures per 
28 days. Patients had a mean duration of epilepsy of approximately 23 years. 
The efficacy outcomes are summarized in Table 2. Overall, brivaracetam was efficacious for the 
adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day 
and 200 mg/day.  
 
Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days 

Study 
 

Placebo Brivaracetam  
* Statistically significant (p-value) 

50 mg/day 100 mg/day 200 mg/day 
Study N01253(1) 
 n= 96 n= 101   
50 % Responder rate 16.7 32.7*  

(p=0.008) 
~ ~ 

 
Percent reduction over placebo (%)  NA 22.0*  

(p=0.004) 
~ ~ 

Study N01252(1) 
 n = 100 n = 99 n = 100  
50 % Responder rate  20.0 27.3 

(p=0.372) 
36.0(2) 
(p=0.023) 

~ 
 

Percent reduction over placebo (%) NA 9.2 
(p=0.274) 

20.5(2) 
(p=0.010) 

~ 
 

Study N01358 
 n = 259  n = 252 n = 249 
50% Responder rate 21.6 ~ 38.9*  

(p<0.001) 
37.8*  

(p<0.001) 
Percent reduction over placebo (%) NA ~ 22.8*  

(p<0.001)  
23.2*  

(p<0.001) 
n = randomised patients who received at least 1 dose of study medication  
~ Dose not studied 



 

30 

* Statistically significant 
(1) Approximately 20 % of the patients were on concomitant levetiracetam  
(2) The primary outcome for N01252 did not achieve statistical significance based on the sequential 
testing procedure . The 100 mg/day dose was nominally significant. 
 
In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 
100 mg/day than with 50 mg/day. Apart from dose-dependent increases in incidences of somnolence 
and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNS-
related AEs and with long-term use. 
 
Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by 
category of reduction from baseline in POS frequency per 28 days in all 3 studies. Patients with more 
than a 25 % increase in POS are shown at left as “worse”. Patients with an improvement in percent 
reduction in baseline POS frequency are shown in the 4 right-most categories. The percentages of 
patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % 
for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.   
 

Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 

12 weeks across all three double-blind pivotal trials 

 
 
In a pooled analysis of the three pivotal trials, no differences in efficacy (measured as 50 % responder 
rate) was observed within the dose range of 50 mg/day to 200 mg/day when brivaracetam is combined 
with inducing or non-inducing AEDs. In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% 
(10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became 
seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.  
 
Improvement in the median percent reduction in seizure frequency per 28 days has been observed in 
patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with 
brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 
50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).  
 
The efficacy of brivaracetam in monotherapy has not been established. Brivaracetam is not 
recommended for use in monotherapy.  
 



 

31 

Treatment with levetiracetam 
 
In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant 
AED in about 20 % of the patients. Although the number of subjects is limited, there was no observed 
benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect 
competition at the SV2A binding site. No additional safety or tolerability concerns were observed. 
 
In a third study, a pre-specified analysis demonstrated efficacy over placebo for 100 mg/day and 200 
mg/day in patients with prior exposure to levetiracetam. The lower efficacy observed in these patients 
compared to the leveticacetam-naïve patients was likely due to the higher number of prior AEDs used 
and higher baseline seizure frequency. 
 
Elderly (65 years of age and above) 

The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 
65 and 80 years. Although data are limited, the efficacy was comparable to younger subjects. 
 
Open label extension studies 

Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the 
long-term open-label extension studies. From entry into the randomized studies,5.3 % of the subjects 
exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for 
subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively. However, as a high 
proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a 
selection bias may have occurred, as the subjects who stayed in the study responded better than those 
who have terminated prematurely. 
 
Paediatric population 
 
In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in 
adolescents and adults. Experience with epilepsy medicines suggests that the results of efficacy studies 
performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric 
dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8). Doses in 
patients from 4 years of age were defined by weight-based dose adaptations which have been 
established to achieve similar plasma concentrations to the ones observed in adults taking efficacious 
doses (section 5.2).  
 
A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 
years) who continued treatment after completing the PK study (see section 5.2) and children directly 
enrolled into the safety study. Children who directly enrolled received a brivaracetam starting dose of 
1 mg/kg/day and depending on response and tolerability, the dose was increased up to 5 mg/kg/day by 
doubling the dose at weekly intervals. No child received a dose greater than 200 mg/day. For children 
weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response 
and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 
50 mg/day.  
 
From the pooled open-label safety and PK studies in adjunctive therapy, 149 children have received 
brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, 
and 28 for ≥36 months. 
 
The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not 
been established (see section 4.2). Brivaracetam was evaluated in these patients in a short term open-
label pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month 
to <4 years of age (see section 5.2). 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset 
seizures. 
 



 

32 

5.2 Pharmacokinetic properties 
 
Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same 
AUC, while the maximum plasma concentration is slightly higher after intravenous administration. 
Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject 
variability, and features complete absorption, very low protein binding, renal excretion following 
extensive biotransformation, and pharmacologically inactive metabolites.  
 
Absorption 
 
Brivaracetam is rapidly and completely absorbed after oral administration and the absolute 
bioavailablity is approximately 100 %. The median tmax for tablets taken without food is 1 hour (tmax 
range is 0.25 to 3 h).  
Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and 
decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of 
absorption remained unchanged. 
 
Distribution 
 
Brivaracetam is weakly bound (≤ 20 %) to plasma proteins. The volume of distribution is 0.5 L/kg, a 
value close to that of the total body water. 
Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.  
 
Biotransformation 
 
Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding 
carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl 
side chain (approximately 30 % the elimination). The hydrolysis of the amide moiety leading to the 
carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic 
amidase. In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19. Both 
metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by 
hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). In vivo, 
in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy 
metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals 
with one or both mutated alleles. The three metabolites are not pharmacologically active. 
 
Elimination 
 
Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95 % of 
the dose, including metabolites, is excreted in the urine within 72 hours after intake. Less than 1 % of 
the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine. The 
terminal plasma half-life (t1/2) is approximately 9 hours. The total plasma clearance in patients was 
estimated to 3.6 L/h.  
 
Linearity 
 
Pharmacokinetics is dose-proportional from 10 to at least 600 mg. 
 
Interactions with medicinal products 
 
Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated 
hydrolysis and CYP-mediated oxidations. In vitro, brivaracetam is not a substrate of human P-
glycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion 
transporter polypeptide 1B1 (OATP1B1) and OATP1B3. 
In vitro assays showed that brivaracetam disposition should not be significantly affected by CYP (eg. 
CYP1A, 2C8, 2C9, 2D6 and 3A4) inhibitors. 
 



 

33 

In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the 
transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and 
OCT1 at clinically relevant concentrations. In vitro, brivaracetam did not induce CYP1A2.  
 
Pharmacokinetics in special patient groups 
 
Elderly (65 years of age and above) 

In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) 
receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 
7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively. The steady-state plasma 
clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects 
(0.83 ml/min/kg). (see section 4.2). 
 
Renal impairment 

A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not 
requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) 
relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were 
increased 3-, 4-, and 21-fold, respectively. The renal clearance of these non active metabolites was 
decreased 10-fold. The hydroxyacid metabolite did not reveal any safety concerns in non clinical 
studies. Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2). 
 
Hepatic impairment 

A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed 
similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), 
relative to matched healthy controls. (see section 4.2) 
 
Paediatric population 

In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using 
the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated. Brivaracetam 
was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 
4 mg/kg/day. All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 
100 mg/day, and 200 mg/day. At the end of the evaluation period, subjects may have been eligible for 
entry into a long-term follow-up study continuing on their last received dose (see section 4.8). Plasma 
concentrations were shown to be dose-proportional in all age groups. Population pharmacokinetics 
modeling indicated that the dose of 2.0 mg/kg twice a day provides the same steady-state average 
plasma concentration as in adults receiving 100 mg twice daily. The estimated plasma clearance was 
1.61 L/h, 2.18 L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively. In 
comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight). 
Currently, no clinical data are available in neonates. 
 
Body weight 

A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range 
from 46 kg to 115 kg. However, this is not considered to be a clinically relevant difference.  
 
Gender 

There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender. 
  
Race 

The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, , Asian) in a 
population pharmacokinetic modeling from epilepsy patients. The number of patients with other ethnic 
background was limited. 
 
Pharmacokinetic/pharmacodynamics relationship 
The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was 
estimated to be 0.57 mg/L. This plasma concentration is slightly above the median exposure obtained 
after brivaracetam doses of 50 mg/day. Further seizure frequency reduction is obtained by increasing 
the dose to 100 mg/day and reaches a plateau at 200 mg/day. 



 

34 

 
5.3 Preclinical safety data 
 
In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS 
depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of 
the pharmacologically active dose of brivaracetam, 2 mg/kg. Learning and memory function were not 
affected.  
 
Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at 
exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria). However, 
toxicological data accumulated on brivaracetam and on a structurally-related compound indicate that 
the dog liver changes have developed through mechanisms not relevant for humans. No adverse liver 
changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42-
fold the clinical AUC exposure. In monkeys, CNS signs (prostrate, loss of balance, clumsy 
movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time. 
 
Genotoxicity studies have not detected any mutagenic or clastogenic activity. Carcinogenicity studies 
did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors 
in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitone-
like liver enzyme induction, which is a known rodent specific phenomenon.  
 
Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in 
either rat or rabbit. Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam 
with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose. In rats, 
brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with 
concentrations similar to maternal plasma levels. 
 
Brivaracetam did not show any dependence potential in rats. 
 
Juvenile animals studies 
 

In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum 
recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased 
body weight and lower brain weight). There were no adverse effects on CNS function, 
neuropathological and brain histopathological examination. In juvenile dogs, the brivaracetam-induced 
changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals. 
There were no adverse effects in any of the standard developmental or maturation endpoints. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate 
Citric acid anhydrous (for pH-adjustment) 
Methyl parahydroxybenzoate (E218) 
Carmellose sodium  
Sucralose 
Sorbitol liquid (E420) 
Glycerol (E422) 
Raspberry flavour (propylene glycol (E1520) 90 % - 98 %) 
Purified water. 
 
6.2 Incompatibilities 
 
Not applicable 
 



 

35 

6.3 Shelf life 
 
4 years. 
After first opening: 5 months 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a box also 
containing a 5 ml and 10 ml graduated oral dosing syringe (polypropylene, polyethylene) and an 
adaptor for the syringe (polyethylene). 
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance 
with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/021 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 



 

36 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg/ml solution for injection/infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 10mg brivaracetam 
Each 5 ml vial contains 50 mg brivaracetam 
 
Excipient(s) with known effect: 
Each ml of solution for injection/infusion contains 3.8 mg sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection/infusion (injection/infusion) 
Clear, colourless, solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without 
secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 

Adults 
Brivaracetam may be initiated with either intravenous or oral administration. When converting from 
oral to intravenous administration or vice versa, the total daily dose and frequency of administration 
should be maintained. Brivaracetam solution for injection/infusion is an alternative for patients when 
oral administration is temporarily not feasible. 
 
The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of 
required seizure reduction versus potential side effects. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening. Based on individual patient 
response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.  
 
There is no experience with twice daily intravenous administration of brivaracetam for a period longer 
than 4 days. 
 
Missed doses 

If patients missed one dose or more, it is recommended that they take a single dose as soon as they 
remember and take the following dose at the usual morning or evening time. This may avoid the 
brivaracetam plasma concentration falling below the efficacy level and prevent breakthrough seizures 
from occurring. 



 

37 

 
Discontinuation 

If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a 
weekly basis. After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 
20 mg/day is recommended. 
 
Special populations 
 

Elderly (65 years of age and above) 

No dose adjustment is needed in elderly patients (see section 5.2). 
The clinical experience in patients ≥ 65 years is limited. 
 
Renal impairment 

No dose adjustment is needed in patients with impaired renal function (see section 5.2). Brivaracetam 
is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data. 
Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal 
function. 
 
Hepatic impairment 

Exposure to brivaracetam was increased in adult patients with chronic liver disease. In adults, a 
50 mg/day starting dose should be considered. In children and adolescents weighing 50 kg or greater, a 
50 mg/day starting dose is recommended. A maximum daily dose of 150 mg administered in 2 divided 
doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2).  
In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended. 
The maximum dose should not exceed 3 mg/kg/day. No clinical data are available in paediatric 
patients with hepatic impairment. 
 
Paediatric population 

 
As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for 
patients when oral administration is temporarily not feasible. There is no experience with twice daily 
intravenous administration of brivaracetam for a period longer than 4 days. 
 
The following table summarises the recommended posology for children from 4 years of age and 
adolescents. More details are provided below the table. 
 
 Children (≥4 years) and 

adolescents ≥50 kg 
 

Administered in 2 equally divided 
doses 

Children (≥4 years) and 
adolescents <50 kg 

 
Administered in 2 equally divided 

doses 
Therapeutic dose range 50 - 200 mg/day 1 - 4 mg/kg/day 
Recommended starting dose 50 mg/day   

(or 100 mg/day)* 
1 mg/kg/day 
(or 2 mg/kg/day)* 

Recommended maintenance 
dose 

100 mg/day 2 mg/kg/day 

* Based on physician assessment of need for seizure control. 
 
Children (from 4 years of age) and adolescents weighing 50 kg or more  
The recommended starting dose is 50mg/day. Brivaracetam may also be initiated at 100 mg/day based 
on physician assessment of need for seizure control. The dose should be administered in two equally 
divided doses, once in the morning and once in the evening.The recommended maintenance dose is 
100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose 
range of 50 mg/day and 200 mg/day. 
 



 

38 

Children (from 4 years of age) and adolescents weighing less than 50 kg 

The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at 2 mg/kg/day 
based on physician assessment of need for seizure control. The dose should be administered in two 
equally divided doses, once in the morning and once in the evening. The recommended maintenance 
dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective 
dose range of 1 mg/kg/day and 4 mg/kg/day. 
 
Children less than 4 years 

The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been 
established. 
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a 
posology can be made. 
 

Method of administration  
 

- Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.  
- Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 

15-minute intravenous infusion (see section 6.6). This medicinal product must not be mixed 
with other medicinal products. 

 
Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions; e.g. 
status epilepticus and is therefore not recommended for such conditions. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients 
listed in section 6.1.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs 
(AEDs), including brivaracetam, in several indications. A meta-analysis of randomized placebo-
controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The 
mechanism of this risk is not known and the available data do not exclude the possibility of an 
increased risk for brivaracetam. 
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment 
should be considered. Patients (and caregivers of patients) should be advised to seek medical advice 
should any signs of suicidal ideation or behaviour emerge. See also section 4.8, paediatric data. 
 
Hepatic impairment 
 
There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic 
impairment. Dose adjustments are recommended for patients with hepatic impairment (see section 
4.2). 
 
Excipients 
 
The solution for injection/infusion contains less than 1 mmol sodium (23mg) per vial, that is to say 
essentially ‘sodium free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Formal interaction studies have only been performed in adults. 
 



 

39 

Pharmacodynamic interactions 
 

Concomitant treatment with levetiracetam 

In the clinical studies, although the numbers were limited, there was no observed benefit of 
brivaracetam versus placebo in patients taking levetiracetam concurrently. No additional safety or 
tolerability concern was observed (see section 5.1). 
 
Interaction with alcohol 

In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single 
dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic 
interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, 
attention and memory. Intake of brivaracetam with alcohol is not recommended. 
 
Pharmacokinetic interactions 
 
Effects of other agents on the pharmacokinetics of brivaracetam 

In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway 
of brivaracetam is by CYP-independent hydrolysis. A second disposition pathway involves 
hydroxylation mediated by CYP2C19 (see section 5.2).  
 
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong 
inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated 
interaction is considered to be low. 
 
Rifampicin 

In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 
5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 
45 %. Prescribers should consider adjusting the brivaracetam dose in patients starting or ending 
treatment with rifampicin.  
 
Strong enzyme inducing AEDs 

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing 
AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).  
 
Other enzyme inducers 

Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the 
systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John’s wort should 
be done with caution. 
 
Effects of brivaracetam on other medicinal products  
Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by 
CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low. 
 
In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms 
except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products 
metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam). When tested in vitro 
brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6. No CYP3A4 induction 
was found in vivo (see midazolam above). CYP2B6 induction has not been investigated in vivo and 
brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 
(e.g. efavirenz). In vitro, interaction studies to determine the potential inhibitory effects on transporters 
concluded that there were no clinically relevant effects, except for OAT3. In vitro, brivaracetam 
inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest 
clinical dose. Brivaracetam 200mg/day may increase plasma concentrations of medicinal products 
transported by OAT3. 
 



 

40 

Antiepileptic drugs 
 
Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were 
investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a 
population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drug-
drug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and 
topiramate). The effect of the interactions on the plasma concentration is summarised in table 1 
(increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time 
curve as “AUC”, maximum observed concentration as Cmax).  
 

Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs 

AED coadministered Influence of AED on brivaracetam 
plasma concentration 

Influence of brivaracetam on 
AED plasma concentration 

Carbamazepine AUC 29 % ↓ 
Cmax 13 % ↓ 
No dose adjustment required 

Carbamazepine - None 
Carbamazepine-epoxide ↑ 
(See below)  
No dose adjustment required. 

Clobazam No data available None 
Clonazepam No data available None 
Lacosamide No data available None  
Lamotrigine None  None  
Levetiracetam None  None  
Oxcarbazepine  None  None (monohydroxy derivative, 

MHD) 
Phenobarbital AUC 19 % ↓ 

No dose adjustment required 
None  

Phenytoin AUC 21 % ↓ 
No dose adjustment required 

None 
a AUC 20% ↑ 
a Cmax 20% ↑ 

Pregabalin No data available None  
Topiramate None  None  
Valproic acid None  None  
Zonisamide No data available None  

a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam 
 
Carbamazepine  

Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased 
concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled studies, 
the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with 
little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively. No 
safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of 
carbamazepine epoxide. 
 
Oral contraceptives 
 
Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol 
(0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. 
When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum 
daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel 
(0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed 
without impact on suppression of ovulation. There was generally no change in the concentration-time 
profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle 
stimulating hormone (FSH), and sex hormone binding globulin (SHBG). 
 



 

41 

4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential  
 
Physicians should discuss family planning and contraception with women of childbearing potential 
taking brivaracetam (see Pregnancy). 
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated. 
 
Pregnancy 
 

Risk related to epilepsy and antiepileptic medicinal products in general 

For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the 
prevalence of malformations is two to three times greater than the rate of approximately 3 % in the 
general population. In the treated population, an increase in malformations has been noted with 
polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible 
has not been elucidated. Discontinuation of anti-epileptic treatments may result in exacerbation of the 
disease which could be harmful to the mother and the foetus. 
 
Risk related to brivaracetam 
There is a limited amount of data from the use of brivaracetam in pregnant women. There is no data on 
placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see 
section 5.3). The potential risk for humans is unknown. Animal studies did not detect any teratogenic 
potential of brivaracetam (see section 5.3). 
 
In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with 
carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, 
carbamazepine-epoxide (see section 4.5). There is insufficient data to determine the clinical 
significance of this effect in pregnancy. 
 
As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically 
necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus). 
 
Breast-feeding 
 
It is unknown whether brivaracetam is excreted in human breast milk. Studies in rats have shown 
excretion of brivaracetam in breast milk (see section 5.3). A decision should be made whether to 
discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the 
medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the 
amount of carbamazepine-epoxide excreted in breast milk could increase. There is insufficient data to 
determine the clinical significance. 
 
Fertility 
 
No human data on the effect of brivaracetam on fertility are available. In rats, there was no effect on 
fertility with brivaracetam (see section 5.3).  
 
4.7 Effects on ability to drive and use machines 
 
Brivaracetam has minor or moderate influence on the ability to drive and use machines. 
 
Due to possible differences in individual sensitivity some patients might experience somnolence, 
dizziness, and other central nervous system (CNS) related symptoms. Patients should be advised not to 
drive a car or to operate other potentially hazardous machines until they are familiar with the effects of 
brivaracetam on their ability to perform such activities.  
 



 

42 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received 
brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥ 
24 months and 569 for ≥ 60 months (5 years). 
 
The most frequently reported adverse reactions (>10%) with brivaracetam treatment were: somnolence 
(14.3 %) and dizziness (11.0 %). They were usually mild to moderate in intensity. Somnolence and 
fatigue (8.2 %) were reported at a higher incidence with increasing dose. The types of adverse 
reactions reported during the first 7 days of treatment were similar to those reported for the overall 
treatment period. 
 
The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized 
to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7 % for 
patients randomized to placebo. The adverse reactions most frequently resulting in discontinuation of 
brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %). 
 
Tabulated list of adverse reactions 
 
In the table below, adverse reactions, which were identified based on review of the three placebo-
controlled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ 
Class and frequency.  
The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon 
(≥ 1/1,000 to < 1/100). Within each frequency grouping, undesirable effects are presented in order of 
decreasing seriousness. 
 
System organ class Frequency Adverse reactions from clinical trials 
Infections and 
infestations 

Common Influenza 

Blood and lymphatic 
system disorders 

Uncommon Neutropenia 

Metabolism and nutrition 
disorders 

Common  Decreased appetite 

Immune system disorders Uncommon Type I hypersensitivity 
Psychiatric disorders Common Depression, anxiety, insomnia, irritability 

Uncommon Suicidal ideation, psychotic disorder, 
aggression, agitation 

Nervous system disorders Very common  Dizziness, somnolence 
Common 
 

Convulsion, vertigo 

Respiratory, thoracic and 
mediastinal disorders 

Common  
 

Upper respiratory tract infections, cough 

Gastrointestinal 
disorders 

Common  
 

Nausea, vomiting, constipation 

General disorders and 
administration site 
conditions 

Common  
 

Fatigue 

 
Description of selected adverse reactions 
 
Neutropenia has been reported in 0.5 % (6/1,099) brivaracetam patients and 0 % (0/459) placebo 
patients. Four of these subjects had decreased neutrophil counts at baseline, and experienced 
additional decrease in neutrophil counts after initiation of brivaracetam treatment. None of the 6 cases 
of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam 
and none had associated infections. 



 

43 

 
Suicidal ideation has been reported in 0.3 % (3/1,099) brivaracetam patients and 0.7 % (3/459) 
placebo patients. In the short-term clinical studies of brivaracetam in epilepsy patients, there were no 
cases of completed suicide and suicide attempt, however both have been reported in open-label 
extension studies(see section 4.4). 
 
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of 
brivaracetam patients (9/3022) during clinical development. 
 
Adverse reactions with intravenous administration generally appeared to be similar to those observed 
with oral administration. Intravenous administration was associated with infusion site pain in 2.8 % of 
the patients. 
 
Open-label extension studies 
 
In patients who were followed up in the open-label extension studies for up to 8 years, the safety 
profile was similar to that observed in the short-term, placebo-controlled studies.  
 
Paediatric population 
 
The safety profile of brivaracetam observed in children was consistent with the safety profile observed 
in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of 
paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural 
disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority 
of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of 
study drug. An additional adverse reaction reported in children was psychomotor hyperactivity 
(4.7 %).  
 
There are limited safety data from open-label studies in children from 1 month to <4 years of age. 
Limited data are available on neurodevelopment in children <4 years of age. No clinical data are 
available in neonates. 
 
Elderly  
 
Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with 
epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age. The safety profile in elderly 
patients appears to be similar to that observed in younger adult patients. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness 
have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. 
 
Management of overdose 
 
There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include 
general supportive measures. Since less than 10 % of brivaracetam is excreted in urine, haemodialysis 
is not expected to significantly enhance brivaracetam clearance (see section 5.2). 



 

44 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23  
 
Mechanism of action 
 
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a 
transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although 
the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of 
neurotransmitters. Binding to SV2A is believed to be the primary mechanism for brivaracetam 
anticonvulsant activity. 
 
Clinical efficacy and safety 
 
The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established 
in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 
16 years of age and older. The daily dose of brivaracetam ranged from 5 to 200 mg/day across these 
studies. All studies had an 8-week baseline period followed by a 12-week treatment period with no up-
titration. 1,558 patients received study drug of which 1,099 received brivaracetam. Study enrollment 
criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant 
AEDs. Patients were required to have at least 8 POS during the baseline period. The primary endpoints 
in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % 
responder rate based on 50 % reduction in POS frequency from baseline. 
The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine 
(25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and 
levetiracetam (9.8 %). The median baseline seizure frequency across the 3 studies was 9 seizures per 
28 days. Patients had a mean duration of epilepsy of approximately 23 years. 
The efficacy outcomes are summarized in Table 2. Overall, brivaracetam was efficacious for the 
adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day 
and 200 mg/day.  
 



 

45 

Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days 

Study 
 

Placebo Brivaracetam  
* Statistically significant (p-value) 

50 mg/day 100 mg/day 200 mg/day 
Study N01253(1) 
 n= 96 n= 101   
50 % Responder rate 16.7 32.7*  

(p=0.008) 
~ ~ 

 
Percent reduction over placebo (%)  NA 22.0*  

(p=0.004) 
~ ~ 

Study N01252(1) 
 n = 100 n = 99 n = 100  
50 % Responder rate  20.0 27.3 

(p=0.372) 
36.0(2) 
(p=0.023) 

~ 
 

Percent reduction over placebo (%) NA 9.2 
(p=0.274) 

20.5(2) 
(p=0.010) 

~ 
 

Study N01358 
 n = 259  n = 252 n = 249 
50% Responder rate 21.6 ~ 38.9*  

(p<0.001) 
37.8*  

(p<0.001) 
Percent reduction over placebo (%) NA ~ 22.8*  

(p<0.001)  
23.2*  

(p<0.001) 
n = randomised patients who received at least 1 dose of study medication  
~ Dose not studied 
* Statistically significant 
(1) Approximately 20 % of the patients were on concomitant levetiracetam  
(2) The primary outcome for N01252 did not achieve statistical significance based on the sequential 
testing procedure, The 100 mg/day dose was nominally significant. 
 
In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 
100 mg/day than with 50 mg/day. Apart from dose-dependent increases in incidences of somnolence 
and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNS-
related AEs and with long-term use. 
 
Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by 
category of reduction from baseline in POS frequency per 28 days in all 3 studies. Patients with more 
than a 25 % increase in POS are shown at left as “worse”. Patients with an improvement in percent 
reduction in baseline POS frequency are shown in the 4 right-most categories. The percentages of 
patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % 
for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.   
 



 

46 

Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 
12 weeks across all three double-blind pivotal trials 

 
 
In a pooled analysis of the three pivotal trials, no differences in efficacy (measured as 50 % responder 
rate) was observed within the dose range of 50 mg/day to 200 mg/day when brivaracetam is combined 
with inducing or non-inducing AEDs. In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% 
(10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became 
seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.  
 
Improvement in the median percent reduction in seizure frequency per 28 days has been observed in 
patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with 
brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 
50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).  
 
The efficacy of brivaracetam in monotherapy has not been established. Brivaracetam is not 
recommended for use in monotherapy.  
 
Treatment with levetiracetam 
 
In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant 
AED in about 20 % of the patients. Although the number of subjects is limited, there was no observed 
benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect 
competition at the SV2A binding site. No additional safety or tolerability concerns were observed. 
 
In a third study, a pre-specified analysis demonstrated efficacy over placebo for 100 mg/day and 200 
mg/day in patients with prior exposure to levetiracetam. The lower efficacy observed in these patients 
compared to the leveticacetam-naïve patients was likely due to the higher number of prior AEDs used 
and higher baseline seizure frequency. 
 
Elderly (65 years of age and above) 

The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 
65 and 80 years. Although data are limited, the efficacy was comparable to younger subjects. 
 



 

47 

Open label extension studies 

Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the 
long-term open-label extension studies. From entry into the randomized studies,5.3 % of the subjects 
exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for 
subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively. However, as a high 
proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a 
selection bias may have occurred, as the subjects who stayed in the study responded better than those 
who have terminated prematurely. 
 
Paediatric population 
 
In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in 
adolescents and adults. Experience with epilepsy medicines suggests that the results of efficacy studies 
performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric 
dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8). Doses in 
patients from 4 years of age were defined by weight-based dose adaptations which have been 
established to achieve similar plasma concentrations to the ones observed in adults taking efficacious 
doses (section 5.2).  
 
A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 
years) who continued treatment after completing the PK study (see section 5.2) and children directly 
enrolled into the safety study. Children who directly enrolled received a brivaracetam starting dose of 
1 mg/kg/day and depending on response and tolerability, the dose was increased up to 5 mg/kg/day by 
doubling the dose at weekly intervals. No child received a dose greater than 200 mg/day. For children 
weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response 
and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 
50 mg/day.  
 
From the pooled open-label safety and PK studies in adjunctive therapy, 149 children have received 
brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, 
and 28 for ≥36 months. 
 
The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not 
been established (see section 4.2). Brivaracetam was evaluated in these patients in a short term open-
label pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month 
to <4 years of age (see section 5.2). 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset 
seizures. 
 
5.2 Pharmacokinetic properties 
 
Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same 
AUC, while the maximum plasma concentration is slightly higher after intravenous administration. 
Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject 
variability, and features complete absorption, very low protein binding, renal excretion following 
extensive biotransformation, and pharmacologically inactive metabolites.  
 



 

48 

Absorption 
 
Brivaracetam is rapidly and completely absorbed after oral administration and the absolute 
bioavailablity is approximately 100 %. The median tmax for tablets taken without food is 1 hour (tmax 
range is 0.25 to 3 h).  
Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and 
decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of 
absorption remained unchanged. 
 
Distribution 
 
Brivaracetam is weakly bound (≤ 20 %) to plasma proteins. The volume of distribution is 0.5 L/kg, a 
value close to that of the total body water. 
Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.  
 
Biotransformation 
 
Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding 
carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl 
side chain (approximately 30 % the elimination). The hydrolysis of the amide moiety leading to the 
carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic 
amidase. In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19. Both 
metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by 
hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). In vivo, 
in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy 
metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals 
with one or both mutated alleles. The three metabolites are not pharmacologically active. 
 
Elimination 
 
Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95 % of 
the dose, including metabolites, is excreted in the urine within 72 hours after intake. Less than 1 % of 
the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine. The 
terminal plasma half-life (t1/2) is approximately 9 hours. The total plasma clearance in patients was 
estimated to 3.6 L/h.  
 
Linearity 
 
Pharmacokinetics is dose-proportional from 10 to at least 600 mg. 
 
Interactions with medicinal products 
 
Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated 
hydrolysis and CYP-mediated oxidations. In vitro, brivaracetam is not a substrate of human P-
glycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion 
transporter polypeptide 1B1 (OATP1B1) and OATP1B3. 
In vitro assays showed that brivaracetam disposition should not be significantly affected by CYP (eg. 
CYP1A, 2C8, 2C9, 2D6 and 3A4) inhibitors. 
 
In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the 
transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and 
OCT1 at clinically relevant concentrations. In vitro, brivaracetam did not induce CYP1A2.  
 



 

49 

Pharmacokinetics in special patient groups 
 
Elderly (65 years of age and above) 

In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) 
receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 
7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively. The steady-state plasma 
clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects 
(0.83 ml/min/kg). (see section 4.2). 
 
Renal impairment 

A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not 
requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) 
relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were 
increased 3-, 4-, and 21-fold, respectively. The renal clearance of these non active metabolites was 
decreased 10-fold. The hydroxyacid metabolite did not reveal any safety concerns in non clinical 
studies. Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2). 
 
Hepatic impairment 

A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed 
similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), 
relative to matched healthy controls. (see section 4.2) 
 
Paediatric population 

In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using 
the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated. Brivaracetam 
was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 
4 mg/kg/day. All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 
100 mg/day, and 200 mg/day. At the end of the evaluation period, subjects may have been eligible for 
entry into a long-term follow-up study continuing on their last received dose (see section 4.8). Plasma 
concentrations were shown to be dose-proportional in all age groups. Population pharmacokinetics 
modeling indicated that the dose of 2.0 mg/kg twice a day provides the same steady-state average 
plasma concentration as in adults receiving 100 mg twice daily. The estimated plasma clearance was 
1.61 L/h, 2.18 L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively. In 
comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight).  
Currently, no clinical data are available in neonates. 
 
Body weight 

A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range 
from 46 kg to 115 kg. However, this is not considered to be a clinically relevant difference.  
 
Gender 

There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender. 
  
Race 

The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, , Asian) in a 
population pharmacokinetic modeling from epilepsy patients. The number of patients with other ethnic 
background was limited. 
 
Pharmacokinetic/pharmacodynamics relationship 
The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was 
estimated to be 0.57 mg/L. This plasma concentration is slightly above the median exposure obtained 
after brivaracetam doses of 50 mg/day. Further seizure frequency reduction is obtained by increasing 
the dose to 100 mg/day and reaches a plateau at 200 mg/day. 
 



 

50 

5.3 Preclinical safety data 
 
In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS 
depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of 
the pharmacologically active dose of brivaracetam, 2 mg/kg. Learning and memory function were not 
affected.  
 
Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at 
exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria). However, 
toxicological data accumulated on brivaracetam and on a structurally-related compound indicate that 
the dog liver changes have developed through mechanisms not relevant for humans. No adverse liver 
changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42-
fold the clinical AUC exposure. In monkeys, CNS signs (prostrate, loss of balance, clumsy 
movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time. 
 
Genotoxicity studies have not detected any mutagenic or clastogenic activity. Carcinogenicity studies 
did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors 
in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitone-
like liver enzyme induction, which is a known rodent specific phenomenon.  
 
Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in 
either rat or rabbit. Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam 
with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose. In rats, 
brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with 
concentrations similar to maternal plasma levels. 
 
Brivaracetam did not show any dependence potential in rats. 
 
Juvenile animals studies 
 

In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum 
recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased 
body weight and lower brain weight). There were no adverse effects on CNS function, 
neuropathological and brain histopathological examination. In juvenile dogs, the brivaracetam-induced 
changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals. 
There were no adverse effects in any of the standard developmental or maturation endpoints. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 

Sodium acetate (trihydrate) 
Acetic acid, glacial (for pH-adjustment) 
Sodium chloride  
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products. 
 
6.3 Shelf life 
 
4 years. 
Following dilution, brivaracetam solution for injection/infusion was found to be physically compatible 
and chemically stable when mixed with the diluents listed in the section 6.6 for 24 hours and stored in 
PVC or polyolefin bags at temperature up to 25°C. From a microbiological point of view, the product 



 

51 

should be used immediately after dilution. If not used immediately, in-use storage time and conditions 
prior to use are the responsibility of the user. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
For storage conditions after dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container  
 
10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with 
siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. 
Each single use vial contains an extractable volume of not less than 5.0 ml of solution for 
injection/infusion.  
 
Each carton contains 10 vials. 
 
6.6 Special precautions for disposal and other handling 
 
This medicinal product is for single use only, any unused solution should be discarded. 
Product with particulate matter or discoloration should not be used.  
Brivaracetam solution for injection/infusion is physically compatible and chemically stable when 
mixed with the following diluents  
 
Diluents 
- Sodium chloride 9 mg/ml (0.9 %) solution for injection 
- Glucose 50 mg/ml (5 %) solution for injection  
- Lactated Ringer’s solution for injection. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/022 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 January 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



 

52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 



 

53 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine l'Alleud 
Belgium 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
- Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 
any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
- Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
 

- At the request of the European Medicines Agency; 
 

- Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached. 

 



 

54 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

56 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
56 film-coated tablets 
100 x 1 film-coated tablet 
14 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
  
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

57 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/001 14 film-coated tablets 
EU/1/15/1073/002 56 film-coated tablets 
EU/1/15/1073/003 100 x 1 film-coated tablet 
EU/1/15/1073/023 14 x 1 film-coated tablet 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

58 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

59 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

60 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED 
TABLETS) (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

61 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

62 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Briviact 10 mg tablets  
brivaracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
 
(not for packsizes 14 x1 and 100 x 1 film-coated tablet)  

 



 

63 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 25 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 25 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
56 film-coated tablets 
100 x 1 film-coated tablet 
14 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
  
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

64 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/005 14 film-coated tablets 
EU/1/15/1073/006 56 film-coated tablets 
EU/1/15/1073/007 100 x 1 film-coated tablet 
EU/1/15/1073/024 14 x 1 film-coated tablet 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

65 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 25 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 25 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

66 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

67 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED 
TABLETS) (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 25 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 25 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separatly. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

68 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

69 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Briviact 25 mg tablets  
brivaracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
 
(not for packsizes 14 x1 and 100 x 1 film-coated tablet)  

 



 

70 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 50 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 50 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
56 film-coated tablets 
100 x 1 film-coated tablet 
14 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

71 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/009 14 film-coated tablets 
EU/1/15/1073/010 56 film-coated tablets 
EU/1/15/1073/011 100 x 1 film-coated tablet 
EU/1/15/1073/025 14 x 1 film-coated tablet 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

72 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON of MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 50 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 50 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

73 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

74 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED 
TABLETS) 
(WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 50 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 50 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separatly. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

75 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

76 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Briviact 50 mg tablets  
brivaracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
 

(not for packsizes 14 x1 and 100 x 1 film-coated tablet)  

 



 

77 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 75 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 75 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
56 film-coated tablets 
100 x 1 film-coated tablet 
14 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

78 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/013 14 film-coated tablets 
EU/1/15/1073/014 56 film-coated tablets 
EU/1/15/1073/015 100 x 1 film-coated tablet 
EU/1/15/1073/026 14 x 1 film-coated tablet 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

79 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON of MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 75 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 75 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

80 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

81 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED 
TABLETS) 
(WITHOUT BLUEBOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 75 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 75 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separatly. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
  
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

82 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

83 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Briviact 75 mg tablets  
brivaracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
 
(not for packsizes 14 x1 and 100 x 1 film-coated tablet)  

 



 

84 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 100 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 100 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
56 film-coated tablets 
100 x 1 film-coated tablet 
14 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

85 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/017 14 film-coated tablets 
EU/1/15/1073/018 56 film-coated tablets 
EU/1/15/1073/019 100 x 1 film-coated tablet 
EU/1/15/1073/027 14 x 1 film-coated tablet 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

86 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 100 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 100 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

87 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

88 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED 
TABLETS) 
(WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 100 mg film-coated tablets  
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 100 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous. 
See leaflet for further information. (Omitted from cartons of 14 film-coated tablets) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can be sold separatly. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

89 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 

90 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Briviact 100 mg tablets  
brivaracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
 
(not for packsizes 14 x1 and 100 x 1 film-coated tablet)  

 



 

91 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE 
PACKAGING   
 
OUTER CARTON / BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg/ml oral solution 
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of oral solution contains 10 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol liquid (E420), propylene glycol (E1520), sodium citrate, carmellose sodium, methyl 
parahydroxybenzoate (E218), and glycerol (E422).  
See leaflet for further information. (Only for outer carton) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml  
Two oral syringes (5 ml and 10 ml) are included in the carton. Check with your doctor which one you 
should use.  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Syringe 10 ml and 5ml (as symbols - only for the outer carton) 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening of the bottle, use within 5 months. 
Opening date (Only for outer carton) 
 



 

92 

 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A.  
Allée de la Recherche 60 (address only for outer carton) 
B-1070 Bruxelles 
Belgium (name and address only for outer carton, logo on carton and etiquette) 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/021  
 
 
13. BATCH NUMBER 
 

Lot 
 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
briviact 10 mg/ml (Only for outer carton) 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. (Only for outer carton) 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
(Only for outer carton) 



 

93 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Briviact 10 mg/ml solution for injection/infusion 
brivaracetam  
 
 
2. STATEMENT OF ACTIVE SUB STANCE(S) 
 
Each ml of solution for injection/infusion contains 10 mg brivaracetam. 
One vial of 5 ml contains 50 mg brivaracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sodium acetate (trihydrate), sodium chloride.  
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 mg/5 ml  
10 vials solution for injection/infusion 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 

94 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1073/022 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
<Justification for not including Braille accepted> 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



 

95 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Briviact 10 mg/ml injection/infusion 
brivaracetam 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
50 mg/5 ml 
 
 
6. OTHER 
 
 



 

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

97 

Package leaflet: Information for the patient 
 

Briviact 10 mg film-coated tablets 
Briviact 25 mg film-coated tablets 
Briviact 50 mg film-coated tablets 
Briviact 75 mg film-coated tablets 
Briviact 100 mg film-coated tablets 

brivaracetam 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Briviact is and what it is used for  
2. What you need to know before you take Briviact 
3. How to take Briviact 
4. Possible side effects  
5. How to store Briviact  
6. Contents of the pack and other information 
 
 
1. What Briviact is and what it is used for 

 
What Briviact is 
Briviact contains the active substance brivaracetam. It belongs to a group of medicines called 
‘anti-epileptics’. These medicines are used to treat epilepsy. 
 
What Briviact is used for 
- Briviact is used in adults, adolescents and children from 4 years of age. 
- It is used to treat a type of epilepsy that has partial seizures with or without a secondary 

generalisation.  
- Partial seizures are fits that start by only affecting one side of the brain. These partial seizures 

can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary 
generalisation’.  

- You have been given this medicine to lower the number of fits (seizures) you have.  
- Briviact is used together with other medicines for epilepsy. 
 
 
2. What you need to know before you take Briviact  
 
Do not take Briviact if: 
- you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of 

this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before 
taking Briviact.  

 



 

98 

Warnings and precautions  
Talk to your doctor or pharmacist before taking Briviact if: 
- You have thoughts of harming or killing yourself. A small number of people being treated with 

anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves. If 
you have any of these thoughts at any time, contact your doctor immediately. 

- You have liver problems - your doctor may need to adjust your dose. 
 
Children  
Briviact is not recommended for use in children under 4 years of age. 
 
Other medicines and Briviact 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor if you are taking any of the following medicines – this is because your 
doctor may need to adjust your Briviact dose: 
- Rifampicin - a medicine used to treat bacterial infections. 
- St John’s wort (also known as Hypericum perforatum) - a herbal medicine used to treat 

depression and anxiety as well as other conditions. 
 
Briviact with alcohol 
- Combining this medicine with alcohol is not recommended.  
- If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.  
 
Pregnancy and breast-feeding 
It is not recommended to take Briviact if you are pregnant or breast-feeding, as the effects of Briviact 
on pregnancy and the unborn baby or the new-born child are not known. Seek advice immediately 
from your doctor if you are pregnant or are planning to become pregnant. 
 
Do not stop treatment without talking to your doctor first. Stopping treatment could increase your 
seizures and harm your baby. 
 
Driving and using machines 
- You may feel sleepy, dizzy or tired while taking Briviact.  
- These effects are more likely at the start of the treatment or after a dose increase. 
- Do not drive, cycle or use any tools or machines until you know how the medicine affects you. 
 
Briviact contains lactose and sodium 
Briviact film-coated tablets contain: 

-  lactose (a type of sugar) - If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicine. 

- sodium – This medecine contains less than 1 mmol sodium (23mg) per tablet, that is to say 
essentially ‘sodium free’. 

 
 
3. How to take Briviact 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
You will take Briviact together with other medicines for epilepsy. 
 
How much to take 
Your doctor will work out the right daily dose for you.Take the daily dose in two equal divided doses - 
one in the morning and one in the evening at about the same time each day. 
 
Adults, adolescents and children weighing 50 kg or more 



 

99 

- The recommended dose is from 25 mg to 100 mg taken twice a day . Your doctor may then 
decide to adjust your dose to find the best dose for you.   

 
Children and adolescents weighing less than 50 kg  
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. 

Your doctor may then decide to adjust your dose to find the best dose for you. 
 
People with liver problems 
If you have problems with your liver:  

- As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 
75 mg twice a day.  

- As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg 
for each kg of bodyweight twice a day. 

 
How to take Briviact tablets 
- Swallow the tablets whole with a glass of liquid.  
- The medicine may be taken with or without food. 
 
How long to take Briviact for 
Briviact is a long term treatment – keep taking Briviact until your doctor tells you to stop.  
 
If you take more Briviact than you should 
If you have taken more Briviact than you should, talk to your doctor. You may feel dizzy and sleepy. 
 
If you forget to take Briviact 
- If you miss a dose take it as soon as you remember.  
- Then take your next dose at the time you would normally take it.  
- Do not take a double dose to make up for a forgotten dose. 
- If you are not sure what to do, ask your doctor or pharmacist. 
 
If you stop taking Briviact 
- Do not stop taking this medicine unless your doctor tells you to. This is because stopping 

treatment could increase the number of fits you have. 
- If your doctor asks you to stop taking this medicine they will lower your dose gradually. This 

helps to stop your fits coming back or getting worse  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common: may affect more than 1 in 10 people 

- feeling sleepy or dizzy 
 
Common: may affect up to 1 in 10 people 

- flu 
- feeling very tired (fatigue) 
- convulsion, a feeling of ‘spinning’ (vertigo) 
- feeling and being sick, constipation 
- depression, anxiety, not being able to sleep (insomnia), irritability 
- infections of the nose and throat (such as the ‘common cold’), cough 
- decreased appetite  

 
Uncommon: may affect up to 1 in 100 people 

- allergic reactions 



 

100 

- abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive, 
nervous excitement (agitation)  

- thoughts or attempts of harming or killing yourself: tell your doctor straight away 
- a decrease in white blood cells (called ‘neutropenia’) - shown in blood tests  
 

Additional side effects in children  
 
Common: may affect up to 1 in 10 people 

- restlessness and hyperactivity (psychomotor hyperactivity)  
 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Briviact 
 
- Keep this medicine out of the sight and reach of children. 
- Do not use this medicine after the expiry date which is stated on the carton and blister after 

EXP. The expiry date refers to the last day of that month. 
- This medicinal product does not require any special storage conditions. 
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Briviact contains  
The active substance is brivaracetam. 
Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam. 
 
The other ingredients are: 
Core 
Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate  
 
Coating 
- 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc. 
- 25 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron 
oxide yellow (E172), iron oxide black (E172). 
- 50 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron 
oxide yellow (E172), iron oxide red (E172). 
- 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron 
oxide yellow (E172), iron oxide red (E172), iron oxide black (E172). 
- 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron 
oxide yellow (E172), iron oxide black (E172). 
 
What Briviact looks like and contents of the pack 
Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed 
with ‘u10’ on one side. 
Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one 
side. 
Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50’ on 
one side. 
Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75’ on 
one side.  



 

101 

Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with 
‘u100’ on one side. 
 
Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 
14 x 1 or 100 x 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated 
tablets. 
All packs are available in PVC/PCTFE - Aluminium blisters. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.  
 
Manufacturer 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43-(0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
UCB Pharma (Produtos Farmacêuticos), Lda 
Tel: + 351 / 21 302 5300 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 



 

102 

  
Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  

 
 



 

103 

Package leaflet: Information for the patient 
 

Briviact 10mg/ml oral solution 
brivaracetam 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Briviact is and what it is used for  
2. What you need to know before you take Briviact 
3. How to take Briviact 
4. Possible side effects  
5. How to store Briviact  
6. Contents of the pack and other information 
 
 
1. What Briviact is and what it is used for 

 
What Briviact is 
Briviact contains the active substance brivaracetam. It belongs to a group of medicines called 
‘anti-epileptics’. These medicines are used to treat epilepsy. 
 
What Briviact is used for 
- Briviact is used in adults, adolescents and children from 4 years of age. 
- It is used to treat a type of epilepsy that has partial seizures with or without a secondary 

generalisation.  
- Partial seizures are fits that start by only affecting one side of the brain. These partial seizures 

can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary 
generalisation’.  

- You have been given this medicine to lower the number of fits (seizures) you have.  
- Briviact is used together with other medicines for epilepsy. 
 
 
2. What you need to know before you take Briviact  
 
Do not take Briviact if: 
- you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of 

this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before 
taking Briviact.  

 
Warnings and precautions  
Talk to your doctor or pharmacist before taking Briviact if: 
- You have thoughts of harming or killing yourself. A small number of people being treated with 

anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves. If 
you have any of these thoughts at any time, contact your doctor immediately. 

- You have liver problems - your doctor may need to adjust your dose. 



 

104 

 
Children  
Briviact is not recommended for use in children under 4 years of age. 
 
Other medicines and Briviact 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor if you are taking any of the following medicines – this is because your 
doctor may need to adjust your Briviact dose: 
- Rifampicin - a medicine used to treat bacterial infections. 
- St John’s wort (also known as Hypericum perforatum) - a herbal medicine used to treat 

depression and anxiety as well as other conditions. 
 
Briviact with alcohol 
- Combining this medicine with alcohol is not recommended.  
- If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.  
 
Pregnancy and breast-feeding 
It is not recommended to take Briviact if you are pregnant or breast-feeding, as the effects of Briviact 
on pregnancy and the unborn baby or the new-born child are not known. Seek advice immediately 
from your doctor if you are pregnant or are planning to become pregnant. 
 
Do not stop treatment without talking to your doctor first. Stopping treatment could increase your 
seizures and harm your baby. 
 
Driving and using machines 
- You may feel sleepy, dizzy or tired while taking Briviact.  
- These effects are more likely at the start of the treatment or after a dose increase. 
- Do not drive, cycle or use any tools or machines until you know how the medicine affects you. 
 
Briviact oral solution contains methyl parahydroxybenzoate, sodium, sorbitol and propylene 
glycol 
- Methyl parahydroxybenzoate (E218): This may cause allergic reactions (possibly delayed). 
- Sodium: This medicine contains less than 1 mmol sodium (23mg) per millilitre, that is to say 

essentially ‘sodium free  
- Sorbitol (E420) (a type of sugar): This medicine contains 239.8 mg sorbitol in each ml. Sorbitol 

is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to 
some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare 
genetic disorder in which a person cannot break down fructose, talk to your doctor before you 
(or your child) take or receive this medicine.  

- Propylene glycol (E1520): This medicine contains maximum 5.5 mg propylene glycol in each 
millilitre. 

 
 
3. How to take Briviact 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure.  
 
You will take Briviact together with other medicines for epilepsy. 
 
How much to take 
Your doctor will work out the right daily dose for you. Take the daily dose in two equal divided doses 
- one in the morning and one in the evening at about the same time each day. 
 



 

105 

Adults, adolescents and children weighing 50 kg or more 
- The recommended dose is from 25 mg to 100 mg taken twice a day. Your doctor may then 

decide to adjust your dose to find the best dose for you.  
 
Children and adolescents weighing less than 50 kg  
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. 

Your doctor may then decide to adjust your dose to find the best dose for you.  
 

The table below only shows examples of doses to take. Your doctor will work out the right dose for 
you, depending on your weight. 
 
  Dose taken twice daily for children from 4 years of age 

weighing less than 50 kg. 
Weight  0.5 mg/kg 

= 0.05 ml/kg 
1 mg/kg 
= 0.1 ml/kg 

1.5 mg/kg 
= 0.15 ml/kg 

2 mg/kg 
= 0.2 ml/kg 

10 kg 0.5 ml 1 ml 1.5 ml 2 ml 
15 kg 0.75 ml 1.5 ml 2.25 ml 3 ml 
20 kg 1 ml 2 ml 3 ml 4 ml 
25 kg 1.25 ml 2.5 ml 3.75 ml 5 ml 
30 kg 1.5 ml 3 ml 4.5 ml 6 ml 
35 kg 1.75 ml 3.5 ml 5.25 ml 7 ml 
40 kg 2 ml 4 ml 6 ml 8 ml 
45 kg 2.25 ml 4.5 ml 6.75 ml 9 ml 
50 kg 2.5 ml 5 ml 7.5 ml 10 ml 
 
People with liver problems 
If you have problems with your liver:  

- As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 
75 mg twice a day.  

- As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg 
for each kg of bodyweight twice a day. 

 
How to take Briviact oral solution 
- You can take Briviact oral solution on its own, or dilute it in water or juice shortly before 

swallowing.  
- The medicine may be taken with or without food.  
 
Instructions for use for patients or carers: 
Two oral syringes will be provided in the carton. Check with your doctor which one you should use.  
- If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to 

ensure accurate dosing. 
- If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the 

10 ml oral syringe provided in the carton to ensure accurate dosing. 
 
5 ml oral dosing syringe   10 ml oral dosing syringe   
The 5 ml oral syringe has 2 overlapping 
graduations: in steps of  0.25 ml and in steps of 
0.1 ml. 
 

The 10 ml oral syringe has only one graduation in 
steps of 0.25 ml. 
 

 



 

106 

- Open the bottle: press the cap and turn it anti-clockwise (figure 1). 
 

 
 
Follow these steps the first time you take Briviact:  
- Take off the adaptor from the oral syringe (figure 2).  
- Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do 

not need to remove the adaptor after use. 
 

   
 
Follow these steps each time you take Briviact: 
- Put the oral syringe into the adaptor opening (figure 4).  
- Turn the bottle upside down (figure 5). 

 

   
 

- Hold the bottle upside down in one hand and use the other hand to fill the oral syringe. 
- Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6). 
- Then push the plunger up to remove any possible air bubbles (figure 7).  
- Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your 

doctor (figure 8). 
 

        
 



 

107 

- Turn the bottle the right way up (figure 9).  
- Take the oral syringe out of the adaptor (figure 10). 
 

   
 
There are two ways in which you can choose to drink the medicine: 

- empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom of 
the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to 
make it easy to drink) or 

- drink the solution directly from the oral syringe without water – drink the whole contents of 
the syringe (figure 12). 

 

                            
 

- Close the bottle with the plastic screw cap (you do not need to remove the adaptor). 
- Wash the oral syringe with water only (figure 13). 
- Keep the bottle, the oral syringe, and the leaflet in the carton.  

 

  
 
How long to take Briviact for 
Briviact is a long term treatment – keep taking Briviact until your doctor tells you to stop.  
 
If you take more Briviact than you should 
If you have taken more Briviact than you should, talk to your doctor. You may feel dizzy and sleepy. 
 
If you forget to take Briviact 
- If you miss a dose take it as soon as you remember.  
- Then take your next dose at the time you would normally take it.  
- Do not take a double dose to make up for a forgotten dose. 
- If you are not sure what to do, ask your doctor or pharmacist. 
 



 

108 

If you stop taking Briviact 
- Do not stop taking this medicine unless your doctor tells you to. This is because stopping 

treatment could increase the number of fits you have. 
- If your doctor asks you to stop taking this medicine they will lower your dose gradually. This 

helps to stop your fits coming back or getting worse.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common: may affect more than 1 in 10 people 

- feeling sleepy or dizzy 
 
Common: may affect up to 1 in 10 people 

- flu 
- feeling very tired (fatigue) 
- convulsion, a feeling of ‘spinning’ (vertigo) 
- feeling and being sick, constipation 
- depression, anxiety, not being able to sleep (insomnia), irritability 
- infections of the nose and throat (such as the ‘common cold’), cough 
- decreased appetite   

 
Uncommon: may affect up to 1 in 100 people 

- allergic reactions 
- abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive, 

nervous excitement (agitation)  
- thoughts or attempts of harming or killing yourself: tell your doctor straight away 
- a decrease in white blood cells (called ‘neutropenia’) - shown in blood tests  

 
Additional side effects in children  
 
Common: may affect up to 1 in 10 people 

- restlessness and hyperactivity (psychomotor hyperactivity)  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Briviact 
 
- Keep this medicine out of the sight and reach of children. 
- Do not use this medicine after the expiry date which is stated on the cardboard box and bottle 

after EXP. The expiry date refers to the last day of that month. 
- This medicinal product does not require any special storage conditions. 
- After first opening of the bottle, use within 5 months. 
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 
 
 



 

109 

6. Contents of the pack and other information 
 
What Briviact contains  
The active substance is brivaracetam. 
Each millilitre (ml) contains 10 milligrams (mg) brivaracetam. 
 
The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), 
carmellose sodium, sucralose, sorbitol liquid (E420), glycerol (E422), raspberry flavour (propylene 
glycol (E1520) 90 % - 98 %), water, purified. 
 
What Briviact looks like and contents of the pack 
Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid. 
 
The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 
5 ml oral syringe and an adaptor for the syringe. 
 
Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.  
 
Manufacturer 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43-(0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 



 

110 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
UCB Pharma (Produtos Farmacêuticos), Lda 
Tel: + 351 / 21 302 5300 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 
 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu.  
 
 



 

111 

Package leaflet: Information for the patient 
 

Briviact 10mg/ml solution for injection/infusion 
brivaracetam 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Briviact is and what it is used for  
2. What you need to know before you use Briviact 
3. How to use Briviact 
4. Possible side effects  
5. How to store Briviact  
6. Contents of the pack and other information 
 
 
1. What Briviact is and what it is used for 

 
What Briviact is 
Briviact contains the active substance brivaracetam. It belongs to a group of medicines called 
‘anti-epileptics’. These medicines are used to treat epilepsy. 
 
What Briviact is used for 
- Briviact is used in adults, adolescents and children from 4 years of age. 
- It is used to treat a type of epilepsy that has partial seizures with or without a secondary 

generalisation.  
- Partial seizures are fits that start by only affecting one side of the brain. These partial seizures 

can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary 
generalisation’.  

- You have been given this medicine to lower the number of fits (seizures) you have.  
- Briviact is used together with other medicines for epilepsy. 
 
 
2. What you need to know before you take Briviact  
 
Do not use Briviact if: 
- you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of 

this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before 
taking Briviact. 

 
Warnings and precautions  
Talk to your doctor or pharmacist before using Briviact if: 
- You have thoughts of harming or killing yourself. A small number of people being treated with 

anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves. If 
you have any of these thoughts at any time, contact your doctor immediately. 

- You have liver problems - your doctor may need to adjust your dose. 



 

112 

 
Children  
Briviact is not recommended for use in children under 4 years of age. 
 
Other medicines and Briviact 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor if you are taking any of the following medicines – this is because your 
doctor may need to adjust your Briviact dose: 
- Rifampicin - a medicine used to treat bacterial infections. 
- St John’s wort (also known as Hypericum perforatum) - a herbal medicine used to treat 

depression and anxiety as well as other conditions. 
 
Briviact with alcohol 
- Combining this medicine with alcohol is not recommended.  
- If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.  
 
Pregnancy and breast-feeding 
It is not recommended to take Briviact if you are pregnant or breast-feeding, as the effects of Briviact 
on pregnancy and the unborn baby or the new-born child are not known. Seek advice immediately 
from your doctor if you are pregnant or are planning to become pregnant. 
 
Do not stop treatment without talking to your doctor first. Stopping treatment could increase your 
seizures and harm your baby. 
 
Driving and using machines 
- You may feel sleepy, dizzy or tired while using Briviact.  
- These effects are more likely at the start of the treatment or after a dose increase. 
- Do not drive, cycle or use any tools or machines until you know how the medicine affects you. 
 
Briviact contains sodium 
Briviact solution for injection/infusion contains less than 1 mmol sodium (23mg) per vial, that is to 
say essentially ‘sodium free’. 
 
 
3. How to use Briviact 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
You will use Briviact together with other medicines for epilepsy. 
 
- When you start taking this medicine you will take Briviact orally (as tablets or an oral solution) 

or be given it as an injection or infusion. 
- Briviact solution for injection/infusion is used for a short amount of time when you cannot take 

Briviact orally. 
- You can switch between taking Briviact orally to the solution for injection/infusion, and the 

other way around. 
 
How much you will be given  
Your doctor will work out the right daily dose for you.Take the daily dose in two equal divided doses - 
one in the morning and one in the evening at about the same time each day. 
 
Adults, adolescents and children weighing 50 kg or more 
- The recommended dose is from 25 mg to 100 mg taken twice a day. Your doctor may then 

decide to adjust your dose to find the best dose for you.  



 

113 

 
Children and adolescents weighing less than 50 kg  
- Your doctor may prescribe the injection only for a few days if you cannot take your medicine by 

mouth. 
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. 

Your doctor may then decide to adjust your dose to find the best dose for you.   
 
People with liver problems 
If you have problems with your liver:  

- As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 
75 mg twice a day.  

As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each 
kg of bodyweight twice a day. 
 
How Briviact is given 
Briviact is administered as an injection or infusion into a vein by a doctor or a nurse. The medicine is 
injected slowly into your vein or given as an infusion (drip) over 15 minutes. 
 
How long to use Briviact for 
- Your doctor will decide for how many days you will be given the injections or infusion.  
- For the long term treatment with Briviact, your doctor will ask to you to take Briviact tablets or 

oral solution.  
 
If you have more Briviact than you should 
 If you think you have been given too much Briviact, tell your doctor straight away. 
 
If you stop using Briviact 
- Do not stop taking this medicine unless your doctor tells you to. This is because stopping 

treatment could increase the number of fits you have. 
- If your doctor asks you to stop taking this medicine they will lower your dose gradually. This 

helps to stop your fits coming back or getting worse.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common: may affect more than 1 in 10 people 

- feeling sleepy or dizzy 
 
Common: may affect up to 1 in 10 people 

- flu 
- feeling very tired (fatigue) 
- convulsion, a feeling of ‘spinning’ (vertigo) 
- feeling and being sick, constipation 
- pain or discomfort at the injection or infusion site 
- depression, anxiety, not being able to sleep (insomnia), irritability 
- infections of the nose and throat (such as the ‘common cold’), cough 
- decrease appetite 

 
Uncommon: may affect up to 1 in 100 people 

- allergic reactions 
- abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive, 

nervous excitement (agitation)  
- thoughts or attempts of harming or killing yourself: tell your doctor straight away 



 

114 

- a decrease in white blood cells (called ‘neutropenia’) - shown in blood tests  
 
Additional side effects in children  
 
Common: may affect up to 1 in 10 people 

- restlessness and hyperactivity (psychomotor hyperactivity)  
 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Briviact 
 
- Keep this medicine out of the sight and reach of children. 
- Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. 

The expiry date refers to the last day of that month. 
- Briviact may be diluted before it is injected by your doctor or nurse. In such cases, it should be 

used straight after dilution. 
- This medicinal product does not require any special storage conditions. 
- Each vial of Briviact solution for injection/infusion must be used only once (single use). Any 

unused solution should be discarded. 
- Only clear solution free from particles and discoloration should be used. 
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Briviact contains  
The active substance is brivaracetam. 

- Each ml contains 10 mg brivaracetam 
- Each 5 ml vial contains 50 mg brivaracetam 

 

The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for 
injection. 
 
What Briviact looks like and contents of the pack 
Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution. 
Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials. 
 
Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.  
 
Manufacturer 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 



 

115 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43-(0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 
UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
UCB Pharma (Produtos Farmacêuticos), Lda 
Tel: + 351 / 21 302 5300 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 
 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 



 

116 

This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
The following information is intended for medical or healthcare professionals only 
 
Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion: 
 
• Intravenous bolus: may be administered directly without dilution 
• Intravenous infusion: may be administered over 15 minutes in a compatible diluent 
 
Briviact may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 
50 mg/ml (5 %) solution for injection or lactated Ringer’s solution.  
Each vial of Briviact solution for injection/infusion must be used only once (single use). Any unused 
solution should be discarded (see section 3). 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET