Kigabeq

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



2 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kigabeq 100 mg soluble tablets 
Kigabeq 500 mg soluble tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Kigabeq 100 mg soluble tablets 
 
Each soluble tablet contains 100 mg vigabatrin. 
 
Kigabeq 500 mg soluble tablets 
 
Each soluble tablet contains 500 mg vigabatrin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Soluble tablet 
 
White oval tablets. The tablets are scored on one side and can be divided into equal doses. 
- 500 mg tablet size: 16.0 mm x 9.0 mm 
- 100 mg tablet size: 9.4 mm x 5.3 mm 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: 
- Treatment in monotherapy of infantile spasms (West's syndrome). 
- Treatment in combination with other antiepileptic medicinal products for patients with resistant 

partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all 
other appropriate medicinal product combinations have proved inadequate or have not been 
tolerated. 

 
4.2 Posology and method of administration 
 
Vigabatrin treatment may only be initiated by a specialist in epileptology, neurology or paediatric 
neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology 
or paediatric neurology. 
 
Posology 
 
Monotherapy for infantile spasms (West’s Syndrome) 
The recommended starting dose is 50 mg/kg/day. Subsequent dosing can be titrated by 25 mg/kg/day 
increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.  
  



3 

Table 1: Number of soluble tablets according to body weight, starting dose and dose increment 
in infantile spasms 
 

Body 
weight 

(kg) 

Starting dose of 
50 mg/kg/day 

 

Proposed doses for first 
titration step (75 mg/kg/day) 

(Day 3) 

Proposed doses for second 
titration step (100 mg/kg/day) 

(Day 6) 

3 0.5 x 100 mg tablet morning 1 x 100 mg tablet evening 
1 x 100 mg tablet morning 
1.5 x 100 mg tablet evening 

1.5 x 100 mg tablet morning 
1.5 x 100 mg tablet evening 

4 1 x 100 mg tablet morning 1 x 100 mg tablet evening 
1.5 x 100 mg tablet morning 
1.5 x 100 mg tablet evening 

2 x 100 mg tablet morning 
2 x 100 mg tablet evening 

5 1 x 100 mg tablet morning 1.5 x 100 mg tablet evening 
1.5 x 100 mg tablet morning 
2 x 100 mg tablet evening 

2.5 x 100 mg tablet morning 
2.5 x 100 mg tablet evening 

6 1.5 x 100 mg tablet morning 1.5 x 100 mg tablet evening 
2 x 100 mg tablet morning 
2.5 x 100 mg tablet evening 

3 x 100 mg tablet morning 
3 x 100 mg tablet evening 

7 1.5 x 100 mg tablet morning 2 x100 mg tablet evening 
2.5 x 100 mg tablet morning 
2.5 x 100 mg tablet evening 

3.5 x 100 mg tablet morning 
3.5 x 100 mg tablet evening 

8 2 x 100 mg tablet morning 2 x 100 mg tablet evening 
3 x 100 mg tablet morning 
3 x 100 mg tablet evening 

4 x 100 mg tablet morning 
4 x 100 mg tablet evening 

9 2 x 100 mg tablet morning 2.5 x 100 mg tablet evening 
3.5 x 100 mg tablet morning 
3.5 x 100 mg tablet evening 

4.5 x 100 mg tablet morning 
4.5 x 100 mg tablet evening 

10 0.5 x 500 mg tablet morning 0.5 x 500 mg tablet evening 
0.5 x 500 mg tablet morning 
1 x 500 mg tablet evening 

1 x 500 mg tablet morning 
1 x 500 mg tablet evening 

11 2.5 x 100 mg tablet morning 3 x 100 mg tablet evening 
4 x 100 mg tablet morning 
4 x 100 mg tablet evening 

1 x 500 mg tablet morning 
1 x 500 mg and 1 x 100 mg 
tablet evening 

12 3 x 100 mg tablet morning 3 x 100 mg tablet evening 
4.5 x 100 mg tablet morning 
4.5 x 100 mg tablet evening 

1 x 500 mg and 1 x 100 mg 
tablet morning 
1 x 500 mg and 1 x 100 mg 
tablet evening 

13 3 x 100 mg tablet morning 3.5 x 100 mg tablet evening 
4.5 x 100 mg tablet morning 
1 x 500 mg tablet evening 

1 x 500 mg and 1 x 100 mg 
tablet morning 
1 x 500 mg and 2 x 100 mg 
tablet evening 

14 3.5 x 100 mg tablet morning 3.5 x 100 mg tablet evening 
1 x 500 mg tablet morning 
1 x 500 mg tablet evening 

1 x 500 mg and 2 x 100 mg 
tablet morning 
1 x 500 mg and 2 x 100 mg 
tablet evening 

15 0.5 x 500 mg tablet morning 1 x 500 mg tablet evening 

1 x 500 mg tablet morning 
1 x 500 mg and 1 x 100 mg 
tablet evening 

1.5 x 500 mg tablet morning 
1.5 x 500 mg tablet evening 

16 4 x 100 mg tablet morning 4 x 100 mg tablet evening 

1 x 500 mg and 1 x 100 mg 
tablet morning 
1 x 500 mg and 1 x 100 mg 
tablet evening 

1 x 500 mg and 3 x 100 mg 
tablet morning 
1 x 500 mg and 3 x 100 mg 
tablet evening 

 
Resistant partial epilepsy (focal onset seizures) 
The recommended starting dose is 40 mg/kg/day.  
 
Maintenance recommendations in relation to bodyweight are: 
Bodyweight:   10 to 15 kg:  0.5 to 1 g/day 
   15 to 30 kg:  1 to 1.5 g/day 
 
Table 2: Number of soluble tablets according to body weight and starting dose in resistant 
partial epilepsy 
 



4 

Body weight 
(kg) 

Starting dose of 
40 mg/kg/day 

 

3 0.5 x 100 mg tablet morning 0.5 x 100 mg tablet evening 

4 0.5 x 100 mg tablet morning 1 x 100 mg tablet evening 

5 1 x 100 mg tablet morning 1 x 100 mg tablet evening 

6 1 x 100 mg tablet morning 1.5 x 100 mg tablet evening 

7 1.5 x 100 mg tablet morning 1.5 x 100 mg tablet evening 

8 1.5 x 100 mg tablet morning 2 x 100 mg tablet evening 

10 2 x 100 mg tablet morning 2 x 100 mg tablet evening 
13 2.5 x 100 mg tablet morning 

2.5 x 100 mg tablet evening 

15 3 x 100 mg tablet morning 3 x 100 mg tablet evening 

17 3.5 x 100 mg tablet morning 3.5 x 100 mg tablet evening 

19 3.5 x 100 mg tablet morning 4 x 100 mg tablet evening 

22 4.5 x 100 mg tablet morning 4.5 x 100 mg tablet evening 

25 1 x 500 mg tablet morning 1 x 500 mg tablet evening 

28 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 

30 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 
 
 
Kigabeq is for oral or gastric administration twice daily and may be taken before or after meals.  
 
The maximum recommended dose should not be exceeded. 
 
If control of epilepsy is not clinically significantly improved after an adequate treatment course, 
vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close 
medical supervision. 
 
Renal impairment 
Since vigabatrin is eliminated via the kidneys, caution should be exercised when administering the 
medicinal product to patients with creatinine clearance less than 60 ml/min. Adjustment of dose 
should be considered. Such patients may respond to a lower maintenance dose. Patients should be 
monitored for adverse reactions such as sedation or confusion (see sections 4.4 and 4.8). 
 
Hepatic impairment 
Vigabatrin is not metabolised by hepatic enzymes, hence there is no need of adjustment of dose or 
frequency of administration. 
 
Paediatric population 



5 

There is no relevant use of Kigabeq in neonates (below 27 days of age) in the indication “infantile 
spasms” and in children and adolescents above 7 years of age in the indication “resistant partial 
epilepsy” (focal onset seizures). 
 
Method of administration  
 
Kigabeq is for oral or gastric use and may be taken before or after meals.  
Gastric administration should be used for children who cannot swallow, but can be fed by enteral 
route. 
The method of administration will be determined by a physician specialised in epileptology, neurology 
or paediatric neurology. 
 
For instructions on dissolution and handling of the medicinal product before administration, see 
section 6.6. 
 
Oral administration 
Since no stability studies have been performed with other solvents than water, for preparing oral 
solution only water should be used. When the tablets are fully disintegrated, the whole content of 
solution should be administered straight away to the child directly from the drinking glass. If there is a 
risk of regurgitation or if the child is not old enough to drink from a glass, the whole content of 
solution should be withdrawn with a syringe for oral use, the end of the syringe should be put in the 
mouth of the child and gently pushed on the plunger. 

Once the child has entirely drunk the medicine solution, the drinking glass should be rinsed with one 
or two teaspoons of water (approximately 5 or 10 ml) and dispensed to the child by the same way. 
 
Gastric administration 
For patients who cannot swallow, administration of Kigabeq using a gastric tube is possible.  
Tablets are disintegrated in approximately 5 or 10 ml of water and the resulting solution is introduced 
into the tube using an adapted syringe. The gastric tube should be rinsed with 10 ml of water. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Visual field defects (VFD) have been reported in patients receiving vigabatrin with a high prevalence 
(about 1/3 of patients). Frequencies found in an open clinical study are presented in section 4.8. The 
onset is usually after months to years of vigabatrin therapy. The degree of visual field constriction may 
be severe and this may have practical consequences for the patient. Vigabatrin can cause permanent 
vision loss. 
 
Most of the patients with perimetry-confirmed defects have been asymptomatic. Hence, this 
undesirable effect can only be reliably detected by systematic perimetry which is usually possible only 
in patients with a developmental age of more than 9 years. For younger patients electroretinography 
should be used (see Visual Field Defects). 
Available data suggests that visual field defects are irreversible even after discontinuation of 
vigabatrin. A deterioration of VFD after the treatment is discontinued cannot be excluded. 
 
Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with 
alternatives. 
 
Vigabatrin is not recommended for use in patients with any pre-existing clinically significant visual 
field defect. 
 



6 

Patients should undergo systematic screening examination when starting vigabatrin and at regular 
intervals for detection of visual field defects. Visual field testing should continue at 6 month intervals 
for the whole duration of treatment. The assessment must be continued 6 to 12 months after the 
discontinuation of therapy (see Visual Field Defects).  
 
Visual Field Defects (VFD) 
 
Based on available data, the usual pattern is a concentric constriction of the visual field of both eyes, 
which is generally more marked nasally than temporally. In the central visual field (within 30 degree 
of eccentricity), frequently an annular nasal defect is seen. However, the VFDs reported in patients 
receiving vigabatrin have ranged from mild to severe. Severe cases are potentially disabling.  
 
Most patients with perimetry-confirmed defects had not previously spontaneously noticed any 
symptoms, even in cases where a severe defect was observed in perimetry. Available evidence 
suggests that the VFD is irreversible even after discontinuation of vigabatrin. A deterioration of VFD 
after the treatment is discontinued cannot be excluded. 
Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin 
therapy have VFDs. Males may be at greater risk than females. Frequencies found in an open clinical 
study are presented in section 4.8. A possible association between the risk of visual field defects and 
the extent of vigabatrin exposure, both in terms of daily dose (from 1 gram to more than 3 grams) and 
in terms of duration of treatment (maximum during the first three years) has been shown in this study. 
 
All patients should have ophthalmological consultation before or shortly after the initiation of 
vigabatrin treatment.  
 
Perimetry is seldom possible in children less than 9 years of developmental age. The risks of treatment 
must be very carefully weighed against possible benefit in children. Currently, there is no established 
method to diagnose or exclude visual field defects in children in whom a standardised perimetry 
cannot be performed. Frequency and severity have only been indirectly characterised in this 
population on the presence of electroretinogram or visual evoked potential anomalies. 
 
Electroretinography is recommended in infants and children who are unable to cooperate with 
perimetry. Based on the available data the first oscillatory potential and 30 Hz flicker responses of the 
electroretinogram appear to be correlated with a vigabatrin associated VFD. These responses are 
delayed and reduced beyond the normal limits. Such changes have not been seen in vigabatrin treated 
patients without a VFD. 
 
The parents and/or caregivers must be given a thorough description of the frequency and implications 
of the development of VFD during vigabatrin treatment. 
VFD may not be detected until it is severe and undetected moderate defects may affect child integrity. 
Therefore, vision assessment is required at baseline (no later than 4 weeks after starting treatment) and 
at least every 6 months while on therapy. The assessment must be continued 6 to 12 months after the 
discontinuation of therapy.  
 
Available data suggests that visual field defects are irreversible.  
 
If a visual field constriction is observed during follow-up, consideration should be given to gradual 
discontinuation of vigabatrin. If the decision to continue treatment is made, consideration should be 
given to more frequent follow-up (perimetry) in order to detect progression or sight threatening 
defects. 
 
Vigabatrin should not be used concomitantly with other retinotoxic medicinal products.  
 
Neurologic and psychiatric conditions  
 



7 

In view of the results of the animal safety studies (see section 5.3) it is recommended that patients 
treated with vigabatrin are closely observed for adverse reactions on neurological function. 
 
Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in 
association with non-specific slow wave activity on electroencephalogram have been described soon 
after the initiation of vigabatrin treatment. Risk factors for the development of these reactions include 
higher than recommended starting dose, faster dose escalation at higher steps than recommended and 
renal failure. These events have been reversible following dose reduction or discontinuation of 
vigabatrin (see section 4.8).  
 
Abnormal Magnetic Resonance Imaging signals 
Abnormal Magnetic Resonance Imaging (MRI) signal changes characterised by increased T2 signal 
and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and 
cerebellum have been observed in some infants treated with vigabatrin for infantile spasms. In a 
retrospective epidemiologic study in infants with infantile spasms (N=205), the prevalence of these 
changes was 22% in vigabatrin treated patients versus 4% in patients treated with other therapies.  
 
In the study above, in post-marketing experience, and in published literature reports, these changes 
generally resolved with discontinuation of treatment. In a few patients, the lesion resolved despite 
continued use.  
 
Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients 
treated with vigabatrin for infantile spasms. The benefit/risk ratio of vigabatrin should be evaluated on 
an individual patient basis. If new movement disorders occur during treatment with vigabatrin, 
consideration should be given to dose reduction or a gradual discontinuation of treatment. 
 
Some patients may experience an increase in seizure frequency or the onset of new types of seizures 
with vigabatrin (see section 4.8). Patients with myoclonic seizures may be particularly susceptible to 
this effect. New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases. 
These phenomena may also be the consequence of an overdose, a decrease in plasma concentrations of 
concomitant antiepileptic treatment, or a paradoxical effect.  
 
Abrupt withdrawal may lead to rebound seizures. If a patient is to be withdrawn from vigabatrin 
treatment, it is recommended that this is done by gradual dose reduction over a 2- to 4-week period.  
 
Vigabatrin should be used with caution in patients with a history of psychosis, depression or 
behavioural problems. Psychiatric events (e.g., agitation, depression, abnormal thinking, paranoid 
reactions) have been reported during vigabatrin treatment. These events occurred in patients with and 
without a psychiatric history and were usually reversible when vigabatrin doses were reduced or 
gradually discontinued. 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled trials of 
antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this effect is not known and the available data do not exclude the 
possibility of an increased risk for vigabatrin.  
 
Therefore, patients should be monitored for signs of suicidal ideation and behaviour, and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical 
advice immediately should signs of suicidal ideation or behaviour emerge. 
 
Renal impairment 
 



8 

Since vigabatrin is eliminated via the kidneys, caution should be exercised in patients with a creatinine 
clearance of less than 60 ml/min. These patients should be monitored closely for undesirable effects 
such as sedation and confusion (see section 4.2). 
 
Interference with serological testing 
 
Vigabatrin may lead to a decrease in measured plasma activity of alanine aminotransferase (ALT) and 
to a lesser extent, aspartate aminotransferase (AST). The magnitude of suppression for ALT has been 
reported to vary between 30% and 100%. Therefore, these liver tests may be quantitatively unreliable 
in patients taking vigabatrin (see section 4.8). 
 
Vigabatrin may increase the amount of amino acids in the urine possibly leading to a false positive test 
for certain rare genetic metabolic disorders (e.g., alpha aminoadipic aciduria). 
 
Risk of medication error 
Because both tablet strengths (100 mg and 500 mg) can be used concomitantly there may be confusion 
between the tablets or tablet halves administered with a risk of incorrect dosing. Special attention 
should be paid to the tablet size to correctly identify the strength. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome 
P450 metabolising-enzymes, interactions with other medicinal products are unlikely. However, during 
controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has 
been observed. The exact nature of this interaction is presently not understood, however, in the 
majority of cases it is unlikely to be of therapeutic significance. 
 
The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been 
monitored during controlled clinical trials and no clinically significant interactions have been detected. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
This medicinal product is not intended for use in women of child-bearing potential. 
 
Breastfeeding 
 
This medicinal product is not intended for use in women who are breastfeeding. 
 
Fertility 
 
Fertility studies in rats have shown no effect on male and female fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Kigabeq has major influence on the ability to perform hazardous activities. 
 
In view of the fact that drowsiness has been observed in clinical trials with vigabatrin, patients should 
be warned of this possibility at the start of treatment. 
Visual field defects which can significantly affect the ability to perform hazardous activities have been 
frequently reported in association with vigabatrin. Patients should be evaluated for the presence of 
visual field defects (see also section 4.4). Special care should be taken with young patients cycling, 
climbing or performing any other hazardous activity. 
 



9 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most commonly reported adverse reaction related to vigabatrin are visual field defects (ranging 
from mild to severe and occurring usually after months to years of vigabatrin therapy), psychiatric 
disorders such as agitation, excitation, aggression, nervousness, depression, paranoid reaction, nervous 
system disorders such as marked sedation, stupor and confusion. Rarely seen events include suicide 
attempts, encephalopathy and retinal disorders.  
 
Some patients may experience an increase in seizure frequency, including status epilepticus with 
vigabatrin. Patients with myoclonic seizures may be particularly susceptible to this effect. New onset 
myoclonus and exacerbation of existing myoclonus may occur in rare cases. 
 
Tabulated list of adverse reactions 
 
The adverse reactions listed below have been reported during pre- or post-approval use of vigabatrin 
worldwide. They are not specific to the paediatric population. 
 
Undesirable effects ranked under headings of frequency are listed below, using the following 
convention: 
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
  



10 

 
 
System 
organ class 

Very 
common 

Common Uncommon Rare Very rare Not known 

Blood and 
lymphatic 
system 
disorders 

  anaemia          

Psychiatric 
disorders 

   agitation, 
aggression, 
nervousness, 
depression, 
paranoid 
reaction  

hypomania, 
mania, 
psychotic 
disorder  

suicide 
attempt  

hallucination    

Nervous 
system 
disorders 

somnolenc
e  

speech 
disorder, 
headache, 
dizziness, 
paraesthesia, 
disturbance in 
attention and 
memory 
impairment, 
mental 
impairment 
(thought 
disturbance), 
tremor  

coordination 
abnormal 
(ataxia)  

encephalo
pathy  

optic neuritis  brain MRI 
abnormalities. 
movement 
disorders, 
including 
dystonia, 
dyskinesia and 
hypertonia, 
either alone or 
in association 
with 
abnormalities 
in MRI  

Eye 
disorders 

visual field 
defect  

vision blurred, 
diplopia, 
nystagmus  

  retinal 
disorder 
(such as 
peripheral 
retinal 
atrophy)  

optic atrophy    

Gastrointesti
nal disorders 

  nausea, 
vomiting, 
abdominal 
pain  

        

Hepatobiliar
y disorders 

        hepatitis    

Skin and 
subcutaneou
s tissue 
disorders 

    rash  angioede
ma, 
urticaria  

    

Musculoskel
etal and 
connective 
tissue 
disorders 

arthralgia            

General 
disorders 
and 

fatigue  oedema, 
irritability  

        



11 

administratio
n site 
conditions 
Investigation
s 

  weight 
increased  

        

 
Visual field defects 
Epidemiology of VFD in patients with refractory partial epilepsy was observed in an observational, 
open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 
years old, with refractory partial epilepsy for at least one year. 
 
Patients were split in three treatment groups: patients currently treated with vigabatrin (group I), 
patients previously exposed to vigabatrin (group II) and patients never exposed to vigabatrin (group 
III).  
 
The following table presents the main findings at inclusion and the first and last conclusive 
evaluations in the evaluable population (n=524): 
 
 Children (from 8 to 12 years old) Adolescents and adults (>12 years old) 

Group I 1 Group II 2 Group III Group I 3 Group II 4 Group III 
N=38 N=47 N=41 N=150 N=151 N=97 

Visual field 
defect with 
non-identified 
aetiology: 

      

- Observed at 
inclusion 

1 (4.4%) 3 (8.8%) 2 (7.1%) 31 (34.1%) 20 (19.2%) 1 (1.4%) 

- Observed at 
first 
conclusive 
evaluation 

4 (10.5%) 6 (12.8%) 2 (4.9%) 59 (39.3%) 39 (25.8%) 4 (4.1%) 

- Observed at 
last conclusive 
evaluation 

10 (26.3%) 7 (14.9%) 3 (7.3%) 70 (46.7%) 47 (31.1%) 5 (5.2%) 

 
1 Median treatment duration: 44.4 months, mean daily dose 1.48 g 
2 Median treatment duration: 20.6 months, mean daily dose 1.39 g 
3 Median treatment duration: 48.8 months, mean daily dose 2.10 g 
4 Median treatment duration: 23.0 months, mean daily dose 2.18 g 
 
  



12 

Description of selected adverse reactions 
 
Psychiatric reactions have been reported during vigabatrin therapy. These reactions occurred in 
patients with and without a psychiatric history and were usually reversible when vigabatrin doses were 
reduced or gradually discontinued (see section 4.4). Depression was a common psychiatric reaction in 
clinical trials but seldom required discontinuation of vigabatrin.  
Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in 
association with non-specific slow wave activity on electroencephalogram have been described soon 
after the initiation of vigabatrin treatment. Such reactions have been fully reversible following dose 
reduction or discontinuation of vigabatrin (see section 4.4).  
Laboratory data indicate that vigabatrin treatment does not lead to renal toxicity. Decreases in ALT 
and AST, which are considered to be a result of inhibition of these aminotransferases by vigabatrin, 
have been observed. Chronic treatment with vigabatrin may be associated with a slight decrease in 
haemoglobin which rarely attains significance. 
 
Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been 
observed in some infants treated with vigabatrin for infantile spasms. The clinical significance of these 
MRI abnormalities is unknown. As routine MRI surveillance of this paediatric population is not 
recommended, the frequency of MRI abnormalities cannot be reliably estimated from the available 
data. Movement disorders either alone or in association with abnormalities in MRI have been reported 
in patients treated with vigabatrin for infantile spasms but their frequency is not known. 
 
Paediatric population 
 
Psychiatric disorders 
Very common: excitation, agitation 
 
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 
 
Vigabatrin overdose has been reported. When provided, doses were most commonly between 7.5 to 
30 g; however, ingestions up to 90 g have been reported. Nearly half of the cases involved multiple 
drug ingestions. When reported, the most common symptoms included drowsiness or coma. Other less 
frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, 
bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.  
 
Management 
 
There is no specific antidote. The usual supportive measures should be employed. Measures to remove 
unabsorbed medicinal product should be considered. Activated charcoal has been shown to not 
significantly adsorb vigabatrin in an in vitro study. The effectiveness of haemodialysis in the treatment 
of vigabatrin overdose is unknown. In isolated case reports in renal failure patients receiving 
therapeutic doses of vigabatrin, haemodialysis reduced vigabatrin plasma concentrations by 40% to 
60%. 
 
  



13 

 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04 
 
Mechanism of action 
 
Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the 
breakdown of GABA (gamma aminobutyric acid). Vigabatrin increases the concentration of GABA, 
the major inhibitory neurotransmitter in the brain.  
 
Clinical efficacy and safety 
 
Controlled and long-term clinical trials have shown that vigabatrin is an effective anticonvulsant agent 
when given as first line treatment in patients with infantile spasms and as add-on therapy in patients 
with epilepsy not controlled satisfactorily by conventional therapy. This efficacy is particularly 
marked in patients with seizures of partial origin. 
 
5.2 Pharmacokinetic properties 
 
Adults 
 
Absorption 
Vigabatrin is a water soluble compound and it is rapidly and completely absorbed from the 
gastrointestinal tract. Food administration does not alter the extent of vigabatrin absorption. Time to 
reach maximum plasma concentrations (tmax) is approximately 1 hour. 
 
Distribution 
Vigabatrin is widely distributed with an apparent volume of distribution slightly greater than total 
body water. Binding to plasma proteins is negligible. Plasma and cerebrospinal fluid concentrations 
are linearly related to dose over the recommended dose range. 
 
Biotransformation 
Vigabatrin is not significantly metabolised. No metabolites have been identified in plasma. 
 
Elimination 
Vigabatrin is eliminated via renal excretion with a terminal half-life of 5-8 hours. Oral clearance 
(Cl/F) of vigabatrin is approximately 7 l/h (i.e. 0.10 l/h/kg). Approximately 70% of a single oral dose 
was recovered as unchanged drug in the urine in the first 24 hours post-dose. 
 
Pharmacokinetic/pharmacodynamic relationship(s) 
There is no direct correlation between plasma concentration and efficacy. The duration of the effect of 
the medicinal product is dependent on the GABA transaminase re-synthesis rate. 
 
Paediatric population 
 
Pharmacokinetic properties of vigabatrin have been investigated in groups of six neonates (age 15-
26 days), six infants (age 5-22 months) and six children (age 4.6-14.2 years) with refractory epilepsy.  
 
After administration of a single 37-50 mg/kg dose of an oral solution vigabatrin tmax was 
approximately 2.5 hours in neonates and infants, and 1 hour in children. Mean terminal half-life of 
vigabatrin was about 7.5 hours in neonates, 5.7 hours in infants and 5.5 hours in children. The mean 
Cl/F of active S-enantiomer of vigabatrin in infants and children was 0.591 l/h/kg and 0.446 l/h/kg 
respectively. 



14 

 
5.3 Preclinical safety data 
 
Animal safety studies carried out in the rat, mouse, dog and monkey have indicated that vigabatrin has 
no significant adverse reactions on the liver, kidney, lung, heart or gastrointestinal tract.  
 
In the brain, microvacuolation due to intramyelinic oedema has been observed in white matter tracts of 
rat, mouse and dog at doses of 30-50 mg/kg/day. In the monkey these lesions are minimal or 
equivocal. In both rat and dog they were reversible on stopping vigabatrin treatment and even 
regressed with continued treatment.  
 
Vigabatrin-associated retinotoxicity has been observed in 80-100% of albino rats at the dose of 
300 mg/kg/day orally, but not in pigmented rats, dogs or monkeys. The retinal changes in albino rats 
were characterised as focal or multifocal disorganisation of the outer nuclear layer while the other 
layers of retina were not affected.  
 
Animal experiments have shown that vigabatrin has no negative influence on fertility or pup 
development. No teratogenicity was seen in rats in doses up to 150 mg/kg (3 times the human dose) or 
in rabbits in doses up to 100 mg/kg. However, in rabbits, a slight increase in the incidence of cleft 
palate at doses of 150-200 mg/kg was seen. 
 
Studies with vigabatrin revealed no evidence of mutagenic or carcinogenic effects.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Crospovidone type B 
Mannitol  
Sodium stearyl fumarate 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
4 years 
Use immediately following preparation of the oral solution. 
After first opening: 100 days  
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Kigabeq 100 mg soluble tablets 
 
HDPE bottle closed with a child resistant tamper evident PP screw cap. 
Pack size: 100 soluble tablets.  
 
Kigabeq 500 mg soluble tablets 
 
HDPE bottle closed with a child resistant tamper evident PP screw cap. 
Pack size: 50 soluble tablets.  



15 

 
6.6 Special precautions for disposal and other handling 
 
Dissolution of soluble tablet 
 
Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the 
age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water. Wait until 
the tablet(s) fully disintegrate; tablets generally disintegrate in less than one minute but disintegration 
can be fastened by gently hand stirring the oral solution.  
The resulting solution is whitish and cloudy. This is normal and due to presence of water-insoluble 
excipients. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ORPHELIA Pharma SAS  
85 boulevard Saint-Michel 
75005 PARIS 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Kigabeq 100 mg soluble tablets 
EU/1/18/1302/001  
 
Kigabeq 500 mg soluble tablets 
EU/1/18/1302/002  
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 September 2018 
 
 
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. 
 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER(S) 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 
 

 



17 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) responsible for batch release 

Farmea 
10, rue Bouché Thomas 
ZAC d'Orgemont 
F-49000 Angers 
France 
 
Centre Spécialités Pharmaceutiques 

  76-78 avenue du Midi 
  63800 Cournon d’Auvergne 

France 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 

• Periodic safety update reports  
 

The requirements for submission of periodic safety update reports 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 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.  

 

 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kigabeq 100 mg soluble tablets 
vigabatrin  
For children aged 1 month to less than 7 years 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each soluble tablet contains 100 mg vigabatrin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 soluble tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral and gastric 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 
 
 
 



21 

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 
 
ORPHELIA Pharma SAS  
85 boulevard Saint-Michel 
75005 PARIS 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1302/001  
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Kigabeq 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR BOTTLE CONTAINING 100 SOLUBLE TABLETS OF KIGABEQ 100 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kigabeq 100 mg soluble tablets 
vigabatrin  
For children aged 1 month to less than 7 years 
 



22 

 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each soluble tablet contains 100 mg vigabatrin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 soluble tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral and gastric 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 
 
 
 
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 
 
ORPHELIA Pharma SAS  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1302/001  



23 

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



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON CONTAINING 1 BOTTLE OF 50 SOLUBLE TABLETS OF KIGABEQ 500 MG 
 
  
1. NAME OF THE MEDICINAL PRODUCT 
 
Kigabeq 500 mg soluble tablets 
vigabatrin  
For children aged 1 month to less than 7 years 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each soluble tablet contains 500 mg vigabatrin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 soluble tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral and gastric 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 
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



25 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ORPHELIA Pharma SAS  
85 boulevard Saint-Michel 
75005 PARIS 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1302/002 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Kigabeq 500 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



26 

 
 
PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING  
 
LABEL FOR BOTTLE CONTAINING 50 SOLUBLE TABLETS OF KIGABEQ 500 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kigabeq 500 mg soluble tablets 
vigabatrin  
For children aged 1 month to less than 7 years 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each soluble tablet contains 500 mg vigabatrin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 soluble tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral and gastric 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 
 
 
 



27 

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 
 
ORPHELIA Pharma SAS 
85 boulevard Saint-Michel 
75005 PARIS 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1302/002 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
  



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



29 

Package leaflet: Information for the user 
 

Kigabeq 100 mg soluble tablets 
For children aged 1 month to less than 7 years 

 
Kigabeq 500 mg soluble tablets 

For children aged 1 month to less than 7 years 
 
 

vigabatrin 
 

 
Read all of this leaflet carefully before you give this medicine to your child because it contains 
important information. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your child’s doctor or pharmacist. 
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as your child’s. 
- If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Kigabeq is and what it is used for  
2. What you need to know before your child takes Kigabeq 
3. How to give Kigabeq  
4. Possible side effects  
5. How to store Kigabeq  
6. Contents of the pack and other information 
 
 
1. What Kigabeq is and what it is used for 
 
Kigabeq contains vigabatrin and it is used for treating infants and children aged from 1 month to less 
than 7 years. It is used to treat infantile spasms (West’s syndrome) or, together with other epilepsy 
medicines to treat partial epilepsy that is not controlled well enough with current treatment.  
 
 
2. What you need to know before your child takes Kigabeq  
 
Do not give Kigabeq: 
- if your child is allergic to vigabatrin or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your child’s doctor before you give Kigabeq if your child: 
- has or has had depression or any other psychiatric illness in the past 
- has had any kidney problems as he/she could develop symptoms like sedation or confusion  
- has had any eye problems. 
 

Visual field loss (loss of sight from the edges of your child’s field of vision) may occur during 
treatment with vigabatrin. You should discuss this possibility with the doctor before your child begins 
treatment and the doctor will tell you how to detect this side effect. This visual field loss may be 
severe and permanent, so it must be detected early to avoid progression. Worsening of visual field loss 
may continue after stopping treatment. It is important that you tell the doctor promptly if there is any 



30 

change in your child’s vision. The doctor will check your child’s visual field before your child starts 
taking vigabatrin and carry on checking it at regular intervals during the treatment. 
 
If your child develops symptoms like sleepiness, reduced consciousness and movements (stupor) or 
confusion, tell your child’s doctor who may reduce the dose or stop Kigabeq treatment. 
 
A small number of people being treated with epilepsy medicines such as vigabatrin have had thoughts 
of harming or killing themselves. Look for symptoms suggestive of such thoughts: disturbed sleep, 
loss of appetite or weight, isolation, loss of interest for favorite activities. 
If at any time your child has had these symptoms, immediately contact child’s doctor. 
 
Movement disorders can occur in young infants treated for infantile spasms (West’s syndrome). If you 
see unusual movements in your child, tell your child’s doctor who may change the treatment. 
 
Tell your child’s doctor if your child has had or is going to perform laboratory tests because this 
medicine may lead to abnormal results. 
 
You must speak to your child’s doctor if your child’s condition does not improve within a month of 
starting vigabatrin.  
 
Children 
Do not give this medicine to children less than 1 month of age or more than 7 years of age. 
 
Other medicines and Kigabeq 
Tell your child’s doctor if the child is taking, has recently taken or might take any other medicines. 
Kigabeq should not be used in combination with other medicines that may have side effects related to 
the eye. 
 
Pregnancy and breast-feeding  
This medicine is not intended for use in women of child-bearing potential or in breast-feeding women. 
 
Driving and using machines 
Your child should not ride a bicycle, climb or take part in hazardous activity if the child has symptoms 
like drowsiness or dizziness with Kigabeq. Visual disorders, which can affect the ability to cycle, 
climb or take part in hazardous activity, have occurred in some patients taking this medicine. 
 
 
3. How to give Kigabeq 
 
Always give this medicine to your child exactly as the doctor has told you. Check with the doctor or 
pharmacist if you are not sure. 
 
Dose 
Never change the dose yourself. The doctor works out the dose individually for your child, taking 
account of the child’s body weight. 
 
Kigabeq is available as 100 mg or 500 mg tablets which can be given together to make up the right 
dose for your child. Always check the label and the size of the tablets to make sure you are giving the 
right dose. 
 
In infantile spasms (West’s Syndrome), the recommended starting dose is 50 milligrams per kilogram 
bodyweight daily. In resistant partial epilepsy (focal onset seizures), the recommended starting dose is 
40 milligrams per kilogram daily. The doctor will adjust the dose during treatment as necessary. If 
your child has kidney problems, the doctor may prescribe a smaller dose. 
 



31 

The following table gives the number of Kigabeq tablets to give to your child according to the dose 
prescribed by your child’s doctor.  
 

Dose 
(mg per day) 

Number of tablets (strength) 
Morning  

Number of tablets (strength) 
Evening 

150 Half a tablet (100 mg) One tablet (100 mg) 
200 One tablet (100 mg) One tablet (100 mg) 
250 One tablet (100 mg) One and a half tablets (100 mg) 
300 One and a half tablets (100 mg) One and a half tablets (100 mg) 
350 One and a half tablets (100 mg) Two tablets (100 mg) 
400 Two tablets (100 mg) Two tablets (100 mg) 
450 Two tablets (100 mg) Two and a half tablets (100 mg) 

500 
Half a tablet (500 mg) or two and a half tablets (100 

mg) 
Half a tablet (500 mg) or two and a half tablets (100 

mg) 
550 Two and a half tablets (100 mg) Three tablets (100 mg) 
600 Three tablets (100 mg) Three tablets (100 mg) 
650 Three tablets (100 mg) Three and a half tablets (100 mg) 
700 Three and a half tablets (100 mg) Three and a half tablets (100 mg) 
750 Half a tablet (500 mg) One tablet (500 mg) 
800 Four tablets (100 mg) Four tablets (100 mg) 
850 Four tablets (100 mg) Four and a half tablets (100 mg) 
900 Four and a half tablets (100 mg) Four and a half tablets (100 mg) 
950 Four and a half tablets (100 mg) One tablet (500 mg) 

1000 One tablet (500 mg) One tablet (500 mg) 
1100 One tablet (500 mg)  One tablet (500 mg) and one tablet (100 mg) 
1200 One tablet (500 mg) and one tablet (100 mg) One tablet (500 mg) and one tablet (100 mg) 
1300 One tablet (500 mg) and one tablet (100 mg) One tablet (500 mg) and two tablets (100 mg) 
1400 One tablet (500 mg) and two tablets (100 mg) One tablet (500 mg) and two tablets (100 mg) 
1500 One and a half tablets (500 mg) One and a half tablets (500 mg) 

 
How to give this medicine 
Ask your child’s doctor to show you how to give this medicine. Check with the doctor or pharmacist if 
you are not sure. 
 
Kigabeq is to be given by mouth and may be taken before or after meals. The tablet can be cut into 
equal halves. 
 
Use only water to prepare solution. 
 
• Pour one or two teaspoonfuls (about 5 to 10 ml) of water into a drinking glass or beaker 
• Add the right dose of Kigabeq tablets (as whole or half tablets) to the water 
• Wait until the tablet has broken down completely. This takes less than a minute but you can speed 

it up by stirring the mixture gently by hand 
• The mixture will be whitish and cloudy. This is normal and the cloudiness is because the tablet 

contains some non-active ingredients that do not dissolve completely 
• Give the mixture straightway to your child direct from the drinking glass or beaker 
• If your child cannot drink from the glass or beaker then you can use an oral syringe to gently 

squirt the mixture into your child's mouth, taking care not to cause choking: sit just in front and 
below your child in order that he/she has the head leaning forward and administer the mixture 
against his cheek 

• Rinse the glass or beaker with one or two teaspoonfuls (about 5 to 10 ml) of water and give this to 
your child to make sure that the child receives all the medicine 



32 

• If the child cannot swallow, the mixture can be given through a gastric tube, using a suitable 
syringe. The tube should be rinsed with 10 ml of water 

 
If your child takes too much Kigabeq 
If your child accidentally takes too many Kigabeq tablets, tell the doctor immediately or go to your 
nearest hospital or poison information centre. Possible signs of overdose include drowsiness or 
reduced level of consciousness. 
 
If you forget to give your child Kigabeq 
If you forget to give your child a dose, give the dose as soon as you remember. If it is almost time for 
the next dose, just give one dose. Do not give a double dose to make up for a forgotten tablet.  
 
If you stop giving Kigabeq to your child 
Do not stop giving this medicine without talking to your child’s doctor. If the doctor decides to stop 
the treatment you will be advised to gradually reduce the dose. Do not stop suddenly as this may cause 
your child’s seizures to occur again. 
If you have any further questions on the use of this medicine, ask the doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Some patients may have more seizures (fits) whilst taking Kigabeq. If this happens, contact your 
child’s doctor immediately. 
 
Serious side effects 
Get medical advice immediately if your child has the following: 
Very common side effects (may affect more than 1 in 10 people) 
- Visual field changes – About 33 out of 100 patients treated with vigabatrin may have changes in 

the visual field (narrow visual field). This visual field defect can range from mild to severe. It is 
usually detected after months or years of treatment with vigabatrin. The changes in the visual 
field may be permanent, so it is important to detect them early to avoid progression . If your 
child has visual disturbances, contact your child’s doctor or hospital immediately. 

 
Other side effects include: 
Very common side effects (may affect more than 1 in 10 people) 
- excitation or restlessness 
- tiredness and pronounced sleepiness 
- joint pain  
 
Common side effects (may affect up to 1 in 10 people) 
- headache  
- weight gain  
- shaking (tremor ) 
- swelling (oedema)  
- dizziness  
- sensation of numbness or tingling (pins and needles)  
- reduced concentration and memory  
- psychological problems including agitation, aggression, nervousness, irritability, depression, 

thought disturbance and feeling suspicious without reason (paranoia). These side effects usually 
stop when vigabatrin doses are reduced or the medicine is gradually discontinued. However, do 
not decrease the dose without first talking to your child’s doctor. Contact the doctor if your 
child has these psychological effects  

- nausea (feeling sick), vomiting and abdominal pain  
- blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness  
- speech disorder  
- decrease in the number of red blood cells (anaemia) 



33 

Uncommon side effects (may affect up to 1 in 100 people) 
- lack of coordination or fumbling  
- more severe psychological problems such as feeling elated or over-excited, which causes 

unusual behaviour, and feeling detached from reality  
- skin rash  

Rare side effects (may affect up to 1 in 1,000 people) 
- serious allergic reaction, which causes swelling of the face or throat. If your child has these 

symptoms, you should tell his/her doctor immediately  
- hives or nettle rash 
- marked sedation (sleepiness), stupor and confusion (encephalopathy). These side effects usually 

stop when doses are reduced or the medicine is gradually discontinued. However, do not 
decrease the dose without first talking to your child’s doctor. Contact the doctor if your child 
has these effects  

- suicide attempt 
- other eye problems such as retinal disorder, causing, for example, poor vision at night and 

difficulty adjusting from bright to dim areas, sudden or unexplained loss of vision, sensitivity to 
light  

Very rare side effects (may affect up to 1 in 10,000 people) 
- other eye problems such as pain in eyes (optic neuritis) and loss of vision, including colour 

vision (optic atrophy)  
- hallucinations (feeling, seeing or hearing things that are not there)  
- liver problems  

 
Not known (frequency cannot be estimated from the available data) 
- movement disorders and abnormalities in magnetic resonance imaging (MRI) brain scans in 

young infants treated for infantile spasms 
 
Reporting of side effects 
If your child gets any side effects, talk to your child’s 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 Kigabeq 
 
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 the bottle. The expiry 
date refers to the last day of that month. This medicine should be used within 100 days after first 
opening. 
 
This medicinal product does not require any special storage conditions. 
 
The solution should be administered immediately after preparation. 
 
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 Kigabeq contains  



34 

- The active substance is vigabatrin. 
- One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin 
- One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin 
- The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate 
 
What Kigabeq looks like and contents of the pack 
Kigabeq are white oval scored soluble tablets. 

100 mg tablet size: 9.4 mm x 5.3 mm  
500 mg tablet size: 16.0 mm x 9.0 mm 
 
The solution in water is whitish and cloudy. 
 
Pack sizes: 
Kigabeq 100 mg is supplied in packs of 100 soluble tablets. 
Kigabeq 500 mg is supplied in packs of 50 soluble tablets 
 
 
Marketing Authorisation Holder 
ORPHELIA Pharma SAS  
85 boulevard Saint-Michel 
75005 PARIS 
France  
 
Manufacturer 
FARMEA 
10 rue Bouché-Thomas ZAC d'Orgemont 
49000 Angers 
France 
 
Centre Spécialités Pharmaceutiques 
76-78 avenue du Midi 
63800 Cournon d’Auvergne 
France 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 
België/Belgique/Belgien 
ORPHELIA Pharma SAS 
Tél/Tel: + 33 1 42 77 08 18 
 
 

Lietuva 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 
 

България 
ORPHELIA Pharma SAS 
Teл.: + 33 1 42 77 08 18 
 
 

Luxembourg/Luxemburg 
ORPHELIA Pharma SAS 
Tél/Tel: + 33 1 42 77 08 18 

Česká republika 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 
 

Magyarország 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

Danmark Malta 



35 

ORPHELIA Pharma SAS 
Tlf: + 33 1 42 77 08 18 
 

ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

Deutschland 
Desitin Arzneimittel GmbH  
Weg beim Jäger 214  
D-22335 Hamburg  
Tel.: +49 (0) 40 591 01 0  
E-Mail: epi.info@desitin.de 
 

Nederland 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Eesti 
(ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

Norge 
ORPHELIA Pharma SAS 
Tlf: + 33 1 42 77 08 18 
 

Ελλάδα 
ORPHELIA Pharma SAS 
Τηλ: + 33 1 42 77 08 18 
 
 

Österreich 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

España 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

Polska 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

France 
CEMAG Care 
55 rue de Turbigo 
75003 Paris 
Tel: + 33 1 86 22 02 11 
 

Portugal 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Hrvatska 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 
Ireland 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

România 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 
Slovenija 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Ísland 
ORPHELIA Pharma SAS 
Sími: + 33 1 42 77 08 18 
 
 

Slovenská republika 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Italia 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Suomi/Finland 
ORPHELIA Pharma SAS 
Puh/Tel: + 33 1 42 77 08 18 
 
 

Κύπρος 
ORPHELIA Pharma SAS 
Τηλ: + 33 1 42 77 08 18 
 

Sverige 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 

Latvija 
ORPHELIA Pharma SAS 
Tel: + 33 1 42 77 08 18 
 

United Kingdom 
VERITON PHARMA LTD 
Tel: + 44 (0) 1932 690 325 
Fax: +44 (0) 1932 341 091 
Web: www.veritonpharma.com 
 



36 

 
  
 
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  
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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