Lyrica

1 

 

 
 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 25 mg hard capsules 
Lyrica 50 mg hard capsules 

Lyrica 75 mg hard capsules 

Lyrica 100 mg hard capsules 

Lyrica 150 mg hard capsules 

Lyrica 200 mg hard capsules 
Lyrica 225 mg hard capsules 

Lyrica 300 mg hard capsules 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Lyrica 25 mg hard capsules  

Each hard capsule contains 25 mg of pregabalin. 

 

Lyrica 50 mg hard capsules 

Each hard capsule contains 50 mg of pregabalin. 
 

Lyrica 75 mg hard capsules 

Each hard capsule contains 75 mg of pregabalin. 

 

Lyrica 100 mg hard capsules  
Each hard capsule contains 100 mg of pregabalin. 

 

Lyrica 150 mg hard capsules 

Each hard capsule contains 150 mg of pregabalin.  

 
Lyrica 200 mg hard capsules 

Each hard capsule contains 200 mg of pregabalin.  

 

Lyrica 225 mg hard capsules 

Each hard capsule contains 225 mg of pregabalin. 

 
Lyrica 300 mg hard capsules 

Each hard capsule contains 300 mg of pregabalin. 

 

Excipients with known effect 

 
Lyrica 25 mg hard capsules  

Each hard capsule also contains 35 mg lactose monohydrate. 

 

Lyrica 50 mg hard capsules 

Each hard capsule also contains 70 mg lactose monohydrate. 
 

Lyrica 75 mg hard capsules 

Each hard capsule also contains 8.25 mg lactose monohydrate. 

 

Lyrica 100 mg hard capsules 
Each hard capsule also contains 11 mg lactose monohydrate. 

 

Lyrica 150 mg hard capsules 

Each hard capsule also contains 16.50 mg lactose monohydrate. 

 

Lyrica 200 mg hard capsules 
Each hard capsule also contains 22 mg lactose monohydrate. 



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Lyrica 225 mg hard capsules 

Each hard capsule also contains 24.75 mg lactose monohydrate. 

 
Lyrica 300 mg hard capsules 

Each hard capsule also contains 33 mg lactose monohydrate. 

 

 

For the full list of excipients, see section 6.1. 
 

 

3. PHARMACEUTICAL FORM 

 

Hard capsules 
 

Lyrica 25 mg hard capsules 

White marked “Pfizer” on the cap and “PGN 25” on the body with black ink.  

 

Lyrica 50 mg hard capsules 

White marked “Pfizer” on the cap and “PGN 50” on the body with black ink. The body is also marked 
with a black band. 

 

Lyrica 75 mg hard capsules 

White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink.  

 
Lyrica 100 mg hard capsules 

Orange marked “Pfizer” on the cap and “PGN 100” on the body with black ink.  

 

Lyrica 150 mg hard capsules 

White marked “Pfizer” on the cap and “PGN 150” on the body with black ink.  
 

Lyrica 200 mg hard capsules 

Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink.  

 

Lyrica 225 mg hard capsules 

White and light orange marked “Pfizer” on the cap and “PGN 225” on the body with black ink.  
 

Lyrica 300 mg hard capsules 

White and orange, marked “Pfizer” on the cap and “PGN 300” on the body with black ink.  

 

 
4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Neuropathic pain 
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.  

 

Epilepsy 

Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary 

generalisation. 
 

Generalised anxiety disorder 

Lyrica is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.  

 



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4.2 Posology and method of administration 

 

Posology 
The dose range is 150 to 600 mg per day given in either two or three divided doses. 

 

Neuropathic pain 

Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. 

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day 
after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an 

additional 7-day interval. 

 

Epilepsy 

Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses. 
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day 

after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. 

 

Generalised anxiety disorder 

The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment 

should be reassessed regularly. 
 

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient 

response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an 

additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day 

may be achieved after an additional week. 
 

Discontinuation of pregabalin 

In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended 

this should be done gradually over a minimum of 1 week independent of the indication (see 

sections 4.4 and 4.8). 
 

Renal impairment 

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. 

As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose 

reduction in patients with compromised renal function must be individualised according to creatinine 

clearance (CLcr), as indicated in Table 1 determined using the following formula: 

 

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For 

patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. 

In addition to the daily dose, a supplementary dose should be given immediately following every 
4 hour haemodialysis treatment (see Table 1).  

 

 
patients) femalefor  0.85 (  

mol/l)( creatinine serum

(kg)weight   (years) age - 14023.1
(ml/min)CL  cr 













 
=





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Table 1. Pregabalin Dose Adjustment Based on Renal Function 

 

Creatinine 

clearance 

(CLcr) 

(ml/min) 

Total pregabalin daily dose* Dose regimen 

 Starting dose 
(mg/day) 

Maximum dose 
(mg/day) 

 

≥ 60 150 600 BID or TID 

≥ 30 - < 60 75 300 BID or TID 

≥ 15 - < 30 25 – 50 150 Once Daily or BID 

< 15 25 75 Once Daily 

Supplementary dosage following haemodialysis (mg) 

 25 100 Single dose+ 
TID = Three divided doses 
BID = Two divided doses 

* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose 
+ Supplementary dose is a single additional dose 

 

Hepatic impairment 

No dose adjustment is required for patients with hepatic impairment (see section 5.2).  

 
Paediatric population 

The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years 

of age) have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 

but no recommendation on a posology can be made. 

 

Elderly 
Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see 

section 5.2). 

 

Method of administration 

Lyrica may be taken with or without food. 
Lyrica is for oral use only. 

 

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 

 

Diabetic patients 

In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin 

treatment may need to adjust hypoglycaemic medicinal products. 
 

Hypersensitivity reactions 

There have been reports in the postmarketing experience of hypersensitivity reactions, including cases 

of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as 

facial, perioral, or upper airway swelling occur. 
 

Dizziness, somnolence, loss of consciousness, confusion and mental impairment 

Pregabalin treatment has been associated with dizziness and somnolence, which could increase the 

occurrence of accidental injury (fall) in the elderly population. There have also been postmarketing 

reports of loss of consciousness, confusion and mental impairment. Therefore, patients should be 
advised to exercise caution until they are familiar with the potential effects of the medicinal product. 

 



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Vision-related effects 

In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 

did patients treated with placebo which resolved in a majority of cases with continued dosing. In the 
clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction 

and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the 

incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1). 

 

In the postmarketing experience, visual adverse reactions have also been reported, including loss of 
vision, visual blurring or other changes of visual acuity, many of which were transient.  

Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.  

 

Renal failure 

Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show 
reversibility of this adverse reaction. 

 

Withdrawal of concomitant anti-epileptic medicinal products 

There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once 

seizure control with pregabalin in the add-on situation has been reached, in order to reach 

monotherapy on pregabalin. 
 

Withdrawal symptoms 

After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms 

have been observed in some patients. The following events have been mentioned: insomnia, headache, 

nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and 
dizziness, suggestive of physical dependence. The patient should be informed about this at the start of 

the treatment. 

 

Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use 

or shortly after discontinuing pregabalin. 
 

Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and 

severity of withdrawal symptoms may be dose-related. 

 

Congestive heart failure 

There have been postmarketing reports of congestive heart failure in some patients receiving 
pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during 

pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these 

patients. Discontinuation of pregabalin may resolve the reaction. 

 

Treatment of central neuropathic pain due to spinal cord injury 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions 

in general, central nervous system adverse reactions and especially somnolence was increased. This 

may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity 

agents) needed for this condition. This should be considered when prescribing pregabalin in this 

condition. 
 

Respiratory depression 

There have been reports of severe respiratory depression in relation to pregabalin use.  Patients with 

compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant 

use of CNS depressants and the elderly may be at higher risk of experiencing this severe adverse 
reaction. Dose adjustments may be necessary in these patients (see section 4.2). 

 

Suicidal ideation and behaviour 

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in 

several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs 

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 pregabalin. 



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Therefore 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 signs of suicidal ideation or behaviour emerge. 

 

Reduced lower gastrointestinal tract function 

There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g. 

intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with 
medications that have the potential to produce constipation, such as opioid analgesics. When 

pregabalin and opioids will be used in combination, measures to prevent constipation may be 

considered (especially in female patients and elderly). 

 

Concomitant use with opioids 
Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS 

depression (see section 4.5). In a case-control study of opioid users, those patients who took pregabalin 

concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use 

alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk was observed at low 

doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk 

at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]). 
 

Misuse, abuse potential or dependence 

Cases of misuse, abuse and dependence have been reported. Caution should be exercised in patients 

with a history of substance abuse and the patient should be monitored for symptoms of pregabalin 

misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have 
been reported). 

 

Encephalopathy 

Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may 

precipitate encephalopathy. 
 

Lactose intolerance 

Lyrica contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, 

the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.  

 

Sodium content 
Lyrica contains less than 1 mmol sodium (23 mg) per hard capsule. Patients on low sodium diets can 

be informed that this medicinal product is essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism 

in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism 

in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, 

pharmacokinetic interactions. 

 
In vivo studies and population pharmacokinetic analysis 

Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed 

between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, 

oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, 

insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin 
clearance. 

 

Oral contraceptives, norethisterone and/or ethinyl oestradiol 

Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol 

does not influence the steady-state pharmacokinetics of either substance. 

 



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Central nervous system influencing medical products 

Pregabalin may potentiate the effects of ethanol and lorazepam. 

 
In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients 

taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal 

products. Pregabalin appears to be additive in the impairment of cognitive and gross motor function 

caused by oxycodone. 

 
Interactions and the elderly 

No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction 

studies have only been performed in adults. 

 

4.6 Fertility, pregnancy and lactation 
 

Women of childbearing potential/Contraception in males and females 

As the potential risk for humans is unknown, effective contraception must be used in women of child 

bearing potential. 

 

Pregnancy 
There are no adequate data from the use of pregabalin in pregnant women. 

 

Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is 

unknown. 

 
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother 

clearly outweighs the potential risk to the foetus). 

 

Breast-feeding 

Pregabalin is excreted into human milk (see section 5.2). The effect of pregabalin on newborns/infants 
is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue 

pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of 

therapy for the woman. 

 

Fertility 

There are no clinical data on the effects of pregabalin on female fertility.  
 

In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were 

exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on 

sperm motility.  

 
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats 

have shown adverse reproductive and developmental effects. The clinical relevance of these findings is 

unknown (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 
 

Lyrica may have minor or moderate influence on the ability to drive and use machines. Lyrica may 

cause dizziness and somnolence and therefore may influence the ability to drive or use machines. 

Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous 

activities until it is known whether this medicinal product affects their ability to perform these 
activities. 

 

4.8 Undesirable effects 

 

The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 

5,600 were in double-blind placebo controlled trials. The most commonly reported adverse reactions 
were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all 



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controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving 

pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in 

discontinuation from pregabalin treatment groups were dizziness and somnolence. 
 

In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more 

than one patient, are listed by class and frequency (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). Within each frequency grouping, undesirable 
effects are presented in order of decreasing seriousness. 

 

The adverse reactions listed may also be associated with the underlying disease and/or concomitant 

medicinal products. 

 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions 

in general, CNS adverse reactions and especially somnolence was increased (see section 4.4). 

 

Additional reactions reported from postmarketing experience are included in italics in the list below. 

 

Table 2. Pregabalin Adverse Drug Reactions 
 

System Organ Class Adverse drug reactions 

Infections and infestations 

Common Nasopharyngitis 

Blood and lymphatic system disorders 

Uncommon Neutropaenia 
Immune system disorders 

Uncommon Hypersensitivity 

Rare Angioedema, allergic reaction 

Metabolism and nutrition disorders 

Common Appetite increased 

Uncommon Anorexia, hypoglycaemia  
Psychiatric disorders  

Common Euphoric mood, confusion, irritability, disorientation, insomnia, 

libido decreased 

Uncommon Hallucination, panic attack, restlessness, agitation, depression, 

depressed mood, elevated mood, aggression, mood swings, 
depersonalisation, word finding difficulty, abnormal dreams, libido 

increased, anorgasmia, apathy 

Rare Disinhibition 

Nervous system disorders  

Very Common Dizziness, somnolence, headache 
Common Ataxia, coordination abnormal, tremor, dysarthria, amnesia, 

memory impairment, disturbance in attention, paraesthesia, 

hypoaesthesia, sedation, balance disorder, lethargy 

Uncommon Syncope, stupor, myoclonus, loss of consciousness, psychomotor 

hyperactivity, dyskinesia, dizziness postural, intention tremor, 
nystagmus, cognitive disorder, mental impairment, speech disorder, 

hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise 

Rare Convulsions, parosmia, hypokinesia, dysgraphia 

Eye disorders 

Common Vision blurred, diplopia 

Uncommon Peripheral vision loss, visual disturbance, eye swelling, visual field 
defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry 

eye, lacrimation increased, eye irritation 

Rare Vision loss, keratitis, oscillopsia, altered visual depth perception, 

mydriasis, strabismus, visual brightness 

Ear and labyrinth disorders  



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System Organ Class Adverse drug reactions 

Common Vertigo 

Uncommon Hyperacusis 

Cardiac disorders 
Uncommon Tachycardia, atrioventricular block first degree, sinus bradycardia, 

congestive heart failure 

Rare QT prolongation, sinus tachycardia, sinus arrhythmia 

Vascular disorders  

Uncommon Hypotension, hypertension, hot flushes, flushing, peripheral 
coldness 

Respiratory, thoracic and mediastinal disorders  

Uncommon Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, 

nasal dryness 

Rare Pulmonary oedema, throat tightness 

Not known Respiratory depression 
Gastrointestinal disorders  

Common Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal 

distension, dry mouth 

Uncommon Gastrooesophageal reflux disease, salivary hypersecretion, 

hypoaesthesia oral 
Rare Ascites, pancreatitis, swollen tongue, dysphagia 

Hepatobiliary disorders  

Uncommon Elevated liver enzymes* 

Rare Jaundice 

Very rare Hepatic failure, hepatitis 
Skin and subcutaneous tissue disorders  

Uncommon Rash papular, urticaria, hyperhidrosis, pruritus 

Rare Stevens Johnson syndrome, cold sweat 

Musculoskeletal and connective tissue disorders  

Common Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm 

Uncommon Joint swelling, myalgia, muscle twitching, neck pain, muscle 
stiffness 

Rare Rhabdomyolysis 

Renal and urinary disorders  

Uncommon Urinary incontinence, dysuria 

Rare Renal failure, oliguria, urinary retention 
Reproductive system and breast disorders  

Common Erectile dysfunction 

Uncommon Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast 

pain  

Rare Amenorrhoea, breast discharge, breast enlargement, gynaecomastia 
General disorders and administration site conditions 

Common Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, 

feeling abnormal, fatigue 

Uncommon Generalised oedema, face oedema, chest tightness, pain, pyrexia, 

thirst, chills, asthenia 
Investigations 

Common Weight increased 

Uncommon Blood creatine phosphokinase increased, blood glucose increased, 

platelet count decreased, blood creatinine increased, blood 

potassium decreased, weight decreased 

Rare White blood cell count decreased 
* Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST). 

 

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms 

have been observed in some patients. The following reactions have been mentioned: insomnia, 

headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, 



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hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about 

this at the start of the treatment. 

 
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and 

severity of withdrawal symptoms may be dose-related. 

 

Paediatric population 

The pregabalin safety profile observed in five paediatric studies in patients with partial seizures with or 
without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, 

n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; 

pharmacokinetic and tolerability study, n=65; and two 1 year open label follow on safety studies, n=54 

and n=431) was similar to that observed in the adult studies of patients with epilepsy. The most 

common adverse events observed in the 12-week study with pregabalin treatment were somnolence, 
pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis. 

The most common adverse events observed in the 14-day study with pregabalin treatment were 

somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2). 

 

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 
 

In the postmarketing experience, the most commonly reported adverse reactions observed when 

pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. 

Seizures were also reported. 

 
In rare occasions, cases of coma have been reported. 

 

Treatment of pregabalin overdose should include general supportive measures and may include 

haemodialysis if necessary (see section 4.2 Table 1). 

 

 
5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16 
 

The active substance, pregabalin, is a gamma-aminobutyric acid analogue 

[(S)-3-(aminomethyl)-5-methylhexanoic acid].  

 

Mechanism of action 

Pregabalin binds to an auxiliary subunit (2- protein) of voltage-gated calcium channels in the central 

nervous system. 

 

Clinical efficacy and safety 

 

Neuropathic pain  
Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury. 

Efficacy has not been studied in other models of neuropathic pain. 

 

Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing 

(BID) and up to 8 weeks with three times a day (TID) dosing. Overall, the safety and efficacy profiles 
for BID and TID dosing regimens were similar. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 12 

 

In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain 

was seen by Week 1 and was maintained throughout the treatment period. 
 

In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 

18% of the patients on placebo had a 50% improvement in pain score. For patients not experiencing 

somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% 

of patients on placebo. For patients who experienced somnolence the responder rates were 48% on 
pregabalin and 16% on placebo. 

 

In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 

7% of the patients on placebo had a 50% improvement in pain score.  

 
Epilepsy 

Adjunctive Treatment 

Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID 

dosing. Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar. 

 

A reduction in seizure frequency was observed by Week 1. 
 

Paediatric population 

The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below 

the age of 12 and adolescents has not been established. The adverse events observed in a 

pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) 
with partial onset seizures were similar to those observed in adults. Results of a 12-week 

placebo-controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled 

study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the 

efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and 

two 1 year open label safety studies in 54 and 431 paediatric patients respectively, from 3 months to 
16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory 

infections were observed more frequently than in adult studies of patients with epilepsy (see sections 

4.2, 4.8 and 5.2). 

 

In the 12-week placebo-controlled study, paediatric patients (4 to 16 years of age) were assigned to 

pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 
600 mg/day), or placebo. The percentage of subjects with at least a 50% reduction in partial onset 

seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day 

(p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus 

placebo) and 22.6% of those receiving placebo.  

 
In the 14-day placebo-controlled study, paediatric patients (1 month to younger than 4 years of age) 

were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo. Median 24-hour 

seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 

and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively. Pregabalin 

14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo 
(p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.  

 

Monotherapy (newly diagnosed patients) 

Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. 

Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom 
endpoint. Pregabalin and lamotrigine were similarly safe and well tolerated.  

 

Generalised Anxiety Disorder 

Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week 

duration and a long-term relapse prevention study with a double-blind relapse prevention phase of 

6 months duration. 
 



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Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was 

observed by Week 1. 

 
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the 

patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint. 

 

In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 

did patients treated with placebo which resolved in a majority of cases with continued dosing. 
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated 

funduscopic examination) was conducted in over 3600 patients within controlled clinical trials. In 

these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of 

placebo-treated patients. Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% 

of placebo-treated patients. Funduscopic changes were observed in 1.7% of pregabalin-treated and 
2.1% of placebo-treated patients. 

 

5.2 Pharmacokinetic properties 

 

Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy 

receiving anti-epileptic drugs and patients with chronic pain. 
 

Absorption 

Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations 

occurring within 1 hour following both single and multiple dose administration. Pregabalin oral 

bioavailability is estimated to be  90% and is independent of dose. Following repeated 
administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is 

decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay 

in tmax to approximately 2.5 hours. However, administration of pregabalin with food has no clinically 

significant effect on the extent of pregabalin absorption. 

 
Distribution  

In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and 

monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating 

rats. In humans, the apparent volume of distribution of pregabalin following oral administration is 

approximately 0.56 l/kg. Pregabalin is not bound to plasma proteins. 

 
Biotransformation  

Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabelled pregabalin, 

approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin. The 

N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted 

for 0.9% of the dose. In preclinical studies, there was no indication of racemisation of pregabalin 
S-enantiomer to the R-enantiomer. 

 

Elimination 

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.  

Pregabalin mean elimination half-life is 6.3 hours. Pregabalin plasma clearance and renal clearance are 
directly proportional to creatinine clearance (see section 5.2 Renal impairment). 

 

Dose adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see 

section 4.2 Table 1). 

 

Linearity/non-linearity 
Pregabalin pharmacokinetics are linear over the recommended daily dose range. Inter-subject 

pharmacokinetic variability for pregabalin is low (< 20%). Multiple dose pharmacokinetics are 

predictable from single-dose data. Therefore, there is no need for routine monitoring of plasma 

concentrations of pregabalin. 

 



 14 

Gender 

Clinical trials indicate that gender does not have a clinically significant influence on the plasma 

concentrations of pregabalin. 
 

Renal impairment 

Pregabalin clearance is directly proportional to creatinine clearance. In addition, pregabalin is 

effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment 

plasma pregabalin concentrations are reduced by approximately 50%). Because renal elimination is the 
major elimination pathway, dose reduction in patients with renal impairment and dose supplementation 

following haemodialysis is necessary (see section 4.2 Table 1). 

 

Hepatic impairment 

No specific pharmacokinetic studies were carried out in patients with impaired liver function. Since 
pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug 

in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma 

concentrations. 

 

Paediatric population 

Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 
23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day 

in a pharmacokinetic and tolerability study. 

 

After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to 

reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 
2 hours postdose. 

 

Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each 

age group. The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an 

increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing 
≥30 kg. 

 

Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 

4 to 6 hours in those 7 years of age and older. 

 

Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of 
pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume 

of distribution, and these relationships were similar in paediatric and adult patients.  

 

Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 

4.2, 4.8 and 5.1). 
 

Elderly 

Pregabalin clearance tends to decrease with increasing age. This decrease in pregabalin oral clearance 

is consistent with decreases in creatinine clearance associated with increasing age. Reduction of 

pregabalin dose may be required in patients who have age related compromised renal function (see 
section 4.2 Table 1). 

 

Breast-feeding mothers 

The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated 

in 10 lactating women who were at least 12 weeks postpartum. Lactation had little to no influence on 
pregabalin pharmacokinetics. Pregabalin was excreted into breast milk with average steady-state 

concentrations approximately 76% of those in maternal plasma. The estimated infant dose from breast 

milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the 

maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively. These estimated doses 

are approximately 7% of the total daily maternal dose on a mg/kg basis. 

 



 15 

5.3 Preclinical safety data 

 

In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically 
relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were observed, 

including hypoactivity, hyperactivity and ataxia. An increased incidence of retinal atrophy commonly 

observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times 

the mean human exposure at the maximum recommended clinical dose. 

 
Pregabalin was not teratogenic in mice, rats or rabbits. Foetal toxicity in rats and rabbits occurred only 

at exposures sufficiently above human exposure. In prenatal/postnatal toxicity studies, pregabalin 

induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended 

human exposure. 

 
Adverse effects on fertility in male and female rats were only observed at exposures sufficiently in 

excess of therapeutic exposure. Adverse effects on male reproductive organs and sperm parameters 

were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were 

associated with spontaneous degenerative processes in male reproductive organs in the rat. Therefore 

the effects were considered of little or no clinical relevance. 

 
Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests. 

 

Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No tumours were 

observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended 

clinical dose of 600 mg/day. In mice, no increased incidence of tumours was found at exposures 
similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at 

higher exposures. The non-genotoxic mechanism of pregabalin-induced tumour formation in mice 

involves platelet changes and associated endothelial cell proliferation. These platelet changes were not 

present in rats or in humans based on short-term and limited long-term clinical data. There is no 

evidence to suggest an associated risk to humans. 
 

In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats. 

However, juvenile rats are more sensitive. At therapeutic exposures, there was evidence of CNS 

clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain 

suppression). Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure. 

Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times 
the human therapeutic exposure. Nine weeks after exposure, this effect was no longer observable.  
 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Lyrica 25 mg, 50 mg, 150 mg hard capsules 

 

Capsules content: 

Lactose monohydrate 
Maize starch 

Talc 

 

Capsules shell: 

Gelatin 
Titanium dioxide (E171) 

Sodium laurilsulphate 

Silica, colloidal anhydrous 

Purified water 

 



 16 

Printing ink: 

Shellac  

Black iron oxide (E172) 
Propylene glycol 

Potassium hydroxide 

 

Lyrica 75 mg, 100 mg, 200 mg, 225 mg, 300 mg hard capsules 

 
Capsules content: 

Lactose monohydrate 

Maize starch 

Talc 

 
Capsules shell: 

Gelatin 

Titanium dioxide (E171) 

Sodium laurilsulphate 

Silica, colloidal anhydrous 

Purified water 
Red iron oxide (E172) 

 

Printing ink: 

Shellac  

Black iron oxide (E172) 
Propylene glycol 

Potassium hydroxide 

 

6.2 Incompatibilities 

 
Not applicable. 

 

6.3 Shelf life 

 

3 years. 

 
6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 
 

Lyrica 25 mg hard capsules 

PVC/Aluminium blisters containing 14, 21, 56, 84, 100, or 112 hard capsules. 

100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

HDPE bottle containing 200 hard capsules. 
Not all pack sizes may be marketed. 

 

Lyrica 50 mg hard capsules 

PVC/Aluminium blisters containing 14, 21, 56, 84, or 100 hard capsules. 

100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 
Not all pack sizes may be marketed. 

 

Lyrica 75 mg hard capsules 

PVC/Aluminium blisters containing 14, 56, 70 100, or 112 hard capsules. 

100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

HDPE bottle containing 200 hard capsules. 
Not all pack sizes may be marketed. 



 17 

 

Lyrica 100 mg hard capsules 

PVC/Aluminium blisters containing 21, 84, or 100 hard capsules. 
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

Not all pack sizes may be marketed. 

 

Lyrica 150 mg hard capsules 

PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules. 
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

HDPE bottle containing 200 hard capsules. 

Not all pack sizes may be marketed. 

 

Lyrica 200 mg hard capsules 
PVC/Aluminium blisters containing 21, 84, or 100 hard capsules. 

100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

Not all pack sizes may be marketed. 

 

Lyrica 225 mg hard capsules 

PVC/Aluminium blisters containing 14, 56, or 100 hard capsules. 
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

Not all pack sizes may be marketed. 

 

Lyrica 300 mg hard capsules 

PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules. 
100 x 1 hard capsules in PVC/Aluminium perforated unit dose blisters. 

HDPE bottle containing 200 hard capsules. 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 
 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

8. MARKETING AUTHORISATION NUMBER(S)  

 

Lyrica 25 mg hard capsules 

EU/1/04/279/001-005 
EU/1/04/279/026 

EU/1/04/279/036 

EU/1/04/279/046 

 

Lyrica 50 mg hard capsules 
EU/1/04/279/006-010 

EU/1/04/279/037 

 

Lyrica 75 mg hard capsules 

EU/1/04/279/011-013 

EU/1/04/279/027 
EU/1/04/279/030 



 18 

EU/1/04/279/038 

EU/1/04/279/045 

 
Lyrica 100 mg hard capsules 

EU/1/04/279/014-016 

EU/1/04/279/39 

 

Lyrica 150 mg hard capsules 
EU/1/04/279/017-019 

EU/1/04/279/028 

EU/1/04/279/031 

EU/1/04/279/040 

 
Lyrica 200 mg hard capsules 

EU/1/04/279/020 – 022 

EU/1/04/279/041 

 

Lyrica 225 mg hard capsules 

EU/1/04/279/033 – 035 
EU/1/04/279/042 

 

Lyrica 300 mg hard capsules 

EU/1/04/279/023 – 025 

EU/1/04/279/029 
EU/1/04/279/032 

EU/1/04/279/043 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 06 July 2004 

Date of last renewal: 06 July 2009 

 

 

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. 

 
 

http://www.ema.europa.eu/


 19 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 20 mg/ml oral solution 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 
Each ml contains 20 mg of pregabalin 

 

Excipients with known effect 

Each ml contains 1.3 mg of methyl parahydroxybenzoate (E218), 0.163 mg of propyl 

parahydroxybenzoate (E216) 
 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 
Oral solution 

Clear colourless liquid  

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 

 

Neuropathic pain 

Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.  
 

Epilepsy 

Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary 

generalisation. 

 

Generalised Anxiety Disorder 
Lyrica is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. 

 

4.2 Posology and method of administration 

 

Posology 
The dose range is 150 to 600 mg (7.5 to 30 ml) per day given in either two or three divided doses. 

 

Neuropathic pain 

Pregabalin treatment can be started at a dose of 150 mg (7.5 ml) per day given as two or three divided 

doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg 
(15 ml) per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg (30 ml) 

per day after an additional 7-day interval. 

 

Epilepsy 

Pregabalin treatment can be started with a dose of 150 mg (7.5 ml) per day given as two or three 
divided doses. Based on individual patient response and tolerability, the dose may be increased to 

300 mg (15 ml) per day after 1 week. The maximum dose of 600 mg (30 ml) per day may be achieved 

after an additional week. 

 



 20 

Generalised Anxiety Disorder 

The dose range is 150 to 600 mg (7.5 to 30 ml) per day given as two or three divided doses. The need 

for treatment should be reassessed regularly. 
 

Pregabalin treatment can be started with a dose of 150 mg (7.5 ml) per day. Based on individual 

patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after 1 week. 

Following an additional week the dose may be increased to 450 mg (22.5 ml) per day. The maximum 

dose of 600 mg (30 ml) per day may be achieved after an additional week. 
 

Discontinuation of pregabalin 

In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended 

this should be done gradually over a minimum of 1 week independent of the indication (see 

sections 4.4 and 4.8). 
 

Renal impairment 

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. 

As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose 

reduction in patients with compromised renal function must be individualised according to creatinine 

clearance (CLcr), as indicated in Table 1 determined using the following formula: 

 

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For 

patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. 

In addition to the daily dose, a supplementary dose should be given immediately following every 

4 hour haemodialysis treatment (see Table 1).  

 
Table 1. Pregabalin dose adjustment based on renal function 

 

Creatinine 

clearance 

(CLcr) 
(ml/min) 

Total pregabalin daily dose* Dose regimen 

 Starting dose 

(mg/day) 

Maximum dose 

(mg/day) 

 

≥ 60 150 (7.5 ml) 600 (30 ml) BID or TID 

≥ 30 - < 60 75 (3.75 ml) 300 (15 ml) BID or TID 

≥ 15 - < 30 25 – 50 (1.25-

2.5 ml) 

150 (7.5 ml) Once Daily or BID 

< 15 25 (1.25 ml) 75 (3.75 ml) Once Daily 

Supplementary dose following haemodialysis (mg) 

 25 (1.25 ml) 100 (5 ml) Single dose+ 
TID = Three divided doses 

BID = Two divided doses 
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose 
+ Supplementary dose is a single additional dose 

 

Hepatic impairment 

No dose adjustment is required for patients with hepatic impairment (see section 5.2).  

 

Paediatric population 

The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years 
of age) have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 

but no recommendation on a posology can be made. 
 

 
patients) femalefor  0.85 x(  

mol/l)( creatinine serum

(kg)weight x  (years) age - 14023.1
(ml/min)CL  cr













 
=





 21 

Elderly 

Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see 

section 5.2). 
 

Method of administration 

Lyrica may be taken with or without food. 

Lyrica is for oral use only. 

A graduated oral syringe and a Press-In Bottle Adapter (PIBA) are provided with the product.  
See section 6.6 for information on administration. 

 

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 

 

Diabetic patients 

In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin 

treatment may need to adjust hypoglycaemic medicinal products. 
 

Hypersensitivity reactions 

There have been reports in the postmarketing experience of hypersensitivity reactions, including cases 

of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as 

facial, perioral, or upper airway swelling occur. 
 

Dizziness, somnolence, loss of consciousness, confusion and mental impairment 

Pregabalin treatment has been associated with dizziness and somnolence, which could increase the 

occurrence of accidental injury (fall) in the elderly population. There have also been postmarketing 

reports of loss of consciousness, confusion and mental impairment. Therefore, patients should be 
advised to exercise caution until they are familiar with the potential effects of the medicinal product. 

 

Vision-related effects 

In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 

did patients treated with placebo which resolved in a majority of cases with continued dosing. In the 

clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction 
and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the 

incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1). 

 

In the postmarketing experience, visual adverse reactions have also been reported, including loss of 

vision, visual blurring or other changes of visual acuity, many of which were transient. 
Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms. 

 

Renal failure 

Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show 

reversibility of this adverse reaction. 
 

Withdrawal of concomitant anti-epileptic medicinal products 

There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once 

seizure control with pregabalin in the add-on situation has been reached, in order to reach 

monotherapy on pregabalin. 
 

Withdrawal symptoms 

After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms 

have been observed in some patients. The following events have been mentioned: insomnia, headache, 

nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and 

dizziness, suggestive of physical dependence. The patient should be informed about this at the start of 
the treatment. 



 22 

Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use 

or shortly after discontinuing pregabalin. 

 
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and 

severity of withdrawal symptoms may be dose-related. 

 

Congestive heart failure 

There have been postmarketing reports of congestive heart failure in some patients receiving 
pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during 

pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these 

patients. Discontinuation of pregabalin may resolve the reaction. 

 

Treatment of central neuropathic pain due to spinal cord injury 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions 

in general, central nervous system adverse reactions and especially somnolence was increased. This 

may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity 

agents) needed for this condition. This should be considered when prescribing pregabalin in this 

condition. 

 
Respiratory depression 

There have been reports of severe respiratory depression in relation to pregabalin use.  Patients with 

compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant 

use of CNS depressants and the elderly may be at higher risk of experiencing this severe adverse 

reaction. Dose adjustments may be necessary in these patients (see section 4.2). 
 

Suicidal ideation and behaviour 

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in 

several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs 

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 pregabalin.  

 

Therefore 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 signs of suicidal ideation or behaviour emerge. 

 
Reduced lower gastrointestinal tract function 

There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g. 

intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with 

medications that have the potential to produce constipation, such as opioid analgesics. When pregabalin 

and opioids will be used in combination, measures to prevent constipation may be considered 
(especially in female patients and elderly). 

 

Concomitant use with opioids 

Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS 

depression (see section 4.5). In a case-control study of opioid users, those patients who took pregabalin 
concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use 

alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk was observed at low 

doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk 

at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]). 

 
Misuse, abuse potential or dependence 

Cases of misuse, abuse and dependence have been reported. Caution should be exercised in patients 

with a history of substance abuse and the patient should be monitored for symptoms of pregabalin 

misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have 

been reported). 

 



 23 

Encephalopathy 

Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may 

precipitate encephalopathy. 
 

Excipients which may cause allergic reactions 

Lyrica oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which 

may cause allergic reactions (possibly delayed).  

 
Sodium content 

Lyrica contains less than 1 mmol sodium (23 mg) per maximum daily dose of 600 mg (30 ml). Patients 

on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction  
 

Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism 

in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism 

in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, 

pharmacokinetic interactions. 

 
In vivo studies and population pharmacokinetic analysis 

Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed 

between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, 

oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, 

insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin 
clearance.  

 

Oral contraceptives, norethisterone and/or ethinyl oestradiol 

Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol 

does not influence the steady-state pharmacokinetics of either substance. 
 

Central nervous system influencing medical products 

Pregabalin may potentiate the effects of ethanol and lorazepam. 

 

In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients 

taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal 
products. Pregabalin appears to be additive in the impairment of cognitive and gross motor function 

caused by oxycodone.  

 

Interactions and the elderly 

No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction 
studies have only been performed in adults. 

 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential/Contraception in males and females 
As the potential risk for humans is unknown, effective contraception must be used in women of child 

bearing potential. 

 

Pregnancy 

There are no adequate data from the use of pregabalin in pregnant women.  
 

Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is 

unknown. 

 

Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother 

clearly outweighs the potential risk to the foetus).  
 



 24 

Breast-feeding 

Pregabalin is excreted into human milk (see section 5.2). The effect of pregabalin on newborns/infants 

is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue 
pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of 

therapy for the woman. 

 

Fertility 

There are no clinical data on the effects of pregabalin on female fertility.  
 

In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were 

exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on 

sperm motility.  

 
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats 

have shown adverse reproductive and developmental effects. The clinical relevance of these findings is 

unknown (see section 5.3).  

 

4.7 Effects on ability to drive and use machines 

 
Lyrica may have minor or moderate influence on the ability to drive and use machines. Lyrica may 

cause dizziness and somnolence and therefore may influence the ability to drive or use machines. 

Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous 

activities until it is known whether this medicinal product affects their ability to perform these 

activities. 
 

4.8 Undesirable effects 

 

The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 

5,600 were in double-blind placebo controlled trials. The most commonly reported adverse reactions 
were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all 

controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving 

pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in 

discontinuation from pregabalin treatment groups were dizziness and somnolence. 

 

In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more 
than one patient, are listed by class and frequency (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). Within each frequency grouping, undesirable 

effects are presented in order of decreasing seriousness. 

 
The adverse reactions listed may also be associated with the underlying disease and/or concomitant 

medicinal products. 

 

In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions 

in general, CNS adverse reactions and especially somnolence was increased (see section 4.4).  
 

Additional reactions reported from postmarketing experience are included in italics in the list below. 

 



 25 

Table 2. Pregabalin Adverse Drug Reactions 

 

System Organ Class Adverse drug reactions 

Infections and infestations 
Common Nasopharyngitis 

Blood and lymphatic system disorders 

Uncommon Neutropaenia 

Immune system disorders 

Uncommon Hypersensitivity 
Rare Angioedema, allergic reaction 

Metabolism and nutrition disorders 

Common Appetite increased 

Uncommon Anorexia, hypoglycaemia  

Psychiatric disorders  

Common Euphoric mood, confusion, irritability, disorientation, insomnia, 
libido decreased 

Uncommon Hallucination, panic attack, restlessness, agitation, depression, 

depressed mood, elevated mood, aggression, mood swings, 

depersonalisation, word finding difficulty, abnormal dreams, libido 

increased, anorgasmia, apathy 
Rare Disinhibition 

Nervous system disorders  

Very Common Dizziness, somnolence, headache 

Common Ataxia, coordination abnormal, tremor, dysarthria, amnesia, 

memory impairment, disturbance in attention, paraesthesia, 
hypoaesthesia, sedation, balance disorder, lethargy 

Uncommon Syncope, stupor, myoclonus, loss of consciousness, psychomotor 

hyperactivity, dyskinesia, dizziness postural, intention tremor, 

nystagmus, cognitive disorder, mental impairment, speech disorder, 

hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise 

Rare Convulsions, parosmia, hypokinesia, dysgraphia 
Eye disorders 

Common Vision blurred, diplopia 

Uncommon Peripheral vision loss, visual disturbance, eye swelling, visual field 

defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry 

eye, lacrimation increased, eye irritation 
Rare Vision loss, keratitis, oscillopsia, altered visual depth perception, 

mydriasis, strabismus, visual brightness 

Ear and labyrinth disorders  

Common Vertigo 

Uncommon Hyperacusis 
Cardiac disorders 

Uncommon Tachycardia, atrioventricular block first degree, sinus bradycardia, 

congestive heart failure 

Rare QT prolongation, sinus tachycardia, sinus arrhythmia 

Vascular disorders  
Uncommon Hypotension, hypertension, hot flushes, flushing, peripheral 

coldness 

Respiratory, thoracic and mediastinal disorders  

Uncommon Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, 

nasal dryness 

Rare Pulmonary oedema, throat tightness  
Not known Respiratory depression 



 26 

System Organ Class Adverse drug reactions 

Gastrointestinal disorders  

Common Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal 

distension, dry mouth 
Uncommon Gastrooesophageal reflux disease, salivary hypersecretion, 

hypoaesthesia oral 

Rare Ascites, pancreatitis, swollen tongue, dysphagia 

Hepatobiliary disorders  

Uncommon Elevated liver enzymes* 
Rare Jaundice 

Very rare Hepatic failure, hepatitis 

Skin and subcutaneous tissue disorders  

Uncommon Rash papular, urticaria, hyperhidrosis, pruritus 

Rare Stevens Johnson syndrome, cold sweat 

Musculoskeletal and connective tissue disorders  
Common Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm 

Uncommon Joint swelling, myalgia, muscle twitching, neck pain, muscle 

stiffness 

Rare Rhabdomyolysis 

Renal and urinary disorders  
Uncommon Urinary incontinence, dysuria 

Rare Renal failure, oliguria, urinary retention 

Reproductive system and breast disorders  

Common Erectile dysfunction 

Uncommon Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast 
pain  

Rare Amenorrhoea, breast discharge, breast enlargement, gynaecomastia 

General disorders and administration site conditions 

Common Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, 

feeling abnormal, fatigue 

Uncommon Generalised oedema, face oedema, chest tightness, pain, pyrexia, 
thirst, chills, asthenia 

Investigations 

Common Weight increased 

Uncommon Blood creatine phosphokinase increased, blood glucose increased, 

platelet count decreased, blood creatinine increased, blood 
potassium decreased, weight decreased 

Rare White blood cell count decreased  
* Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST). 

 

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms 

have been observed in some patients. The following reactions have been mentioned: insomnia, 
headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, 

hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about 

this at the start of the treatment. 

 

Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and 
severity of withdrawal symptoms may be dose-related. 

 

Paediatric population 

The pregabalin safety profile observed in five paediatric studies in patients with partial seizures with or 

without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, 

n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; 
pharmacokinetic and tolerability study, n=65; and two 1 year open label follow on safety studies, n=54 

and n=431) was similar to that observed in the adult studies of patients with epilepsy. The most 

common adverse events observed in the 12-week study with pregabalin treatment were somnolence, 

pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis. 



 27 

The most common adverse events observed in the 14-day study with pregabalin treatment were 

somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2). 

 
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 

In the postmarketing experience, the most commonly reported adverse reactions observed when 

pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. 

Seizures were also reported. 
 

In rare occasions, cases of coma have been reported. 

 

Treatment of pregabalin overdose should include general supportive measures and may include 

haemodialysis if necessary (see section 4.2 Table 1). 

 
 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 
Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16 

 

The active substance, pregabalin, is a gamma-aminobutyric acid analogue 

[(S)-3-(aminomethyl)-5-methylhexanoic acid]. 

 
Mechanism of action 

Pregabalin binds to an auxiliary subunit (2- protein) of voltage-gated calcium channels in the central 

nervous system. 

 

Clinical efficacy and safety 

 
Neuropathic pain  

Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury. 

Efficacy has not been studied in other models of neuropathic pain. 

 

Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing 
(BID) and up to 8 weeks with three times a day (TID) dosing. Overall, the safety and efficacy profiles 

for BID and TID dosing regimens were similar. 

 

In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain 

was seen by Week 1 and was maintained throughout the treatment period. 
 

In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 

18% of the patients on placebo had a 50% improvement in pain score. For patients not experiencing 

somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% 

of patients on placebo. For patients who experienced somnolence the responder rates were 48% on 

pregabalin and 16% on placebo. 
 

In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 

7% of the patients on placebo had a 50% improvement in pain score. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 28 

Epilepsy 

Adjunctive Treatment 

Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with BID or TID dosing. 
Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar. 

 

A reduction in seizure frequency was observed by Week 1.  

 

Paediatric population 
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below 

the age of 12 and adolescents has not been established. The adverse events observed in a 

pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) 

with partial onset seizures were similar to those observed in adults. Results of a 12-week 

placebo-controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled 
study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the 

efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and 

two 1 year open label safety studies in 54 and 431 paediatric patients respectively, from 3 months to 

16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory 

infections were observed more frequently than in adult studies of patients with epilepsy (see sections 

4.2, 4.8 and 5.2). 
 

In the 12-week placebo-controlled study, paediatric patients (4 to 16 years of age) were assigned to 

pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 

600 mg/day), or placebo. The percentage of subjects with at least a 50% reduction in partial onset 

seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day 
(p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus 

placebo) and 22.6% of those receiving placebo.  

 

In the 14-day placebo-controlled study, paediatric patients (1 month to younger than 4 years of age) 

were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo. Median 24-hour 
seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 

and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively. Pregabalin 

14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo 

(p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.  

 

Monotherapy (newly diagnosed patients) 
Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. 

Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom 

endpoint. Pregabalin and lamotrigine were similarly safe and well tolerated. 

 

Generalised Anxiety Disorder 
Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week 

duration and a long-term relapse prevention study with a double-blind relapse prevention phase of 

6 months duration. 

 

Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was 
observed by Week 1.  

 

In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the 

patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint. 

 
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 

did patients treated with placebo which resolved in a majority of cases with continued dosing. 

Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated 

funduscopic examination) was conducted in over 3600 patients within controlled clinical trials. In 

these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of 

placebo-treated patients. Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% 



 29 

of placebo-treated patients. Funduscopic changes were observed in 1.7% of pregabalin-treated and 

2.1% of placebo-treated patients. 

 
5.2 Pharmacokinetic properties 

 

Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy 

receiving anti-epileptic drugs and patients with chronic pain. 

 
Absorption 

Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations 

occurring within 1 hour following both single and multiple dose administration. Pregabalin oral 

bioavailability is estimated to be  90% and is independent of dose. Following repeated 

administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is 

decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay 
in tmax to approximately 2.5 hours. However, administration of pregabalin with food has no clinically 

significant effect on the extent of pregabalin absorption. 

 

Distribution 

In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and 
monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating 

rats. In humans, the apparent volume of distribution of pregabalin following oral administration is 

approximately 0.56 l/kg. Pregabalin is not bound to plasma proteins. 

 

Biotransformation 
Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabelled pregabalin, 

approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin. The 

N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted 

for 0.9% of the dose. In preclinical studies, there was no indication of racemisation of pregabalin 

S-enantiomer to the R-enantiomer. 
 

Elimination 

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.  

Pregabalin mean elimination half-life is 6.3 hours. Pregabalin plasma clearance and renal clearance are 

directly proportional to creatinine clearance (see section 5.2 Renal impairment). 

 
Dose adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see 

section 4.2 Table 1). 

 

Linearity/non-linearity 

Pregabalin pharmacokinetics are linear over the recommended daily dose range. Inter-subject 
pharmacokinetic variability for pregabalin is low (< 20%). Multiple dose pharmacokinetics are 

predictable from single-dose data. Therefore, there is no need for routine monitoring of plasma 

concentrations of pregabalin. 

 

Gender 
Clinical trials indicate that gender does not have a clinically significant influence on the plasma 

concentrations of pregabalin.  

 

Renal impairment 

Pregabalin clearance is directly proportional to creatinine clearance. In addition, pregabalin is 

effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment 
plasma pregabalin concentrations are reduced by approximately 50%). Because renal elimination is the 

major elimination pathway, dose reduction in patients with renal impairment and dose supplementation 

following haemodialysis is necessary (see section 4.2 Table 1). 

 

Hepatic impairment 



 30 

No specific pharmacokinetic studies were carried out in patients with impaired liver function. Since 

pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug 

in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma 
concentrations. 

 

Paediatric population 

Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 

23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day 
in a pharmacokinetic and tolerability study. 

 

After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to 

reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 

2 hours postdose. 
 

Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each 

age group. The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an 

increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing 

≥30 kg. 

 
Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 

4 to 6 hours in those 7 years of age and older. 

 

Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of 

pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume 
of distribution, and these relationships were similar in paediatric and adult patients. 

 

Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 

4.2, 4.8 and 5.1). 

 
Elderly 

Pregabalin clearance tends to decrease with increasing age. This decrease in pregabalin oral clearance 

is consistent with decreases in creatinine clearance associated with increasing age. Reduction of 

pregabalin dose may be required in patients who have age related compromised renal function (see 

section 4.2 Table 1). 

 
Breast-feeding mothers 

The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated 

in 10 lactating women who were at least 12 weeks postpartum. Lactation had little to no influence on 

pregabalin pharmacokinetics. Pregabalin was excreted into breast milk with average steady-state 

concentrations approximately 76% of those in maternal plasma. The estimated infant dose from breast 
milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the 

maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively. These estimated doses 

are approximately 7% of the total daily maternal dose on a mg/kg basis. 

 

5.3 Preclinical safety data 
 

In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically 

relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were observed, 

including hypoactivity, hyperactivity and ataxia. An increased incidence of retinal atrophy commonly 

observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times 
the mean human exposure at the maximum recommended clinical dose.  

 

Pregabalin was not teratogenic in mice, rats or rabbits. Foetal toxicity in rats and rabbits occurred only 

at exposures sufficiently above human exposure. In prenatal/postnatal toxicity studies, pregabalin 

induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended 

human exposure. 
 



 31 

Adverse effects on fertility in male and female rats were only observed at exposures sufficiently in 

excess of therapeutic exposure. Adverse effects on male reproductive organs and sperm parameters 

were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were 
associated with spontaneous degenerative processes in male reproductive organs in the rat. Therefore 

the effects were considered of little or no clinical relevance. 

 

Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests. 

 
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No tumours were 

observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended 

clinical dose of 600 mg/day. In mice, no increased incidence of tumours was found at exposures 

similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at 

higher exposures. The non-genotoxic mechanism of pregabalin-induced tumour formation in mice 
involves platelet changes and associated endothelial cell proliferation. These platelet changes were not 

present in rats or in humans based on short-term and limited long-term clinical data. There is no 

evidence to suggest an associated risk to humans. 

 

In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.  

However, juvenile rats are more sensitive. At therapeutic exposures, there was evidence of CNS 
clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain 

suppression). Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure. 

Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times 

the human therapeutic exposure. Nine weeks after exposure, this effect was no longer observable.  
 
 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Methyl parahydroxybenzoate (E218) 
Propyl parahydroxybenzoate (E216) 

Sodium dihydrogen phosphate, anhydrous 

Disodium phosphate, anhydrous (E339) 

Sucralose (E955)  

Artificial strawberry flavour [contains small amounts of ethanol (alcohol)] 
Purified water 

 

6.2 Incompatibilities 

 

Not applicable. 

 
6.3 Shelf life 

 

2 years. 

 

6.4 Special precautions for storage 
 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 
A white high density polyethylene (HDPE) bottle with polyethylene-lined closure, containing 473 ml 

of oral solution, in a cardboard carton. The carton also contains, in a clear polyethylene wrap, a 5 ml 

graduated oral syringe and a Press-In Bottle adapter (PIBA). 

 



 32 

6.6 Special precautions for disposal and other handling  

 

No special requirements for disposal. 
 

Method of Administration 

 

1. Open bottle and at first use insert the Press-In Bottle Adapter (PIBA) (Figures 1 and 2). 
 
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle 

(Figures 3 and 4). 

 

3. Remove the filled syringe from the bottle in the upright position (Figures 5 and 6).  
 
4. Discharge the syringe contents into the mouth (Figure 7). Repeat steps 2 to 4 as needed to 

achieve the required dose (Table 3). 

 

5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place)  
(Figures 8 and 9).  

 

                              
 Figure 1   Figure 2        Figure 3 

                                                                     
 Figure 4               Figure 5             Figure 6 

                           
 Figure 7           Figure 8               Figure 9 

 



 33 

Table 3. Oral Syringe Withdrawals to Deliver Prescribed Dose of Lyrica 

 

Lyrica Dose 

(mg) 

Total Solution 

Volume (ml) 

First Syringe 

Withdrawal (ml) 

Second Syringe 

Withdrawal (ml) 

Third Syringe 

Withdrawal (ml) 

25 1.25 1.25 Not required Not required 

50 2.5 2.5 Not required Not required 

75 3.75 3.75 Not required Not required 

100 5 5 Not required Not required 

150 7.5 5 2.5 Not required 

200 10 5 5 Not required 

225 11.25 5 5 1.25 

300 15 5 5 5 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 
 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/04/279/044 
 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 06 July 2004 

Date of latest renewal: 06 July 2009 
 

 

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. 

 

http://www.ema.europa.eu/


 34 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

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 

 



 35 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  

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

 

Capsules 

Pfizer Manufacturing Deutschland GmbH 

Betriebsstātte Freiburg  
Mooswaldallee 1  

79090 Freiburg  

Germany 

 

Oral Solution 
Pfizer Service Company 

Hoge Wei 10 

B1930 Zaventem 

Belgium 

 

or 
 

Pfizer Innovative Supply Point International BVBA 

Hoge Wei 10 

B1930 Zaventem 

Belgium 
 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 
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; 



 36 

• 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. 



 37 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

ANNEX III 
 

LABELLING AND PACKAGING LEAFLET 



 38 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

A. LABELLING 



 39 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) 

for 25 mg hard capsules. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 25 mg hard capsules 

pregabalin 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 25 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate: See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

21 hard capsules 

56 hard capsules 

84 hard capsules 
100 hard capsules 

100 x 1 hard capsules 

112 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 
Do not use if box has been opened. 

 

 

8. EXPIRY DATE 

 

EXP 

 



 40 

 

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 

 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 
 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/001-005  

EU/1/04/279/026 

EU/1/04/279/036 
 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 25 mg 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  

SN 

NN  



 41 

  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Bottle immediate packaging for 25 mg hard capsules – pack of 200 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 25 mg hard capsules 

pregabalin 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each hard capsule contains 25 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose monohydrate. Read the package leaflet before use. 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

200 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
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 

 

 
 



 42 

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 

 

Upjohn 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/046 

 

 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 
 

 

16. INFORMATION IN BRAILLE 

 
Lyrica 25 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 
 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  

SN 

NN  



 43 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg 

hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 25 mg hard capsules 

pregabalin 
 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 
 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 



 44 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 

50 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 50 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 50 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

21 hard capsules 

56 hard capsules 

84 hard capsules 
100 hard capsules 

100 x 1 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 
Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 
 

 

8. EXPIRY DATE 

 

EXP 

 

 



 45 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/006-010 

EU/1/04/279/037 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 50 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 
2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  
SN 

NN  



 46 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 50 mg hard 

capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 50 mg hard capsules 

pregabalin 
 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 
 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 



 47 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Bottle immediate packaging for 75 mg hard capsules – pack of 200 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 75 mg hard capsules 

pregabalin 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each hard capsule contains 75 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose monohydrate. Read the package leaflet before use. 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

200 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
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 

 

 
 



 48 

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 

 

Upjohn 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/030 

 

 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 
 

 

16. INFORMATION IN BRAILLE 

 
Lyrica 75 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 
 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  

SN 

NN  



 49 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Carton of blister pack (14, 56, 70, 100, and 112) and perforated unit dose blister pack (100) for 

75 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 75 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 75 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

56 hard capsules 

70 hard capsules 

100 hard capsules 
100 x 1 hard capsules 

112 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 
Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 
 

 

8. EXPIRY DATE 

 

EXP  

 

 



 50 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/011-013 

EU/1/04/279/027 

EU/1/04/279/038 

EU/1/04/279/045 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 75 mg 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC 

SN 

NN  



 51 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 56, 70, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard 

capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 75 mg hard capsules 

pregabalin 
 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 
 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 

 



 52 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg 

hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 100 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 100 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

21 hard capsules 

84 hard capsules 

100 hard capsules 

100 x 1 hard capsules 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 53 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/014 – 016 

EU/1/04/279/039 

 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 100 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 
2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  
SN 

NN  



 54 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 100 mg hard capsules 

pregabalin 

 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 

 

3. EXPIRY DATE 

 
EXP  

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 

 



 55 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Bottle immediate packaging for 150 mg hard capsules – pack of 200 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 150 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each hard capsule contains 150 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

200 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Oral use. 

Read the package leaflet before 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 

 
 

 



 56 

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 

 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 
Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/031 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 150 mg 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC  

SN 

NN  



 57 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 

150 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 150 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 150 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

56 hard capsules 

100 hard capsules 

100 x 1 hard capsules 
112 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 

 
 

8. EXPIRY DATE 

 

EXP 

 

 



 58 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/017 – 019 

EU/1/04/279/028 

EU/1/04/279/040 

 
 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 150 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC 

SN 

NN 



 59 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 150 mg hard 

capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 150 mg hard capsules 

pregabalin 
 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 
 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 



 60 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg 

hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 200 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 200 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

21 hard capsules 

84 hard capsules 

100 hard capsules 

100 x 1 hard capsules 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 

 

 

8. EXPIRY DATE 

 

EXP  

 

 



 61 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/020 - 022 

EU/1/04/279/041 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 200 mg 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC  

SN 

NN  



 62 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 200 mg hard capsules 

pregabalin 

 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 

 

3. EXPIRY DATE 

 
EXP  

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 



 63 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg 

hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 225 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 225 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

56 hard capsules 

100 hard capsules 

100 x 1 hard capsules 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 64 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/033 – 035 

EU/1/04/279/042 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 
 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 225 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 
2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 

PC  
SN 

NN  



 65 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 225 mg hard capsules 

pregabalin 

 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 

 

3. EXPIRY DATE 

 
EXP 

 

 

4. BATCH NUMBER 

 

Lot 
 

 

5. OTHER 

 



 66 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Bottle immediate packaging for 300 mg hard capsules – pack of 200 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 300 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each hard capsule contains 300 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

200 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Oral use. 

Read the package leaflet before 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 

 
 

 



 67 

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 

 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 
Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/032 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 300 mg 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC  

SN 

NN  



 68 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 

300 mg hard capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 300 mg hard capsules 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 300 mg pregabalin. 
 

 

3. LIST OF EXCIPIENTS 

 

This product contains lactose monohydrate. See the package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules 

56 hard capsules 

100 hard capsules 

100 x 1 hard capsules 
112 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

Sealed Pack 

Do not use if box has been opened. 

 
 

8. EXPIRY DATE 

 

EXP  

 

 



 69 

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 

 
Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 

Netherlands 

 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/023-025 

EU/1/04/279/029 

EU/1/04/279/043 

 
 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 300 mg 

 

 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC  

SN 

NN  



 70 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 300 mg hard 

capsules 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lyrica 300 mg hard capsules 

pregabalin 
 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Upjohn 

 
 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 
Lot 

 

 

5. OTHER 

 

 



 71 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 20 mg/ml oral solution 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each ml contains 20 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

Other ingredients include E216 (propyl parahydroxybenzoate) and E218 (methyl 

parahydroxybenzoate). See leaflet for further information. 
 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

473 ml oral solution with a 5 ml oral syringe and a Press-In Bottle Adapter (PIBA). 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

 

 



 72 

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 

 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 
Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/044 
 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Lyrica 20 mg/ml 

 
 

17. UNIQUE IDENTIFIER-2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER-HUMAN READABLE DATA 

 
PC  

SN 

NN  



 73 

 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Lyrica 20 mg/ml oral solution 

pregabalin  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
Each ml contains 20 mg pregabalin. 

 

 

3. LIST OF EXCIPIENTS 

 

Other ingredients include E216 (propyl parahydroxybenzoate) and E218 (methyl 

parahydroxybenzoate). See leaflet for further information. 
 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

473 ml oral solution 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Oral use. 

Read the package leaflet before 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 

 

 

 



 74 

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 

 

Upjohn EESV 

Rivium Westlaan 142 

2909 LD Capelle aan den IJssel 
Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/279/044 
 

 

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 

 



 75 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

B. PACKAGE LEAFLET 
 



 76 

Package leaflet: Information for the user 

 

 Lyrica 25 mg hard capsules, 
 Lyrica 50 mg hard capsules, 

 Lyrica 75 mg hard capsules, 

Lyrica 100 mg hard capsules, 

Lyrica 150 mg hard capsules, 

Lyrica 200 mg hard capsules, 
Lyrica 225 mg hard capsules, 

Lyrica 300 mg hard capsules 

pregabalin 

 

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 Lyrica is and what it is used for 
2. What you need to know before you take Lyrica 

3. How to take Lyrica 

4. Possible side effects 

5. How to store Lyrica 

6. Contents of the pack and other information 
 

 

1. What Lyrica is and what it is used for 

 

Lyrica belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised 

Anxiety Disorder (GAD) in adults. 
 

Peripheral and central neuropathic pain: Lyrica is used to treat long lasting pain caused by damage 

to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. 

Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, 

aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be 
associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on 

physical and social functioning and overall quality of life. 

 

Epilepsy: Lyrica is used to treat a certain form of epilepsy (partial seizures with or without secondary 

generalisation) in adults. Your doctor will prescribe Lyrica for you to help treat your epilepsy when 
your current treatment is not controlling your condition. You should take Lyrica in addition to your 

current treatment. Lyrica is not intended to be used alone, but should always be used in combination 

with other anti-epileptic treatment. 

 

Generalised Anxiety Disorder: Lyrica is used to treat Generalised Anxiety Disorder (GAD). The 
symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can 

also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty 

concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This 

is different to the stresses and strains of everyday life. 

 

 



 77 

2. What you need to know before you take Lyrica 

 

Do not take Lyrica 
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6). 

 

Warnings and Precautions 

Talk to your doctor or pharmacist before taking Lyrica. 

 

• Some patients taking Lyrica have reported symptoms suggesting an allergic reaction. These 
symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. 

Should you experience any of these reactions, you should contact your physician immediately. 

 

• Lyrica has been associated with dizziness and somnolence, which could increase the occurrence of 
accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to 

any effect the medicine might have. 

 

• Lyrica may cause blurring or loss of vision, or other changes in eyesight, many of which are 
temporary. You should immediately tell your doctor if you experience any changes in your vision. 

 

• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in 
their diabetic medicines. 

 

• Certain side effects may be more common, such as sleepiness, because patients with spinal cord 
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar 
side effects to Pregabalin and the severity of these effects may be increased when taken together. 

 

• There have been reports of heart failure in some patients when taking Lyrica; these patients were 
mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your 

doctor if you have a history of heart disease. 
 

• There have been reports of kidney failure in some patients when taking Lyrica. If while taking 
Lyrica you notice decreased urination, you should tell your doctor as stopping the medicine may 

improve this. 

 

• A small number of people being treated with anti-epileptics such as Lyrica have had thoughts of 
harming or killing themselves. If at any time you have these thoughts, immediately contact your 

doctor. 

 

• When Lyrica is taken with other medicines that may cause constipation (such as some types of 
pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked 

or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to 

this problem. 

 

• Before taking this medicine you should tell your doctor if you have a history of alcoholism or any 
drug abuse or dependence. Do not take more medicine than prescribed. 

 

• There have been reports of convulsions when taking Lyrica or shortly after stopping Lyrica. If you 
experience a convulsion, contact your doctor immediately. 

 

• There have been reports of reduction in brain function (encephalopathy) in some patients taking 
Lyrica when they have other conditions. Tell your doctor if you have a history of any serious 

medical conditions, including liver or kidney disease. 

 

• There have been reports of breathing difficulties. If you have nervous system disorders, respiratory 
disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different 
dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths. 



 78 

 

Children and adolescents 

The safety and efficacy in children and adolescents (under 18 years of age) has not been established 

and therefore, pregabalin should not be used in this age group. 

Other medicines and Lyrica 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines.  

 

Lyrica and certain other medicines may influence each other (interaction). When taken with certain 

other medicines which have sedative effects (including opioids), Lyrica may potentiate these effects, 

and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and 
decreased concentration may be increased if Lyrica is taken together with medicines containing: 

 

Oxycodone – (used as a pain-killer) 

Lorazepam – (used for treating anxiety) 

Alcohol  
 

Lyrica may be taken with oral contraceptives. 

 

Lyrica with food, drink and alcohol 

Lyrica capsules may be taken with or without food.  
 

It is advised not to drink alcohol while taking Lyrica. 

 

Pregnancy and breast-feeding  

Lyrica should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by 

your doctor. Effective contraception must be used by women of child-bearing potential. If you are 
pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 

or pharmacist for advice before taking this medicine. 

 

Driving and using machines 

Lyrica may produce dizziness, sleepiness and decreased concentration. You should not drive, operate 
complex machinery or engage in other potentially hazardous activities until you know whether this 

medicine affects your ability to perform these activities. 

 

Lyrica contains lactose monohydrate  

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicine.  

 

Lyrica contains sodium  

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially 

‘sodium-free’. 
 
 

3. How to take Lyrica 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 
 

Your doctor will determine what dose is appropriate for you. 

 

Lyrica is for oral use only. 

 

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:  

• Take the number of capsules as instructed by your doctor.  

• The dose, which has been adjusted for you and your condition, will generally be between 150 mg 
and 600 mg each day.  



 79 

• Your doctor will tell you to take Lyrica either twice or three times a day. For twice a day take 
Lyrica once in the morning and once in the evening, at about the same time each day. For three 

times a day take Lyrica once in the morning, once in the afternoon and once in the evening, at 
about the same time each day. 

 

If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or 

pharmacist. 

 
If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have 

problems with your kidneys. 

 

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your 

kidneys. 
 

Swallow the capsule whole with water. 

 

Continue taking Lyrica until your doctor tells you to stop.  

 

If you take more Lyrica than you should 
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of 

Lyrica capsules with you. You may feel sleepy, confused, agitated, or restless as a result of taking 

more Lyrica than you should. Fits have also been reported. 

 

If you forget to take Lyrica 
It is important to take your Lyrica capsules regularly at the same time each day. If you forget to take a 

dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry on 

with the next dose as normal. Do not take a double dose to make up for a forgotten dose. 

 

If you stop taking Lyrica 
Do not stop taking Lyrica unless your doctor tells you to. If your treatment is stopped it should be done 

gradually over a minimum of 1 week.  

 

After stopping long and short-term Lyrica treatment, you need to know that you may experience 

certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-

like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These symptoms 
may occur more commonly or severely if you have been taking Lyrica for a longer period of time. 

 

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  
 

Dizziness, drowsiness, headache. 

 

Common: may affect up to 1 in 10 people 

 

• Increased appetite. 

• Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability. 

• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty 
with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling 

abnormal. 

• Blurred vision, double vision. 

• Vertigo, problems with balance, fall. 



 80 

• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen. 

• Difficulties with erection. 

• Swelling of the body including extremities. 
• Feeling drunk, abnormal style of walking. 

• Weight gain. 

• Muscle cramp, joint pain, back pain, pain in limb. 

• Sore throat. 
Uncommon: may affect up to 1 in 100 people 
 

• Loss of appetite, weight loss, low blood sugar, high blood sugar. 

• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding 
words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental 

impairment, difficulty with thinking, increase in sexual interest, problems with sexual 
functioning including inability to achieve a sexual climax, delayed ejaculation. 

• Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes 
of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive 

skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of 

consciousness, fainting, increased sensitivity to noise, feeling unwell. 

• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation. 

• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, 
 changes in heart beat, heart failure. 

• Flushing, hot flushes. 

• Difficulty breathing, dry nose, nasal congestion. 
• Increased saliva production, heartburn, numb around mouth. 

• Sweating, rash, chills, fever. 

• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain. 

• Breast pain. 

• Difficulty with or painful urination, incontinence. 
• Weakness, thirst, chest tightness. 

• Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino 
transferase increased, aspartate aminotransferase increased, platelet count decreased, 

neutropaenia, increase in blood creatinine, decrease in blood potassium). 

• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring. 
• Painful menstrual periods. 

• Coldness of hands and feet. 
 

Rare: may affect up to 1 in 1,000 people  

 

• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision 
loss. 

• Dilated pupils, cross eyes. 

• Cold sweat, tightness of the throat, swollen tongue. 

• Inflammation of the pancreas. 
• Difficulty in swallowing. 

• Slow or reduced movement of the body. 

• Difficulty with writing properly. 

• Increased fluid in the abdomen. 

• Fluid in the lungs. 
• Convulsions. 

• Changes in the recording of electrical changes (ECG) in the heart which correspond to heart 
rhythm disturbances. 

• Muscle damage. 

• Breast discharge, abnormal breast growth, breast growth in males. 
• Interrupted menstrual periods. 

• Kidney failure, reduced urine volume, urinary retention.  



 81 

• Decrease in white blood cell count. 

• Inappropriate behaviour. 

• Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis) 
and a serious skin reaction characterized by rash, blisters, peeling skin and pain). 

• Jaundice (yellowing of the skin and eyes). 
 

Very rare: may affect up to 1 in 10,000 people  

 

• Liver failure. 

• Hepatitis (inflammation of the liver). 
 

If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, 

you should seek immediate medical advice. 
 

Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury 

may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to 

Pregabalin and the severity of these effects may be increased when taken together. 

 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet.  

 

The following adverse reaction has been reported in the postmarketing experience: Trouble breathing, 

shallow breaths. 

 
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 Lyrica 

 

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 or bottle. The expiry date 

refers to the last day of that month. 

 

This medicine 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 Lyrica contains 

 

The active substance is pregabalin. Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 

150 mg, 200 mg, 225 mg or 300 mg pregabalin. 
 

The other ingredients are: lactose monohydrate, maize starch, talc, gelatine, titanium dioxide (E171), 

sodium laurilsulphate, anhydrous colloidal silica, black ink, (which contains shellac, black iron oxide 

(E172), propylene glycol, potassium hydroxide) and water.  

 
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 82 

 

What Lyrica looks like and contents of the pack 

25 mg capsules 
White hard capsules, with “Pfizer” marked on the cap and “PGN 25” on 

the body. 

50 mg capsules 
White hard capsules, with “Pfizer” marked on the cap and “PGN 50”on 

the body. The capsule body is marked with a black band. 

75 mg capsules 
White and orange hard capsules with “Pfizer” marked on the cap and 

“PGN 75” on the body. 

100 mg capsules 
Orange hard capsules, with “Pfizer” marked on the cap and “PGN 100” on 
the body. 

150 mg capsules 
White hard capsules, with “Pfizer” marked on the cap and “PGN 150” on 

the body. 

200 mg capsules 
Light orange hard capsules, with “Pfizer” marked on the cap and “PGN 

200” on the body. 

225 mg capsules 
White and light orange hard capsules, with “Pfizer” marked on the cap and 

“PGN 225” on the body. 

300 mg capsules 
White and orange hard capsules, with “Pfizer” marked on the cap and 
“PGN 300” on the body. 

 

Lyrica is available in eight pack sizes made of PVC with an aluminium foil backing: a 14 capsules 
pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a 56 capsules pack 

containing 4 blister strips, a 70 capsules pack containing 5 blister strips, a 84 capsules pack containing 

4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 capsules pack containing 

8 blister strips and 100 x 1 capsules as perforated unit dose blisters. 

 
In addition, Lyrica is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 

150 mg and 300 mg strengths. 
 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer 

 

Marketing Authorisation Holder: 

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands. 
 

Manufacturer: 

Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, 

Germany. 

 
For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Pfizer S.A. / N.V. 
Tél/Tel: +32 (0)2 554 62 11 

 

Lietuva 

Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. +3705 2514000 

 

България 

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 
 

Česká republika 

Pfizer spol s.r.o. 

Tel: +420-283-004-111 

 

Magyarország 

Pfizer Kft. 

Tel. + 36 1 488 37 00 

 



 83 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 
 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 4301 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

Ελλάδα 
UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Österreich 
Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

España 

Pfizer GEP, S.L  

Tel: +34 91 490 99 00 
 

Polska 

Pfizer Polska Sp. z o.o. 

Tel.: +48 22 335 61 00 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 

 

Portugal 

Laboratórios Pfizer, Lda. 

Tel: +351 21 423 5500 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Ireland 
Pfizer Healthcare Ireland 

Tel: +1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

Slovenija 
Pfizer Luxembourg SARL, 

Pfizer, podružnica za svetovanje s področja 

farmacevtske dejavnosti, Ljubljana 

Tel: +386 (0)1 52 11 400 

 

Ísland 
Icepharma hf. 

Sími: +354 540 8000 

 

Slovenská republika 
Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

Italia 

Pfizer Established Medicine Italy S.r.l. 
Tel: +39 06 33 18 21 

Suomi/Finland 

Pfizer Oy 
Puh./Tel: +358 (0)9 43 00 40 

 

Κύπρος 

GPA Pharmaceuticals Ltd 

Τηλ: +357 22863100 
 

Sverige 

Pfizer AB 

Tel: +46 (0)8 550 520 00 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 
 

This leaflet was last revised in: 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

http://www.ema.europa.eu/


 84 

Package leaflet: Information for the user 

 

Lyrica 20 mg/ml oral solution 
pregabalin 

 

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 Lyrica is and what it is used for 

2. What you need to know before you take Lyrica 

3. How to take Lyrica 
4. Possible side effects 

5. How to store Lyrica 

6. Contents of the pack and other information 

 

 
1. What Lyrica is and what it is used for 

 

Lyrica belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised 

Anxiety Disorder (GAD) in adults. 

 
Peripheral and central neuropathic pain: Lyrica is used to treat long lasting pain caused by damage 

to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. 

Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, 

aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be 

associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on 

physical and social functioning and overall quality of life. 
 

Epilepsy: Lyrica is used to treat a certain form of epilepsy (partial seizures with or without secondary 

generalisation-epileptic fits starting on one specific part of the brain) in adults. Your doctor will 

prescribe Lyrica for you to help treat your epilepsy when your current treatment is not controlling your 

condition. You should take Lyrica in addition to your current treatment. Lyrica is not intended to be 
used alone, but should always be used in combination with other anti-epileptic treatment. 

 

Generalised Anxiety Disorder: Lyrica is used to treat Generalised Anxiety Disorder (GAD). The 

symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can 

also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty 
concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This 

is different to the stresses and strains of everyday life. 

 

 

2. What you need to know before you take Lyrica 
 

Do not take Lyrica 

if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).  

 

Warnings and Precautions 

Talk to your doctor or pharmacist before taking Lyrica. 
 



 85 

• Some patients taking Lyrica have reported symptoms suggesting an allergic reaction. These 
symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. 

Should you experience any of these reactions, you should contact your physician immediately. 
 

• Lyrica has been associated with dizziness and somnolence, which could increase the occurrence of 
accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to 

any effect the medicine might have. 

 

• Lyrica may cause blurring or loss of vision, or other changes in eyesight, many of which are 
temporary. You should immediately tell your doctor if you experience any changes in your vision.  

 

• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in 
their diabetic medicines. 

 

• Certain side effects may be more common, such as sleepiness, because patients with spinal cord 
injury may be taking other medicines to treat, for example, pain or spasticity, that have similar 

side effects to Pregabalin and the severity of these effects may be increased when taken together.  

 

• There have been reports of heart failure in some patients when taking Lyrica; these patients were 
mostly elderly with cardiovascular conditions. Before taking this medicine you should tell your 

doctor if you have a history of heart disease. 

 

• There have been reports of kidney failure in some patients when taking Lyrica. If while taking 
Lyrica you notice decreased urination, you should tell your doctor as stopping the medicine may 
improve this. 

 

• A small number of people being treated with anti-epileptics such as Lyrica have had thoughts of 
harming or killing themselves. If at any time you have these thoughts, immediately contact your 

doctor. 
 

• When Lyrica is taken with other medicines that may cause constipation (such as some types of 
pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked 

or paralysed bowel). Tell your doctor if you experience constipation, especially if you are prone to 

this problem. 
 

• Before taking this medicine you should tell your doctor if you have a history of alcoholism or any 
drug abuse or dependence. Do not take more medicine than prescribed. 

 

• There have been reports of convulsions when taking Lyrica or shortly after stopping Lyrica. If you 
experience a convulsion, contact your doctor immediately. 

 

• There have been reports of reduction in brain function (encephalopathy) in some patients taking 
Lyrica when they have other conditions. Tell your doctor if you have a history of any serious 

medical conditions, including liver or kidney disease. 
 

• There have been reports of breathing difficulties. If you have nervous system disorders, respiratory 
disorders, renal impairment, or you are older than 65, your doctor may prescribe you a different 

dosing regimen. Contact your doctor if you experience trouble breathing or shallow breaths. 

 

Children and adolescents 
The safety and efficacy in children and adolescents (under 18 years of age) has not been established 

and therefore, pregabalin should not be used in this age group. 

 

Other medicines and Lyrica 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  



 86 

 

Lyrica and certain other medicines may influence each other (interaction). When taken with certain 

other medicines which have sedative effects (including opioids), Lyrica may potentiate these effects, 
and could lead to respiratory failure, coma and death. The degree of dizziness, sleepiness and 

decreased concentration may be increased if Lyrica is taken together with medicines containing: 

 

Oxycodone – (used as a pain-killer) 

Lorazepam – (used for treating anxiety) 
Alcohol  

Lyrica may be taken with oral contraceptives. 

 

Lyrica with food, drink and alcohol 

Lyrica may be taken with or without food. 
 

It is advised not to drink alcohol while taking Lyrica 

 

Pregnancy and breast-feeding  

Lyrica should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by 

your doctor. Effective contraception must be used by women of child-bearing potential. If you are 
pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor 

or pharmacist for advice before taking this medicine. 

 

Driving and using machines 

Lyrica may produce dizziness, sleepiness and decreased concentration. You should not drive, operate 
complex machinery or engage in other potentially hazardous activities until you know whether this 

medicine affects your ability to perform these activities. 

 

Lyrica contains methyl parahydroxybenzoate and propyl parahydroxybenzoate 

Lyrica oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate 
(E216) which may cause allergic reactions (possibly delayed).  

 

Lyrica contains ethanol 

Lyrica oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml. 

 

Lyrica contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per maximum daily dose of 600 mg (30 ml), 

that is to say essentially ‘sodium-free’. 
 

 

3. How to take Lyrica 

 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 

 

Your doctor will determine what dose is appropriate for you. 

 
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:  

• Take the solution as instructed by your doctor. 

• The dose, which has been adjusted for you and your condition, will generally be between 150 mg 
(7.5 ml) and 600 mg (30 ml) each day.  

• Your doctor will tell you to take Lyrica either twice or three times a day. For twice a day take 
Lyrica once in the morning and once in the evening, at about the same time each day. For three 

times a day take Lyrica once in the morning, once in the afternoon and once in the evening, at 

about the same time each day. 

 

If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or 
pharmacist. 



 87 

 

If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have 

problems with your kidneys. 
 

Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your 

kidneys. 

 

Continue taking Lyrica until your doctor tells you to stop.  
 

Administration: 

 

Instructions for use 

 
Lyrica is for oral use only. 

 

1. Open the bottle: Press downward on the cap and turn it counter-clockwise (Figure 1). 
 

2. First time use only: A Press-In Bottle Adapter (PIBA) is provided with the oral syringe. This 
is the device that gets inserted into the neck of the bottle to make it easier to withdraw the 
solution using the oral syringe. If the PIBA is not already in place, remove the PIBA and 5 ml 

oral syringe from the plastic overwrap. With the bottle on a flat surface, insert the PIBA into 

the bottle neck while keeping the PIBA’s flat surface facing up and pressing on it (Figure 2).  

 

3. Push the syringe plunger to the bottom of the barrel of the syringe (toward its tip) to remove 
excess air. Attach the syringe to the PIBA with a slight twisting motion (Figure 3).  

 

4. Invert the bottle (with the syringe attached) and fill the syringe with the liquid by pulling the 
syringe plunger down to just beyond the graduation mark corresponding to the quantity in 

millilitres (ml) prescribed by your doctor (Figure 4). Remove air bubbles from the syringe by 
pushing the plunger up to the appropriate graduation mark. 

 

5. Return the bottle to an upright position with the syringe still in the PIBA/bottle (Figure 5). 
 

6. Remove the syringe from the bottle/PIBA (Figure 6). 
 

7. Empty the contents of the syringe directly into mouth by pushing the syringe plunger to the 
bottom of the syringe barrel (Figure 7). 

 

Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).  

 
[For example, a 150 mg (7.5 ml) dose will require two withdrawals from the bottle to achieve 

the entire dose. Using the oral syringe, first withdraw 5 ml and empty contents of syringe 

directly into the mouth, then refill the oral syringe with 2.5 ml and empty the remaining 

contents into the mouth.] 

 
8. Rinse the syringe by drawing water into the syringe and pushing the syringe plunger to the 

bottom of the syringe barrel, at least three times (Figure 8).  

 

9. Replace the cap on the bottle (leaving the PIBA in place in the bottle neck) (Figure 9). 
 



 88 

                                    
 Figure 1   Figure 2               Figure 3 

 

                                                             
 Figure 4        Figure 5     Figure 6 

 

                                
 Figure 7   Figure 8                   Figure 9 

 

Table 1. Oral Syringe Withdrawals to Deliver Prescribed Dose of Lyrica 
 
Lyrica Dose 

(mg) 
Total Solution 
Volume (ml) 

First Syringe 
Withdrawal (ml) 

Second Syringe 
Withdrawal (ml) 

Third Syringe 
Withdrawal (ml) 

25 1.25 1.25 Not required Not required 
50 2.5 2.5 Not required Not required 
75 3.75 3.75 Not required Not required 

100 5 5 Not required Not required 
150 7.5 5 2.5 Not required 
200 10 5 5 Not required 
225 11.25 5 5 1.25 

300 15 5 5 5 

 

If you take more Lyrica than you should 

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of 

Lyrica oral solution with you. You may feel sleepy, confused, agitated, or restless as a result of taking 
more Lyrica than you should. Fits have also been reported. 

 



 89 

If you forget to take Lyrica 

It is important to take your Lyrica oral solution regularly at the same time each day. If you forget to 

take a dose, take it as soon as you remember unless it is time for your next dose. In that case, just carry 
on with the next dose as normal. Do not take a double dose to make up for a forgotten dose. 

 

If you stop taking Lyrica 

Do not stop taking Lyrica unless your doctor tells you to. If your treatment is stopped it should be done 

gradually over a minimum of 1 week.  
 

After stopping long and short-term Lyrica treatment, you need to know that you may experience 

certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, 

flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These 

symptoms may occur more commonly or severely if you have been taking Lyrica for a longer period 
of time. 

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  

 

Dizziness, drowsiness, headache. 
 

Common: may affect up to 1 in 10 people  

 

• Increased appetite. 

• Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability. 
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty 

with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling 

abnormal. 

• Blurred vision, double vision. 

• Vertigo, problems with balance, fall. 
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, swollen abdomen. 

• Difficulties with erection. 

• Swelling of the body including extremities. 

• Feeling drunk, abnormal style of walking. 

• Weight gain. 
• Muscle cramp, joint pain, back pain, pain in limb. 

• Sore throat. 
 

Uncommon: may affect up to 1 in 100 people  

 

• Loss of appetite, weight loss, low blood sugar, high blood sugar. 

• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding 
words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental 

impairment, difficulty with thinking, increase in sexual interest, problems with sexual 

functioning including inability to achieve a sexual climax, delayed ejaculation. 

• Changes in eyesight, unusual eye movement, changes in vision including tunnel vision, flashes 
of light, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive 

skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, loss of 

consciousness, fainting, increased sensitivity to noise, feeling unwell.  

• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation. 

• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, 
 changes in heart beat, heart failure. 



 90 

• Flushing, hot flushes. 

• Difficulty breathing, dry nose, nasal congestion. 

• Increased saliva production, heartburn, numb around mouth. 
• Sweating, rash, chills, fever. 

• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain. 

• Breast pain. 

• Difficulty with or painful urination, incontinence. 

• Weakness, thirst, chest tightness. 
• Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino 

transferase increased, aspartate aminotransferase increased, platelet count decreased, 

neutropaenia, increase in blood creatinine, decrease in blood potassium). 

• Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring. 

• Painful menstrual periods. 
• Coldness of hands and feet. 
 

Rare: may affect up to 1 in 1,000 people 

 

• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness, vision 
loss. 

• Dilated pupils, cross eyes. 

• Cold sweat, tightness of the throat, swollen tongue. 

• Inflammation of the pancreas. 

• Difficulty in swallowing. 
• Slow or reduced movement of the body. 

• Difficulty with writing properly. 

• Increased fluid in the abdomen. 

• Fluid in the lungs. 

• Convulsions. 
• Changes in the recording of electrical changes (ECG) in the heart which correspond to heart 

rhythm disturbances. 

• Muscle damage. 

• Breast discharge, abnormal breast growth, breast growth in males. 

• Interrupted menstrual periods. 
• Kidney failure, reduced urine volume, urinary retention. 

• Decrease in white blood cell count. 

• Inappropriate behaviour. 

• Allergic reactions (which may include difficulty breathing, inflammation of the eyes (keratitis) 
and a serious skin reaction characterized by rash, blisters, peeling skin and pain). 

• Jaundice (yellowing of the skin and eyes). 
 

Very rare: may affect up to 1 in 10,000 people  

 

• Liver failure. 
• Hepatitis (inflammation of the liver). 
 

If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, 

you should seek immediate medical advice. 

 
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury 

may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to 

Lyrica and the severity of these effects may be increased when taken together. 

 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. 

 



 91 

The following adverse reaction has been reported in the postmarketing experience: Trouble breathing, 

shallow breaths. 

 
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 Lyrica 

 

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 or bottle. The expiry date 

refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 
Do not throw away any medicines via wastewater. 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 Lyrica contains 

 

The active substance is pregabalin. Each ml contains 20 mg of pregabalin.  

 
The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 

sodium dihydrogen phosphate, anhydrous, disodium phosphate, anhydrous (E339), sucralose (E955), 

artificial strawberry flavour (contains small amounts of ethanol (alcohol), purified water. 

 

What Lyrica looks like and contents of the pack  

 
Lyrica 20 mg/ml oral solution is a clear colourless solution in a white bottle containing 473 ml of oral 

solution, in a cardboard carton. The carton also contains, in a clear polyethylene wrap, a graduated 

5 ml oral syringe and a press-in bottle adapter (PIBA). 

 

Marketing Authorisation Holder and Manufacturer 
 

Marketing Authorisation Holder: 

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands. 

 

Manufacturer: 
Pfizer Service Company, Hoge Wei 10, B1930 Zaventem, Belgium 

 

or 

 

Pfizer Innovative Supply Point International BVBA, Hoge Wei 10, B1930 Zaventem, Belgium 
 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 92 

België/Belgique/Belgien 

Pfizer S.A. / N.V. 

Tél/Tel: +32 (0)2 554 62 11 
 

Lietuva 

Pfizer Luxembourg SARL filialas Lietuvoje 

Tel. +3705 2514000 
 

България 

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 
Česká republika 

Pfizer spol s.r.o. 

Tel: +420-283-004-111 

 

Magyarország 

Pfizer Kft. 

Tel. + 36 1 488 37 00 

 

Danmark 
Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Malta 
Vivian Corporation Ltd. 

Tel: +356 21344610 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 
 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 4301 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

Ελλάδα 

UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

España 
Pfizer GEP, S.L  

Tel: +34 91 490 99 00 

 

Polska 
Pfizer Polska Sp. z o.o. 

Tel.: +48 22 335 61 00 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 
 

Portugal 

Laboratórios Pfizer, Lda. 

Tel: +351 21 423 5500 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 
Ireland 

Pfizer Healthcare Ireland 

Tel: +1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

Slovenija 

Pfizer Luxembourg SARL, 

Pfizer, podružnica za svetovanje s področja 

farmacevtske dejavnosti, Ljubljana 

Tel: +386 (0)1 52 11 400 
 

Ísland 

Icepharma hf. 

Sími: +354 540 8000 

 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 
Italia 

Pfizer Established Medicine Italy S.r.l. 

Tel: +39 06 33 18 21 

Suomi/Finland 

Pfizer Oy 

Puh./Tel: +358 (0)9 43 00 40 

 



 93 

Κύπρος 

GPA Pharmaceuticals Ltd 

Τηλ: +357 22863100 
 

Sverige 

Pfizer AB 

Tel: +46 (0)8 550 520 00 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 
 

This leaflet was last revised in:  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


 94 

 

 
 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

ANNEX IV 

 

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS 

OF THE MARKETING AUTHORISATION(S) 



 95 

Scientific conclusions 

 

Taking into account the PRAC Assessment Report on the PSUR(s) for pregabalin, the scientific 

conclusions of CHMP are as follows: 

 

In view of available data on risk of respiratory depression from spontaneous reports and in view of a 

plausible mechanism of action, the PRAC considers a causal relationship between pregabalin and 

respiratory depression is established and concluded that the product information of products 

containing pregabalin should be amended accordingly.  

 

Update of section 4.4 of the SmPC to add a warning regarding respiratory depression related to 

pregabalin in patients without concomitant use of opioids and/or other CNS depressants and without 

risk factors as well in the setting of risk factors such as underlying respiratory impairment and/or 

use of CNS depressants.  

 

The CHMP agrees with the scientific conclusions made by the PRAC. 

 
Grounds for the variation to the terms of the marketing authorisation(s) 

 

On the basis of the scientific conclusions for pregabalin the CHMP is of the opinion that the benefit-

risk balance of the medicinal product(s) containing pregabalin is unchanged subject to the proposed 

changes to the product information. 

 

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.  


	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
	SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)