Pregabalin Zentiva k.s.

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



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1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Pregabalin Zentiva k.s. 300 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Each hard capsule contains 25 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 47.57 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Each hard capsule contains 50 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 5 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Each hard capsule contains 75 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Each hard capsule contains 100 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 10 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Each hard capsule contains 150 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 15 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Each hard capsule contains 200 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Each hard capsule contains 225 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate. 
 
Pregabalin Zentiva k.s. 300 mg hard capsules 
Each hard capsule contains 300 mg of pregabalin. 
 
Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 



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3. PHARMACEUTICAL FORM 
 
Hard capsule 
 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting 
“25”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting 
“50”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, 
containing almost white powder. 
 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, 
containing almost white powder. 
 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting 
“150”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with 
imprinting “200”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting 
“225”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 300 mg hard capsules 
Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, 
containing almost white powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Neuropathic pain 
Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in 
adults. 
 
Epilepsy 
Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without 
secondary generalisation. 
 
Generalised anxiety disorder 
Pregabalin Zentiva k.s. 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 per day given in either two or three divided doses. 
 



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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). 
 
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). 
 

CLcr (ml/min) =  (× 0.85 for female patients) 1.23 × [140 - age (years)] × weight (kg) serum creatinine (µmol/l) 



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Paediatric population 

The safety and efficacy of pregabalin 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 
Pregabalin Zentiva k.s. may be taken with or without food. 
Pregabalin Zentiva k.s. 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 post-marketing 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 post-
marketing 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 post-marketing 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. 
 



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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 post-marketing 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. 
 
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 post-marketing 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). 
 



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Encephalopathy 
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may 
precipitate encephalopathy. 
 
Lactose intolerance 
Pregabalin Zentiva k.s. contains lactose monohydrate. Patients with rare hereditary problems 
of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not 
take this medicine. 
 
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 post-marketing 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. 
Pregabalin 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. 
 



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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 
 
Pregabalin may have minor or moderate influence on the ability to drive and use machines. Pregabalin 
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 post-marketing 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 



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System Organ Class Adverse drug reactions 
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 
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 



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System Organ Class Adverse drug reactions 
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 four 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 1 year open 
label follow on safety study, n = 54) 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 post-marketing 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. 

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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 (α2-δ 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. 
 
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 a 
1 year open label safety study in 54 paediatric patients 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). 
 



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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% 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. 
 



13 

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 
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. 



14 

 
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. 
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. 
 
 



15 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsules content 
Lactose monohydrate 
Pregelatinized maize starch 
Talc 
 
Capsule shell 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Capsule cap and body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 
− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Capsule cap and body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 
− Shellac 
− Black iron oxide (E172) 
− Propylene glycol 
− Strong ammonia solution 
− Potassium hydroxide 
 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Capsule cap  
− Red iron oxide (E172) 
− Yellow iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Capsule body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 

− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Capsule cap and body 

− Red iron oxide (E172) 
− Yellow iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin. 
Printing ink 

− Shellac 



16 

− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Capsule cap and body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 

− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Capsule cap and body 

− Red iron oxide (E172) 
− Yellow iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 

− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Capsule cap  
− Red iron oxide (E172) 
− Yellow iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Capsule body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 

− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 
Pregabalin Zentiva k.s. 300 mg hard capsules 
Capsule cap  
− Red iron oxide (E172) 
− Yellow iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Capsule body 

− Black iron oxide (E172) 
− Titanium dioxide (E171) 
− Gelatin 
Printing ink 

− Shellac 
− Black iron oxide (E172) 
− Polyethylene glycol 
 



17 

6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 30 °C. 
 
6.5 Nature and contents of container 
 
Pregabalin Zentiva k.s. 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters 
as primary packaging. 
Pregabalin Zentiva k.s. 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules 
are packed into PVC/alu blisters as primary packaging. 
 
Pregabalin Zentiva k.s. 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard 
capsules. 
Pregabalin Zentiva k.s. 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 
hard capsules. 
Pregabalin Zentiva k.s. 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Pregabalin Zentiva k.s. 25 mg hard capsules: 
EU/1/16/1166/001 
EU/1/16/1166/002 
EU/1/16/1166/003 
EU/1/16/1166/004 
EU/1/16/1166/029 
EU/1/16/1166/005 
 
Pregabalin Zentiva k.s. 50 mg hard capsules: 
EU/1/16/1166/006 
EU/1/16/1166/007 
EU/1/16/1166/008 
EU/1/16/1166/009 
EU/1/16/1166/030 



18 

EU/1/16/1166/010 
 
Pregabalin Zentiva k.s. 75 mg hard capsules: 
EU/1/16/1166/011 
EU/1/16/1166/012 
EU/1/16/1166/031 
EU/1/16/1166/013 
 
Pregabalin Zentiva k.s. 100 mg hard capsules: 
EU/1/16/1166/014 
EU/1/16/1166/015 
EU/1/16/1166/032 
EU/1/16/1166/016 
 
Pregabalin Zentiva k.s. 150 mg hard capsules: 
EU/1/16/1166/017 
EU/1/16/1166/018 
EU/1/16/1166/033 
EU/1/16/1166/019 
 
Pregabalin Zentiva k.s. 200 mg hard capsules: 
EU/1/16/1166/020 
EU/1/16/1166/021 
EU/1/16/1166/034 
EU/1/16/1166/022 
 
Pregabalin Zentiva k.s. 225 mg hard capsules: 
EU/1/16/1166/023 
EU/1/16/1166/024 
EU/1/16/1166/035 
EU/1/16/1166/025 
 
Pregabalin Zentiva k.s. 300 mg hard capsules: 
EU/1/16/1166/026 
EU/1/16/1166/027 
EU/1/16/1166/036 
EU/1/16/1166/028 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 27 February 2017. 
 
 
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 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 

  



20 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Zentiva, k.s. 
U Kabelovny 130 
Dolni Měcholupy 
102 37 Prague 10 
Czech Republic 
 
S.C. Zentiva, S.A. 
B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 
Romania 
 
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  
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required  pharmacovigilance activities and interventions detailed 
in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 25 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
56 hard capsules 
84 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



24 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/001 
EU/1/16/1166/002 
EU/1/16/1166/003 
EU/1/16/1166/004 
EU/1/16/1166/029 
EU/1/16/1166/005 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



25 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 25 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 50 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
56 hard capsules 
84 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



27 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, 
IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10  
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/006 
EU/1/16/1166/007 
EU/1/16/1166/008 
EU/1/16/1166/009 
EU/1/16/1166/030 
EU/1/16/1166/010 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



28 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. OTHER 
 
  



29 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 75 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



30 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/011 
EU/1/16/1166/012 
EU/1/16/1166/031 
EU/1/16/1166/013 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



31 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 75 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. OTHER 
 
  



32 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 100 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
21 hard capsules 
84 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



33 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/014 
EU/1/16/1166/015 
EU/1/16/1166/032 
EU/1/16/1166/016 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



34 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 100 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 150 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



36 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/017 
EU/1/16/1166/018 
EU/1/16/1166/033 
EU/1/16/1166/019 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



37 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 200 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
21 hard capsules 
84 hard capsules 
98 hard capsules 
100 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 
 
Do not store above 30 °C. 
 
 



39 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/020 
EU/1/16/1166/021 
EU/1/16/1166/034 
EU/1/16/1166/022 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



40 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
  



41 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 225 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
98 hard capsules 
100 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 
 
Do not store above 30 °C. 
 
 



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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/023 
EU/1/16/1166/024 
EU/1/16/1166/035 
EU/1/16/1166/025 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 225 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 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. OTHER 
 
 
  



44 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
PAPER FOLDING BOX 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 300 mg hard capsules 
Pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each hard capsule contains 300 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
98 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE 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 
 
Do not store above 30 °C. 
 
 



45 

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 
 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1166/026 
EU/1/16/1166/027 
EU/1/16/1166/036 
EU/1/16/1166/028 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Zentiva k.s. 300 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 
 
BLISTERS 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Zentiva k.s. 300 mg hard capsules 
Pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Zentiva logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 
  



47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



48 

Package leaflet: Information for the user 
 

Pregabalin Zentiva k.s. 25 mg hard capsules 
Pregabalin Zentiva k.s. 50 mg hard capsules 
Pregabalin Zentiva k.s. 75 mg hard capsules 

Pregabalin Zentiva k.s. 100 mg hard capsules 
Pregabalin Zentiva k.s. 150 mg hard capsules 
Pregabalin Zentiva k.s. 200 mg hard capsules 
Pregabalin Zentiva k.s. 225 mg hard capsules 
Pregabalin Zentiva k.s. 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 Pregabalin Zentiva k.s. is and what it is used for 
2. What you need to know before you take Pregabalin Zentiva k.s. 
3. How to take Pregabalin Zentiva k.s. 
4. Possible side effects 
5. How to store Pregabalin Zentiva k.s. 
6. Contents of the pack and other information 
 
 
1. What Pregabalin Zentiva k.s. is and what it is used for 
 
Pregabalin Zentiva k.s. belongs to a group of medicines used to treat epilepsy, neuropathic pain 
and generalised anxiety disorder (GAD) in adults. 
 
Peripheral and central neuropathic pain 
Pregabalin Zentiva k.s. 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 
Pregabalin Zentiva k.s. is used to treat a certain form of epilepsy (partial seizures with or without 
secondary generalisation) in adults. Your doctor will prescribe Pregabalin Zentiva k.s. for you to help 
treat your epilepsy when your current treatment is not controlling your condition. You should take 
Pregabalin Zentiva k.s. in addition to your current treatment. Pregabalin Zentiva k.s. is not intended 
to be used alone, but should always be used in combination with other anti-epileptic treatment. 
 
Generalised anxiety disorder 
Pregabalin Zentiva k.s. 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. 



49 

 
 
2. What you need to know before you take Pregabalin Zentiva k.s. 
 
Do not take Pregabalin Zentiva k.s. 
• 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 Pregabalin Zentiva k.s. 
• Some patients taking pregabalin 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. 

• Pregabalin 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. 

• Pregabalin 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 pregabalin; 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 pregabalin. If while 
taking Pregabalin Zentiva k.s. 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 pregabalin have had 
thoughts of harming or killing themselves. If at any time you have these thoughts, immediately 
contact your doctor. 

• When pregabalin 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 pregabalin or shortly after stopping 
pregabalin. If you experience a convulsion, contact your doctor immediately. 

• There have been reports of reduction in brain function (encephalopathy) in some patients taking 
pregabalin when they have other conditions. Tell your doctor if you have a history of any 
serious medical conditions, including liver or kidney disease. 

 
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 Pregabalin Zentiva k.s. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
Pregabalin Zentiva k.s. and certain other medicines may influence each other (interaction). When 
taken with certain other medicines which have sedative effects (including opioids), pregabalin may 
potentiate these effects, and could lead to failure, coma and death. The degree of dizziness, sleepiness 



50 

and decreased concentration may be increased if pregabalin is taken together with medicines 
containing: 
• oxycodone (used as a pain-killer). 
• lorazepam (used for treating anxiety). 
• alcohol. 
Pregabalin Zentiva k.s. may be taken with oral contraceptives. 
 
Pregabalin Zentiva k.s. with food, drink and alcohol 
Pregabalin Zentiva k.s. hard capsules may be taken with or without food. 
It is advised not to drink alcohol while taking Pregabalin Zentiva k.s.. 
 
Pregnancy and breast-feeding 
Pregabalin Zentiva k.s. 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 
Pregabalin 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. 
 
Pregabalin Zentiva k.s. 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 medicinal product. 
 
 
3. How to take Pregabalin Zentiva k.s. 
 
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. 
Pregabalin Zentiva k.s. is for oral use only. 
 
Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder 
Take the number of hard 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. 
Your doctor will tell you to take Pregabalin Zentiva k.s. either twice or three times a day. For twice a 
day take Pregabalin Zentiva k.s. once in the morning and once in the evening, at about the same time 
each day. For three times a day take Pregabalin Zentiva k.s. 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 Pregabalin Zentiva k.s. 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 Pregabalin Zentiva k.s. 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 Pregabalin Zentiva k.s. until your doctor tells you to stop. 
 
If you take more Pregabalin Zentiva k.s. than you should 
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box 
of Pregabalin Zentiva k.s. hard capsules with you. You may feel sleepy, confused, agitated, or restless 
as a result of taking more Pregabalin Zentiva k.s. than you should. Fits have also been reported. 
 



51 

If you forget to take Pregabalin Zentiva k.s. 
It is important to take your Pregabalin Zentiva k.s. hard 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 Pregabalin Zentiva k.s. 
Do not stop taking Pregabalin Zentiva k.s. 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 pregabalin treatment, you need to know that you may experience 
certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, 
flulike symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These 
symptoms may occur more commonly or severely if you have been taking pregabalin 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 heartbeat, heart failure. 
• Flushing, hot flushes. 



52 

• 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 

aminotransferase increased, aspartate aminotransferase increased, platelet count decreased, 
neutropenia, 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 
pregabalin and the severity of these effects may be increased when taken together. 
 
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. 
 

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


53 

 
5. How to store Pregabalin Zentiva k.s. 
 
Keep this medicine out of the sight and reach of children. 
Do not store above 30 °C. 
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. 
The expiry date refers to the last day of that month. 
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 Pregabalin Zentiva k.s. contains 
The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 
200 mg, 225 mg or 300 mg of pregabalin. 
 
The other ingredients are lactose monohydrate, pregelatinized maize starch, talc, titanium 
dioxide (E171), gelatin, shellac, black iron oxide (E172). 
 
The 50 mg capsules also contain propylene glycol, strong ammonia solution, potassium hydroxide. 
The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg capsules also contain polyethylene 
glycol. 
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172), yellow 
iron oxide (E172). 
 

What Pregabalin Zentiva k.s. looks like and contents of the pack 

25 mg capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “25”, containing almost white powder. 

50 mg capsules Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder. 

75 mg capsules Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder. 

100 mg capsules Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder. 

150 mg capsules Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder. 

200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder. 

225 mg capsules Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder. 

300 mg capsules Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder. 
 
Pregabalin Zentiva k.s. 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters 
as primary packaging. 
Pregabalin Zentiva k.s. 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules 
are packed into PVC/alu blisters as primary packaging. 
 
Pregabalin Zentiva k.s. 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard 
capsules. 
Pregabalin Zentiva k.s. 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 
hard capsules. 
Pregabalin Zentiva k.s. 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules. 
Not all pack sizes may be marketed. 
 



54 

Marketing Authorisation Holder  
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
Manufacturer 
Zentiva, k.s. 
U Kabelovny 130 
102 37 Prague 10 
Czech Republic 
 
or 
 
S.C. Zentiva, S.A. 
B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 
Romania 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Zentiva, k.s. 
Tél/Tel: +32 280 86 420 
PV-Belgium@zentiva.com 

Lietuva 
Zentiva, k.s. 
Tel: +370 52152025 
PV-Lithuania@zentiva.com 

България 
Zentiva, k.s. 
Тел: + 359 2 805 72 08 
PV-Bulgaria@zentiva.com 

Luxembourg/Luxemburg 
Zentiva, k.s. 
Tél/Tel: +352 208 82330 
PV-Luxembourg@zentiva.com 

Česká republika 
Zentiva, k.s. 
Tel: +420 267 241 111 
PV-Czech-Republic@zentiva.com 

Magyarország 
Zentiva, k.s. 
Tel.: +36 165 55 722 
PV-Hungary@zentiva.com 

Danmark 
Zentiva, k.s. 
Tlf: +45 787 68 400 
PV-Denmark@zentiva.com 

Malta 
Zentiva, k.s. 
Tel: +356 277 82 052 
PV-Malta@zentiva.com 

Deutschland 
Zentiva Pharma GmbH  
Tel: +49 (0) 800 53 53 010 
PV-Germany@zentiva.com 

Nederland 
Zentiva, k.s. 
Tel: +31 202 253 638 
PV-Netherlands@zentiva.com 

Eesti 
Zentiva, k.s. 
Tel: +372 52 70308 
PV-Estonia@zentiva.com 

Norge 
Zentiva, k.s. 
Tlf: +47 219 66 203 
PV-Norway@zentiva.com 

Ελλάδα 
Zentiva, k.s. 
Τηλ: +30 211 198 7510 
PV-Greece@zentiva.com 

Österreich 
Zentiva, k.s. 
Tel: +43 720 778 877 
PV-Austria@zentiva.com 

España 
Zentiva, k.s. 
Tel: +34 931 815 250 
PV-Spain@zentiva.com 

Polska 
Zentiva Polska Sp. z o.o. 
Tel: + 48 22 375 92 00 
PV-Poland@zentiva.com 



55 

France 
Zentiva France 
Tél: +33 (0) 800 089 219  
PV-France@zentiva.com 

Portugal 
Zentiva Portugal, Lda 
Tel: +351210601360 
PV-Portugal@zentiva.com 

Hrvatska 
Zentiva, k.s. 
Tel: +385 155 17 772 
PV-Croatia@zentiva.com 

România 
ZENTIVA S.A. 
Tel: +40 021.304.7597 
zentivaRO@zentiva.com 

Ireland 
Zentiva, k.s. 
Tel: +353 766 803 944 
PV-Ireland@zentiva.com 

Slovenija 
Zentiva, k.s. 
Tel: +386 360 00 408 
PV-Slovenia@zentiva.com 

Ísland 
Zentiva, k.s. 
Sími: +354 539 0650 
PV-Iceland@zentiva.com 

Slovenská republika 
Zentiva, a.s. 
Tel: +421 2 3918 3010 
PV-Slovakia@zentiva.com 

Italia 
Zentiva Italia S.r.l. 
Tel: +39-02-38598801 
PV-Italy@zentiva.com 

Suomi/Finland 
Zentiva, k.s. 
Puh/Tel: +358 942 598 648 
PV-Finland@zentiva.com 

Κύπρος 
Zentiva, k.s. 
Τηλ: +357 240 30 144 
PV-Cyprus@zentiva.com 

Sverige 
Zentiva, k.s. 
Tel: +46 840 838 822 
PV-Sweden@zentiva.com 

Latvija 
Zentiva, k.s. 
Tel: +371 67893939 
PV-Latvia@zentiva.com 

United Kingdom 
Zentiva Pharma UK Limited 
Tel: +44 (0) 845 372 7101 
PV-United-Kingdom@zentiva.com 

 
 
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/

	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