Pregabalin Sandoz GmbH

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
Pregabalin Sandoz GmbH 50 mg hard capsules 
Pregabalin Sandoz GmbH 75 mg hard capsules 
Pregabalin Sandoz GmbH 100 mg hard capsules 
Pregabalin Sandoz GmbH 150 mg hard capsules 
Pregabalin Sandoz GmbH 200 mg hard capsules 
Pregabalin Sandoz GmbH 225 mg hard capsules 
Pregabalin Sandoz GmbH 300 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
Each hard capsule contains 25 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
Each hard capsule contains 50 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
Each hard capsule contains 75 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 100 mg hard capsules 
Each hard capsule contains 100 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
Each hard capsule contains 150 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
Each hard capsule contains 200 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
Each hard capsule contains 225 mg of pregabalin. 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
Each hard capsule contains 300 mg of pregabalin. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule. 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
Pale yellow-brown opaque  cap and body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to 
nearly white coloured powder. 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly 
white coloured powder. 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to 
nearly white coloured powder. 
 



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Pregabalin Sandoz GmbH 100 mg hard capsules 
Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white 
coloured powder. 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white 
coloured powder. 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly 
white coloured powder. 
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm), filled with white 
to nearly white coloured powder. 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm), filled with 
white to nearly white coloured powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Epilepsy 
Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or 
without secondary generalisation. 
 
Generalised anxiety disorder 
Pregabalin Sandoz GmbH 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. 
 
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 has to be discontinued, it is recommended pregabalin 
this should be done gradually over a minimum of 1 week independent of the indication (see 
sections 4.4 and 4.8). 
 



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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). 
 
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 section 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 Sandoz GmbH may be taken with or without food.  



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Pregabalin Sandoz GmbH 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. 
 
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. 
 



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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. 
 
Adverse reactions in patients with spinal cord injury 
The incidence of adverse reactions in general, central nervous system adverse reactions and especially 
somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury. This 
may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity 
agents) needed for 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). 
 
Encephalopathy 
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may 
precipitate encephalopathy. 
 
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 



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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 medicinal 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. 
 
Pregabalin Sandoz GmbH 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). 
 



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4.7 Effects on ability to drive and use machines 
 
Pregabalin Sandoz GmbH may have minor or moderate influence on the ability to drive and use 
machines. Pregabalin Sandoz GmbH 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 program 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. 
 
The incidence of adverse reactions in general, central nervous system adverse reactions and especially 
somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (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, 



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System Organ Class Adverse drug reactions 

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 

Gastrointestinal disorders  

Common  Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal 
distension, dry mouth  

Uncommon  Gastrooesophageal reflux disease, salivary hypersecretion, 
hypoaesthesia oral  



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System Organ Class Adverse drug reactions 

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. 



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Paediatric population 
The pregabalin safety profile observed in five paediatric studies in patients with partial seizures with 
or without secondary generalization (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 (α2-δ protein) of voltage-gated calcium channels in the central 
nervous system, 
 
Clinical efficacy and safety 
 
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) 

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


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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 study 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% 
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 



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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 
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. 
 



14 

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. 
 
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 



15 

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 
 
Pregabalin Sandoz GmbH 25, 300 mg hard capsules 
 
Capsule content 
Pregelatinised maize starch 
Maize starch 
Talc 
 
Capsule shell 
Gelatin 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
Iron oxide red (E172) 
Iron oxide black (E172) 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
 
Capsule content 
Pregelatinised maize starch 
Maize starch 
Talc 
 
Capsule shell 
Gelatin 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
 
Pregabalin Sandoz GmbH 75, 100, 200, 225 mg hard capsules 
 
Capsule content 
Pregelatinised maize starch 
Maize starch 
Talc 
 
Capsule shell 
Gelatin 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
Iron oxide red (E172) 
 



16 

Pregabalin Sandoz GmbH 150 mg hard capsules 
 
Capsule content 
Pregelatinised maize starch 
Maize starch 
Talc 
 
Capsule shell 
Gelatin 
Titanium dioxide (E171) 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
3 years. 
 
[Pregabalin Sandoz GmbH 25, 50, 75, 150, 300 mg hard capsules] 
After first opening of the container: 6 months. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
PVC/PVDC//Alu blister.  
HDPE container with PP screw cap. 
 
Pack sizes: 
Blister packs: 14, 28, 56, 70, 84, 100 or 120 hard capsules. 
Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.  
Container packs: 200 hard capsules 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
PVC/PVDC//Alu blister.  
HDPE container with PP screw cap. 
 
Pack sizes: 
Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules 
Blister packs (unit dose): 84 x 1 hard capsules.  
Container packs: 200 hard capsules 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
PVC/PVDC//Alu blister.  
HDPE container with PP screw cap. 
 
Pack sizes: 
Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules 
Blister packs (unit dose): 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules  
Container packs: 100, 200 or 250 hard capsules 
 
Pregabalin Sandoz GmbH 100 mg hard capsules 
PVC/PVDC//Alu blister.  



17 

 
Pack sizes: 
Blister packs: 14, 21, 28, 56, 84 or 100 hard capsules 
Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules  
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
PVC/PVDC//Alu blister.  
HDPE container with PP screw cap. 
 
Pack sizes: 
Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules 
Blister packs (unit dose): 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules  
Container packs: 100, 200 or 250 hard capsules 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
PVC/PVDC//Alu blister.  
 
Pack sizes: 
Blister packs: 21, 28, 84 or 100 hard capsules 
Blister packs (unit dose): 84 x 1 or 100 x 1 hard capsules  
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
PVC/PVDC//Alu blister.  
 
Pack sizes: 
Blister packs: 14, 56, 70, 84, 100 or 120 hard capsules 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
PVC/PVDC//Alu blister.  
HDPE container with PP screw cap. 
 
Pack sizes: 
Blister packs: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules 
Blister packs (unit dose): 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules  
Container packs: 100, 200 or 250 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 
 
Sandoz GmbH 
Biochemiestrasse 10 
A-6250 Kundl 
Austria 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
EU/1/15/1012/001-010 
EU/1/15/1012/084 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 



18 

EU/1/15/1012/011-017 
EU/1/15/1012/085 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
EU/1/15/1012/018-033 
 
Pregabalin Sandoz GmbH 100 mg hard capsules 
EU/1/15/1012/034-041 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
EU/1/15/1012/042-056 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
EU/1/15/1012/057-062 
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
EU/1/15/1012/063-068 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
EU/1/15/1012/069-083 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 June 2015 
Date of latest renewal: 19 June 2020 
 
 
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 
 
Lek Pharmaceuticals d.d. 
Verovškova 57 
1526 Ljubljana 
Slovenia 
 
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; 
• 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 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 25 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
28 hard capsules 
56 hard capsules 
70 hard capsules 
84 hard capsules 
100 hard capsules 
120 hard capsules 
56 x 1 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



24 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/001-010 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 25 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



25 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 25 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 25 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
200 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Use within 6 months after first opening. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



27 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/084 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Outer carton: Pregabalin Sandoz GmbH 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 



28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 50 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
28 hard capsules 
56 hard capsules 
84 hard capsules 
100 hard capsules 
84 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



29 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/011-017 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



30 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 50 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 50 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
200 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Use within 6 months after first opening. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



32 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/085 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Outer carton: Pregabalin Sandoz GmbH 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  



33 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 75 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 hard capsules 
200 hard capsules 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Use within 6 months after first opening. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



34 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/031-033 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Outer carton: Pregabalin Sandoz GmbH 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  



35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 75 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
28 hard capsules 
56 hard capsules 
70 hard capsules 
84 hard capsules 
100 hard capsules 
120 hard capsules 
14 x 1 hard capsules 
56 x 1 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



36 

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/018-029 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  



37 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE 
BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 75 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 



38 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/030 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN 
NN  



39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACKS – WITHOUT BLUE BOX  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 75 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
70 x 1 hard capsules. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 



40 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/030 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



41 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 75 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



42 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 100 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 100 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
28 hard capsules 
56 hard capsules 
84 hard capsules 
100 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



43 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/034-041 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



44 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 100 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 150 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 hard capsules 
200 hard capsules 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Use within 6 months after first opening. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



46 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/054-056 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Outer carton: Pregabalin Sandoz GmbH 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN 
NN  



47 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 150 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
28 hard capsules 
56 hard capsules 
70 hard capsules 
84 hard capsules 
100 hard capsules 
120 hard capsules 
56 x 1 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



48 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/042-052 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 150 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 



49 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE 
BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 150 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 



50 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/053 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN 
 



51 

 
PARTICULARS TO APPEAR ON THE OUTERPACKAGING 
 
MULTIPACKS – WITHOUT BLUE BOX  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 150 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
70 x 1 hard capsules. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 



52 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/053 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC 
SN 
NN  
 
 



53 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 150 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



54 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 200 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
21 hard capsules 
28 hard capsules 
84 hard capsules 
100 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



55 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/057-062 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN 
NN  
 
 



56 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 200 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



57 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 225 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
70 hard capsules 
84 hard capsules 
100 hard capsules 
120 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



58 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/063-068 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 225 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



59 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 225 mg hard capsules 
pregabalin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



60 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON FOR CONTAINER AND LABEL FOR CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 300 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 hard capsules 
200 hard capsules 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Use within 6 months after first opening. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



61 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/081-083 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Outer carton: Pregabalin Sandoz GmbH 300 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  



62 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 300 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
21 hard capsules 
28 hard capsules 
56 hard capsules 
70 hard capsules 
56 x 1 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



63 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/069-073 
EU/1/15/1012/077 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 300 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC 
SN  
NN  
 
 



64 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING THE 
BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 300 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 84 (2 packs of 42) hard capsules 
Multipack: 100 (2 packs of 50) hard capsules 
Multipack: 120 (2 packs of 60) hard capsules 
Multipack: 84 x 1 (2 packs of 42 x 1) hard capsules 
Multipack: 100 x 1 (2 packs of 50 x 1) hard capsules 
Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



65 

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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/074-076 
EU/1/15/1012/078-080  
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 



66 

 
PARTICULARS TO APPEAR ON THE OUTERPACKAGING 
 
MULTIPACKS – WITHOUT BLUE BOX  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
pregabalin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 300 mg of pregabalin. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
42 hard capsules. Component of a multipack, can’t be sold separately. 
50 hard capsules. Component of a multipack, can’t be sold separately. 
60 hard capsules. Component of a multipack, can’t be sold separately. 
42 x 1 hard capsules. Component of a multipack, can’t be sold separately. 
50 x 1 hard capsules. Component of a multipack, can’t be sold separately. 
70 x 1 hard capsules. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



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 
 
Sandoz GmbH 
Biochemiestrasse 10 
6250 Kundl 
Austria 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/15/1012/074-076 
EU/1/15/1012/078-080  
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pregabalin Sandoz GmbH 300 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. [For outer carton only] 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
[For outer carton only] 
PC  
SN  
NN  
 
 



68 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pregabalin Sandoz GmbH 300 mg hard capsules 
pregabalin 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Sandoz 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. OTHER 
 
 



69 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



70 

Package leaflet: Information for the user 
 

Pregabalin Sandoz GmbH 25 mg hard capsules 
Pregabalin Sandoz GmbH 50 mg hard capsules 
Pregabalin Sandoz GmbH 75 mg hard capsules 
Pregabalin Sandoz GmbH 100 mg hard capsules 
Pregabalin Sandoz GmbH 150 mg hard capsules 
Pregabalin Sandoz GmbH 200 mg hard capsules 
Pregabalin Sandoz GmbH 225 mg hard capsules 
Pregabalin Sandoz GmbH 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 Sandoz GmbH is and what it is used for 
2. What you need to know before you take Pregabalin Sandoz GmbH 
3. How to take Pregabalin Sandoz GmbH 
4. Possible side effects 
5. How to store Pregabalin Sandoz GmbH 
6. Contents of the pack and other information 
 
 
1. What Pregabalin Sandoz GmbH  is and what it is used for 
 
Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised 
Anxiety Disorder (GAD) in adults. 
 
Epilepsy: Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy (partial seizures with or 
without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Sandoz GmbH for 
you to help treat your epilepsy when your current treatment is not controlling your condition. You 
should take Pregabalin Sandoz GmbH in addition to your current treatment. Pregabalin Sandoz GmbH 
is not intended to be used alone, but should always be used in combination with other anti-epileptic 
treatment. 
 
Generalised Anxiety Disorder: Pregabalin Sandoz GmbH 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 Pregabalin Sandoz GmbH 
 
Do not take Pregabalin Sandoz GmbH 
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6). 
 



71 

Warnings and Precautions  
Talk to your doctor or pharmacist before taking Pregabalin Sandoz GmbH. 
 
• 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 Sandoz GmbH 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 Sandoz GmbH 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 Sandoz GmbH 

have had thoughts of harming or killing themselves. If at any time you have these thoughts, 
immediately contact your doctor. 

 
• When Pregabalin Sandoz GmbH 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.  

 
• 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 
 



72 

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 Sandoz GmbH 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
 
Pregabalin Sandoz GmbH and certain other medicines may influence each other (interaction). When 
taken with certain other medicines, which have sedative effects (including opioids), Pregabalin Sandoz 
GmbH 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 Pregabalin Sandoz GmbH is 
taken together with medicines containing: 
 
Oxycodone – (used as a pain-killer) 
Lorazepam – (used for treating anxiety) 
Alcohol 
 
Pregabalin Sandoz GmbH may be taken with oral contraceptives. 
 
Pregabalin Sandoz GmbH with food, drink and alcohol 
Pregabalin Sandoz GmbH capsules may be taken with or without food. 
 
It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH. 
 
Pregnancy and breast-feeding 
Pregabalin Sandoz GmbH 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 Sandoz GmbH 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. 
 
 
3. How to take Pregabalin Sandoz GmbH 
 
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 Sandoz GmbH is for oral use only. 
 
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. 
• Your doctor will tell you to take Pregabalin Sandoz GmbH either twice or three times a day. For 

twice a day take Pregabalin Sandoz GmbH once in the morning and once in the evening, at 
about the same time each day. For three times a day take Pregabalin Sandoz GmbH 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 Sandoz GmbH is too strong or too weak, talk 
to your doctor or pharmacist. 
 



73 

If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz GmbH 
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 Sandoz GmbH until your doctor tells you to stop. 
 
If you take more Pregabalin Sandoz GmbH than you should 
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of 
Pregabalin Sandoz GmbH capsules with you. You may feel sleepy, confused, agitated, or restless as a 
result of taking more Pregabalin Sandoz GmbH than you should. Fits have also been reported. 
 
If you forget to take Pregabalin Sandoz GmbH 
It is important to take your Pregabalin Sandoz GmbH 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 Sandoz GmbH 
Do not stop taking Pregabalin Sandoz GmbH 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 Sandoz GmbH 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 Pregabalin Sandoz 
GmbH 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. 



74 

• 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 

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). 



75 

 
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 Pregabalin Sandoz GmbH 
 
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 blister, container or carton after 
EXP. The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
HDPE bottles: Use within 6 months after first opening. 
 
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 Sandoz GmbH 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 pregelatinised maize starch, maize starch, talc, gelatin, titanium 

dioxide (E171), yellow iron oxide (E172) (all strengths except 150 mg), red iron oxide (E172) 
(all strengths except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg). 

 
What Pregabalin Sandoz GmbH looks like and contents of the pack 

25 mg capsules Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm) 
filled with white to nearly white coloured powder. 
 50 mg capsules Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) 
filled with white to nearly white coloured powder. 

75 mg capsules Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm) 
filled with white to nearly white coloured powder. 
   

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


76 

100 mg capsules Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with 
white to nearly white coloured powder. 
 150 mg capsules White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm) filled with 

white to nearly white coloured powder. 
 200 mg capsules Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled 

with white to nearly white coloured powder. 
 225 mg capsules Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 

6.9 mm) filled with white to nearly white coloured powder. 
 300 mg capsules Red opaque cap and pale yellow-brown opaque body, capsule size 0 

(21.7 mm x 7.6 mm) filled with white to nearly white coloured powder. 
  

 
Pregabalin Sandoz GmbH is available in the following presentations:  
PVC/PVDC//Alu blisters packed in carton.  
PVC/PVDC//Alu unit dose blisters packed in carton 
HDPE container with PP screw cap packed in carton. 
 
25 mg capsules: 
Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules. 
Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules. 
HDPE bottles containing 200 hard capsules. 
 
50 mg capsules: 
Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules. 
Unit dose blisters containing 84 x 1 hard capsules. 
HDPE bottles containing 200 hard capsules. 
 
75 mg capsules: 
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules. 
Unit dose blisters containing 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules. 
HDPE bottles containing 100, 200 or 250 hard capsules. 
 
100 mg capsules: 
Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules. 
Unit dose blisters containing 84 x 1 or 100 x 1 hard capsules. 
 
150 mg capsules: 
Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules. 
Unit dose blisters containing 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules. 
HDPE bottles containing 100, 200 or 250 hard capsules. 
 
200 mg capsules: 
Blisters containing 21, 28, 84 or 100 hard capsules. 
Unit dose blisters containing 84 x 1 or 100 x 1 hard capsules. 
 
225 mg capsules: 
Blisters containing 14, 56, 70, 84, 100 or 120 hard capsules. 
 
300 mg capsules: 
Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules. 
Unit dose blisters containing 56 x 1, 84 x 1 (2 x 42), 100 x 1 (2 x 50) or 210 x 1 (3 x 70) hard capsules. 
HDPE bottles containing 100, 200 or 250 hard capsules. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria 



77 

 
Manufacturer 
Lek Pharmaceuticals d.d. 
Verovškova 57 
1526 Ljubljana 
Slovenia 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sandoz nv/sa 
Medialaan 40 
B-1800 Vilvoorde 
Tél/Tel.: +32 2 722 97 97 
regaff.belgium@sandoz.com 
 

Lietuva 
Sandoz Pharmaceuticals d.d. filialas 
Šeimyniškių 3A, 
LT 09312 Vilnius 
Tel: +370 5 26 36 037 
Info.lithuania@sandoz.com 
 

България 
КЧТ Сандоз България 
Бул.“Никола Вапцаров“ No. 55 
сгр. 4, ет. 4 
1407 София 
Teл.: + 359 2 970 47 47  
regaffairs.bg@sandoz.com 
 

Luxembourg/Luxemburg 
Sandoz nv/sa 
Medialaan 40 
B-1800 Vilvoorde 
Tél/Tel.: +32 2 722 97 97 
regaff.belgium@sandoz.com 

Česká republika 
Sandoz s.r.o. 
Na Pankráci 1724/129 
CZ-140 00 Praha 4 - Nusle 
Tel: +420 225 775 111 
office.cz@sandoz.com 
 

Magyarország 
Sandoz Hungária Kft. 
Tel.: +36 1 430 2890 

Danmark 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmark 
Tlf: + 45 6395 1000 
Info.danmark@sandoz.com  

Malta 
Medical Logistics Ltd. 
ADC Building, Triq L-Esportaturi 
Mriehel, BKR 3000 
Malta 
Tel: +356 2277 8000 
mgatt@medicallogisticsltd.com 
 

Deutschland 
Hexal AG 
Industriestrasse  25 
D-83607 Holzkirchen 
Tel: +49 8024 908 0  
E-mail: service@hexal.com 
 

Nederland 
Sandoz B.V. 
Veluwezoom 22  
NL-1327 AH Almere 
Tel: +31 36 5241600 
info.sandoz-nl@sandoz.com 

Eesti 
Sandoz d.d. Eesti filiaal 
Pärnu mnt 105 
EE-11312 Tallinn 
Tel.: +372 665 2400 
info.ee@sandoz.com 

Norge 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmark 
Tlf: + 45 6395 1000 
Info.danmark@sandoz.com 
 

Ελλάδα Österreich 



78 

Novartis (Hellas) S.A.C.I. 
Εθνική Οδός No 1 (12ο km) 
Μεταμόρφωση 
GR-144 51 Αθήνα 
Τηλ: +30 210 2811712 
 

Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Tel: +43 5338 2000 
 

España 
Sandoz Farmacéutica, S.A.  
Centro empresarial Parque Norte 
Edificio Roble 
C/Serrano Galvache, N°56 
28033 Madrid  
Spain 
Tel: +34 900 456 856 
registros.spain@sandoz.com 
 

Polska 
Sandoz Polska Sp. z o.o. 
ul. Domaniewska 50C  
02-672 Warszawa 
Tel.: + 48 22 209 70 00 
biuro.pl@sandoz.com 
 

France 
Sandoz SAS 
49 avenue Georges Pompidou 
F-92593 Levallois-Perret Cedex 
Tél: + 33 1 4964 4800 
 

Portugal 
Sandoz Farmacêutica Lda. 
Phone: +351 21 924 19 11 
 

Hrvatska 
Sandoz d.o.o. 
Maksimirska 120 
10000 Zagreb 
Tel: + 385 1 2353111 
e-mail: upit.croatia@sandoz.com 
 

România 
S.C. Sandoz S.R.L.  
Str. Livezeni nr.7A,  
540472 Târgu Mureş 
+40 21 4075160 

Ireland 
Rowex Ltd., 
Bantry, Co. Cork, 
Ireland. 
P75 V009 
Tel: + 353 27 50077 
e-mail: reg@rowa-pharma.ie 
 

Slovenija 
Lek farmacevtska družba d.d. 
Tel: +386 1 580 21 11 

Ísland 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmörk 
Tlf: + 45 6395 1000 
Info.danmark@sandoz.com 
 

Slovenská republika 
Sandoz d.d. organizačná zložka 
Žižkova 22B 
SK-811 02 Bratislava 
Tel: + 421 2 50 706 111 
 

Italia 
Sandoz  S.p.A  
Largo Umberto Boccioni 1 
I - 21040 Origgio/VA 
Tel: + 39 02 96541 
 

Suomi/Finland 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 Kööpenhamina S 
Tanska 
Tlf: + 45 6395 1000 
Info.suomi@sandoz.com 

 
Κύπρος 
Panayiotis Hadjigeorgiou  
Γιλντίζ 31, 3042 
CY-000 00 Πόλη: Λεμεσός 

 
Sverige 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 Köpenhamn S  



79 

Τηλ: 00357 25372425 
hapanicos@cytanet.com.cy  
 

Danmark 
Tlf: + 45 6395 1000 
Info.sverige@sandoz.com 
 

Latvija 
Sandoz d..d Latvia filiāle 
K.Valdemāra iela 33-29 
Rīga, LV1010 
Tel: + 371 67892006 
 

United Kingdom (Northern Ireland) 
Sandoz GmbH 
Biochemiestr. 10 
A-6250 Kundl 
Tel: +43 5338 2000 
 

 
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