Pregabalin Mylan Pharma

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ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 

 

 

 

 

 

 

 

 

 

 

 

  



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1.  NAME OF THE MEDICINAL PRODUCT 

 

Pregabalin Mylan Pharma 25 mg hard capsules 
Pregabalin Mylan Pharma 50 mg hard capsules 
Pregabalin Mylan Pharma 75 mg hard capsules 
Pregabalin Mylan Pharma 100 mg hard capsules 
Pregabalin Mylan Pharma 150 mg hard capsules 
Pregabalin Mylan Pharma 200 mg hard capsules 
Pregabalin Mylan Pharma 225 mg hard capsules 
Pregabalin Mylan Pharma 300 mg hard capsules 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Pregabalin Mylan Pharma 25 mg hard capsules 
 
Each hard capsule contains 25 mg of pregabalin. 
 
Pregabalin Mylan Pharma 50 mg hard capsules 
 
Each hard capsule contains 50 mg of pregabalin. 
 
Pregabalin Mylan Pharma 75 mg hard capsules 
 
Each hard capsule contains 75 mg of pregabalin. 
 
Pregabalin Mylan Pharma 100 mg hard capsules 
 
Each hard capsule contains 100 mg of pregabalin. 
 
Pregabalin Mylan Pharma 150 mg hard capsules 
 
Each hard capsule contains 150 mg of pregabalin. 
 
Pregabalin Mylan Pharma 200 mg hard capsules 
 
Each hard capsule contains 200 mg of pregabalin. 
 
Pregabalin Mylan Pharma 225 mg hard capsules 
 
Each hard capsule contains 225 mg of pregabalin. 
 
Pregabalin Mylan Pharma 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 Mylan Pharma 25 mg hard capsules 
 



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No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with 
white to off-white powder. The capsule is axially printed with MYLAN over PB25 in black ink 
on cap and body. 
 
Pregabalin Mylan Pharma 50 mg hard capsules 
 
The 50 mg capsules are No. 3, dark peach opaque cap and white opaque body, hard-shell gelatin 
capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 
PB50 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 75 mg hard capsules 
 
The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell 
gelatin capsule filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB75 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 100 mg hard capsules 
 
The 100 mg capsules are No. 3, dark peach opaque cap and dark peach opaque body, hard-shell 
gelatin capsules filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB100 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 150 mg hard capsules 
 
The 150 mg capsules are No. 2, light peach opaque cap and white opaque body, hard-shell 
gelatin capsules filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB150 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 200 mg hard capsules 
 
The 200 mg capsules are No. 1, light peach opaque cap and light peach opaque body, hard-shell 
gelatin capsules filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB200 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 225 mg hard capsules 
 
The 225 mg capsules are No. 1, dark peach opaque cap and dark peach opaque body, hard-shell 
gelatin capsules filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB225 in black ink on cap and body. 
 
Pregabalin Mylan Pharma 300 mg hard capsules 
 
The 300 mg capsules are No. 0, light peach opaque cap and white opaque body, hard-shell 
gelatin capsules filled with white to off-white powder. The capsule is axially printed with 
MYLAN over PB300 in black ink on cap and body.  
 
4.  CLINICAL PARTICULARS 

 

4.1  Therapeutic indications 

 
Epilepsy 
 
Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with 
or without secondary generalisation. 
 



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Generalised Anxiety Disorder 
 
Pregabalin Mylan Pharma 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 pregabalin has to be discontinued, it is 
recommended this should be done gradually over a minimum of 1 week independent of the 
indication (see sections 4.4 and 4.8). 
 
Special populations 
 
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 



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 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 Mylan Pharma 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 patients with renal impairment). 
 
Method of administration 
 
Pregabalin Mylan Pharma may be taken with or without food. 
Pregabalin Mylan Pharma is for oral use only. 
 
4.3  Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
4.4  Special warnings and precautions for use 
 

Diabetic patients 
 
In accordance with current clinical practice, some diabetic patients who gain weight on 
pregabalin treatment may need to adjust hypoglycaemic medicinal products. 
 
Hypersensitivity reactions 
 
There have been reports in the post-marketing experience of hypersensitivity reactions, including 
cases of angioedema. Pregabalin should be discontinued immediately if symptoms of 
angioedema, such as facial, perioral, or upper airway swelling occur. 
 
Dizziness, somnolence, loss of consciousness, confusion and mental impairment 
 



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Pregabalin treatment has been associated with dizziness and somnolence, which could increase 
the occurrence of accidental injury (fall) in the elderly population. There have also been 
post-marketing reports of loss of consciousness, confusion and mental impairment. Therefore, 
patients should be advised to exercise caution until they are familiar with the potential effects of 
the medicinal product. 
 
Vision-related effects 
 
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred 
vision than did patients treated with placebo which resolved in a majority of cases with 
continued dosing. In the clinical studies where ophthalmologic testing was conducted, the 
incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated 
patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in 
placebo-treated patients (see section 5.1). 
 
In the post-marketing experience, visual adverse reactions have also been reported, including 
loss of vision, visual blurring or other changes of visual acuity, many of which were transient.  
Discontinuation of pregabalin may result in resolution or improvement of these visual 
symptoms. 
 
Renal failure 
 
Cases of renal failure have been reported and in some cases discontinuation of pregabalin did 
show reversibility of this adverse reaction. 
 
Withdrawal of concomitant anti-epileptic medicinal products 
 
There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, 
once seizure control with pregabalin in the add-on situation has been reached, in order to reach 
monotherapy on pregabalin. 
 
Withdrawal symptoms 
 
After discontinuation of short-term and long-term treatment with pregabalin, withdrawal 
symptoms have been observed in some patients. The following events have been mentioned: 
insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, 
convulsion, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should 
be informed about this at the start of the treatment. 
 
Convulsions, including status epilepticus and grand mal convulsions, may occur during 
pregabalin use or shortly after discontinuing pregabalin. 
 
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence 
and severity of withdrawal symptoms may be dose-related. 
 
Congestive heart failure 
 
There have been post-marketing reports of congestive heart failure in some patients receiving 
pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients 
during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution 
in these patients. Discontinuation of pregabalin may resolve the reaction. 
 
Adverse reactions in patients with spinal cord injury 
 



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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. 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents 
in several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic 
drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism 
of this risk is not known and the available data do not exclude the possibility of an increased risk 
for pregabalin. 
 
Therefore patients should be monitored for signs of suicidal ideation and behaviours and 
appropriate treatment should be considered. Patients (and caregivers of patients) should be 
advised to seek medical advice should signs of suicidal ideation or behaviour emerge. 
 
Reduced lower gastrointestinal tract function 
 
There are post-marketing reports of events related to reduced lower gastrointestinal tract 
function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was 
co-administered with medications that have the potential to produce constipation, such as opioid 
analgesics. When pregabalin and opioids will be used in combination, measures to prevent 

constipation may be considered (especially in female patients and elderly). 
 
Concomitant use with opioids 
 
Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS 
depression (see section 4.5). In a case-control study of opioid users, those patients who took 
pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared 
to opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk 
was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there 
was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 
5.06]). 
 
Misuse, abuse potential or dependence 
 
Cases of misuse, abuse and dependence have been reported. Caution should be exercised in 
patients with a history of substance abuse and the patient should be monitored for symptoms of 
pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, 
drug-seeking behaviour have been reported). 
 
Encephalopathy 
 
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that 
may precipitate encephalopathy. 
 
Sodium content 
 
This medicine contains less than 1 mmol sodium (23 mg) per capsule. That is to say essentially 
‘sodium-free’ 
 



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4.5  Interaction with other medicinal products and other forms of interaction 

 

Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible 
metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug 
metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject 
to, pharmacokinetic interactions. 
 
In vivo studies and population pharmacokinetic analysis 
 
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed 
between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, 
lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral 
antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically 
significant effect on pregabalin clearance. 
 
Oral contraceptives, norethisterone and/or ethinyl oestradiol 
 
Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl 
oestradiol does not influence the steady-state pharmacokinetics of either substance. 
 
Central nervous system influencing medical products 
 
Pregabalin may potentiate the effects of ethanol and lorazepam.  
 
In the postmarketing experience, there are reports of respiratory failure, coma and deaths in 
patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant 
medicinal products. Pregabalin appears to be additive in the impairment of cognitive and gross 
motor function caused by oxycodone. 
 
Interactions and the elderly 
 
No specific pharmacodynamic interaction studies were conducted in elderly volunteers. 
Interaction studies have only been performed in adults. 
 
4.6  Fertility, pregnancy and lactation 
 

Women of childbearing potential/Contraception in males and females 
 
As the potential risk for humans is unknown, effective contraception must be used in women of 
child bearing potential. 
 
Pregnancy 
 
There are no adequate data from the use of pregabalin in pregnant women. 
 
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for 
humans is unknown. 
 
Pregabalin Mylan Pharma 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 



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to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child 
and the benefit of therapy for the woman. 
 
Fertility 
 
There are no clinical data on the effects of pregabalin on female fertility. 
 
In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were 
exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no 
effects on sperm motility. 
 
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male 
rats have shown adverse reproductive and developmental effects. The clinical relevance of these 
findings is unknown (see section 5.3). 
 
4.7  Effects on ability to drive and use machines 

 

Pregabalin Mylan Pharma may have minor or moderate influence on the ability to drive and use 
machines. Pregabalin Mylan Pharma 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 

 

Summary of the safety profile 
 
The pregabalin clinical programme involved over 8900 patients exposed to pregabalin, of whom 
over 5600 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. 
 
Tabulated list of adverse reactions 
 
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, CNS 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. 
 



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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 
 
Rare 

 
 
Hypersensitivity 
 
Angioedema, allergic reaction 

Metabolism and nutrition disorders 

 
Common 
 
Uncommon 

 
 
Appetite increased 
 
Anorexia, hypoglycaemia 

Psychiatric disorders 

 
Common 
 
 
Uncommon 
 
 
 
 
 
 
Rare 

 
 
Euphoric mood, confusion, irritability, 
disorientation, insomnia, libido decreased 
 
Hallucination, panic attack, restlessness, 
agitation, depression, depressed mood, 
elevated mood, aggression, mood swings, 
depersonalisation, word finding 
difficulty, abnormal dreams, libido increased, 
anorgasmia, apathy 
 
Disinhibition 

Nervous system disorders 
 

Very common 
 
Common 
 
 
 
 
 
Uncommon 
 
 
 
 
 
 
 
Rare 

 
 
Dizziness, somnolence, headache 
 
Ataxia, coordination abnormal, tremor, 
dysarthria, amnesia, memory impairment, 
disturbance in attention, paraesthesia, 

hypoaesthesia, sedation, balance disorder, 
lethargy 
 
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 
 
Convulsion, parosmia, hypokinesia, 
dysgraphia 

Eye disorders 

 

 
 



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Common 
 
Uncommon 
 
 
 
 
Rare 

Vision blurred, diplopia  
 
Peripheral vision loss, visual disturbance, eye 
swelling, visual field defect, visual acuity 
reduced, eye pain, asthenopia, photopsia, dry 
eye, lacrimation increased, eye irritation 
 
Vision loss, keratitis, oscillopsia, altered 
visual depth perception, mydriasis, 
strabismus, visual brightness 

Ear and labyrinth disorders 

 

Common 
 
Uncommon 

 
 
Vertigo 
 
Hyperacusis 

Cardiac disorders 

 

Uncommon 
 
 
Rare 
 

 
 
Tachycardia, atrioventricular block first 
degree, sinus bradycardia, congestive heart 
failure 
 
QT prolongation, sinus tachycardia, sinus 
arrhythmia 

Vascular disorders 

 
Uncommon 
 

 
 
Hypotension, hypertension, hot flushes, 
flushing, peripheral coldness 

Respiratory, thoracic and mediastinal 

disorders 

 
Uncommon 
 
Rare 
 

 
 
 
Dyspnoea, epistaxis, cough, nasal congestion, 
rhinitis, snoring, nasal dryness 
 
Pulmonary oedema, throat tightness 

Gastrointestinal disorders 
 

Common 
 
 
 
 
Uncommon 
 
 
 
Rare 

 
 
Vomiting, nausea, constipation, diarrhoea, 
flatulence, abdominal distension, dry mouth 
 
 
 
Gastrooesophageal reflux disease, salivary 
hypersecretion, hypoaesthesia oral 
 
 
Ascites, pancreatitis, Swollen tongue, 
dysphagia 

Hepatobiliary disorders 
 

Uncommon 
 

 

Rare 
 
 

 
 

Elevated liver enzymes 
 
 
Jaundice 
 
 



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Very rare Hepatic failure, hepatitis 
Skin and subcutaneous tissue disorders 

 

Uncommon 
 
 
Rare 

 
 
Rash papular, urticaria, hyperhidrosis, 
pruritus 
 
 
Stevens Johnson syndrome, cold sweat 

Musculoskeletal and connective tissue 

disorders  

Common 
 
 
Uncommon 
 
 
Rare 

 
 
Muscle cramp, arthralgia, back pain, pain in 
limb, cervical spasm  
 
Joint swelling, myalgia, muscle twitching, 
neck pain, muscle stiffness 
 
Rhabdomyolysis 

Renal and urinary disorders 
 

Uncommon 
 
Rare 

 
 
Urinary incontinence, dysuria 
 
Renal failure, oliguria, urinary retention 

Reproductive system and breast disorders 
 
Common 
 

Uncommon 
 
 
Rare 
 

 
 
Erectile dysfunction 
 
Sexual dysfunction, ejaculation delayed, 
dysmenorrhoea, breast pain 
 
Amenorrhoea, breast discharge, breast 
enlargement, gynaecomastia 

General disorders and administration site 

conditions 

 

Common 
 

 

Uncommon 

 
 
 
Oedema peripheral, oedema, gait abnormal, 
fall, feeling drunk, feeling abnormal, fatigue 
 
Generalised oedema, face oedema, chest 
tightness, pain, pyrexia, thirst, chills, asthenia 

Investigations 
 

Common 
 

Uncommon 
 
 
 
 
Rare 

 
 
Weight increased 
 
Blood creatine phosphokinase increased, 
blood glucose increased, platelet count 
decreased, blood creatinine increased, blood 
potassium decreased, weight decreased 

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, 



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depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. The patient 
should be informed about this at the start of the treatment. 
 
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence 
and severity of withdrawal symptoms may be dose-related. 
 
Paediatric population 

 

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

with or without secondary 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 1month to younger than 4years 

of age, n=175; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on 

safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy. 

The most common adverse events observed in the 12-week study with pregabalin treatment were 

somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and 

nasopharyngitis. The most common adverse events observed in the 14-day study with pregabalin 

treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 

and 5.2). 

 
Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. 

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting 

system listed in Appendix V. 

 
4.9  Overdose 

 

Symptoms 
 
In the post-marketing experience, the most commonly reported adverse reactions observed when 
pregabalin was taken in overdose included somnolence, confusional state, agitation, and 
restlessness. Seizures were also reported. 
 
In rare occasions, cases of coma have been reported. 
 
Management 
 
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]. 
 

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


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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) 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 1month to younger than 4years of age  

performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the 

treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients 

from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and 

upper respiratory infections were observed more frequently than in adult studies of patients with 

epilepsy (see sections 4.2, 4.8 and 5.2). 

 

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 (1month to younger than 4years of 
age) were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo. Median 24-
hour seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 
7 mg/kg/day, 5.4 and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively. 
Pregabalin 14 mg/kg/day significantly reduced the log-transformed partial onset seizure 
frequency versus placebo (p=0.0223); pregabalin 7 mg/kg/day did not show improvement 
relative to placebo. 
 
Monotherapy (newly diagnosed patients) 
Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. 
Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom 
endpoint. Pregabalin and lamotrigine were similarly safe and well tolerated. 
 
Generalised Anxiety Disorder 
Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 
week duration and a long-term relapse prevention study with a double blind relapse prevention 
phase of 6 months duration. 
 



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Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) 
was observed by Week 1. 
 
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% 
of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline 
to endpoint. 
 
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred 
vision than did patients treated with placebo which resolved in a majority of cases with 
continued dosing. 
 
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated 
funduscopic examination) was conducted in over 3600 patients within controlled clinical trials. 
In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% 
of placebo-treated patients. Visual field changes were detected in 12.4% of pregabalin-treated, 
and 11.7% of placebo-treated patients. Funduscopic changes were observed in 1.7% of 
pregabalin-treated and 2.1% of placebo-treated patients. 
 
5.2  Pharmacokinetic properties 

 

Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy 
receiving anti-epileptic drugs and patients with chronic pain. 
 
Absorption 
 
Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma 
concentrations occurring within 1 hour following both single and multiple dose administration. 
Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose. Following 
repeated administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin 
absorption is decreased when given with food resulting in a decrease in Cmax by approximately 
25-30% and a delay in tmax to approximately 2.5 hours. However, administration of pregabalin 
with food has no clinically significant effect on the extent of pregabalin absorption. 
 
Distribution 
 
In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, 
and monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk 
of lactating rats. In humans, the apparent volume of distribution of pregabalin following oral 
administration is approximately 0.56 l/kg. Pregabalin is not bound to plasma proteins. 
 
Biotransformation 
 
Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabelled 
pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged 
pregabalin. The N-methylated derivative of pregabalin, the major metabolite of pregabalin found 
in urine, accounted for 0.9% of the dose. In preclinical studies, there was no indication of 
racemisation of pregabalin S-enantiomer to the R-enantiomer. 
 
Elimination 
 
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged 
drug. Pregabalin mean elimination half-life is 6.3 hours. Pregabalin plasma clearance and renal 
clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment). 
 



16 
 

Dose adjustment in patients with reduced renal function or undergoing haemodialysis is 
necessary (see section 4.2 Table 1). 
 
Linearity/non-linearity 
 
Pregabalin pharmacokinetics are linear over the recommended daily dose range. Inter-subject 
pharmacokinetic variability for pregabalin is low (<20%). Multiple dose pharmacokinetics are 
predictable from single-dose data. Therefore, there is no need for routine monitoring of plasma 
concentrations of pregabalin. 
 
Gender 
 
Clinical trials indicate that gender does not have a clinically significant influence on the plasma 
concentrations of pregabalin. 
 
Renal impairment 
 
Pregabalin clearance is directly proportional to creatinine clearance. In addition, pregabalin is 
effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment 
plasma pregabalin concentrations are reduced by approximately 50%). Because renal elimination 
is the major elimination pathway, dose reduction in patients with renal impairment and dose 
supplementation following haemodialysis is necessary (see section 4.2 Table 1). 
 
Hepatic impairment 
 
No specific pharmacokinetic studies were carried out in patients with impaired liver function. 
Since pregabalin does not undergo significant metabolism and is excreted predominantly as 
unchanged drug in the urine, impaired liver function would not be expected to significantly alter 
pregabalin plasma concentrations. 
 
Paediatric population 

 
Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 
to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 
15 mg/kg/day in a pharmacokinetic and tolerability study. 
 
After oral administration of pregabalin in paediatric patients in the fasted state, in general, time 
to reach peak plasma concentration was similar across the entire age group and occurred 
0.5 hours to 2 hours postdose. 
 
Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within 
each age group. The AUC was lower by 30% in paediatric patients below a weight of 30  kg due 
to an increased body weight adjusted clearance of 43% for these patients in comparison to 
patients weighing ≥30 kg. 
 
Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of 
age, and 4 to 6 hours in those 7 years of age and older. 
 
Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate 
of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral 
volume of distribution, and these relationships were similar in paediatric and adult patients. 
 
Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see 
sections 4.2, 4.8 and 5.1). 
 



17 
 

Elderly 
 
Pregabalin clearance tends to decrease with increasing age. This decrease in pregabalin oral 
clearance is consistent with decreases in creatinine clearance associated with increasing age. 
Reduction of pregabalin dose may be required in patients who have age related compromised 
renal function (see section 4.2 Table 1). 
 
Breast-feeding mothers 
 
The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was 
evaluated in 10 lactating women who were at least 12 weeks postpartum. Lactation had little to 
no influence on pregabalin pharmacokinetics. Pregabalin was excreted into breast milk with 
average steady-state concentrations approximately 76% of those in maternal plasma. The 
estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day) of 
women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 
0.62 mg/kg/day, respectively. These estimated doses are approximately 7% of the total daily 
maternal dose on a mg/kg basis. 
 
5.3  Preclinical safety data 

 

In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at 
clinically relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were 
observed, including hypoactivity, hyperactivity and ataxia. An increased incidence of retinal 
atrophy commonly observed in aged albino rats was seen after long term exposure to pregabalin 
at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose. 
 
Pregabalin was not teratogenic in mice, rats or rabbits. Foetal toxicity in rats and rabbits 
occurred only at exposures sufficiently above human exposure. In prenatal/postnatal toxicity 
studies, pregabalin induced offspring developmental toxicity in rats at exposures >2 times the 
maximum recommended human exposure. 
 
Adverse effects on fertility in male and female rats were only observed at exposures sufficiently 
in excess of therapeutic exposure. Adverse effects on male reproductive organs and sperm 
parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic 
exposure or were associated with spontaneous degenerative processes in male reproductive 
organs in the rat. Therefore the effects were considered of little or no clinical relevance. 
 
Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests. 
 
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No tumours 
were observed in rats at exposures up to 24 times the mean human exposure at the maximum 
recommended clinical dose of 600 mg/day. In mice, no increased incidence of tumours was 
found at exposures similar to the mean human exposure, but an increased incidence of 
haemangiosarcoma was observed at higher exposures. The non-genotoxic mechanism of 
pregabalin-induced tumour formation in mice involves platelet changes and associated 
endothelial cell proliferation. These platelet changes were not present in rats or in humans based 
on short term and limited long term clinical data. There is no evidence to suggest an associated 
risk to humans. 
 
In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats. 
However, juvenile rats are more sensitive. At therapeutic exposures, there was evidence of CNS 
clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight 
gain suppression). Effects on the oestrus cycle were observed at 5-fold the human therapeutic 
exposure. Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after 



18 
 

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 

 

Capsules content 
 
Hydroxylpropylcellulose 
Maize starch 
Talc 
 
Capsules shell 
 
Iron oxide yellow (E172) 
Titanium dioxide (E171) 
Erythrosine (E127) 
Gelatin 
Sodium laurilsulfate 
Purified water 
 
Printing ink 
 
Shellac 
Iron oxide black (E172) 
Propylene glycolAmmonia solution, concentrated 
Potassium hydroxide 
Purified water 
 
6.2  Incompatibilities 

 

Not applicable. 
 
6.3  Shelf life 

 

3 years. 
 
6.4  Special precautions for storage 

 

Blister: Store in the original package in order to protect from moisture. 

Bottle: Keep the bottle tightly closed in order to protect from moisture. 

 
6.5  Nature and contents of container 

 

Pregabalin Mylan Pharma 25 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard 
capsules. 
 
Pregabalin Mylan Pharma 50 mg hard capsules 
 



19 
 

PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules. 
 
Pregabalin Mylan Pharma 75 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard 
capsules. 
HDPE bottle pack containing 200 hard capsules. 
 
Pregabalin Mylan Pharma 100 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsule 
 
Pregabalin Mylan Pharma 150 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard 
capsules 
HDPE bottle pack containing 200 hard capsules. 
 
Pregabalin Mylan Pharma 200 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsule 
 

Pregabalin Mylan Pharma 225 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsule. 
 

Pregabalin Mylan Pharma 300 mg hard capsules 
 
PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules. 
PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsules. 
HDPE bottle pack containing 200 hard capsules. 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal 

 

No special requirements. 
 
 
7.  MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 
 



20 
 

8.  MARKETING AUTHORISATION NUMBER(S) 

 

Pregabalin Mylan Pharma 25 mg hard capsules 
 

EU/1/15/998/001 

EU/1/15/998/002 

EU/1/15/998/003 

EU/1/15/998/004 

EU/1/15/998/005 

EU/1/15/998/006 

EU/1/15/998/007 

EU/1/15/998/008 

 
Pregabalin Mylan Pharma 50 mg hard capsules 
 
EU/1/15/998/009 
EU/1/15/998/010 
EU/1/15/998/011 
EU/1/15/998/012 
EU/1/15/998/013 
EU/1/15/998/014 
EU/1/15/998/015 
 
Pregabalin Mylan Pharma 75 mg hard capsules 
 
EU/1/15/998/016 
EU/1/15/998/017 
EU/1/15/998/018 
EU/1/15/998/019 
EU/1/15/998/020 
EU/1/15/998/021 
EU/1/15/998/022 
 
Pregabalin Mylan Pharma 100 mg hard capsules 
 
EU/1/15/998/023 
EU/1/15/998/024 
EU/1/15/998/025 
EU/1/15/998/026 
EU/1/15/998/027 
 
Pregabalin Mylan Pharma 150 mg hard capsules 
 
EU/1/15/998/028 
EU/1/15/998/029 
EU/1/15/998/030 
EU/1/15/998/031 
EU/1/15/998/032 
EU/1/15/998/033 
EU/1/15/998/034 
 
Pregabalin Mylan Pharma 200 mg hard capsules 
 



21 
 

EU/1/15/998/035 

EU/1/15/998/036 

EU/1/15/998/037 

EU/1/15/998/038 

EU/1/15/998/039 

 
Pregabalin Mylan Pharma 225 mg hard capsules 
 

EU/1/15/998/040 

EU/1/15/998/041 

EU/1/15/998/042 

EU/1/15/998/043 

EU/1/15/998/044 

 
Pregabalin Mylan Pharma 300 mg hard capsules 
 
EU/1/15/998/045 
EU/1/15/998/046 
EU/1/15/998/047 
EU/1/15/998/048 
EU/1/15/998/049 
EU/1/15/998/050 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 25 June 2015 

Date of last renewal: DDMMYY 
 
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/


22 
 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 

 



23 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers responsible for batch release 
 
Mylan Hungary Kft 
Mylan utca 1, Komárom, 2900, 
Hungary 
 
McDermott Laboratories Limited trading as Gerard Laboratories 
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 
Ireland 
 
Mylan B.V. 
Dieselweg 25, 3752 LB Bunschoten 
The Netherlands 
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. 

  



24 
 

 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



25 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

  



26 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 25 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 25 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
21 hard capsules 
56 hard capsules 
84 hard capsules 
100 hard capsules 
56 x 1 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 

 
 
 



27 
 

8. EXPIRY DATE 

 
EXP 
 
 

9. SPECIAL STORAGE CONDITIONS 

 
Store in the original package in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/001 
EU/1/15/998/002 
EU/1/15/998/003 
EU/1/15/998/004 
EU/1/15/998/005 
EU/1/15/998/006 
EU/1/15/998/007 
EU/1/15/998/008 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 25 mg 
 



28 
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



29 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 25 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 

 

 

 

 

 

 
 

 

 

 

 

 

  



30 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 50 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 50 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
21 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 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 



31 
 

 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/009 
EU/1/15/998/010 
EU/1/15/998/011 
EU/1/15/998/012 
EU/1/15/998/013 
EU/1/15/998/014 
EU/1/15/998/015 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 
 
Pregabalin Mylan Pharma 50 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 



32 
 

 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



33 
 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 50 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 

 

  



34 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 75 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 75 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
56 hard capsules 
100 hard capsules 
200 hard capsules 
14 x 1 hard capsules 
56 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 



35 
 

 
 

9. SPECIAL STORAGE CONDITIONS 

 
Blister: Store in the original package in order to protect from moisture. 
Bottle: Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/016 
EU/1/15/998/017 
EU/1/15/998/018 
EU/1/15/998/022 
EU/1/15/998/019 
EU/1/15/998/020 
EU/1/15/998/021 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 75 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 



36 
 

2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



37 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 75 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 
 

  



38 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 75 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 75 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
200 hard capsules 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 

 
Read the package leaflet before use. 
 
Oral use. 
 
<For multilayer label only> 
‘Peel here’ 
 
 

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 
 
 



39 
 

9. SPECIAL STORAGE CONDITIONS 

 
Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/15/998/022 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
  



40 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 100 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 100 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
21 hard capsules 
84 hard capsules 
100 hard capsules 
84 x 1 hard capsules  
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 
 



41 
 

 

9. SPECIAL STORAGE CONDITIONS 

 
Store in the original package in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/023 
EU/1/15/998/024 
EU/1/15/998/025 
EU/1/15/998/026 
EU/1/15/998/027 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 100 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



42 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



43 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 100 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 
 
  



44 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 150 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 150 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
56 hard capsules 
100 hard capsules 
200 hard capsules 
14 x 1 hard capsules 
56 x 1 hard capsules 
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 



45 
 

 
 

9. SPECIAL STORAGE CONDITIONS 

 
Blister: Store in the original package in order to protect from moisture. 
Bottle: Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/028 
EU/1/15/998/029 
EU/1/15/998/030 
EU/1/15/998/034 
EU/1/15/998/031 
EU/1/15/998/032 
EU/1/15/998/033 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 150 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 



46 
 

2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



47 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 150 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 
 
  



48 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 150 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 150 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
200 hard capsules 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 

 
Read the package leaflet before use. 
 
Oral use. 
 
<For multilayer label only> 
‘Peel here’ 
 
 

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 
 
 



49 
 

9. SPECIAL STORAGE CONDITIONS 

 
Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/15/998/034 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 
  



50 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 200 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 200 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
21 hard capsules 
84 hard capsules 
100 hard capsules 
84 x 1 hard capsules 
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 
 
 



51 
 

9. SPECIAL STORAGE CONDITIONS 

 
Store in the original package in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/035 
EU/1/15/998/036 
EU/1/15/998/037 
EU/1/15/998/038 
EU/1/15/998/039 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 200 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



52 
 

 
PC 
SN 
NN  



53 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 200 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 

 
  



54 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 225 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 225 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
56 hard capsules 
100 hard capsules 
56 x 1 hard capsules 
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 
 
 



55 
 

9. SPECIAL STORAGE CONDITIONS 

 
Store in the original package in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/040 
EU/1/15/998/041 
EU/1/15/998/042 
EU/1/15/998/043 
EU/1/15/998/044 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 225 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



56 
 

 
PC 
SN 
NN  



57 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 225 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 
 
  



58 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 300 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 300 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
14 hard capsules 
56 hard capsules 
100 hard capsules 
200 hard capsules 
56 x 1 hard capsules 
100 x 1 hard capsules 
 
 

5. METHOD AND ROUTE 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 
 



59 
 

 

9. SPECIAL STORAGE CONDITIONS 

 
Blister: Store in the original package in order to protect from moisture. 
Bottle: Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S)  

 
EU/1/15/998/045 
EU/1/15/998/046 
EU/1/15/998/047 
EU/1/15/998/050 
EU/1/15/998/048 
EU/1/15/998/049 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan Pharma 300 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 



60 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



61 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 300 mg hard capsules 
pregabalin 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S 
 
 

3. EXPIRY DATE 

 
EXP 
 
 

4. BATCH NUMBER 

 
Lot 
 
 

5. OTHER 

 
 

 
  



62 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan Pharma 300 mg hard capsules 
pregabalin 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 

 
Each hard capsule contains 300 mg pregabalin. 
 
 

3. LIST OF EXCIPIENTS 

 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 
Hard capsule. 
 
200 hard capsules 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 

 
Read the package leaflet before use. 
 
Oral use. 
 
<For multilayer label only> 
‘Peel here’ 
 
 

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 
 
 



63 
 

9. SPECIAL STORAGE CONDITIONS 

 
Keep the bottle tightly closed in order to protect from moisture. 
 
 

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 

 
Mylan S.A.S 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/15/998/050 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 

16. INFORMATION IN BRAILLE 

 
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
  



64 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



65 
 

Package leaflet: Information for the user 
 

Pregabalin Mylan Pharma 25 mg hard capsules  
Pregabalin Mylan Pharma 50 mg hard capsules  

Pregabalin Mylan Pharma 75 mg hard capsules  

Pregabalin Mylan Pharma 100 mg hard capsules  

Pregabalin Mylan Pharma 150 mg hard capsules  

Pregabalin Mylan Pharma 200 mg hard capsules  

Pregabalin Mylan Pharma 225 mg hard capsules  

Pregabalin Mylan Pharma 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 Mylan Pharma is and what it is used for  
2. What you need to know before you take Pregabalin Mylan Pharma 
3. How to take Pregabalin Mylan Pharma 
4. Possible side effects  
5. How to store Pregabalin Mylan Pharma 
6. Contents of the pack and other information 
 
 
1. What Pregabalin Mylan Pharma is and what it is used for 

 

Pregabalin Mylan Pharma contains the active substance pregabalin which belongs to a group of 
medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults. 
 
 
Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or 
without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Mylan Pharma for 
you to help treat your epilepsy when your current treatment is not controlling your condition. You 
should take Pregabalin Mylan Pharma in addition to your current treatment. Pregabalin Mylan Pharma 
is not intended to be used alone, but should always be used in combination with other anti-epileptic 
treatment. 
 
Generalised Anxiety Disorder: Pregabalin Mylan Pharma 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. 
 
 



66 
 

2. What you need to know before you take Pregabalin Mylan Pharma 

 

Do not take Pregabalin Mylan Pharma: 
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).  
 
Warnings and precautions  

Talk to your doctor or pharmacist before taking Pregabalin Mylan Pharma. 
 

• Some patients taking Pregabalin Mylan Pharma 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 Mylan Pharma 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 Mylan Pharma 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 Mylan 
Pharma; 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 Mylan 
Pharma. If while taking Pregabalin Mylan Pharma 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 Mylan Pharma 
have had thoughts of harming or killing themselves. If at any time you have these thoughts, 
immediately contact your doctor. 

 

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

 



67 
 

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

 
Children and adolescents 

The safety and efficacy in children and adolescents (under 18 years of age) has not been established 
and therefore, pregabalin should not be used in this age group. 
 

Other medicines and Pregabalin Mylan Pharma 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregabalin Mylan Pharma and certain other medicines may influence each other (interaction). When 
taken with certain other medicines, which have sedative effects (including opioids), Pregabalin Mylan 
Pharma 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 Mylan Pharma is 
taken together with medicinal products containing: 

• Oxycodone – (used as a pain-killer) 

• Lorazepam – (used for treating anxiety) 

• Alcohol 
 
Pregabalin Mylan Pharma may be taken with oral contraceptives. 
 
Pregabalin Mylan Pharma with food, drink and alcohol 

Pregabalin Mylan Pharma capsules may be taken with or without food. 
It is advised not to drink alcohol while taking Pregabalin Mylan Pharma. 
 
Pregnancy and breast-feeding 

Pregabalin Mylan Pharma 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 Mylan Pharma 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. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per capsule. That is to say essentially 
‘sodium-free’ 
 
3. How to take Pregabalin Mylan Pharma 

 

Always take this medicine exactly as your doctor or pharmacist 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 Mylan Pharma is for oral use only. 
 
Epilepsy or Generalised Anxiety Disorder: 

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



68 
 

• 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 Mylan Pharma either twice or three times a day. 
For twice a day take Pregabalin Mylan Pharma once in the morning and once in the evening, 
at about the same time each day. For three times a day take Pregabalin Mylan Pharma 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 Mylan Pharma is too strong or too weak, talk 
to your doctor or pharmacist. 
 
If you are an older patient (over 65 years of age), you should take Pregabalin Mylan Pharma 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 Mylan Pharma until your doctor tells you to stop. 
 
If you take more Pregabalin Mylan Pharma than you should 
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of 
Pregabalin Mylan Pharma capsules with you. You may feel sleepy, confused, agitated, or restless as a 
result of taking more Pregabalin Mylan Pharma than you should. Fits have also been reported. 
 
If you forget to take Pregabalin Mylan Pharma 
It is important to take your Pregabalin Mylan Pharma 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 Mylan Pharma 

Do not stop taking Pregabalin Mylan Pharma 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 Mylan Pharma treatment, you need to know that you 
may experience certain side effects. These include, trouble sleeping, headache, nausea, feeling 
anxious, diarrhoea, flulike symptoms, convulsions, nervousness, depression, pain, sweating, and 
dizziness. These symptoms may occur more commonly or severely if you have been taking Pregabalin 
Mylan Pharma 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 



69 
 

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

• Blurred vision, double vision 
• Vertigo, problems with balance, fall 

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

• Difficulties with erection 

• Swelling of the body including extremities 

• Feeling drunk, abnormal style of walking 

• Weight gain 

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

• Sore throat 
 

Uncommon: may affect up to 1 in 100 people 

• Loss of appetite, weight loss, low blood sugar, high blood sugar 
• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty 

finding words, hallucinations, abnormal dreams, panic attacks, 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 



70 
 

• Convulsions 

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

• Muscle damage 

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

• Kidney failure, reduced urine volume, urinary retention 

• Decrease in white blood cell count 

• Inappropriate behaviour 

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

• Jaundice (yellowing of the skin and eyes). 
 

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

• Liver failure. 

• Hepatitis (inflammation of the liver). 
 

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

you should seek immediate medical advice.  

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

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

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety 

of this medicine. 
 

5. How to store Pregabalin Mylan Pharma 

 

Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Blister: Store in the original package in order to protect from moisture. 

Bottle: Keep the bottle tightly closed in order to protect from moisture. 

 
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 Mylan Pharma 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 of pregabalin. 
 

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


71 
 

The other ingredients are: hydroxylpropylcellulose, maize starch, talc, gelatin, titanium dioxide 
(E171), sodium laurilsulfate, purified water, shellac, black iron oxide (E172), propylene glycol, 
potassium hydroxide and concentrated ammonia solution, yellow iron oxide (E172) and erythrosine 
(E127). 
 
What Pregabalin Mylan Pharma looks like and contents of the pack 

 

Hard capsule. 
 

Pregabalin Mylan 

Pharma 25 mg hard 

capsule 

Light peach opaque cap and white opaque body, hard-shell gelatin 
capsule filled with white to off-white powder. The capsule is axially 
printed with MYLAN over PB25 in black ink on cap and body. 
 
Available in blister packs containing 14, 21, 56, 84, 100 capsules and 
in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 
1 capsules. 
 

Pregabalin Mylan 

Pharma 50 mg hard 

capsule 

Dark peach opaque cap and white opaque body, hard-shell gelatin 

capsule filled with white to off-white powder. The capsule is axially 

printed with MYLAN over PB50 in black ink on cap and body. 

Available in blister packs containing 14, 21, 56, 84, 100 capsules and 

in perforated unit dose blister packs containing 84 x 1, 100 x 1 

capsules. 

Pregabalin Mylan 

Pharma 75 mg hard 

capsule 

Light peach opaque cap and light peach opaque body, hard-shell 

gelatin capsule filled with white to off-white powder. The capsule is 

axially printed with MYLAN over PB75 in black ink on cap and 

body. 

Available in blister packs containing 14, 56, 100 capsules, in 

perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 

capsules and in bottles containing 200 capsules. 

Pregabalin Mylan 

Pharma 100 mg hard 

capsule 

Dark peach opaque cap and dark peach opaque body, hard-shell 
gelatin capsule filled with white to off-white powder. The capsule is 
axially printed with MYLAN over PB100 in black ink on cap and 
body. 
 
Available in blister packs containing 21, 84, 100 capsules and in 
perforated unit dose blister packs containing 84 x 1, 100 x 1 
capsules. 
 

Pregabalin Mylan 

Pharma 150 mg hard 

capsule 

Light peach opaque cap and white opaque body, hard-shell gelatin 

capsule filled with white to off-white powder. The capsule is axially 

printed with MYLAN over PB150 in black ink on cap and body. 

Available in blister packs containing 14, 56, 100 capsules, in 

perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 

capsules and in bottles containing 200 capsules. 



72 
 

Pregabalin Mylan 

Pharma 200 mg hard 

capsule 

Light peach opaque cap and light peach opaque body, hard-shell 

gelatin capsule filled with white to off-white powder. The capsule is 

axially printed with MYLAN over PB200 in black ink on cap and 

body. 

Available in blister packs containing 21, 84, 100 capsules and in 

perforated unit dose blister packs containing 84 x 1, 100 x 1 

capsules. 

Pregabalin Mylan 

Pharma 225 mg hard 

capsule 

Dark peach opaque cap and dark peach opaque body, hard-shell 

gelatin capsule filled with white to off-white powder. The capsule is 

axially printed with MYLAN over PB225 in black ink on cap and 

body. 

Available in blister packs containing 14, 56, 100 capsules and in 

perforated unit dose blister packs containing 56 x 1, 100 x 1 

capsules. 

Pregabalin Mylan 

Pharma 300 mg hard 

capsule 

Light peach opaque cap and white opaque body, hard-shell gelatin 

capsule filled with white to off-white powder. The capsule is axially 

printed with MYLAN over PB300 in black ink on cap and body. 

Available in blister packs containing 14, 56, 100 capsules, in 

perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules 

and in bottles containing 200 capsules. 

 
Not all pack sizes may be marketed. 
 

Marketing Authorisation Holder 

Mylan S.A.S 

117 Allée des Parcs 

69800 Saint-Priest 

France 

 
Manufacturer 

Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary 
 
McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange 
Road, Dublin 13, Ireland 
 
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 



73 
 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

 

Lietuva 

BGP Products UAB  

Tel:  +370 5 205 1288 

 

 

България 

Майлан ЕООД  

Teл.: +359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00 

(Belgique/Belgien) 

 

Česká republika 

Mylan Healthcare CZ s.r.o. 

Tel: +420 222 004 400 

 

Magyarország 

Mylan EPD Kft 

Tel: + 36 1 465 2100  

Danmark 

Mylan Denmark ApS 
Tel: +45 28 11 69 32 

 

Malta 

V.J. Salomone Pharma Ltd. 

Tel: + 356 21 22 01 74 

 

Deutschland 

Mylan Healthcare GmbH 

Tel: +49 800 0700 800 

 

Nederland 

Mylan BV 

Tel: + 31 (0)20 426 3300 

Eesti 

BGP Products Switzerland GmbH Eesti 

filiaal  

Tel: +372 6363 052 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

  

 

Ελλάδα  

Generics Pharma Hellas ΕΠΕ  

Τηλ:  +30 210 993 6410  

 

Österreich 

Arcana Arzneimittel GmbH 

Tel: +43 1 416 2418 

 

España 

Mylan Pharmaceuticals, S.L 

Tel: + 34 900 102 712 

 

Polska 

Mylan Healthcare Sp. z.o.o. 

Tel: + 48 22 546 64 00 

 

 

France 

Mylan S.A.S 

Tel: +33 4 37 25 75 00 

 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

 

Hrvatska 

Mylan Hrvatska d.o.o.  

Tel: +385 1 23 50 599 

România 

BGP Products SRL 

Tel: +40 372 579 000 

 

Ireland 

Mylan Ireland limited 
Tel: +353 (0) 87 1694982  

Slovenija 

Mylan Healthcare d.o.o. 
Tel: + 386 1 23 63 180 
 



74 
 

Ísland 

Icepharma hf 

Tel: +354 540 8000 

 

Slovenská republika 

Mylan s.r.o. 

Tel: +421 2 32 199 100 

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

 

Suomi/Finland 

Mylan Finland OY 
Puh/Tel: +358 20 720 9555 
 

Κύπρος 

Varnavas Hadjipanayis Ltd   
Τηλ: +357 2220 7700 

 

Sverige 

Mylan AB  

Tel: + 46 855 522 750 

 

Latvija 

Mylan Healthcare SIA 

Tel: +371 676 055 80 

 

United Kingdom 

Generics [UK] Ltd 

Tel: +44 1707 853000 

 

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. MANUFACTURERS 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