Pregabalin Mylan

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ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 

 

 

 

 

 

 

 

 

 

 

 

  



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1.  NAME OF THE MEDICINAL PRODUCT 

 

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

 

Pregabalin Mylan 25 mg hard capsules 
 
Each hard capsule contains 25 mg of pregabalin. 
 
Pregabalin Mylan 50 mg hard capsules 
 
Each hard capsule contains 50 mg of pregabalin. 
 
Pregabalin Mylan 75 mg hard capsules 
 
Each hard capsule contains 75 mg of pregabalin. 
 
Pregabalin Mylan 100 mg hard capsules 
 
Each hard capsule contains 100 mg of pregabalin. 
 
Pregabalin Mylan 150 mg hard capsules 
 
Each hard capsule contains 150 mg of pregabalin. 
 
Pregabalin Mylan 200 mg hard capsules 
 
Each hard capsule contains 200 mg of pregabalin. 
 
Pregabalin Mylan 225 mg hard capsules 
 
Each hard capsule contains 225 mg of pregabalin. 
 
Pregabalin Mylan 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 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 50 mg hard capsules 
 
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 75 mg hard capsules 
 
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 100 mg hard capsules 
 
No. 3, 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. 
 
Pregabalin Mylan 150 mg hard capsules 
 
No. 2, 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. 
 
Pregabalin Mylan 200 mg hard capsules 
 
No. 1, 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. 
 
Pregabalin Mylan 225 mg hard capsules 
 
No. 1, 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. 
 
Pregabalin Mylan 300 mg hard capsules 
 
No. 0, 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. 
 
 
4.  CLINICAL PARTICULARS 
 

4.1  Therapeutic indications 

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



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

Pregabalin Mylan 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.  
 
Neuropathic pain 
Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses.  
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day 
after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an 
additional 7-day interval. 
 
Epilepsy 
Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided 
doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per 
day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. 
 
Generalised Anxiety Disorder 
The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment 
should be reassessed regularly. 
 
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient 
response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an 
additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day 
may be achieved after an additional week. 
 
Discontinuation of pregabalin 
In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended 
this should be done gradually over a minimum of 1 week independent of the indication (see sections 
4.4 and 4.8). 
 
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: 
 

 



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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 Mylan 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 may be taken with or without food. 
Pregabalin Mylan 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 
 



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In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin 
treatment may need to adjust hypoglycaemic medicinal products. 
 
Hypersensitivity reactions 
 
There have been reports in the post-marketing experience of hypersensitivity reactions, including 
cases of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, 
such as facial, perioral, or upper airway swelling occur. 
 
Dizziness, somnolence, loss of consciousness, confusion and mental impairment 
 
Pregabalin treatment has been associated with dizziness and somnolence, which could increase the 
occurrence of accidental injury (fall) in the elderly population. There have also been post-marketing 
reports of loss of consciousness, confusion and mental impairment. Therefore, patients should be 
advised to exercise caution until they are familiar with the potential effects of the medicinal product.  
 
Vision-related effects 
 
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 
did patients treated with placebo which resolved in a majority of cases with continued dosing. In the  
clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction  
and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the 
incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1). 
 
In the post-marketing experience, visual adverse reactions have also been reported, including loss of 
vision, visual blurring or other changes of visual acuity, many of which were transient. 
Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.  
 
Renal failure 
 
Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show 
reversibility of this adverse reaction. 
 
Withdrawal of concomitant anti-epileptic medicinal products 
 
There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once 
seizure control with pregabalin in the add-on situation has been reached, in order to reach 
monotherapy on pregabalin. 
 
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 
 



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There have been post-marketing reports of congestive heart failure in some patients receiving 
pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during 
pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these 
patients. Discontinuation of pregabalin may resolve the reaction. 
 
Treatment of central neuropathic pain due to spinal cord injury 
 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse 
reactions in general, central nervous system adverse reactions and especially somnolence was 
increased. This may be attributed to an additive effect due to concomitant medicinal products (e.g. 
anti-spasticity agents) needed for this condition. This should be considered when prescribing 
pregabalin in this condition. 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in 
several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs 
has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk 
is not known and the available data do not exclude the possibility of an increased risk for pregabalin. 
 
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek 
medical advice should signs of suicidal ideation or behaviour emerge. 
 
Reduced lower gastrointestinal tract function 
 
There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. 
intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with 
medications that have the potential to produce constipation, such as opioid analgesics. When 
pregabalin and opioids will be used in combination, measures to prevent constipation may be 
considered (especially in female patients and elderly). 
 
Concomitant use with opioids 
 
Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS 
depression (see section 4.5). In a case-control study of opioid users, those patients who took 
pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to 
opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 – 2.36]). This increased risk was 
observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a 
trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]). 
 
Misuse, abuse potential or dependence 
 
Cases of misuse, abuse and dependence have been reported. Caution should be exercised in patients 
with a history of substance abuse and the patient should be monitored for symptoms of pregabalin 
misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour 
have been reported). 
 
Encephalopathy 
 
Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may 
precipitate encephalopathy. 
 
Sodium content 
 



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This medicine contains less than 1 mmol sodium (23 mg) per capsule. That is to say essentially 
‘sodium-free’ 
 
4.5  Interaction with other medicinal products and other forms of interaction 

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

 
Women of childbearing potential/Contraception in males and females 
 
As the potential risk for humans is unknown, effective contraception must be used in women of child 
bearing potential. 
 
Pregnancy 
 
There are no adequate data from the use of pregabalin in pregnant women.  
 
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is 
unknown.  
 
Pregabalin Mylan should not be used during pregnancy unless clearly necessary (if the benefit to the 
mother clearly outweighs the potential risk to the foetus). 
 



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Breast-feeding 
 
Pregabalin is excreted into human milk (see section 5.2). The effect of pregabalin on newborns/infants 
is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue 
pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of 
therapy for the woman. 
 
Fertility 
 
There are no clinical data on the effects of pregabalin on female fertility. 
 
In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were 
exposed to pregabalin at a dose of 600 mg/day. After 3 months of treatment, there were no effects on 
sperm motility. 
 
A fertility study in female rats has shown adverse reproductive effects. Fertility studies in male rats 
have shown adverse reproductive and developmental effects. The clinical relevance of these findings 
is unknown (see section 5.3). 
 
4.7  Effects on ability to drive and use machines 

 
Pregabalin Mylan may have minor or moderate influence on the ability to drive and use machines. 
Pregabalin Mylan 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. 
 
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse 
reactions in general, CNS adverse reactions and especially somnolence was increased (see section 
4.4). 
 
Additional reactions reported from post-marketing experience are included in italics in the list below. 
 



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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). 



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After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms 
have been observed in some patients. The following reactions have been mentioned: insomnia, 
headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, 
hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about 
this at the start of the treatment. 
 
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and 
severity of withdrawal symptoms may be dose-related. 
 
Paediatric population 

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

or without secondary generalization (12-week efficacy and safety study in patients 4 to 16years 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. 
 

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


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The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5- 
methylhexanoic acid]. 
 
Mechanism of action 

 
Pregabalin binds to an auxiliary subunit (α2- δ protein) of voltage-gated calcium channels in the 
central nervous system. 
 
Clinical efficacy and safety 

 
Neuropathic pain 
Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord 
injury. Efficacy has not been studied in other models of neuropathic pain. 
Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing 
(BID) and up to 8 weeks with three times a day (TID) dosing. Overall, the safety and efficacy profiles 
for BID and TID dosing regimens were similar. 
 
In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain 
was seen by week 1 and was maintained throughout the treatment period. 
 
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 
18% of the patients on placebo had a 50% improvement in pain score. For patients not experiencing 
somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% 
of patients on placebo. For patients who experienced somnolence the responder rates were 48% on 
pregabalin and 16% on placebo. 
 
In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 

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

 

Epilepsy 

Adjunctive Treatment 
Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either twice a day 
dosing (BID) or three times a day (TID) dosing. Overall, the safety and efficacy profiles for BID and 
TID dosing regimens were similar. 
 
A reduction in seizure frequency was observed by Week 1. 
 
Paediatric population 

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

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

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

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

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

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

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

1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy 

indicate that the adverse events of pyrexia and upper respiratory infections were observed more 

frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2). 

 

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



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seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day 
(p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus 
placebo) and 22.6% of those receiving placebo. 
 

In the 14-day placebo-controlled study, paediatric patients (1 month to younger than 4 years of age) 
were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo. Median 24-hour 
seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 
and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively. Pregabalin 14 
mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo 
(p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo. 
 
Monotherapy (newly diagnosed patients) 

Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. 
Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom 
endpoint. Pregabalin and lamotrigine were similarly safe and well tolerated. 
 
Generalised Anxiety Disorder 

Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week 
duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 
months duration. 
 
Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was 
observed by Week 1. 
 
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the 
patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint. 
 
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than 
did patients treated with placebo which resolved in a majority of cases with continued dosing. 
 
Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated 
funduscopic examination) was conducted in over 3600 patients within controlled clinical trials. In 
these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of 
placebo-treated patients. Visual field changes were detected in 12.4% of pregabalin-treated, and 
11.7% of placebo-treated patients. Funduscopic changes were observed in 1.7% of pregabalin-treated 
and 2.1% of placebo-treated patients. 
 
5.2  Pharmacokinetic properties 

 

Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy 
receiving anti-epileptic drugs and patients with chronic pain. 
 
Absorption 

 
Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations 
occurring within 1 hour following both single and multiple dose administration. Pregabalin oral 
bioavailability is estimated to be ≥ 90% and is independent of dose. Following repeated 
administration, steady state is achieved within 24 to 48 hours. The rate of pregabalin absorption is 
decreased when given with food resulting in a decrease in Cmax by approximately 25-30% and a delay 
in tmax to approximately 2.5 hours. However, administration of pregabalin with food has no clinically 
significant effect on the extent of pregabalin absorption. 
 
Distribution 

 



16 
 

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. 



17 
 

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

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

 

In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically 
relevant doses. In repeated dose toxicity studies in rats and monkeys CNS effects were observed, 
including hypoactivity, hyperactivity and ataxia. An increased incidence of retinal atrophy commonly 
observed in aged albino rats was seen after long term exposure to pregabalin at exposures ≥ 5 times 
the mean human exposure at the maximum recommended clinical dose. 
 
Pregabalin was not teratogenic in mice, rats or rabbits. Foetal toxicity in rats and rabbits occurred only 
at exposures sufficiently above human exposure. In prenatal/postnatal toxicity studies, pregabalin 
induced offspring developmental toxicity in rats at exposures >2 times the maximum recommended 
human exposure. 
 
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. 



18 
 

 
Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests. 
 
Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No tumours were 
observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended 
clinical dose of 600 mg/day. In mice, no increased incidence of tumours was found at exposures 
similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed 
at higher exposures. The non-genotoxic mechanism of pregabalin-induced tumour formation in mice 
involves platelet changes and associated endothelial cell proliferation. These platelet changes were not 
present in rats or in humans based on short term and limited long term clinical data. There is no 
evidence to suggest an associated risk to humans. 
 
In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats. 
However, juvenile rats are more sensitive. At therapeutic exposures, there was evidence of CNS 
clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain 
suppression). Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure. 
Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at >2 times 
the human therapeutic exposure. Nine weeks after exposure, this effect was no longer observable.  
 
 
6.  PHARMACEUTICAL PARTICULARS 

 

6.1  List of excipients 

 

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 
Propylene glycol  
Iron oxide black (E172) 
Ammonia solution, concentrated 
Potassium hydroxide 
Purified water 
 
6.2  Incompatibilities 

 
Not applicable. 
 
6.3  Shelf life 

 

3 years. 



19 
 

 
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 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 50 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 84 x 1 and 100 x 1 hard capsules. 
 
Pregabalin Mylan 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 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 capsules 
 
Pregabalin Mylan 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 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 capsules. 
 
Pregabalin Mylan 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 capsules. 
 
Pregabalin Mylan 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. 
 



20 
 

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 
 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 

 

Pregabalin Mylan 25 mg hard capsules 
 

EU/1/15/997/001 

EU/1/15/997/002 

EU/1/15/997/003 

EU/1/15/997/004 

EU/1/15/997/005 

EU/1/15/997/006 

EU/1/15/997/007 

EU/1/15/997/008 

 
Pregabalin Mylan 50 mg hard capsules 
 

EU/1/15/997/009 

EU/1/15/997/010 

EU/1/15/997/011 

EU/1/15/997/012 

EU/1/15/997/013 

EU/1/15/997/014 

EU/1/15/997/015 

 
Pregabalin Mylan 75 mg hard capsules 
 

EU/1/15/997/016 

EU/1/15/997/017 

EU/1/15/997/018 

EU/1/15/997/019 

EU/1/15/997/020 

EU/1/15/997/021 

EU/1/15/997/022 

 
Pregabalin Mylan 100 mg hard capsules 
 

EU/1/15/997/023 

EU/1/15/997/024 



21 
 

EU/1/15/997/025 

EU/1/15/997/026 

EU/1/15/997/027 

 
Pregabalin Mylan 150 mg hard capsules 
 

EU/1/15/997/028 

EU/1/15/997/029 

EU/1/15/997/030 

EU/1/15/997/031 

EU/1/15/997/032 

EU/1/15/997/033 

EU/1/15/997/034 

 
Pregabalin Mylan 200 mg hard capsules 
 

EU/1/15/997/035 

EU/1/15/997/036 

EU/1/15/997/037 

EU/1/15/997/038 

EU/1/15/997/039 

 
Pregabalin Mylan 225 mg hard capsules 
 

EU/1/15/997/040 

EU/1/15/997/041 

EU/1/15/997/042 

EU/1/15/997/043 

EU/1/15/997/044 

 
Pregabalin Mylan 300 mg hard capsules 
 

EU/1/15/997/045 

EU/1/15/997/046 

EU/1/15/997/047 

EU/1/15/997/048 

EU/1/15/997/049 

EU/1/15/997/050 

 
 
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 
 

 

 



22 
 

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/


23 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 



24 
 

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 
Logiters Logistica Portugal S.A. 
Estrada dos Arneiros 
4 Azambuja 
2050-544 
Portugal 
 
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. 

  



25 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



26 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

  



27 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 capsule 
84 x 1 hard capsule 
100 x 1 hard capsule 
 
 

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 

 
 
 



28 
 

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/1/15/997/001 
EU/1/15/997/002 
EU/1/15/997/003 
EU/1/15/997/004 
EU/1/15/997/005 
EU/1/15/997/006 
EU/1/15/997/007 
EU/1/15/997/008 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 25 mg 
 



29 
 

 

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

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



30 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 

 

 

  



31 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 



32 
 

 
 

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/1/15/997/009 
EU/1/15/997/010 
EU/1/15/997/011 
EU/1/15/997/012 
EU/1/15/997/013 
EU/1/15/997/014 
EU/1/15/997/015 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 50 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 



33 
 

2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN  



34 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 

 
  



35 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 
 



36 
 

8. EXPIRY DATE 

 
EXP 
 
 

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/1/15/997/016 
EU/1/15/997/017 
EU/1/15/997/018 
EU/1/15/997/022 
EU/1/15/997/019 
EU/1/15/997/020 
EU/1/15/997/021 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 75 mg  



37 
 

 
 

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

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN  



38 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 
 
  



39 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



40 
 

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/1/15/997/022 
 
 

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 

 
 
 
  



41 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



42 
 

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/1/15/997/023 
EU/1/15/997/024 
EU/1/15/997/025 
EU/1/15/997/026 
EU/1/15/997/027 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 100 mg  
 
 

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

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



43 
 

 
PC 
SN 
NN  



44 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 
 
  



45 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 



46 
 

 
 

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/1/15/997/028 
EU/1/15/997/029 
EU/1/15/997/030 
EU/1/15/997/034 
EU/1/15/997/031 
EU/1/15/997/032 
EU/1/15/997/033 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 150 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 



47 
 

2D barcode carrying the unique identifier included. 
 
 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



48 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 
 
  



49 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



50 
 

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/1/15/997/034 
 
 

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 
 
 
 
  



51 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



52 
 

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/1/15/997/035 
EU/1/15/997/036 
EU/1/15/997/037 
EU/1/15/997/038 
EU/1/15/997/039 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 200 mg  
 
 

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

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



53 
 

 
PC 
SN 
NN  



54 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 

 
  



55 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



56 
 

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/1/15/997/040 
EU/1/15/997/041 
EU/1/15/997/042 
EU/1/15/997/043 
EU/1/15/997/044 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 225 mg  
 
 

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

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 



57 
 

 
PC 
SN 
NN  



58 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 
 
  



59 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 
OUTER CARTON FOR BLISTER AND BOTTLE 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 



60 
 

 

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/1/15/997/045 
EU/1/15/997/046 
EU/1/15/997/047 
EU/1/15/997/050 
EU/1/15/997/048 
EU/1/15/997/049 
 
 

13. BATCH NUMBER 

 
Lot 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 
 

15. INSTRUCTIONS ON USE 

 
 
 

16. INFORMATION IN BRAILLE 

 
Pregabalin Mylan 300 mg  
 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 



61 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



62 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 

 
 

 
  



63 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

BOTTLE LABEL 

 

1. NAME OF THE MEDICINAL PRODUCT 

 
Pregabalin Mylan 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 
 
 



64 
 

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/1/15/997/050 
 
 

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 
 
 
 
  



65 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



66 
 

Package leaflet: Information for the user 
 

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

Pregabalin Mylan 75 mg hard capsules  

Pregabalin Mylan 100 mg hard capsules  

Pregabalin Mylan 150 mg hard capsules  

Pregabalin Mylan 200 mg hard capsules  

Pregabalin Mylan 225 mg hard capsules  

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

 

Pregabalin Mylan contains the active substance pregabalin which belongs to a group of medicines 
used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. 
 

Peripheral and central neuropathic pain: Pregabalin Mylan is used to treat long lasting pain caused 
by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes 
or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, 
cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may 
also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact 
on physical and social functioning and overall quality of life. 
 
Epilepsy: Pregabalin Mylan is used to treat a certain form of epilepsy (partial seizures with or without 
secondary generalisation) in adults. Your doctor will prescribe Pregabalin Mylan for you to help treat 
your epilepsy when your current treatment is not controlling your condition. You should take 
Pregabalin Mylan in addition to your current treatment. Pregabalin Mylan is not intended to be used 
alone, but should always be used in combination with other anti-epileptic treatment. 
 



67 
 

Generalised Anxiety Disorder: Pregabalin Mylan 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 Mylan  

 

Do not take Pregabalin Mylan: 
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. 
 

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

 

• When Pregabalin Mylan 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. 

 



68 
 

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

 

• There have been reports of reduction in brain function (encephalopathy) in some patients 
taking Pregabalin Mylan 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  
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregabalin Mylan and certain other medicines may influence each other (interaction). When taken 
with certain other medicines, which have sedative effects (including opioids), Pregabalin Mylan 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 is taken together with 
medicinal products containing: 

• Oxycodone – (used as a pain-killer) 

• Lorazepam – (used for treating anxiety) 

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

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

Pregabalin Mylan 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 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  

 
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. 



69 
 

 
Pregabalin Mylan is for oral use only. 
 
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder: 

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

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

• Your doctor will tell you to take Pregabalin Mylan either twice or three times a day. For twice 
a day take Pregabalin Mylan once in the morning and once in the evening, at about the same 
time each day. For three times a day take Pregabalin Mylan 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 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 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 until your doctor tells you to stop. 
 
If you take more Pregabalin Mylan than you should 

Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of 
Pregabalin Mylan capsules with you. You may feel sleepy, confused, agitated, or restless as a result of 
taking more Pregabalin Mylan than you should. Fits have also been reported. 
 
If you forget to take Pregabalin Mylan  
It is important to take your Pregabalin Mylan 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  
Do not stop taking Pregabalin Mylan 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 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 
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 
 



70 
 

Common: may affect up to 1 in 10 people 

• Increased appetite 

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

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

• Blurred vision, double vision 

• Vertigo, problems with balance, fall 

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

• Difficulties with erection 

• Swelling of the body including extremities 

• Feeling drunk, abnormal style of walking 

• Weight gain 

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

• Sore throat 
 

Uncommon: may affect up to 1 in 100 people 

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

• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty 
finding words, hallucinations, abnormal dreams, panic 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 



71 
 

• Difficulty with writing properly 

• Increased fluid in the abdomen 

• Fluid in the lungs 

• Convulsions 

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

• Muscle damage 

• Breast discharge, abnormal breast growth, breast growth in males 

• Interrupted menstrual periods 

• Kidney failure, reduced urine volume, urinary retention 

• Decrease in white blood cell count 

• Inappropriate behaviour 

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

• Jaundice (yellowing of the skin and eyes). 
 

Very rare: may affecr 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  

 

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 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


72 
 

 
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 looks like and contents of the pack 

 

Hard capsule. 
 



73 
 

Pregabalin Mylan 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 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 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 

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 

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. 

Pregabalin Mylan 

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. 



74 
 

Pregabalin Mylan 

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 

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 
 
Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
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) 

 



75 
 

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 

 

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 
 



76 
 

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