País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
pregabalin
Mylan S.A.S.
N03AX16
pregabalin
Antiepileptics,
Anxiety Disorders; Neuralgia; Epilepsy
EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Revision: 7
Withdrawn
2015-06-25
64 B. PACKAGE LEAFLET Medicinal Product no longer authorised 65 PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN MYLAN PHARMA 25 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 50 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 75 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 100 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 150 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 200 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 225 MG HARD CAPSULES PREGABALIN MYLAN PHARMA 300 MG HARD CAPSULES pregabalin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pregabalin Mylan Pharma is and what it is used for 2. What you need to know before you take Pregabalin Mylan Pharma 3. How to take Pregabalin Mylan Pharma 4. Possible side effects 5. How to store Pregabalin Mylan Pharma 6. Contents of the pack and other information 1. WHAT PREGABALIN MYLAN PHARMA IS AND WHAT IT IS USED FOR Pregabalin Mylan Pharma contains the active substance pregabalin which belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults. EPILEPSY: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Mylan Pharma for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Mylan Pharma in addition to your current treatment. Pregabalin Mylan Pharma is not intended to be used alone, but should always be used in combination with other anti-epil Leer el documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 25 mg hard capsules Pregabalin Mylan Pharma 50 mg hard capsules Pregabalin Mylan Pharma 75 mg hard capsules Pregabalin Mylan Pharma 100 mg hard capsules Pregabalin Mylan Pharma 150 mg hard capsules Pregabalin Mylan Pharma 200 mg hard capsules Pregabalin Mylan Pharma 225 mg hard capsules Pregabalin Mylan Pharma 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Mylan Pharma 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin. Pregabalin Mylan Pharma 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin. Pregabalin Mylan Pharma 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. Pregabalin Mylan Pharma 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin. Pregabalin Mylan Pharma 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin. Pregabalin Mylan Pharma 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin. Pregabalin Mylan Pharma 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin. Pregabalin Mylan Pharma 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Pregabalin Mylan Pharma 25 mg hard capsules Medicinal Product no longer authorised 3 No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB25 in black ink on cap and body. Pregabalin Mylan Pharma 50 mg hard capsules The 50 mg capsules are No. 3, dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB50 in black ink on cap and body. Pregabalin Mylan Pharma 75 mg hard capsules The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell gelat Leer el documento completo