Country: European Union
Language: English
Source: EMA (European Medicines Agency)
pregabalin
Sandoz GmbH
N03AX16
pregabalin
Antiepileptics,
Anxiety Disorders; Epilepsy
EpilepsyPregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Revision: 16
Withdrawn
2015-06-19
70 B. PACKAGE LEAFLET Medicinal product no longer authorised 71 PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN SANDOZ GMBH 25 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 50 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 75 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 100 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 150 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 200 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 225 MG HARD CAPSULES PREGABALIN SANDOZ GMBH 300 MG HARD CAPSULES pregabalin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Pregabalin Sandoz GmbH is and what it is used for 2. What you need to know before you take Pregabalin Sandoz GmbH 3. How to take Pregabalin Sandoz GmbH 4. Possible side effects 5. How to store Pregabalin Sandoz GmbH 6. Contents of the pack and other information 1. WHAT PREGABALIN SANDOZ GMBH IS AND WHAT IT IS USED FOR Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults. EPILEPSY: Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Sandoz GmbH for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Sandoz GmbH in addition to your current treatment. Pregabalin Sandoz GmbH is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. GENERALISED ANXIETY DISORDER: Pregabalin Sandoz Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz GmbH 25 mg hard capsules Pregabalin Sandoz GmbH 50 mg hard capsules Pregabalin Sandoz GmbH 75 mg hard capsules Pregabalin Sandoz GmbH 100 mg hard capsules Pregabalin Sandoz GmbH 150 mg hard capsules Pregabalin Sandoz GmbH 200 mg hard capsules Pregabalin Sandoz GmbH 225 mg hard capsules Pregabalin Sandoz GmbH 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Sandoz GmbH 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin. Pregabalin Sandoz GmbH 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin. Pregabalin Sandoz GmbH 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. Pregabalin Sandoz GmbH 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin. Pregabalin Sandoz GmbH 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin. Pregabalin Sandoz GmbH 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin. Pregabalin Sandoz GmbH 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin. Pregabalin Sandoz GmbH 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Pregabalin Sandoz GmbH 25 mg hard capsules Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder. Pregabalin Sandoz GmbH 50 mg hard capsules Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder. Pregabalin Sandoz GmbH 75 mg hard capsules Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder. Medicinal product no longer authorised 3 Pregabalin Sandoz GmbH 100 mg hard capsules Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder. Pregabalin Sandoz Read the complete document