Country: Malta
Language: English
Source: Medicines Authority
PREGABALIN
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
N03AX16
PREGABALIN 225 mg
HARD CAPSULE
PREGABALIN 225 mg
POM
ANTIEPILEPTICS
Withdrawn
2015-07-09
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN TEVA 25 MG CAPSULES, HARD PREGABALIN TEVA 50 MG CAPSULES, HARD PREGABALIN TEVA 75 MG CAPSULES, HARD PREGABALIN TEVA 100 MG CAPSULES, HARD PREGABALIN TEVA 150 MG CAPSULES, HARD PREGABALIN TEVA 200 MG CAPSULES, HARD PREGABALIN TEVA 225 MG CAPSULES, HARD PREGABALIN TEVA 300 MG CAPSULES, HARD 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 Teva is and what it is used for 2. What you need to know before you take Pregabalin Teva 3. How to take Pregabalin Teva 4. Possible side effects 5. How to store Pregabalin Teva 6. Contents of the pack and other information 1. WHAT PREGABALIN TEVA IS AND WHAT IT IS USED FOR Pregabalin Teva belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults. EPILEPSY: Pregabalin Teva is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Teva for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Teva in addition to your current treatment. Pregabalin Teva is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. GENERALISED ANXIETY DISORDER: Pregabalin Teva 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 Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Teva 25 mg Capsules, hard Pregabalin Teva 50 mg Capsules, hard Pregabalin Teva 75 mg Capsules, hard Pregabalin Teva 100 mg Capsules, hard Pregabalin Teva 150 mg Capsules, hard Pregabalin Teva 200 mg Capsules, hard Pregabalin Teva 225 mg Capsules, hard Pregabalin Teva 300 mg Capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 25 mg of pregabalin. Each capsule, hard contains 50 mg of pregabalin. Each capsule, hard contains 75 mg of pregabalin. Each capsule, hard contains 100 mg of pregabalin. Each capsule, hard contains 150 mg of pregabalin. Each capsule, hard contains 200 mg of pregabalin. Each capsule, hard contains 225 mg of pregabalin. Each capsule, hard contains 300 mg of pregabalin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Pregabalin Teva 25 mg are ivory opaque hard gelatine size 3 capsules with overall closed length 15.9 mm ± 0.3 mm, imprinted by black sign 25 on capsule body, filled with white to off-white granulated powder. Pregabalin Teva 50 mg are ivory opaque hard gelatine size 2 capsules with overall closed length 18.0 mm ± 0.3 mm, imprinted by radial black band on capsule cap and black sign 50 and radial black band on capsule body, filled with white to off-white granulated powder. Pregabalin Teva 75 mg are opaque hard gelatine size 3 capsules with overall closed length 15.9 mm ± 0.3 mm, with pink cap and ivory body imprinted by black sign 75, filled with white to off-white granulated powder. Pregabalin Teva 100 mg are pink opaque hard gelatine size 2 capsules with overall closed length 18.0 mm ± 0.3 mm, imprinted by black sign 100 on capsule body, filled with white to off-white granulated powder. Pregabalin Teva 150 mg are ivory opaque hard gelatine size 2 capsules with overall closed length 18.0 mm ± 0.3 mm, imprinted by black sign 150 on capsule body, filled with white to off-white granulated powder. Pregabalin Teva 200 mg are flesh Read the complete document