Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
pregabalin
Zentiva, k.s.
N03AX16
pregabalin
Antiepileptics,
Anxiety Disorders; Epilepsy
Neuropathic pain , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , Epilepsy , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , Generalised anxiety disorder , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Revision: 15
Authorised
2015-07-17
58 B. PACKAGE LEAFLET 59 PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN ZENTIVA 25 MG HARD CAPSULES PREGABALIN ZENTIVA 50 MG HARD CAPSULES PREGABALIN ZENTIVA 75 MG HARD CAPSULES PREGABALIN ZENTIVA 100 MG HARD CAPSULES PREGABALIN ZENTIVA 150 MG HARD CAPSULES PREGABALIN ZENTIVA 200 MG HARD CAPSULES PREGABALIN ZENTIVA 225 MG HARD CAPSULES PREGABALIN ZENTIVA 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 Zentiva is and what it is used for 2. What you need to know before you take Pregabalin Zentiva 3. How to take Pregabalin Zentiva 4. Possible side effects 5. How to store Pregabalin Zentiva 6. Contents of the pack and other information 1. WHAT PREGABALIN ZENTIVA IS AND WHAT IT IS USED FOR Pregabalin Zentiva 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 Zentiva 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 Zentiva is used to treat a certain form of ep Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Zentiva 25 mg hard capsules Pregabalin Zentiva 50 mg hard capsules Pregabalin Zentiva 75 mg hard capsules Pregabalin Zentiva 100 mg hard capsules Pregabalin Zentiva 150 mg hard capsules Pregabalin Zentiva 200 mg hard capsules Pregabalin Zentiva 225 mg hard capsules Pregabalin Zentiva 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Zentiva 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin. Excipient with known effect Each hard capsule also contains 47.57 mg lactose monohydrate. Pregabalin Zentiva 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin. Excipient with known effect Each hard capsule also contains 5 mg lactose monohydrate. Pregabalin Zentiva 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. Excipient with known effect Each hard capsule also contains 7.5 mg lactose monohydrate. Pregabalin Zentiva 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin. Excipient with known effect Each hard capsule also contains 10 mg lactose monohydrate. Pregabalin Zentiva 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin. Excipient with known effect Each hard capsule also contains 15 mg lactose monohydrate. Pregabalin Zentiva 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin. Excipient with known effect Each hard capsule also contains 20 mg lactose monohydrate. Pregabalin Zentiva 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin. 3 Excipient with known effect Each hard capsule also contains 22.5 mg lactose monohydrate. Pregabalin Zentiva 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin. Excipient with known effect Each hard capsule also contains 30 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Pregabalin Zentiva 25 mg hard capsules Light grey cap and light grey body; approx. 15,9 mm in length, hard gela Przeczytaj cały dokument