Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
PREGABALIN
30capsule Capsules; 28capsule Capsules
SALUTAS PHARMA GMBH
PREGABALIN SANDOZ CAPSULES Pregabalin ( 50mg, 75mg & 150mg capsules) _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET: 1. What is PREGABALIN SANDOZ used for 2. How PREGABALIN SANDOZ works 3. Before you use PREGABALIN SANDOZ 4. How to use PREGABALIN SANDOZ 5. While you are using it 6. Side effects 7. Storage and disposal of PREGABALIN SANDOZ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IS PREGABALIN SANDOZ USED FOR PREGABALIN SANDOZ is used to treat: Neuropathic pain Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation Generalised Anxiety Disorder Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia. HOW PREGABALIN SANDOZ WORKS Pregabalin helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE PREGABALIN SANDOZ _When you must not use it _ Do not start taking Pregabalin Sandoz if you are allergic to pregabalin or any of the ingredients in Pregabalin Sandoz. See the end of this leaflet for a complete list of ingredients in Pregabalin Sandoz. Symptoms of an allergic reaction to Pregabalin Sandoz may include: • Serious, even life- threatening allergic reactions • Suicidal thoughts or actions • Swelling of your hands, legs and feet • Dizziness and sleepiness _Before you start use it _ You should inform your doctor if you have or had any of the following conditions: • depression, mood problems or suicidal thoughts or behavior • kidney problems or get kidney dialysis • heart problem including heart failure • bleeding problem or a low blood platelet count • abuse of prescription medicines, street drugs, or alcohol in the past • swelling in your face, mouth, tongue, lips, gums, neck or throat Baca dokumen lengkap
1 | P a g e 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg Capsules Pregabalin Sandoz 75 mg Capsules Pregabalin Sandoz 150 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Sandoz 50 mg Capsules Each hard capsule contains 50 mg of pregabalin. Hard-gelatin capsule size 3 with white to nearly white coloured powder as filling mass. Capsule shell top part (cap) - White opak, axial: black imprinting “P”; Capsule shell bottom part (body) - White opak, axial: black imprinting: “50”. Pregabalin Sandoz 75 mg Capsules Each hard capsule contains 75 mg of pregabalin. Hard-gelatin capsule size 4 with white to nearly white coloured powder as filling mass. Capsule shell top part (cap) - Swedish orange opak, axial: black imprinting “P”; Capsule shell bottom part (body) - White opak, axial: black imprinting: “75”. Pregabalin Sandoz 150 mg Capsules Each hard capsule contains 150 mg of pregabalin. Hard-gelatin capsule size 2 with white to nearly white coloured powder as filling mass. Capsule shell top part (cap) - White opak, axial: black imprinting “P”; Capsule shell bottom part (body) - White opak, axial: black imprinting: “150”. 3. PHARMACEUTICAL FORM Hard gelatin capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuropathic Pain Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy As adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Management of fibromyalgia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 in either 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 60 Baca dokumen lengkap