País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
UPJOHN (MALAYSIA) SDN. BHD.
PREGABALIN
56Capsule Capsules; 14Capsule Capsules; 112Capsule Capsules
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LYRICA ® CAPSULES_ _ Pregabalin (50 mg, 75 mg, 150 mg Capsules) 1 WHAT IS IN THIS LEAFLET 1. What LYRICA is used for 2. How LYRICA works 3. Before you use LYRICA 4. How to use LYRICA 5. While you are using LYRICA 6. Side Effects 7. Storage and Disposal of LYRICA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT LYRICA IS USED FOR LYRICA 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 LYRICA WORKS LYRICA helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE LYRICA - _When you must not use it _ DO NOT START TAKING LYRICA IF YOU ARE ALLERGIC TO PREGABALIN OR ANY OF THE INGREDIENTS IN LYRICA. See the end of this leaflet for a complete list of ingredients in LYRICA. Symptoms of an allergic reaction to LYRICA may include: - Serious, even life-threatening allergic reactions - Suicidal thoughts or actions - Swelling of your hands, legs and feet - Dizziness and sleepiness _Pregnancy and lactation _ It is not known if LYRICA will harm your unborn baby. You and your healthcare provider will have to decide if you should take LYRICA while you are pregnant. It is known that LYRICA passes into breast milk, but it is not known if it can harm your baby. You and your healthcare provider should discuss whether you should take LYRICA or breast-feed, but you should not do both. - _Before you start to take it _ Tell your healthcare provider about all your medical conditions including if you: - have or had depression, mood problems or suici Leer el documento completo
Pfizer Confidential 1 PFIZER LYRICA ® PREGABALIN 1. NAME OF THE MEDICINAL PRODUCT LYRICA ® 50 mg, 75 mg and 150 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg Each hard capsule contains 50 mg of pregabalin. 75 mg Each hard capsule contains 75 mg of pregabalin. 150 mg Each hard capsule contains 150 mg of pregabalin. 3. PHARMACEUTICAL FORM 50 mg hard capsules White, marked “Pfizer” on the cap and “PGN 50” on the body with black ink. The body is also marked with a black band. 75 mg hard capsules White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink. 150 mg hard capsules White, marked “Pfizer” on the cap and “PGN 150” on the body with black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Pfizer Confidential 2 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. Pregabalin may be taken with or without food. Neuropathic pain Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Fibromyalgia The usual dose range for most patients is 300 to 450 mg per day given in two divided doses. Some patients may derive additional benefit at 600 mg per day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Leer el documento completo