Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
PFIZER (MALAYSIA) SDN. BHD.
PREGABALIN
56Capsule Capsules; 14Capsule Capsules; 112Capsule Capsules
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LYRICA ® Pregabalin (50 mg, 75 mg, 150 mg Capsules) 1 PLD TITLE : LYRICA ® PLD DATE : 03 May 2019 COUNTRY : Malaysia REFERENCES : Malaysia LPD dated 16 January 2017 REASON : To update PRH address change To delete the line stating “MAH Holder / Imported by” : To update serial number Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LYRICA ® Pregabalin (50 mg, 75 mg, 150 mg Capsules) 2 WHAT IS IN THIS LEAFLET 1. What LYRICA is used for 2. How it works 3. Before you take LYRICA 4. How to take 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 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 -_ 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 suicidal thoughts or behavior - have kidney problems or get kidney dialysis - hav Les hele dokumentet
Pfizer Confidential LPD Title : Pregabalin LPD Date : 19 March 2019 Country : Malaysia Reference Document : UK SmPC dated August 2018 (LY 34_0); USPI dated May 2018; CDS version 19 dated 10 June 2016 Reason for Change : Update to Section 4.4 Warning and Precautions Deleted co ntent related to pediatric patients in section 4.4 as per BoH request. 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 cont ains 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 Les hele dokumentet