Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
NOVUGEN PHARMA SDN. BHD.
PREGABALIN
60 Capsules; 100 Capsules; 30 Capsules; 120 Capsules; 10 Capsules; 14 Capsules; 28 Capsules; 56 Capsules; 112 Capsules
PHARMANIAGA MANUFACTURING BERHAD
Novugen Confidential NOVUGAB CAPSULES Pregabalin (50mg, 75mg, 150mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Novugab is used for 2. How it works 3. Before you take Novugab 4. How to take Novugab 5. While you are using Novugab 6. Side Effects 7. Storage and Disposal of Novugab 8. Product 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NOVUGAB IS USED FOR Novugab 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 NOVUGAB WORKS Novugab helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE NOVUGAB _- When you must not use it_ DO NOT START TAKING NOVUGAB IF YOU ARE ALLERGIC TO PREGABALIN OR ANY OF THE INGREDIENTS IN NOVUGAB. See the end of this leaflet for a complete list of ingredients in Novugab. Symptoms of an allergic reaction to Novugab 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 - have heart problems including heart failure - have a bleeding problem or a low blood platelet count - have abused prescription medicines, street drugs, or alcohol in the past - have ever had swelling in your face, mouth, tongue, lips, gums, neck or throat (angioderma) - have brain malfunction (encephalopathy) - cases of misuse, abuse and depende Lire le document complet
Novugen Novugab Capsules Pregabalin 1. NAME OF THE MEDICINAL PRODUCT Novugab 50 mg Capsules, Novugab 75 mg Capsules, and Novugab 150 mg Capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg Each capsule contains 50 mg of pregabalin. 75 mg Each capsule contains 75 mg of pregabalin. 150 mg Each capsule contains 150 mg of pregabalin. 3. PHARMACEUTICAL FORM 50 mg hard capsules White to off-white powder filled in size ‘4’ hard gelatin capsule, printed with ‘P 50’ on white body and ‘N’ on white cap in black ink. 75 mg hard capsules White to off-white powder filled in size ‘4’ hard gelatin capsule, printed with ‘P 75’ on white body and ‘N’ on red cap in black ink. 150 mg hard capsules White to off-white powder filled in size ‘2’ hard gelatin capsule, printed with ‘P 150’ on white body an ‘N’ on white cap in 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. Novugen 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. 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. Novugab is for oral use only. 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 Lire le document complet