Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
HEALOL PHARMACEUTICALS SDN. BHD.
PREGABALIN
4x7capsule Capsules
Aurobindo Pharma Limited, Unit-VII (SEZ)
PEGASET _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Pregabalin Capsules (50 mg, 75 mg and 150 mg) 1 WHAT IS IN THIS LEAFLET 1. What _PEGASET _ is used for 2. How _PEGASET_ works 3. Before you use _PEGASET _ 4. How to use _PEGASET _ 5. While you are using it _ _ 6. Side effects 7. Storage and Disposal of _PEGASET _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT _PEGASET _IS USED FOR Pregabalin belongs to a group of medicines called Anti-epileptics. You have been prescribed Pregabalin because: Pregabalin 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 _PEGASET_ WORKS Pregabalin helps decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE _PEGASET _ _-When you must not use it _ Do not start taking Pregabalin if you are allergic to Pregabalin or any of the Excipients in Pregabalin. See the end of this leaflet for a complete list of Excipients in Pregabalin. Symptoms of an allergic reaction to Pregabalin may include: Serious, even life-threatening allergic reactions Suicidal thoughts or actions. Swelling of your hands, legs and feet. Faintness and sleepiness _ _ _-Before you start to use 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 i Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS PEGASET PREGABALIN CAPSULES 50 MG/75 MG/150 MG _R_ _x_ _ Only_ NAME OF DRUG PRODUCT : Pregabalin Capsules 50 mg Pregabalin Capsules 75 mg Pregabalin Capsules 150 mg (TRADE) NAME OF PRODUCT : PEGASET 50 PEGASET 75 PEGASET 150 STRENGTH : 50 mg, 75 mg & 150 mg PHARMACEUTICAL DOSAGE FORM : Capsule QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Pregabalin Capsules 50 mg_ Each capsule contains Pregabalin 50 mg_ _ _Pregabalin Capsules 75 mg_ Each capsule contains Pregabalin 75 mg_ _ _Pregabalin Capsules 150 mg_ Each capsule contains Pregabalin 150 mg PHARMACEUTICAL FORM: _Pregabalin Capsules 50 mg:_ White cap/ white body, size ‘4’ hard gelatin capsule shells, imprinting with“Z” on cap and “11” on body with black ink contains white to off-white granular powder. _Pregabalin Capsules 75 mg:_ Orange cap/ white body, size ‘4’ hard gelatin capsule shells, imprinting with“Z” on cap and “12” on body with black ink contains white to off-white granular powder. _Pregabalin Capsules 150 mg:_ White cap/ White body, size ‘2’ hard gelatin capsule shells, imprinting with“Z” on cap and “14” on body with black ink contains white to off-white granular powder. CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS 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. POSOLOGY AND METHOD OF ADMINISTRATION _Oral_ 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 afte Belgenin tamamını okuyun