Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREGABALIN
MYLAN HEALTHCARE SDN. BHD.
PREGABALIN
30 Capsules
Mylan Laboratories Limited
_Consumer Medication Information Leaflet (RiMUP)_ ALOJA 75 AND 150 Pregabalin (75 mg and 150 mg) 1 WHAT IS IN THIS LEAFLET 1. What_ ALOJA_ is used for 2. How_ ALOJA_ works _3._ Before you use_ ALOJA_ _4._ How to use_ ALOJA_ 5. While you are using _ALOJA_ 6. Side Effects 7. Storage and Disposal of _ALOJA_ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. MAL no. 12. Serial Number WHAT_ ALOJA_ IS USED FOR _ALOJA_ is used to treat long lasting pain caused by damage to the nerves. _ALOJA_ is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. _ALOJA_ is used to treat Generalised Anxiety Disorder (GAD). Fibromyalgia ALOJA is indicated for the management of fibromyalgia HOW_ ALOJA_ WORKS _ALOJA helps_ decrease the number of nerve signals, and as a result calms down overly sensitive nerve cells. BEFORE YOU USE_ ALOJA_ _- When you must not use it_ If you are allergic to pregabalin or any of the other ingredients of this medicine (_Taking other medicines_). _ALOJA_ should not be taken during pregnancy or when breast- feeding, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. If you are pregnant or breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group. _-_ _Before you start to use it_ There have been reports of heart failure in some patients when taking _ALOJA_; these patients were mostly elderly with cardiovascular conditions. BEFORE TAKING THIS MEDICINE YOU SHOULD TELL YOUR DOCTOR IF YOU HAVE A HISTORY OF HEART DISEASE. Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed. _-_ _Taking o Baca dokumen lengkapnya
ALOJA TM 75 AND 150 (PREGABALIN CAPSULES 75 MG AND 150 MG) 1. NAME OF THE MEDICINAL PRODUCT ALOJA TM 75 Pregabalin Capsules 75 mg ALOJA TM 150 Pregabalin Capsules 150 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALOJA TM 75 Each Capsule contains: Pregabalin Ph. Eur ....................................... 75 mg, Excipients ...............................q.s. For the full list of excipients, see section 6.1. ALOJA TM 150 Each Capsule contains: Pregabalin Ph. Eur .........................................150 mg, Excipients ...............................q.s. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ALOJA TM 75 Hard capsules A No. 4, light peach opaque cap and light peach opaque body, hard- shell gelatin capsule filled with white to off white powder. The capsule is axially printed with MYLAN over PB75 in black ink on cap and body. ALOJA TM 150 Hard capsules A No. 2, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over PB150 in black ink on cap and body. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 as 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 600 mg per day after an ad Baca dokumen lengkapnya