국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ranolazine
A. MENARINI SINGAPORE PTE. LTD.
Ranolazine
60tablet Tablets; 100tablet Tablets; 30tablet Tablets
Menarini - Von Heyden GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ RANEXA PROLONGED RELEASE TABLETS RANOLAZINE (375 MG , 500 MG, 750 MG) 1 WHAT IS IN THIS LEAFLET 1. What Ranexa is used for 2. How Ranexa works 3. Before you use Ranexa 4. How to use Ranexa 5. While you are using Ranexa 6. Side effects 7. Storage and Disposal of Ranexa 8. Product Description 9.Manufacturer and Product Registration holder 10. Date of revision 1. WHAT RANEXA IS USED FOR Ranexa is a medicine used in combination with other medicines to treat stable angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much physical activity. You must talk to a doctor if you do not feel better or if you feel worse. 2. HOW RANEXA WORKS The mechanism of action of ranolazine is largely unknown. Ranolazine may have some antianginal effects by inhibition of the late sodium current in heart cells. 3. BEFORE YOU USE RANEXA _- When you must not use it _ • if you are allergic to ranolazine or any of the other ingredients of this medicine listed in section 6 of this leaflet. • if you have severe kidney problems • if you have moderate or severe liver problems if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol). _- Before you start to use it _ Talk to your doctor before taking Ranexa: • if you have mild or moderate kidney problems. • if you have mild liver problems. • if you have ever had an abnormal electrocardiogram (ECG). • if you are elderly. (More than 75 years of age) • if you have low weight (60 kg or less) • if you have heart failure (NYHA Class III–IV). Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you. _ _ _ _ _- Taking other 전체 문서 읽기
RANEXA ® Ranolazine PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ranexa 375 mg prolonged-release tablets: Each tablet contains 375 mg of ranolazine. Ranexa 500 mg prolonged-release tablets: Each tablet contains 500 mg of ranolazine. Ranexa 750 mg prolonged-release tablets: Each tablet contains 750 mg of ranolazine. Excipients (for 750mg only): Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Ranexa 375 mg prolonged-release tablets: Pale blue oval-shaped tablet engraved with 375 on one side. Ranexa 500 mg prolonged-release tablets: Light orange oval-shaped tablet engraved with 500 on one side. Ranexa 750 mg prolonged-release tablets: Pale green oval-shaped tablet engraved with 750 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets. Adults: The recommended initial dose of Ranexa is 375 mg twice daily. After 2–4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient’s response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1). If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), down-titration of Ranexa to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued. Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in 전체 문서 읽기