Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
ranolazine
Menarini International Operations Luxembourg S.A. (MIOL)
C01EB18
ranolazine
Cardiac therapy
Angina Pectoris
Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,
Revision: 22
Authorised
2008-07-08
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RANEXA 375 MG PROLONGED-RELEASE TABLETS RANEXA 500 MG PROLONGED-RELEASE TABLETS RANEXA 750 MG PROLONGED-RELEASE TABLETS ranolazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illnes are the same as yours. - If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ranexa is and what it is used for 2. What you need to know before you take Ranexa 3. How to take Ranexa 4. Possible side effects 5. How to store Ranexa 6. Contents of the pack and other information 1. WHAT RANEXA IS AND WHAT IS USED FOR Ranexa is a medicine used in combination with other medicines to treat 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 activity. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANEXA DO NOT TAKE RANEXA - 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). WARNING AND PRECAUTIONS Talk to your doctor before taking Ranexa: - if you have mild or moderate kidney problems. - if you have Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Pale blue oval-shaped tablet engraved with 375 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 patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5). Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5). Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30–80 ml/min) (see sections 4.4, 4.8, and 5.2). Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2). _ _ Hepatic impairment: Care Přečtěte si celý dokument