Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Ranolazine
KRKA, d.d., Novo mesto
C01EB18
Ranolazine
Prolonged-release tablet
ranolazine
Marketed
2023-03-31
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RANOLAZINE KRKA 375 MG PROLONGED-RELEASE TABLETS RANOLAZINE KRKA 500 MG PROLONGED-RELEASE TABLETS RANOLAZINE KRKA 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 illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ranolazine Krka is and what it is used for 2. What you need to know before you take Ranolazine Krka 3. How to take Ranolazine Krka 4. Possible side effects 5. How to store Ranolazine Krka 6. Contents of the pack and other information 1. WHAT RANOLAZINE KRKA IS AND WHAT IT IS USED FOR Ranolazine Krka 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 RANOLAZINE KRKA DO NOT TAKE RANOLAZINE KRKA - if you are allergic to ranolazine or any of the other ingredients of this medicine (listed in section 6). - 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). WARNINGS AND PRECAUTIONS Talk to Soma hati kamili
Health Products Regulatory Authority 01 December 2023 CRN00DVH9 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ranolazine Krka 500 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 500 mg ranolazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Pale brownish yellow, oval, biconvex film-coated tablets marked with 500 on one side of the tablet. Tablet dimensions: approximately 17 × 8 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ranolazine Krka 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 Ranolazine Krka is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets. Adults: The recommended initial dose of Ranolazine Krka 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 Ranolazine Krka 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 Soma hati kamili