País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranolazine
A. Menarini Farmaceutica Internazionale SRL
C01EB18
Ranolazine
500mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060300; GTIN: 5038227000324
1 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. In addition to this leaflet, you will find a Patient Alert Card within the box, which contains important safety information that you need to know before you are given Ranexa and during treatment with Ranexa. - Keep this leaflet and the Patient Alert Card. You may need to read it again. - Always show the Patient Alert Card to any doctor involved in your treatment, including physicians treating conditions other than angina pectoris. - Please make sure you have a list of all your other medicines with you at any visit to a health care professional. - 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. 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 IT 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. Leer el documento completo
OBJECT 1 RANEXA PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 16-Feb-2017 | A. Menarini Farmaceutica Internazionale SRL 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 Each tablet contains 375 mg of ranolazine. Each tablet contains 500 mg of ranolazine. Each tablet contains 750 mg of ranolazine. < 750 mg tablet> Excipients: 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 Prolonged-release tablet Pale blue oval-shaped tablet engraved with 375 on one side. Light orange oval-shaped tablet engraved with 500 on one side. 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 Patients should be given the Ranexa package leaflet and the Patient Alert Card and instructed to present their Patient Alert Card and medication list to their health care professional at each visit. 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 24 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 C Leer el documento completo