Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
NICORANDIL
Dexcel-Pharma Limited
C01DX16
NICORANDIL
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Other vasodilators used in cardiac diseases
Authorised
2011-08-05
Nicorandil 10mg, 20mg Tablets 1.3: Product Information 1.3.1 Package Leaflet Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER NICORANDIL 10MG TABLETS NICORANDIL 20MG TABLETS NICORANDIL 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 Nicorandil Tablets are and what they are used for 2. What you need to know before you take Nicorandil Tablets 3. How to take Nicorandil Tablets 4. Possible side effects 5. How to store Nicorandil Tablets 6. Contents of the pack and other information 1. WHAT NICORANDIL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Nicorandil 10mg Tablets or Nicorandil 20mg Tablets (referred to as Nicorandil Tablets throughout this leaflet). The active ingredient in this medicine is called nicorandil. This belongs to a group of medicines called 'potassium-channel activators'. It works by increasing the blood flow through the blood vessels of the heart. It improves the blood and oxygen supply of your heart muscle and reduces its workload. Nicorandil Tablets are used to prevent or attenuate painful, straining symptoms (angina pectoris) of your heart disease. It is used in adult patients who do not tolera Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorandil 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicorandil 20mg Each tablet contains 20 mg nicorandil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white, round, scored on one side and engraved with "20" on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorandil 20mg Tablets are indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonist). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably. It is recommended that the dose be titrated upwards in accordance with the patient's needs, response and tolerance up to 40 mg twice daily, if necessary. A lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache. ELDERLY: There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended. PATIENTS WITH LIVER AND/OR RENAL IMPAIRMENTThere are no special dosage requirements for patients with liver and/or renal impairment. PAEDIATRIC POPULATION: Nicorandil Tablets are not recommended in paediatric patients since its safety and efficacy have not been established in this patient group. METHOD OF ADMINISTRATION Nicorandil Tablets are administered by oral route. The tablets are to be swallowed in the morning and in the evening with a glass of water. The tablets should not be crushed or chewed. The tablet can be divided into equal halves. Administration is independent of food intake. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Přečtěte si celý dokument