País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
Arrow Generics Ltd
C01DA14
Isosorbide mononitrate
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ISOSORBIDE MONONITRATE 20 MG TABLETS ISOSORBIDE MONONITRATE 40 MG TABLETS Isosorbide mononitrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, tell 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 Isosorbide mononitrate is and what it is used for 2. What you need to know before you take Isosorbide mononitrate 3. How to take Isosorbide mononitrate 4. Possible side effects 5. How to store Isosorbide mononitrate 6. Contents of the pack and other information 1. WHAT ISOSORBIDE MONONITRATE IS AND WHAT IT IS USED FOR Isosorbide mononitrate belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Isosorbide mononitrate is used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDE MONONITRATE _ _ DO NOT TAKE ISOSORBIDE MONONITRATE - if you are allergic to the isosorbide mononitrate or to any of the other ingredients of this medicine (listed in section 6). - if you suffer from severe disorders of the heart muscle or the pericardium causing severe impairment of the heart function is severely impaired (called constrictive pericarditis, pericardial tamponade or restrictive cardiomyopathy); You have been diagnosed with any of the following heart Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ISOSORBIDE MONONITRATE TABLETS 40mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg Isosorbide mononitrate. 3. PHARMACEUTICAL FORM White to off-white, uncoated tablets. White to off-white, circular, biconvex uncoated tablets impressed “C” on one face and the identifying letters “IV”on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) Prophylaxis of angina pectoris. 2) As an adjunctive treatment in the management of severe acute or chronic congestive cardiac failure not responding to cardiac glycosides and/or diuretics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ It is recommended that the tablets should be swallowed whole with a little fluid after meals. Dosage should be reduced in patients with renal or hepatic impairment. _Adults:_ _Angina:_ Usually 20mg, two or three times daily. Patients already accustomed to prophylactic nitrate therapy may normally be transferred directly to a therapeutic dose of isosorbide mononitrate. For patients not already receiving prophylactic nitrate therapy, it is recommended that the initial dosage should be 20mg twice daily. The maintenance dose in individual patients is usually between 20-120mg daily. _Congestive cardiac failure:_ In severe congestive cardiac failure doses of 20mg, two or three times daily may be employed depending on individual requirements. The optimum dosage is best determined by continuous haemodynamic monitoring. The use of isosorbide mononitrate tablets in severe congestive cardiac failure should be regarded as an adjunctive therapy to more conventional treatment (_eg_ cardiac glycosides, diuretics). _Elderly:_ Dosage requirements may be reduced especially when hepatic or renal function is impaired. Also, particular care should be taken due to susceptibility to hypotension. _Children: _Safety and efficacy has not been established. _Method of Administration _ For oral administration. 4.3 CONTRAINDICATIONS Known hypersensitivity to iso Llegiu el document complet