Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
IVAX Pharmaceuticals UK Ltd
C01DA14
Isosorbide mononitrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ANGITATE ® 20 MG TABLETS ANGITATE ® 40 MG TABLETS Isosorbide Mononitrate 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 Angitate ® is and what it is used for 2 . What you need to know before you take Angitate ® 3 . How to take Angitate ® 4 . Possible side effects 5 . How to store Angitate ® 6 . Contents of the pack and other information 1. WHAT ANGITATE ® IS AND WHAT IT IS USED FOR This medicine contains an active ingredient called Isosorbide Mononitrate, which 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. Angitate ® 20 mg and 40 mg Tablets can also be used to treat congestive heart failure. Heart failure can happen when the heart muscle is not strong enough to pump the blood around the body. It may cause problems with breathing and swelling of the legs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGITATE ® DO NOT TAKE THIS MEDICINE: • If you are allergic to isosorbide mononitrate, other nitrates or to any of the other ingredients of this medicine (listed in section 6) • If you suffer from severe anaemia (reduction in red blood c Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isosorbide Mononitrate Tablets 20 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Isosorbide Mononitrate, 20 mg. Excipients with a known effect: Each tablet contains approximately 109 mg of lactose and approximately 59 mg sucrose. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablets White round tablets with an embossment "IM 20" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isosorbide Mononitrate Tablets is indicated for the prophylaxis of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Dosage should be reduced in patients with renal or hepatic impairment. ADULTS One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. 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 dose be one tablet of Isosorbide Mononitrate Tablets 20 mg twice a day. _ _ The maintenance dose in individual patients is usually between 20- 120 mg daily. The lowest effective dose should be used. ELDERLY No evidence of a need for routine dosage adjustment in older people has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency. CHILDREN The safety and efficacy of Isosorbide Mononitrate Tablets 20 mg has yet to be established in children. Treatment with Isosorbide Mononitrate Tablets, as with any other nitrates, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4) Method of administration It is recommended that the tablets should be swallowed whole with a drink of water. 4.3 CONTRAINDICATIONS Isosorbide Mononitrate Tablets 20 mg should not be used in cases of acute myocardial infarction with low filling pressures, acute circulatory Read the complete document