Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
Accord-UK Ltd
C01DA14
Isosorbide mononitrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5055565705315
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 conditions: h Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isosorbide mononitrate 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of isosorbide mononitrate. Excipient with known effect: 5 mg of lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM TABLET ISOSORBIDE MONONITRATE 20MG TABLETS: White to off white, round, flat, bevelled edge uncoated tablets, debossed with ‘AS’ on one side and break line on the other side. The tablets can be divided in to equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic treatment of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The usual dose of Isosorbidemononitrate is 1 tablet of Isosorbidemononitrate 20 mg, taken asymmetrically (to allow a nitrate low period) 2 to 3 times daily. If result is not adequate, the dose may be increased to 1 tablet of Isosorbidemononitrate 40 mg, 2 to 3 times daily. The dosage may be increased to 120mg per day. Dosage regime should be designed according to the clinical response of the patient. The lowest effective dose should be used. In patients taking isosorbidemononitrate twice daily, the second dose should be taken 8 hours after the 1st dosage. If the dose is one three times daily, take one every 6 hours. This provides a nitrate-free period of 6 – 8 hours. The maximum dose is 3 tablets isosorbidemononitrate 40 mg per day. In order to prevent possible initial undesirable effect, it may be adequate to initiate treatment with possible lowest dose and slowly increase to the required dose. To prevent tolerance, it is recommended that the dosage be kept as low as possible and that a sufficiently long nitrate-free interval is ensured to restore sensitivity (first dose in the morning and last dose late in the afternoon, e.g. at 8 am and 15 pm). The duration of application is decided by the treating physician. Treatment with isosorbidemononitrate, as with any other nitrate, should not be stopped suddenly. Both Aqra d-dokument sħiħ