البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
Flamingo Pharma (UK) Ltd
C01DA14
Isosorbide mononitrate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5060464500664
FONTS SIZE : Generic Name font size : 12 pt. Composition fonts size : 9 pt. FONTS : Zurich CnBT 330 mm 160 mm 160 mm PACKAGE LEAFLET: INFORMATION FOR THE USER ISOSORBIDE MONONITRATE 10 MG TABLETS ISOSORBIDE MONONITRATE 20 MG TABLETS ISOSORBIDE MONONITRATE 40 MG TABLETS ISOSORBIDE MONONITRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What Isosorbide mononitrate Tablets are and what are they used for 2. What you need to know before you take Isosorbide mononitrate Tablets 3. How to take Isosorbide mononitrate Tablets 4. Possible side effects 5. How to store Isosorbide mononitrate Tablets 6. Contents of the pack and other information Isosorbide mononitrate belongs to a group of medicines called Organic Nitrates. 1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT ARE THEY USED FOR DO NOT TAKE ISOSORBIDE MONONITRATE TABLETS: • if you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients in the product (see section 6) • if you suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) • if you have had a heart attack (myocardial infarction) • if you have had a brain haemorrhage (bleeding) • if you have had a head injury (trauma) • if you have a low blood volume (hypovolaemia) • if you have very low blood pressure • if you are suffering from 'shock' as the blood has stopped circulating properly around your body (circulatory failure) • if you take sildenafil اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isosorbide Mononitrate 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains diluted isosorbide mononitrate equivalent to isosorbide mononitrate 10 mg. Excipient(s) with known effect: Each tablet contains 32.25mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Isosorbide mononitrate 10 mg Tablets are white to off white circular, biconvex uncoated tablets debossed with ‘I’ and ‘10’ separated by break line on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and long term management of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Tablet should be swallowed whole with water. Isosorbide mononitrate 10 mg Tablets: one tablet twice daily, or three times daily _ _ _Adults_: One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. The dosage may be increased up to 120mg per day. Dosage regime should be designed according to the clinical response of the patient. Tablets should be taken after meals, unchewed with water. The lowest effective dose should be used. In patients taking one tablet twice daily the second dose should be taken 8 hours after the first dosage. If the dose is one tablet three times daily, take one every 6 hours and ensure 12 hours treatment-free interval every 24 hours.. _Paediatric population_: The safety and efficacy of Isosorbide Mononitrate 10mg Tablets in children has not been established. _ _ Elderly There is no evidence to suggest that an adjustment of the dosage is necessary. Treatment with Isosorbide mononitrate tablets, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4) Method of administration For oral administration 4.3 CONTRAINDICATIONS Isosorbide mononitrate tablets should not be given to patients with a known sensitivity to isos اقرأ الوثيقة كاملة