Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
Ennogen Pharma Ltd
C01DA14
Isosorbide mononitrate
40mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 290312/1 Ennogen Modisal XL Leaflet UK English 180 x 300 mm 9 pt 1 of 2 27 13-06-17 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : artworkcd@yahoo.com Ph : +91-09845609386 Colours Used Black Keyline Modisal XL 40mg Prolonged Release Tablets (ISOSORBIDE MONONITRATE) PACKAGE LEAFLET: INFORMATION FOR THE USER 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 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, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT MODISAL XL 40MG PROLONGED RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODISAL XL 40MG PROLONGED RELEASE TABLETS 3. HOW TO TAKE MODISAL XL 40MG PROLONGED RELEASE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MODISAL XL 40MG PROLONGED RELEASE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION Modisal XL 40mg Prolonged Release Tablets contain a medicine called isosorbide mononitrate. This belongs to a group of medicines called nitrates that act on your cardiovascular system (the heart and blood vessels). They work by reducing the frequency of your angina attacks. They are called prolonged release tablets because they have been made in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours. These tablets work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Modisal Tablets are used to prevent angina pecto Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Modisal XL 40mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg isosorbide mononitrate. For excipients see 6.1 3 PHARMACEUTICAL FORM Prolonged Release Tablets _ _ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic treatment of angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: One tablet (40mg) once daily given in the morning. The dose may be increased to two tablets (80mg), the whole dose to be given together. The tablets should not be chewed or crushed and should be swallowed with half a glass of fluid. Children: The safety and efficacy of Modisal XL 40mg Prolonged Release Tablets has not been established. Elderly: No need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency. The lowest effective dose should be used. Attenuation of effect (tolerance) has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see Section 4.4). Therapy should not be discontinued suddenly. Both dosage and frequency should be tapered gradually (see Section 4.4). The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all the active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found inside the stool, but all active substance has been released. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe cerebrovascular insufficiency. Phosphodiesterase type-5 inhibitors e.g.sildenafil, tadalafil and vardenafil have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.5). A Lesen Sie das vollständige Dokument