Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
ISOSORBIDE MONONITRATE
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
CCDS ISOSORBIDE MONONITRATE C2013-033 APPROVED: 25 MAR 2013 PROPOSED PIL JULY 2013 SUBMITTED TO IMB ELANTAN® 20MG TABLETS Isosorbide mononitrate PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Elantan is for 2. Before you take Elantan 3. How to take Elantan 4. Possible side effects 5. How to store Elantan 6. Further information. 1. WHAT ELANTAN IS FOR Elantan 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. Elantan 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. BEFORE YOU TAKE ELANTAN DO NOT TAKE ELANTAN IF: • You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Elantan (see section 6) • You suffer from severe anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) • You have had a heart attack (myocardial infarction) • You have had a brain haemorrhage (bleeding) • You have had a head injury (trauma) • You have severely low blood volume (hypovolaemia) • You have severely low blood pressure • Your are suffering from ‘shock’ as the blood has stopped circulating prope Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of isosorbide mononitrate. Excipients: Contains Lactose Monohydrate 151.7mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Elantan 20 mg tablets correspond to a white, round tablet, flat with bevelled edge, score and engraving (E/20) on the upper side and rounded on the lower side The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and long term management of angina pectoris. As adjunctive therapy after acute myocardial infarction and chronic congestive heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Elantan should be swallowed whole with water. Elantan 20 mg: 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 120 mg per day. Dosage regime should be designed according to the clinical response of the patient. Tablets should be taken after meals, unchewed with a little fluid. The lowest effective dose should be used. In patients taking one tablet 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. Elderly There is no evidence to suggest that an adjustment of the dosage is necessary in elderly. Children The safety and efficacy of Elantan has yet to be established in children. Treatment with Elantan, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually ( Read the complete document