Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
Merus Labs Luxco II S.à.R.L.
C01DA; C01DA14
ISOSORBIDE MONONITRATE
25 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may be renewed (B)
Organic nitrates; isosorbide mononitrate
Marketed
1995-05-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ELANTAN® LA 25 MG PROLONGED RELEASE CAPSULES, HARD 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 Elantan LA 25 is and what it is used for 2. What you need to know before you take Elantan LA 25 3. How to take Elantan LA 25 4. Possible side effects 5. How to store Elantan LA 25 6. Contents of the pack and other information. 1. WHAT ELANTAN LA 25 IS AND WHAT IT IS USED FOR Elantan LA 25 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 LA 25 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 ELANTAN LA 25 DO NOT TAKE ELANTAN LA 25: • if you are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6) • if you suffer from severe anaemia • 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 severely blood volume (hypovolaemia) • if you have severe low blood pressure • if you are suffering from “shock” as the blood has stopped circulating properly around your bo Read the complete document
Health Products Regulatory Authority 27 March 2023 CRN00DG89 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 25mg Prolonged Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release capsule contains 25 mg isosorbide mononitrate. Excipients with known effect: lactose monohydrate 6.71mg and sucrose 8.17-11.96mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged- release capsule, hard Hard capsule with brown cap and white body, containing white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and long term management of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ One capsule to be taken in the morning. The dose may be increased up to two capsules per day for patients with higher nitrate requirements. Dosage regime should be designed according to the clinical response of the patient. The lowest effective dose should be used. _Elderly_There is no evidence to suggest an adjustment of the dosage is necessary in elderly. _Paediatric population_ The safety and efficacy of Elantan LA has yet to be established in children. Attenuation of effect has occurred in some patients being treated with prolonged release preparations. In such patients intermittent therapy may be more appropriate (see section 4.4). Treatment with Elantan LA, as with any other nitrate, should not be stopped suddenly. Both dosage and frequency should be tapered gradually (see section 4.4). Method of administration For oral administration. Health Products Regulatory Authority 27 March 2023 CRN00DG89 Page 2 of 8 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Elantan LA should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or very low blood pressure (systolic blood pressure below 90 mmHg), hypertrophic obstructive cardiomyopathy (HOCM) Read the complete document