Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
ISOSORBIDE MONONITRATE
50 Milligram
Prolonged Release Capsules
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® LA 50MG PROLONGED RELEASE CAPSULES, HARD. 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 LA 50 is for 2. Before you take Elantan LA 50 3. How to take Elantan LA 50 4. Possible side effects 5. How to store Elantan LA 50 6. Further information. 1. WHAT ELANTAN LA 50 IS FOR Elantan LA 50 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 50 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 LA 50 DO NOT TAKE ELANTAN LA 50 IF: • You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Elantan LA 50 (see section 6) • You suffer from severe anaemia • 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 blood volume (hypovolaemia) • You have severe low blood pressure • You are suffering from “shock” as the blood has Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 50 mg Prolonged Release Capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release hard capsule contains 50 mg isosorbide mononitrate. Excipients: Each prolonged release hard capsule contains 13.42 mg lactose monohydrate and approximately 16-24 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard (prolonged release capsule). Size 3 hard gelatin opaque capsules. Brown capsule cap and flesh coloured body, containing white to beige odourless 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 For oral administration Elantan LA should be swallowed whole with water. Elantan LA 50mg: one daily, or two capsules daily, together in the morning. 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. The lowest effective dose should be used. ELDERLY There is no evidence to suggest an adjustment of the dosage is necessary in elderly. Children 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). 4.3 CONTRAINDICATIONS Elantan LA should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or Đọc toàn bộ tài liệu