Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Isosorbid-5-mononitrat
Merus Labs Luxco II S.à.R.L.
C01DA; C01DA14
Isosorbid-5-mononitrat
40 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Organic nitrates; isosorbide mononitrate
Marketed
1983-08-02
R Font size body text: 8pt Pharma code: 1415 Colours: Tech Colours: NOTE: Artwork studio checks pre-press suitability of this artwork only. Ensure the artwork has been thoroughly checked for textual accuracy and has been approved as such. Aesica Queenborough Ltd. North Road, Queenborough, Kent ME11 5EL UK Product name: ELANTAN 40 mg - IE Creation date: 18/09/2017 DCMF No: N/A Operator: MW Commodity: N/A Ref no: 4021409 CMO Code: 1008499 Core spec size: 140x260 Revision: CCDS Update Page no: 1 of 2 Amended by: MW Modification date: 25/10/2017 Proof no: 04 BLACK TECHNICAL (do not print) ELANTAN ® 40 MG TABLETS ISOSORBIDE MONONITRATE 4021409 10/392 1415 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 is and what it is used for 2. What you need to know before you take Elantan 3. How to take Elantan 4. Possible side effects 5. How to store Elantan 6. Contents of the pack and other information. 1. WHAT ELANTAN IS AND WHAT IT IS USED 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. Elantan 40mg tablets may also be used in conjunction with other Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 12 January 2021 CRN00C3H8 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elantan 40 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg of isosorbide mononitrate. Excipients with known effect: lactose monohydrate 131.7mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Elantan 40 mg tablets: white, round tablet, flat with bevelled edge, score and engraving (E/40) 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 Posology _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 Elantan twice daily, the second dose should be taken 8 hours after the 1st 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. _Elderly_ There is no evidence to suggest that an adjustment of the dosage is necessary in elderly. _Paediatric population _ 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 (see section 4.4). Method of administration For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Health Products Regulatory Authority 12 January 2021 CRN00C3H8 Page 2 of 8 Elantan should not be Lesen Sie das vollständige Dokument