Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
NITROGLYCERIN (GLYCERYL TRINITRATE)
McDermott Laboratories Ltd t/a Gerard Laboratories
C01DA02
NITROGLYCERIN (GLYCERYL TRINITRATE)
0.2
Transdermal Patch
Product subject to prescription which may be renewed (B)
glyceryl trinitrate
Not Marketed
2013-07-19
PACKAGE LEAFLET PAGE 14 OF 21 PACKAGE LEAFLET: INFORMATION FOR THE USER Cardioplast 0.2 mg/h transdermal patches Cardioplast 0.4 mg/h transdermal patches Cardioplast 0.6 mg/h transdermal patches Glyceryl trinitrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Cardioplast is and what it is used for 2. What you need to know before you use Cardioplast 3. How to use Cardioplast 4. Possible side effects 5. How to store Cardioplast 6. Contents of the pack and other information The full name of your product is Cardioplast 0.2 mg/h transdermal patch, Cardioplast 0.4 mg/h transdermal patch or Cardioplast 0.6 mg/h transdermal patch, however, throughout the leaflet it will be referred to as Cardioplast. 1. WHAT CARDIOPLAST IS AND WHAT IT IS USED FOR Cardioplast is an adhesive patch that delivers a medicine called glyceryl trinitrate. Glyceryl trinitrate is contained in the adhesive and when the patch is in contact with the skin the glyceryl trinitrate passes slowly and steadily from the patch through the skin and into the bloodstream. Glyceryl trinitrate belongs to a group of medicines called nitrate vasodilators which are used to treat the symptoms of angina (chest pain). Vasodilators work by widening of the blood vessels and therefore an increase in blood flow, letting more blood and oxygen reach the heart. Angina usually occurs as a pain or tightness in the chest although it may be felt in the neck or arm. The pain occurs when the heart muscle does not receive the oxygen it needs to do the work it has Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardioplast 0.2mg/h transdermal patches 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glyceryl trinitrate Each Cardioplast 0.2mg/h transdermal patch contains 20.7 mg of glyceryl trinitrate in a patch size of 7.4 cm 2 , releasing 0.2 mg of glyceryl trinitrate per hour (4.8 mg/24 h). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch A translucent rectangular patch with rounded corners, marked with “Glyceryl trinitrate” and the release rate. The following is printed on each patch: “Glyceryl trinitrate 0.2 mg/h (5mg/24 h)” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For prophylaxis of angina pectoris either alone or in combination with other anti-anginal therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults including elderly patients: Cardioplast transdermal patch it is not indicated for the immediate treatment of an acute anginal attacks. If anginal attacks occur, rapid-acting nitrate preparations (like spray) should be used. In order to avoid an attenuation of effect, in patients being treated with sustained release nitrate preparations, intermittent therapy is recommended. The recommended initial dose is one Cardioplast 0.2 mg/h equivalent to 5 mg/24 h patch applied to the skin once daily for a period of approximately 12 hours. The patch is then removed to provide a nitrate-free interval of at least 8 hours which may be increased up to 12 hours to suit individual patients (a daily patch-off period of 8-12 hours). In case of insufficient efficacy, the posology can be progressively increased to one Cardioplast 0.4 mg/h equivalent to 10 mg/24 h patch once daily, and if necessary to a maximum of one Cardioplast 0.6 mg/h equivalent to 15 mg/24 h patch daily. Maximum dose is one Cardioplast 0.6 mg/h patch in each 24 hour period (15mg/24 h). The nitrate-free interval should correspond to a time period when patient does not usually experience crises, and should be covered by another anti-angi Lue koko asiakirja