Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Glyceryl trinitrate
Rottapharm Ltd
C01DA; C01DA02
Glyceryl trinitrate
15 milligram(s)/24 hours
Transdermal patch
Product subject to prescription which may be renewed (B)
Organic nitrates; glyceryl trinitrate
Not marketed
2000-04-14
IE/H/109/001-003/II/023_ _ _ _ PACKAGE LEAFLET: INFORMATION OF THE USER DERMATRANS 5 MG/24 H TRANSDERMAL PATCH DERMATRANS 10 MG/24 H TRANSDERMAL PATCH DERMATRANS 15 MG/24 H TRANSDERMAL PATCH _ _ 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 Dermatrans is and what it is used for 2. What you need to know before you use Dermatrans 3. How to use Dermatrans 4. Possible side effects 5. How to store Dermatrans 6. Contents of the pack and other information 1. WHAT DERMATRANS IS AND WHAT IT IS USED FOR Dermatrans patches contain the active substance glyceryl trinitrate, a vasodilator used in cardiac diseases, which belongs to a group of drugs called organic nitrates. Dermatrans patches are applied to the skin and the active substance will then pass continuously through your skin and into your body. Dermatrans is indicated for the prevention of angina attacks either taken on its own or in combination with other anti-anginal therapy. Angina usually occurs as a pain or tightness in the chest although it may be felt in the neck or arm. Pain occurs when the heart is not sufficiently oxygenated. Dermatrans is not indicated for the treatment of acute attacks. You should use your usual sublingual tablet or spray for treatment of acute attacks. Dermatrans patches are for external use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DERMATRANS DO NOT USE_ _DERMATRANS_: _ - if you are allergic (hypersensitive) to glyceryl trinitrate, related organic nitrates or to any of the other excipients of D Read the complete document
Health Products Regulatory Authority 08 February 2023 CRN00CV0T Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DERMATRANS 15 mg/24 h transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One transdermal patch contains 47.04 mg of glyceryl trinitrate/19.12 cm 2 delivering 15 mg of glyceryl trinitrate in 24 hours (0.6 mg/hour). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Each patch is circular, light yellow and transparent with printed identification code (NR15), covered by a square both sides aluminised and both sides siliconised protective liner. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Preventive treatment of angina pectoris either alone or in combination with other anti-anginal therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Different strengths of DERMATRANS are available. Treatment is usually initiated with one DERMATRANS 5 mg/24 h applied to the skin once daily. DERMATRANS 5 mg/24 h delivers 0.2 mg/h of glyceryl trinitrate. The dose should be adjusted individually during the treatment to achieve optimum therapeutic effect. The maximum daily dose for DERMATRANS should be 15 mg glyceryl trinitrate. DERMATRANS is administered intermittently, with a daily nitrate-free interval, in order to avoid the development of nitrate tolerance. This free interval should correspond for the patient to a period with no attacks. The timing of administration of concomitant anti-anginal agents (beta-blockers and/or calcium antagonists) should be established in order to provide a therapeutic cover during the nitrate-free interval. The nitrate-free interval of 8 - 12 hours must be observed. The development of nitrate tolerance is a well-established event during the preventive treatment of angina. An adequate prescription with a nitrate-free interval guarantees the therapeutic efficacy of nitrates. Patients experiencing nocturnal angina may benefit from overnight treatment with a nitrate-free interval during the day. In these patients, Read the complete document