Country: Malta
Language: English
Source: Medicines Authority
GLYCERYL TRINITRATE
Meda Pharmaceuticals Limited Skyway House, Parsonage Road, Takeley, Bishop''s Stortford, CM22 6PU, United Kingdom
C01DA02
GLYCERYL TRINITRATE
TRANSDERMAL PATCH
GLYCERYL TRINITRATE milligram(s)
POM
CARDIAC THERAPY
Authorised
2006-03-29
2.75” 2.75” 8.25” 2.75” Die Line Fold Line Registration No Copy / Copy Area (0.125” L and R, 0.25” T and B) 8.25” W x 15.5” H leaflet, Front 08 APR 2008 2.5” 2.5” 15.5” 2.5” 2.5” 2.5” 2.5” 0.25” 0.25” Bar Code FPO Bar Code (BC)/BC FPO is 1” W x 0.438” H Artwork (AW) ID #/AW ID place holder area is 1” W x 0.125” H AW ID #/AW ID place holder is to be Arial or Helvetica AW ID #/AW ID place holder is to be a minimum 6pt, but must fit in AW ID area BC, AW ID #, and AW ID place holders print black AW ID place holder (X’s) is to be replaced with AW ID # BC area is 1.5” W x 0.938” H (0.25” QZ L, R; 0.188 QZ T, B) No copy other than BC, AW ID #, or place holders in BC area BC area is centered in the panel BC area top, as the BC/BC FPO reads, is flush to the first fold BC FPO XXXXXX BC FPO XXXXXX BC FPO XXXXXX 2.75” 2.75” 8.25” 2.75” Die Line Fold Line Registration No Copy / Copy Area (0.125” L and R, 0.25” T and B) 8.25” W x 15.5” H leaflet, Back 08 APR 2008 2.5” 2.5” 15.5” 2.5” 2.5” 2.5” 2.5” 0.25” 0.25” 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. 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. • In this leaflet, Minitran 5 mg, 10 mg or 15 mg transdermal patches will be called Minitran patches. What is in this leaflet: 1. What Minitran patches are and what they are used for 2. What you need to know before you use Minitran patches 3. How to use Minitran patches 4. Possible side effects 5. How to store Minitran patches 6. Contents of the pack and other information 1. What Minitran patches are Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minitran 5 mg/ 24 h, transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minitran 5 has a surface area of 6.7 sq cm and contains 18 mg of glyceryl trinitrate. The average amount delivered in 24 hours is 5 mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Adhesive transdermal patch. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Minitran 5 is indicated for: 1. Prophylaxis of angina pectoris either alone or in combination with other anti-anginal therapy. 2. Maintenance of venous patency at peripheral infusion sites. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1. PROPHYLAXIS OF ANGINA PECTORIS _Adults: _ The response to nitrates differs between individuals, and the minimum effective dose should be prescribed in each case. It is therefore recommended that treatment is started with one Minitran 5 patch per day, with upward dosage titration when necessary. Application can either be for a continuous period of 24 hours or intermittently, incorporating a patch free interval (usually at night). Attenuation of effect has occurred in some patients being treated with sustained release nitrate preparations. On the basis of current clinical studies it is recommended that in such cases Minitran should be applied daily with a patch free interval of 8 - 12 hours. 2. MAINTENANCE OF VENOUS PATENCY _Adults _ One Minitran 5 patch is applied distal and close to the site of intravenous cannulation at the time of venepuncture. The patch should be changed daily. Treatment with Minitran 5 should be discontinued when intravenous therapy is stopped. Special populations _Elderly: _ No specific information on use in the elderly is available, but there is no evidence to suggest that an alteration in dose is required. _Paediatric population: _ The safety and efficacy of Minitran in children has yet to be established, and therefore recommendations for its use cannot be made. Method of administration Each Minitran patch is contained in a Read the complete document