Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Testosterone
Laboratoires Besins International
G03BA; G03BA03
Testosterone
50 milligram(s)
Transdermal gel in sachet
Product subject to prescription which may not be renewed (A)
3-oxoandrosten (4) derivatives; testosterone
Not marketed
2003-06-03
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. ANDROGEL 50 MG TRANSDERMAL GEL IN SACHET will be referred to as “this medicine” throughout this leaflet. ANDROGEL 50 MG TRANSDERMAL GEL IN SACHET Testosterone WHAT IS IN THIS LEAFLET: 1. What ANDROGEL is and what it is used for 2. What you need to know before you use ANDROGEL 3. How to use ANDROGEL 4. Possible side effects 5. How to store ANDROGEL 6. Content of the pack and other information 1. WHAT ANDROGEL IS AND WHAT IT IS USED FOR This medicine contains testosterone, a male hormone produced naturally in the body. This medicine is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: - impotence, - infertility, - low sex drive, - tiredness, - depressive moods, - bone loss caused by low hormone levels, - regression of masculine characteristics, - reduced lean body mass, - inability to have/maintain an erection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANDROGEL DO NOT USE THIS MEDICINE - If you are allergic to testosterone or any of the ingredients of this medicine (listed in section 6), - If you are suffering from prostate cancer, - If you are suffering from breast cancer. WARNING AND PRECAUTIONS TAKE SPECIAL CARE WITH THIS MEDICINE Before starting any treatment with this medicine, your testosterone deficiency must be clearly demonstrated by clinical signs (regression of masculine cha Leggi il documento completo
Health Products Regulatory Authority 13 October 2020 CRN009RS8 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Androgel 50 mg, transdermal gel in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of 5 g contains 50 mg of testosterone. Excipients with known effect: Ethanol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal gel. Transparent or slightly opalescent, colourless gel in sachet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see 4.4 Special warnings and precautions for use). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and Elderly men_ The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the physician depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by this medicine. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. _Paediatric population_ This medicine is not indicated for use in children and has not been evaluated clinically in males under 18 years of age. _Use in women_ This medicine is not indicated for use in women. Method of administration Transdermal use. The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms Leggi il documento completo