Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Testosterone
Laboratoires Besins International
G03BA; G03BA03
Testosterone
25 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 sign 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. TESTOGEL 25 MG TRANSDERMAL GEL IN SACHET will be referred to as “this medicine” throughout this leaflet. TESTOGEL 25 MG TRANSDERMAL GEL IN SACHET Testosterone WHAT IS IN THIS LEAFLET: 1. What TESTOGEL is and what it is used for 2. What you need to know before you use TESTOGEL 3. How to use TESTOGEL 4. Possible side effects 5. How to store TESTOGEL 6. Content of the pack an other information 1. WHAT TESTOGEL 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 DO YOU NEED TO KNOW BEFORE YOU USE TESTOGEL DO NOT USE THIS MEDICINE - If you are allergic to testosterone or any of the other 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 Talk to your doctor before using this medicine : - if you are suffering from epilepsy and/or from migraine, as these conditions may be made worse - if you have high blood pressure Lestu allt skjalið
Health Products Regulatory Authority 09 October 2020 CRN009RRR Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Testogel 25 mg transdermal gel in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of 2.5 g contains 25 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 section 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 doctor 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 Lestu allt skjalið