Land: Malta
Taal: Engels
Bron: Malta Medicines Authority
Besins Healthcare SA Avenue Louise, 287-Boite 6, 1050 Brussels, Belgium
G03BA03
TESTOSTERONE 16.2 mg/g
GEL
TESTOSTERONE 16.2 mg/g
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-07-07
Page 1 of 8 TESTOGEL 16.2 MG/G TRANDERMAL GEL Testosterone 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. _ _ _Testogel 16.2 mg/g trandermal gel_ will be referred to as “this medicine” throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Testogel 16.2 mg/g trandermal gel is and what it is used for 2. What do you need to know before you use Testogel 16.2 mg/g trandermal gel 3. How to use Testogel 16.2 mg/g trandermal gel 4. Possible side effects 5. How to store Testogel 16.2 mg/g trandermal gel 6. Contents of the pack and other information 1. WHAT TESTOGEL 16.2 MG/G TRANDERMAL GEL 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 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL 16.2 MG/G TRANDERMAL GEL WHO CAN USE TESTOGEL 16.2 MG/G TRANDERMAL GEL - Only men can use Testogel 16.2 mg/g trandermal gel. - Young men under the age of 18 years should not use this medicine. - This medicine should not be used by females of any age. - Do not allow women (especially women that are pregnant or breast-feeding) or children to come into contact with Testogel 16.2 mg/g trandermal gel gel or the areas Lees het volledige document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Testogel 16.2 mg/g transdermal gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 16.2 mg testosterone. One pump actuation delivers 1.25 g of gel containing 20.25 mg of testosterone. Excipients with known effect: This medicine contains 0.9 g alcohol (ethanol) in each dose of 1.25 g gel. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal gel Transparent or slightly opalescent, colourless gel. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications This medicine is indicated in adults as 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 two pump actuations of gel ( _i.e._ 40.5 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 four pump actuations or 81 mg testosterone per day. The adjustment of posology should be achieved by increments of one pump actuation of gel. The dose should be titrated based on the pre-dose morning testosterone blood levels. Steady state blood testosterone levels are reached usually by the second day of treatment with this medicine. In order to evaluate the need to adjust the testosterone dosage, blood testosterone levels should be measured in the morning before application of the product, after the steady state is reached. Testosterone blood levels should be assessed periodically. The dose may be reduced if the testosterone blood levels are raised above the desired level. If the levels are low, the dosage may be increased stepwise, to a daily administration of 81 mg of testosterone (four actuations of gel) per day. Page 2 of 11 Therapy should Lees het volledige document