Testogel 16.2 mg/g transdermal gel

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Besins Healthcare SA Avenue Louise, 287-Boite 6, 1050 Brussels, Belgium

ATC code:

G03BA03

INN (International Name):

TESTOSTERONE 16.2 mg/g

Pharmaceutical form:

GEL

Composition:

TESTOSTERONE 16.2 mg/g

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-07-07

Patient Information leaflet

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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
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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

Summary of Product characteristics

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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.
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Therapy should