Testogel 16.2 mg/g, gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Testosterone

Available from:

Laboratoires Besins International

ATC code:

G03BA; G03BA03

INN (International Name):

Testosterone

Dosage:

16.2 milligram(s)/gram

Pharmaceutical form:

Gel

Administration route:

external use

Units in package:

packs of 1, 2, 3 or 6 containers

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Laboratoires Besins International

Therapeutic group:

Androgens.

Therapeutic area:

3-oxoandrosten (4) derivatives; testosterone

Therapeutic indications:

Testogel 16.2 mg/g is indicated in adults as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests

Authorization status:

Marketed

Authorization date:

2015-12-11

Patient Information leaflet

common-uk-ie-pl_andro16.2_cv
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TESTOGEL
® 16.2 MG/G 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 16.2mg/g Gel will be referred to as “this medicine”
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What TESTOGEL
®
16.2 mg/g Gel is and what it is used for
2.
What do you need to know before you use TESTOGEL
®
16.2 mg/g Gel
3.
How to use TESTOGEL
®
16.2 mg/g Gel
4.
Possible side effects
5.
How to store TESTOGEL
®
16.2 mg/g Gel
6.
Contents of the pack and other information
1.
WHAT TESTOGEL
® 16.2 MG/G 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
DO NOT USE THIS MEDICINE
-
if you have or are suspected of having prostate cancer
-
if you have or are suspected of having breast cancer
-
if you are allergic to testosterone or any of the other ingredients of
this medicine (listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine.
Before starting any treatment with this medicine, your testostero

Summary of Product characteristics

Health Products Regulatory Authority
04 June 2021
CRN009R2C
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Testogel 16.2 mg/g, 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: Ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
Transparent or slightly opalescent, colourless gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testogel 16.2 mg/g 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.
Therapy should be discontinued if the blood testosterone