Testogel 40.5 mg transdermal gel in sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Testosterone

Available from:

Laboratoires Besins International

ATC code:

G03B; G03BA03

INN (International Name):

Testosterone

Pharmaceutical form:

Transdermal gel in sachet

Therapeutic area:

ANDROGENS; testosterone

Authorization status:

Marketed

Authorization date:

2022-07-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TESTOGEL® 40.5 MG TRANSDERMAL GEL IN SACHET
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® 40.5 mg transdermal gel in sachet
will be referred to as “this medicine” throughout this
leaflet.
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 and 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
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL®
WHO CAN USE TESTOGEL®
-
Only men can use
TESTOGEL®
-
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®
gel or the areas of skin where TESTOGEL®
has been
applied.
DO NOT USE THIS MEDICINE
-
if you have or are suspected of having prostate cancer
-
if you have or are suspect

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2022
CRN00CT81
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Testogel 40.5 mg transdermal gel in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of 2.5 g contains 40.5 mg of testosterone.
Excipients with known effect: TESTOGEL 40.5 mg contains 1.81 g alcohol
(ethanol) in each sachet of 2.5 g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal gel in sachet.
Transparent or slightly opalescent, colourless gel in sachet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TESTOGEL 40.5 mg transdermal gel in sachet 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_
Each sachet provides a dose of 2.5 g of gel (i.e. 40.5 mg of
testosterone). The entire contents of one sachet should be applied
once daily at about the same time, preferably in the morning. The
daily dose should be adjusted up or down by the physician
depending on the clinical or laboratory response in individual
patients,not exceeding 81 mg of testosterone per day (2 sachets
i.e. 5 g of gel). The adjustment of posology should be achieved by
approximately 1.25 g of gel (half sachet) steps.
Steady state plasma testosterone concentrations are reached
approximately on the 2nd day of treatment with TESTOGEL 40.5
mg. 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).
_Patient suffering from severe renal or hepatic insufficiency_
Please see section 4.4 Special warnings and precautions for use.
_Paediatric population_
The safety and efficacy of TESTOGEL 40.5 mg in males under 18 years
have not been established.
No data are available.
Method of administ