Testogel 50 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:

G03BA; G03BA03

INN (International Name):

Testosterone

Dosage:

50 milligram(s)

Pharmaceutical form:

Transdermal gel in sachet

Prescription type:

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

Therapeutic area:

3-oxoandrosten (4) derivatives; testosterone

Authorization status:

Marketed

Authorization date:

2003-06-03

Patient Information leaflet

TESTOGEL® 50 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 50 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,
- regression of masculine characteristics,
- reduced lean body mass,
- inability to have/maintain an erection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL
®
DO NOT USE THIS MEDICINE
- If you are allergic to testosterone or to any of the ingredients of
this medicine. (listed in
section 6),
- If you are suffering from prostate cancer,
- If you are suffering from breast cancer.
WARNINGS 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

Summary of Product characteristics

Health Products Regulatory Authority
09 October 2020
CRN009RRR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Testogel 50 mg transdermal gel in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of 5 g contains 50 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 both