TESTOGEL

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Medi Challenge (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

GEL

Composition:

None

Authorization status:

Registered

Patient Information leaflet

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APPROVED PATIENT INFORMATION LEAFLET FOR TESTOGEL
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 5
TESTOGEL
50 MG TRANSDERMAL GEL PER 5 G SACHET
TESTOSTERONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING TESTOGEL.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
TESTOGEL has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
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.
Contents of the pack and other information
1.
WHAT TESTOGEL IS AND WHAT IT IS USED FOR
TESTOGEL contains testosterone, which is a male hormone.
TESTOGEL is used to replace testosterone when the body is unable to
produce enough on its own.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOGEL
DO NOT USE TESTOGEL:
•
If you are hypersensitive (allergic) to testosterone or any of the
other ingredients of TESTOGEL
(listed in section 6).
•
If you have or suspect you have prostate cancer.
•
If you have or suspect you have breast cancer.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH TESTOGEL:
•
TESTOGEL IS ONLY APPROVED FOR MEN WHO HAVE LOW LEVELS OF TESTOSTERONE
RELATED TO
CERTAIN MEDICAL CONDITIONS. EXAMPLES OF THESE CONDITIONS INCLUDE
GENETIC PROBLEMS, AND
CHEMOTHERAPY OR INFECTIONS THAT HAVE DAMAGED THE TESTICLES.
•
TESTOGEL IS NOT INDICATED FOR USE IN MEN WHO HAVE LOW TESTOSTERONE
LEVELS DUE TO THEIR
AGE. TESTOSTERONE LEVELS CAN DECREASE NATURALLY AS MEN AGE, AND
SOMETIMES THESE LEVELS
CAN BECOME LOWER THAN THE NORMAL RANGE SEEN IN YOUNG, HEALTHY MEN.
AGEING MEN CAN
ALSO EXPERIENCE SIGNS AND SYMPTOMS SUCH AS DECREASES IN ENERGY LEVEL
AND PROBLEMS
WITH SEXUAL FUNCTION, BUT IT IS UNCERTAIN WHETHER THESE ARE CAUSED B

Summary of Product characteristics

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APPROVED PROFESSIONAL INFORMATION FOR TESTOGEL
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
TESTOGEL, 50 mg/5 g, transdermal gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of 5 g contains 50 mg of testosterone.
Excipients with known effect: Ethanol 96 % _v/v._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal gel.
A transparent or slightly opalescent, colourless gel in a sachet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism in adult men
when testosterone deficiency
has been confirmed by clinical features and biochemical tests (see
section 4.4).
TESTOGEL is not for use in children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_Adults 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 adjustment of posology should be achieved in steps of 2,5 g of
gel.
Steady state plasma testosterone concentrations are reached
approximately on the 2
nd
day of
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treatment with TESTOGEL.
In order to adjust the TESTOGEL dose, serum testosterone
concentrations must be measured in the
morning before application, from the 3
rd
day after starting treatment (one week is 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, but not
exceeding 10 g of gel per day.
_Children _
TESTOGEL is not indicated for use in children.
_METHOD OF ADMINISTRATION _
Transdermal use.
The application should be administered by the patient himself, onto
clean, dry, healthy skin over both
shoulders, both arms or abdomen.
After opening the sachets, the total contents must be extracted from
the sachet and applied
immediately onto the skin. TESTOGEL should be gently spread on the
skin, as a thin layer. It is not
necessary to rub it on the skin. Allow drying for at least 3 – 5
minute