TESTAFORTE CREAM

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacorp (Pty) Ltd

Dosage:

50,0 mg

Pharmaceutical form:

CREAM

Composition:

EACH 1,0 ml CREAM CONTAINS TESTOSTERONE 50,0 mg

Authorization status:

Registered

Patient Information leaflet

Page 1 of 12
TESTAFORTE
(5 % w/v cream)
Approved Patient Information Leaflet
SCHEDULING STATUS
S5
TESTAFORTE (5 % _W/V _CREAM) TESTOSTERONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TESTAFORTE
•
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.
•
TestaForte 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 TestaForte is and what it is used for
2. What you need to know before you use TestaForte
3. How to use TestaForte
4. Possible side effects
5. How to store TestaForte
6. Contents of the pack and other information
1.
WHAT TESTAFORTE IS AND WHAT IT IS USED FOR
TestaForte is used to replace the body’s natural hormone
testosterone when not enough is made
by the body.
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Testosterone is a natural hormone, known as an androgen, which
controls normal sexual
development and function in men.
Testosterone is essential for the development and maintenance of the
male reproductive organs
as well as other male characteristics, such as facial and body hair
growth, deep voice, sexual
drive, muscle mass and body fat distribution.
TestaForte is a testosterone containing cream that is applied by the
patient daily to the skin. The
testosterone passes from the cream through the skin and into the
bloodstream. Absorption can be
variable between individuals.
Ask your doctor if you have any questions about why this medicine has
been prescribed for you.
Your doctor may have prescribed it for another reason.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TESTAFORTE
DO NOT USE TESTAFORTE:
•
if you are hypersensitive (allergic) to testosterone or any of the
other ingredients of TestaForte
(listed in section 6). _ _
Some of the symptoms of an allergic reaction may include:
o
shortness of breath
o
wheezing or difficulty breathing
o
swelling of the face, lips, tongue or ot

Summary of Product characteristics

TESTAFORTE
(5 % w/v cream)
Approved Professional Information
Page 1 of 19
SCHEDULING STATUS
S5
1 NAME OF THE MEDICINE
TESTAFORTE (5 % _W/V_ CREAM)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TestaForte contains 5 % _w/v _testosterone (50 mg in 1 ml or 100 mg in
2 ml).
Contains tree nut products (almond oil) and hydroxybenzoates.
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Cream.
TestaForte is a white, opaque, oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TestaForte is indicated for use as testosterone replacement therapy
for male hypogonadism
when testosterone deficiency has been confirmed by clinical features
and biochemical tests.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULT MEN (18 YEARS OLD AND ABOVE)
_APPLICATION TO THE UPPER BODY _
The recommended starting dose of TestaForte when applied to the upper
body is 2 ml of cream
(i.e., 100 mg of testosterone) applied once daily at about the same
time, preferably in the
_ _
Page 2 of 19
morning. The daily dose should be adjusted by the doctor depending on
the clinical and/or
laboratory response in individual patients, not exceeding a maximum of
4 ml of cream per day.
The adjustment of dosage should be achieved by 1 ml increments.
The application should be administered by the patient himself, onto
clean, dry, healthy skin to the
torso. The torso includes the abdomen and the sides of the body from
the waist to just below the
armpits. It is preferable to apply to areas with minimal hair and body
fat.
_APPLICATION TO THE SCROTUM _
The recommended starting dose of TestaForte when applied to the entire
scrotum is 0,5 ml of
cream (i.e., 25 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 and/or
laboratory response in individual patients, not exceeding 1 ml of
cream per day. The adjustment
of dosage should be achieved by 0,25 ml increments.
The application should be administered