TESTOGEL 50MG GEL IN SACHET

Active substance: TESTOSTERONE

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TESTOGEL 50 mg,
gel in sachet
®

Testosterone
Read all of this leaflet carefully before you start using this
medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What TESTOGEL is and what it is used for
2. Before you use TESTOGEL
3. How to use TESTOGEL
4. Possible side effects
5. How to store TESTOGEL
6. Further information

1. What TESTOGEL is and what it is used for
This medicine contains testosterone, a male hormone produced
naturally in the body.
It is a hormone treatment in men used for problems related to
testosterone deficiency as described in Section 2 (Take special
care …).

2. Before you use TESTOGEL
Do not use TESTOGEL
– If you are allergic to testosterone or to any of the ingredients
of the gel,
– If you are suffering from prostate cancer,
– If you are suffering from breast cancer.

Take special care with TESTOGEL
Before starting any treatment with TESTOGEL, your testosterone
deficiency must be clearly demonstrated by clinical signs
(regression of masculine characteristics, reduced lean body mass,
weakness or fatigue, reduced sexual desire/drive, inability to
have/maintain an erection, etc.) and confirmed by laboratory
tests carried out in the same laboratory.
TESTOGEL is not recommended for:
– The treatment of male sterility or impotence,
– Children as no clinical information is available for boys under
18 years,
– By women because of possibly developing male
characteristics.
Androgens may increase the risk of an enlarged prostate gland
(benign prostatic hypertrophy) or prostate cancer. Regular
examinations of the prostate gland before the beginning and
during therapy should be performed to follow your doctor‘s
recommendations.
If you are suffering from severe heart, liver or kidney disease,
treatment with TESTOGEL may cause severe complications in the
form of water retention in your body sometimes accompanied by
congestive heart failure (fluid overload in the heart).
Testosterone may cause a rise in blood pressure. TESTOGEL should
therefore be used with caution if you are suffering from high
blood pressure.
Worsening of breathing problems during sleep have been
reported during treatment with testosterone in some people,
particularly those who are very overweight or are already
suffering from breathing difficulties.
If you have cancer that affects your bones, you may develop
increased levels of calcium in your blood or urine. TESTOGEL may
further affect these calcium levels. Your doctor may wish to check
these calcium levels using blood tests during your treatment with
TESTOGEL.
If you receive testosterone replacement treatment over long
periods of time you may develop an abnormal increase in the
number of red blood cells in your blood (polycythaemia). You will
need regular blood tests to check that this is not happening.
TESTOGEL must be used with caution if you are suffering from
epilepsy and/or from migraine as these conditions may be made
worse.
In case of severe skin reactions, treatment should be reviewed
and stopped if necessary.
The following may indicate you are taking too much of the
product: irritability, nervousness, weight gain, frequent or
prolonged erections. Report any of these to your doctor who will
adjust the daily dose of TESTOGEL.

Before starting treatment your doctor will perform a full
examination. He/she will need to take blood samples on 2 visits
to measure your levels of testosterone before you are given this
medicine. You will have regular check-ups (at least once a year
and twice a year if you are elderly or an at risk patient) during
treatment.
Possible transfer of testosterone
During close and relatively long periods of skin contact
testosterone may be transferred to another person unless you
cover the treated area. This could cause your partner to show the
signs of increased testosterone such as more hair on the face and
body and a deepened voice. It may cause changes in the
menstrual cycle of women. Wearing clothes covering the
application area or showering before contact protects against
such transfer.
The following precautions are recommended:
* wash your hands with soap and water after applying the gel,
* cover the application area with clothing once the gel has
dried,
* take a shower before intimate contact.
If you believe testosterone has been transferred to another person
(woman or child)
* wash the area of skin which may have been affected
immediately with soap and water,
* report any signs such as acne or changes in the growth or
pattern of hair on your body or face to your doctor.
To make sure no-one else is accidentally put at risk you should
leave a long period of time between applying TESTOGEL and
making contact. You should also either wear a T-shirt during
times of close contact to cover the area where TESTOGEL has been
applied or bathe or shower before making contact.
You should preferably wait at least 6 hours between applying the
gel and taking a bath or shower. If you occasionally need to
bathe or shower between 1 and 6 hours after applying the gel it
should not significantly change the effects of your treatment.
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, even those not prescribed,
but particularly oral anticoagulants (used to thin the blood),
insulin or corticosteroids. These particular medicines may lead to
your dose of TESTOGEL being adjusted.
Pregnancy and breast-feeding
TESTOGEL is not to be used by pregnant or breast-feeding women.

Pregnant women must avoid any contact with the TESTOGEL
application sites. This medicine may cause the development of
unwanted male characteristics in the developing baby. In the
event of contact, as recommended above, wash the area of
contact as soon as possible with soap and water.
If your partner becomes pregnant you must follow the advice
regarding avoiding transfer of the testosterone gel.
Driving and using machines
TESTOGEL has no influence on the ability to drive or use
machines.
Sportsmen and women
The attention of sportsmen and women is drawn to the fact that
this proprietary medicine contains an active substance
(testosterone) which may produce a positive reaction in antidoping tests.

3. How to use TESTOGEL
This medicine is for use by adult men only.
Always use TESTOGEL exactly as your doctor has told you. you
should check with your doctor if you are not sure.
The recommended dose is 5g of gel (i.e. 50mg of testosterone)
applied once daily at approximately the same time, preferably
in the morning.
The daily dose may be adjusted by your doctor, on an individual
patient basis, not exceeding 10 g of gel per day.
The gel must be gently spread onto clean, dry, healthy skin as
a thin layer on the shoulders, arms or stomach.
After opening the sachet, the entire contents should be taken
out of the sachet and applied immediately onto the skin. Allow
the gel to dry for at least 3-5 minutes before dressing. Wash your
hands with soap and water after applying.
Do not apply to the genital areas (penis and testes) as the high
alcohol content may cause local irritation.

If you use more TESTOGEL than you should
Seek advice from your doctor.
If you forget to use TESTOGEL
Do not use a double dose to make up for a forgotten individual
dose.
If you stop using TESTOGEL
You should not stop therapy with TESTOGEL unless told to do so
by your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, TESTOGEL can cause side effects, although not
everybody gets them:
Very common side effects may be experienced by 10 people in
every 100
Because of the alcohol this medicine contains, frequent
applications to the skin may cause irritation and skin dryness.
Moreover, acne may occur.
Common side effects (between 1 and 10 people in every 100)
TESTOGEL may cause headaches, hair loss, development of
painful, tender or enlarged breasts, changes to your prostate
gland, diarrhoea, dizziness, an increase in blood pressure,
changes to your mood, changes in laboratory test results
(increase in the number of red blood cells in the blood, lipids),
skin hypersensitivity, stinging and loss of memory.
Other side effects have been observed during treatment with oral
or injectable testosterone: weight gain, changes of the salt in the
blood, muscular pain, nervousness, depression, hostility,
breathing problem during sleep, yellowing of the skin (jaundice),
changes in the results of tests that check how the liver is
working, seborrhoea, sex drive changes, reduction in the number
of sperm, frequent or prolonged erections, blockages that may
make it difficult to pass urine, water retention, hypersensitivity
reactions.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. How to store TESTOGEL
This medicinal product does not require any special storage
conditions.
Keep out of the reach and sight of children.
Do not use TESTOGEL after the expiry date which is stated on the
box.

6. Further information
What TESTOGEL contains
– The active substance is testosterone. Each 5 g sachet contains
50 mg testosterone.
– The other ingredients are Carbomer 980, isopropyl myristate,
ethanol 96%, sodium hydroxide, purified water.
What TESTOGEL looks like
TESTOGEL 50 mg is a colourless gel presented in a 5 g sachet.
TESTOGEL is available in boxes of 1, 2, 7, 10, 14, 28, 30, 50, 60,
90 or 100 sachets (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Besins International
3, rue du Bourg l’Abbé
75003 Paris
France
Distributed in the UK by:
Bayer plc
Bayer House, Strawberry Hill, Newbury,
Berkshire RG14 1JA
Manufacturers
Laboratoires Besins International
13, rue Périer
92120 Montrouge
France
or
Besins Manufacturing Belgium
Groot Bijgaardenstraat, 128
1620 Drogenbos
Belgium
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany,
Greece, Iceland, Ireland, Italy, Luxemburg, Norway, Portugal,
Spain, Sweden, The Netherlands, The United Kingdom: TESTOGEL
This leaflet was last approved in January 2008.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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