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TESTOGEL 50MG GEL IN SACHET

Active substance(s): TESTOSTERONE

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Warning and precautions

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 checkTalk to your doctor before using TESTOGEL®:
- if you are suffering from epilepsy and/or from migraine, as these conditions ups (at least once a year and twice a year if you are elderly or an at risk patient)
during treatment.
may be made worse
Testosterone
- if you have high blood pressure or if you are treated for high blood pressure,
Possible transfer of testosterone
as testosterone may cause a rise in blood pressure
Read all of this leaflet carefully before you start using this medicine - if you are suffering from severe heart, liver or kidney disease, treatment with During close and relatively long periods of skin contact testosterone may be
because it contains important information for you.
TESTOGEL may cause severe complications in the form of water retention in 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
Keep this leaflet. You may need to read it again.
your body sometimes accompanied by (congestive) heart failure
If you have any further questions, ask your doctor or pharmacist.
- as worsening of breathing problems during sleep have been reported during hair on the face and body and a deepened voice. It may cause changes in the
This medicine has been prescribed for you only. Do not pass it on to others. It
treatment with testosterone in some people, particularly those who are very menstrual cycle of women. Wearing clothes covering the application area or
showering before contact protects against such transfer.
may harm them, even if their signs of illness are the same as yours.
overweight or are already suffering from breathing difficulties.
If you get any side effects, talk to your doctor or pharmacist.This includes - if you have cancer that affects your bones, as you may develop increased
any possible side effects not listed in this leaflet. See section 4.
levels of calcium in your blood or urine. TESTOGEL may further affect these The following precautions are recommended:
* wash your hands with soap and water after applying the gel,
calcium levels. Your doctor may wish to check these calcium levels using
* cover the application area with clothing once the gel has dried,
What is in this leaflet:
blood tests during your treatment with TESTOGEL.
* take a shower before intimate contact.
1. What TESTOGEL® is and what it is used for
- have or ever had blood clotting problems
2. What do you need to know before you use TESTOGEL®
- thrombophilia (an abnormality of blood coagulation that increases the risk of
If you believe testosterone has been transferred to another person (woman or
3. How to use TESTOGEL®
thrombosis - blood clots in blood vessels)
4. Possible side effects
Before starting any treatment with TESTOGEL®, your testosterone deficiency child)
* wash the area of skin onto which may have been affected immediately
5. How to store TESTOGEL®
must be clearly demonstrated by clinical signs (regression of masculine
with soap and water,
6. Content of the pack and other information
characteristics, reduced lean body mass, weakness or fatigue, reduced sexual
* report any signs such as acne or changes in the growth or pattern of hair
desire/drive, inability to have/maintain an erection, etc.) and confirmed by
on your body or face to your doctor.
laboratory tests carried out in the same laboratory.
1. What TESTOGEL® is and what it is used for

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TESTOGEL® 50 mg,
gel in sachet

This medicine contains testosterone, a male hormone produced naturally in TESTOGEL® is not recommended for:
the body.
- The treatment of male sterility or impotence,
- Children as no clinical information is available for boys under 18 years,
TESTOGEL® is used in adult men for testosterone replacement to treat various - By women because of possibly developing male characteristics.
health problems caused by a lack of testosterone (male hypogonadism). This
should be confirmed by two separate blood testosterone measurements and Androgens may increase the risk of an enlarged prostate gland (benign prostatic
also include clinical symptoms such as:
hypertrophy) or prostate cancer. Regular examinations of the prostate gland
- impotence,
before the beginning and during therapy should be performed to follow your
- infertility,
doctor’s recommendations.
- low sex drive,
- tiredness,
The following blood checks should be carried out by your doctor before and
- depressive moods,
during the treatment: testosterone blood level, full blood count.
- bone loss caused by low hormone levels,
- regression of masculine characteristics,
If you receive testosterone replacement treatment over long periods of time
- reduced lean body mass,
you may develop an abnormal increase in the number of red blood cells in your
- inability to have/maintain an erection.
blood (polycythaemia). You will need regular blood tests to check that this is
not happening.

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.
Other medicines and TESTOGEL®
Please tell your doctor or pharmacist if you are taking, have recently taken or
might take 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.
2. What do you need to know before you use TESTOGEL®
In case of severe skin reactions, treatment should be reviewed and stopped if Pregnant women must avoid any contact with the TESTOGEL® application sites.
Do not use TESTOGEL®
This medicine may cause the development of unwanted male characteristics in
necessary.
- If you are allergic to testosterone or any of the ingredients of this medicine.
the developing baby. In the event of contact, as recommended above, wash the
(listed in section 6).
The following may indicate you are taking too much of the product: irritability, area of contact as soon as possible with soap and water.
- If you are suffering from prostate cancer,
nervousness, weight gain, frequent or prolonged erections. Report any of these If your partner becomes pregnant you must follow the advice regarding
- If you are suffering from breast cancer.
avoiding transfer of the testosterone gel.
to your doctor who will adjust the daily dose of TESTOGEL®.

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Driving and using machines
TESTOGEL® has no influence on the ability to drive or use machines.

If you have any further questions on the use of this medicine, ask your doctor Keep this medicine out of the sight and reach of children.
or pharmacist.
Do not use this medicine after the expiry date which is stated on the box.

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Sportsmen and women
4. Possible side effects
The attention of sportsmen and women is drawn to the fact that this proprietary
Like
all medicines, this medicine can cause side effects, although not everybody 6. Content of the pack and other information
medicine contains an active substance (testosterone) which may produce a
gets them:
What TESTOGEL® contains
positive reaction in anti-doping tests.
-
The active substance is testosterone. Each 5 g sachet contains 50 mg
Very common side effects may be experienced by 10 people in every 100
testosterone.
3. How to use TESTOGEL®
Because of the alcohol this medicine contains, frequent applications to the skin - The other ingredients are Carbomer 980, isopropyl myristate, ethanol 96%,
may cause irritation and skin dryness. Moreover, acne may occur.
sodium hydroxide, purified water.
This medicine is for use by adult men only.
Always use this medicine exactly as your doctor has told you. You should check Common side effects (between 1 and 10 people in every 100)
TESTOGEL® may cause headaches, hair loss, development of painful, tender
with your doctor if you are not sure.
or enlarged breasts, changes to your prostate gland, diarrhoea, dizziness, an
The recommended dose is 5g of gel (i.e. 50mg of testosterone) applied once increase in blood pressure, changes to your mood, increase in red blood cell
count haematocrit (percentage of red blood cells in blood) and haemoglobin (the
daily at approximately the same time, preferably in the morning.
The daily dose may be adjusted by your doctor, on an individual patient basis, component of red blood cells that carries oxygen) identified by periodic blood
tests, changes in lipid levels, skin hypersensitivity, stinging and loss of memory.
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.

What TESTOGEL® looks like and content of the pack
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
Other side effects have been observed during treatment with oral or injectable 3, rue du Bourg l’Abbé
testosterone: weight gain, changes of the salt in the blood, muscular pain, 75003 Paris
nervousness, depression, hostility, breathing problem during sleep, yellowing France
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, Manufacturers
frequent or prolonged erections, blockages that may make it difficult to pass Laboratoires Besins International
or Besins Manufacturing Belgium
urine, water retention, hypersensitivity reactions.
13, rue Périer
Groot Bijgaardenstraat, 128
If any of the side effects gets serious, or if you notice any side effects not listed 92120 Montrouge
1620 Drogenbos
in this leaflet, please tell your doctor or pharmacist.
France Belgium
Reporting of side effects
United Kingdom
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

Distributed in the UK and in Ireland by
Besins Healthcare (UK) Ltd
1st Floor, 28 Poland Street
London - W1F 8QN - United Kingdom
Tel. +44(0)203862 0920
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®

If you use more TESTOGEL® than you should
Seek advice from your doctor.

Ireland
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353
1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@
hpra.ie.

If you forget to use TESTOGEL®
Do not use a double dose to make up for a forgotten individual dose.

By reporting side effects you can help provide more information on the safety
of this medicine.
This leaflet was last revised in November 2017.

For information in large print, tape, CD or Braille, telephone
+44(0)203862 0920.

5. How to store TESTOGEL®
If you stop using TESTOGEL®
This medicinal product does not require any special storage conditions.
You should not stop therapy with TESTOGEL® unless told to do so by your
doctor.

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