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TESTOGEL 50MG GEL IN SACHET

Active substance(s): TESTOSTERONE

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5002690
5029755

TESTOGEL® 50 mg,
gel in sachet

Warning and precautions

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Take special care with TESTOGEL®
Before starting any treatment with TESTOGEL®, your testosterone deficiency
must be clearly demonstrated by clinical signs (regression of masculine
Testosterone
characteristics, reduced lean body mass, weakness or fatigue, reduced sexual
desire/drive, inability to have/maintain an erection, etc.) and confirmed by
Read all of this leaflet carefully before you start using this medicine laboratory tests carried out in the same laboratory.
because it contains important information for you.
Keep this leaflet. You may need to read it again.
TESTOGEL® is not recommended for:
If you have any further questions, ask your doctor or pharmacist.
- The treatment of male sterility or impotence,
This medicine has been prescribed for you only. Do not pass it on to others. It - Children as no clinical information is available for boys under 18 years,
may harm them, even if their signs of illness are the same as yours.
- By women because of possibly developing male characteristics.
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.
Androgens may increase the risk of an enlarged prostate gland (benign prostatic
hypertrophy) or prostate cancer. Regular examinations of the prostate gland
What is in this leaflet:
before the beginning and during therapy should be performed to follow your
1. What TESTOGEL® is and what it is used for
doctor’s recommendations.
2. What do you need to know before you use TESTOGEL®
3. How to use TESTOGEL®
If you are suffering from severe heart, liver or kidney disease, treatment with
4. Possible side effects
TESTOGEL® may cause severe complications in the form of water retention in
5. How to store TESTOGEL®
your body sometimes accompanied by (congestive) heart failure.
6. Content of the pack and other information
The following blood checks should be carried out by your doctor before and
during the treatment: testosterone blood level, full blood count.
1. What TESTOGEL® is and what it is used for
This medicine contains testosterone, a male hormone produced naturally in Tell your doctor if you have high blood pressure or if you are treated for high
the body.
blood pressure, as testosterone may cause a rise in blood pressure.
Worsening of breathing problems during sleep have been reported during
TESTOGEL® is used in adult men for testosterone replacement to treat various treatment with testosterone in some people, particularly those who are very
health problems caused by a lack of testosterone (male hypogonadism). This overweight or are already suffering from breathing difficulties.
should be confirmed by two separate blood testosterone measurements and
also include clinical symptoms such as:
If you have cancer that affects your bones, you may develop increased levels
- impotence,
of calcium in your blood or urine. TESTOGEL® may further affect these calcium
- infertility,
levels. Your doctor may wish to check these calcium levels using blood tests
- low sex drive,
during your treatment with TESTOGEL®.
- tiredness,
- depressive moods,
If you receive testosterone replacement treatment over long periods of time
- bone loss caused by low hormone levels,
you may develop an abnormal increase in the number of red blood cells in your
- regression of masculine characteristics,
blood (polycythaemia). You will need regular blood tests to check that this is
- reduced lean body mass,
not happening.
- inability to have/maintain an erection.
TESTOGEL® must be used with caution if you are suffering from epilepsy and/
or from migraine as these conditions may be made worse.
2. What do you need to know before you use 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 checkups (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 onto 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.
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.
Do not 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.
- If you are allergic to testosterone or any of the ingredients of this medicine. necessary.
This medicine may cause the development of unwanted male characteristics in
(listed in section 6).
the developing baby. In the event of contact, as recommended above, wash the
- If you are suffering from prostate cancer,
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 breast cancer.
nervousness, weight gain, frequent or prolonged erections. Report any of these
to your doctor who will adjust the daily dose of TESTOGEL®.

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If your partner becomes pregnant you must follow the advice regarding If you stop using TESTOGEL®
avoiding transfer of the testosterone gel.
You should not stop therapy with TESTOGEL® unless told to do so by your
doctor.
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
or pharmacist.
Sportsmen and women
The attention of sportsmen and women is drawn to the fact that this proprietary
4. Possible side effects
medicine contains an active substance (testosterone) which may produce a
Like
all medicines, this medicine can cause side effects, although not everybody
positive reaction in anti-doping tests.
gets them:
3. How to use TESTOGEL®
This medicine is for use by adult men only.

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

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

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box.
6. Content of the pack and other information

What TESTOGEL® contains
The active substance is testosterone. Each 5 g sachet contains 50 mg
-
testosterone.
Very common side effects may be experienced by 10 people in every 100
- The other ingredients are Carbomer 980, isopropyl myristate, ethanol 96%,
Because of the alcohol this medicine contains, frequent applications to the skin
sodium hydroxide, purified water.
may cause irritation and skin dryness. Moreover, acne may occur.

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)
with your doctor if you are not sure.
TESTOGEL® may cause headaches, hair loss, development of painful, tender
The recommended dose is 5g of gel (i.e. 50mg of testosterone) applied once or enlarged breasts, changes to your prostate gland, diarrhoea, dizziness, an
increase in blood pressure, changes to your mood, increase in red blood cell
daily at approximately the same time, preferably in the morning.
The daily dose may be adjusted by your doctor, on an individual patient basis, count haematocrit (percentage of red blood cells in blood) and haemoglobin (the
component of red blood cells that carries oxygen) identified by periodic blood
not exceeding 10 g of gel per day.
tests, changes in lipid levels, skin hypersensitivity, stinging and loss of memory.
The gel must be gently spread onto clean, dry, healthy skin as a thin layer on
Other side effects have been observed during treatment with oral or injectable
the shoulders, arms or stomach.
testosterone: weight gain, changes of the salt in the blood, muscular pain,
After opening the sachet, the entire contents should be taken out of the sachet nervousness, depression, hostility, breathing problem during sleep, yellowing
and applied immediately onto the skin. Allow the gel to dry for at least 3-5 of the skin (jaundice), changes in the results of tests that check how the liver
minutes before dressing. Wash your hands with soap and water after applying. is working seborrhoea, sex drive changes, reduction in the number of sperm,
frequent or prolonged erections, blockages that may make it difficult to pass
Do not apply to the genital areas (penis and testes) as the high alcohol content urine, water retention, hypersensitivity reactions.
If any of the side effects gets serious, or if you notice any side effects not listed
may cause local irritation.
in this leaflet, please tell your doctor or pharmacist.

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

5. How to store TESTOGEL®

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
3, rue du Bourg l’Abbé
75003 Paris
France
Manufacturers
Laboratoires Besins International
or Besins Manufacturing Belgium
Groot Bijgaardenstraat, 128
13, rue Périer
92120 Montrouge
1620 Drogenbos
France Belgium
Distributed in the UK and in Ireland by Besins Healthcare (UK) Ltd,
35A High Street
Marlborough - SN8 1LW
United Kingdom
Tel. +44(0)1672 516885

This medicinal product is authorised in the Member States of the EEA
under the following names:
Ireland
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland,
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes Ireland, Italy, Luxemburg, Norway, Portugal, Spain, Sweden, The Netherlands,
any possible side effects not listed in this leaflet. You can also report side effects The United Kingdom: TESTOGEL®
directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353
1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@ For information in large print, tape, CD or Braille, telephone +44(0)1672
hpra.ie.
516885.
By reporting side effects you can help provide more information on the safety This leaflet was last revised in 02/2015.
of this medicine.

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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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