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Active substance(s): TESTOSTERONE

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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.

Package Leaflet: Information for the Patient
TESTOGEL® 16.2 mg/g Gel
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- 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 only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- 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.

TESTOGEL® 16.2 mg/g must be used with caution if you are suffering from epilepsy
and/or from migraine as these conditions may worsen.
If have diabetes and use insulin to control your blood sugar levels, testosterone treatment
may affect your response to insulin and your antidiabetics’ medication might need
In case of severe skin reactions, treatment should be reviewed and stopped if necessary.
The following signs 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® 16.2 mg/g.

What is in this leaflet:
1. What TESTOGEL® 16.2 mg/g is and what it is used for
2. What do you need to know before you use TESTOGEL® 16.2 mg/g
3. How to use TESTOGEL® 16.2 mg/g
4. Possible side effects
5. How to store TESTOGEL® 16.2 mg/g
6. Contents of the pack and other information

Before starting treatment your doctor will perform a full examination. He/she will need
to take blood samples on two 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.
TESTOGEL® 16.2 mg/g should not be used by women due to possible virilising effects
(such as growth of facial or body hair, deepening of the voice or changes in the
menstrual cycle).

This medicine contains testosterone, a male hormone produced naturally in the body.
TESTOGEL® 16.2 mg/g is used in adult men for testosterone replacement to treat
various health problems caused by a lack of testosterone (male hypogonadism). This
should be confirmed by two separate blood testosterone measurements and also
include clinical symptoms such as:
- impotence
- infertility
- low sex drive
- tiredness
- depressive moods
- bone loss caused by low hormone levels
Do not use TESTOGEL® 16.2 mg/g
- if you have or are suspected of having prostate cancer
- if you have or are suspected of having breast cancer
- if you are allergic to testosterone or any of the other ingredients of this medicine (listed
in section 6)

Sportsmen and women
The attention of sportsmen and women is drawn to the fact that this proprietary medicine
contains an active substance (testosterone) that may produce a positive result in doping
control tests.
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, premature
puberty and genital enlargement in children. Wearing clothes covering the application
area or showering before contact protects against such transfer.

Talk to your doctor or pharmacist before using TESTOGEL® 16.2 mg/g.

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 or if not possible wear clothing such as a shirt
or a T-shirt covering the application site during the contact period
- wear clothing (such as a sleeved shirt) covering the application site during contact
periods with children

Before starting any treatment with TESTOGEL® 16.2 mg/g, 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.

If you believe testosterone has been transferred to another person (woman or child)
- wash the area of skin that 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

If you are arranging for testing of blood samples while using TESTOGEL® 16.2 mg/g you
must ensure that all testosterone measurements are performed in the same laboratory,
because of the variability in analytical values among diagnostic laboratories.

You should preferably wait at least 2 hours between applying the gel and taking a bath
or shower. If you occasionally need to bath or shower between 2 and 6 hours after
applying the gel it should not significantly change the effects of your treatment.

TESTOGEL® 16.2 mg/g is not recommended for:
- the treatment of male sterility or impotence
- children, as no clinical information is available for boys under 18 years

In order to improve the safety of your partner you should wash the area with soap for
instance during a shower before having sexual intercourse or, if not possible, wear a
T-shirt that covers the application site at the time of contact.

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

You should wear a T-shirt that covers the application site when in contact with children
in order to avoid the risk of transferring the gel to the child’s skin.

Warnings and precautions


If you are suffering from severe heart, liver or kidney disease, treatment with TESTOGEL
16.2 mg/g may cause severe complications in the form of water retention in your body,
sometimes accompanied by congestive heart failure (fluid overload in the heart).

Other medicines and TESTOGEL® 16.2 mg/g
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, particularly the following:
- oral anticoagulants (used to thin the blood)
- corticosteroids

The following blood checks should be carried out by your doctor before and during the
treatment: testosterone blood level, full blood count.

These particular medicines may lead to your dose of TESTOGEL® 16.2 mg/g being

Tell your doctor if you have high blood pressure or if you are treated for high blood
pressure, as testosterone may cause a rise in blood pressure. TESTOGEL® 16.2 mg/g
should therefore be used with caution if you are suffering from high blood pressure.

Pregnancy, breast-feeding and fertility
TESTOGEL® 16.2 mg/g is not to be used by pregnant or breast-feeding women.
Pregnant women must avoid any contact with the TESTOGEL® 16.2 mg/g
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 you have cancer that affects your bones, you may develop increased levels of calcium
in your blood or urine. TESTOGEL® 16.2 mg/g may further affect these calcium levels.
Your doctor may wish to check these calcium levels using blood tests during your
treatment with TESTOGEL® 16.2 mg/g.

If your partner becomes pregnant you must follow the advice regarding
avoiding transfer of the testosterone gel.


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.

Spermatozoid production may be reversibly suppressed with TESTOGEL® 16.2 mg/g.

Driving and using machines
TESTOGEL® 16.2 mg/g has no influence on the ability to drive or use machines.

inflammation of the veins, diarrhoea, bloated stomach, pain in the mouth, development
of breasts, tender nipples, pain in the testicles, fluid retention.

This medicine is for use by adult men only.

Other side effects have been observed during treatment with TESTOGEL® 16.2 mg/g :
tiredness, depression, anxiety, headache, dizziness, tingling skin, blood clots, difficulty
breathing, feeling sick, sweating, abnormal body hair growth, muscle or bone pain,
difficulty passing urine, reduced number of sperm, muscle weakness, feeling unwell,
weight gain.

Always use this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Using the pump for the first time
Before using your new pump for the first time, you need to prepare it for use as follows:
- Remove the cap from the canister to reveal the plunger
- Remove the stopper from the spout
- Press the plunger down three times
- Do not use the gel from these three depressions of the plunger. This dose should be
safely discarded.
- Your pump is now ready to use. You will not need to prime it again
- Each time the plunger is depressed it delivers 1.25 g of gel

Because of the alcohol this medicine contains, frequent applications to the skin may
cause irritation and skin dryness.

The recommended dose is 2.5 g of gel (i.e. 40.5 mg of testosterone) applied once
daily at approximately the same time each day, preferably in the morning. To obtain
2.5 g of gel the plunger should be depressed twice. The dose may be adjusted by your
doctor, and the maximum dose is 5 g of gel per day (no more than four depressions
of the plunger).

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.
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:; E-mail:

Your doctor will tell you how many depressions of the plunger to make to get the correct
dose of gel for you. The table below gives you more information on this.

By reporting side effects you can help provide more information on the safety
of this medicine.

Number of

Amount of Gel

Quantity of Testosterone
Applied to the Skin (mg)

The gel must be gently spread onto clean, dry, healthy skin as a thin layer on both
shoulders and upper arms. Do not rub it into 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.

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 stated on the labelling after EXP.
What TESTOGEL® 16.2 mg/g contains
- The active substance is testosterone.
- The other ingredients are Carbomer 980, isopropyl myristate, ethanol 96%, sodium
hydroxide, purified water.
What TESTOGEL® 16.2 mg/g looks like and contents of the pack
TESTOGEL® 16.2 mg/g is a colourless gel presented in a multi-dose container with
metering pump with 88 g gel and delivers a minimum of 60 doses.
One gram of gel contains 16.2 mg testosterone. One pump actuation delivers 1.25 g
of gel containing 20.25 mg of testosterone.
TESTOGEL® 16.2 mg/g is available in packs containing one, two, three or six
containers. Not all pack sizes may be marketed.

If you use more TESTOGEL 16.2 mg/g than you should
Seek advice from your doctor or pharmacist. Treatment of overdose would consist of
discontinuation of TESTOGEL® 16.2 mg/g together with appropriate symptomatic and
supportive care.

If you forget to use TESTOGEL® 16.2 mg/g
Do not use a double dose to make up for a forgotten individual dose. Apply the next
dose at the usual time.
If you stop using TESTOGEL® 16.2 mg/g
You should not stop therapy with TESTOGEL® 16.2 mg/g unless told to do so by your
If you have any further questions on the use of this medicine, ask your doctor or
Like all medicines, this medicine can cause side effects, although not everybody gets

Uncommon side effects (may affect up to 1 in 100 people)
TESTOGEL® 16.2 mg/g may cause an increase in blood pressure, flushing,

Manufacturer (UK and Ireland)
Laboratoires Besins International
13, rue Périer
92120 Montrouge

Besins Manufacturing Belgium
Groot-Bijgaardenstraat 128
1620 Drogenbos

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:
Austria, Belgium, France, Iceland, Italy, Luxembourg, Romania, Spain, The Netherlands,
Czech Republic, Hungary: Androgel 16,2 mg/g
Denmark: Androgel
Germany, Ireland, United Kingdom: Testogel 16.2 mg/g
Finland: Androtopic 16,2 mg/g
Poland: Androtop
Slovenia: Androtop 20,25 mg/sprožitev gel

Common side effects (may affect up to 1 in 10 people)
TESTOGEL® 16.2 mg/g may cause changes to your mood (including mood swings,
anger or aggression, impatience, sleeplessness, abnormal dreams and increased
sex drive) and skin reactions (including acne, hair loss, dry skin, skin irritation, hair
colour changes, rash and sensitive skin), increase in red blood cell count, haematocrit
(percentage of red blood cells in blood) and haemoglobin (the component of red blood
cells that carries oxygen), identified by periodic blood tests and changes to the prostate
gland (including increased blood levels of a protein called prostate specific antigen that
is produced by the prostate).

Marketing Authorisation Holder and Manufacturer
Ireland Marketing Authorisation Holder
UK Marketing Authorisation Holder
Laboratoires Besins International
Besins Healthcare
3 rue du Bourg l’Abbe
Avenue Louise 287
75003 Paris
1050 Brussels

For information in large print, tape, CD or Braille, telephone
+44(0)1672 516885.
This leaflet was last revised in May 2016.

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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.