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TESTOGEL 16.2 MG/G GEL

Active substance(s): TESTOSTERONE / TESTOSTERONE

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Package Leaflet: Information for the Patient
TESTOGEL® 16.2 mg/g Gel
Testosterone
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.
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
1. WHAT TESTOGEL® 16.2 MG/G IS AND WHAT IT IS
USED FOR
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
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
TESTOGEL® 16.2 MG/G
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)
Warnings and precautions
Talk to your doctor or pharmacist before using TESTOGEL® 16.2
mg/g.
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 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.
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
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® 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).
The following blood checks should be carried out by your doctor
before and during the treatment: testosterone blood level, full
blood count.
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.
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®
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 you receive testosterone replacement treatment over long
periods of time you may develop an abnormal increase in the

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number of red blood cells in your blood (polycythaemia). You
will need regular blood tests to check that this is not happening.
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 adjustment.
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.
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).
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.
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
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
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.
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.
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.
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
These particular medicines may lead to your dose of TESTOGEL®
16.2 mg/g being adjusted.
Pregnancy, breast-feeding and fertility
TESTOGEL® 16.2 mg/g is not to be used by pregnant or breastfeeding 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 your partner becomes pregnant you must follow the advice
regarding avoiding transfer of the testosterone gel.
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.

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3. HOW TO USE TESTOGEL® 16.2 MG/G
This medicine is for use by adult men only.

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

Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

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
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.

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
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).
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.
Number of
Depressions
1
2
3
4

Amount of Gel
(g)
1.25
2.5
3.75
5.0

Quantity of Testosterone
Applied to the Skin (mg)
20.25
40.5
60.75
81.0

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.

By reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE TESTOGEL® 16.2 MG/G
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
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6. CONTENTS OF THE PACK AND OTHER INFORMATION
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 multidose 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.
Marketing Authorisation Holder and Manufacturer
UK Marketing Authorisation Holder
Besins Healthcare
Avenue Louise 287
1050 Brussels
Belgium

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 doctor.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them:
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).
Uncommon side effects (may affect up to 1 in 100
people)
TESTOGEL® 16.2 mg/g may cause an increase in blood
pressure, flushing, inflammation of the veins, diarrhoea, bloated
stomach, pain in the mouth, development of breasts, tender
nipples, pain in the testicles, fluid retention.
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.

Ireland Marketing Authorisation Holder
Laboratoires Besins International
3 rue du Bourg l’Abbe
75003 Paris
France
Manufacturer (UK and Ireland)
Laboratoires Besins International
13, rue Périer
92120 Montrouge
France
Besins Manufacturing Belgium
Groot-Bijgaardenstraat 128
1620 Drogenbos
Belgium
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, 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
For information in large print, tape, CD or Braille, telephone
+44(0)203862 0920.
This leaflet was last revised in Aug 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.

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