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TESTIM 50MG TRANSDERMAL GEL

Active substance(s): TESTOSTERONE

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Package leaflet: Information for the user

The following blood checks should be carried out by your doctor before and during the
treatment: testosterone blood level, full blood count.
Testosterone treatment may accelerate the progression of pre-existing prostate cancer.
Your doctor will perform the necessary tests before starting treatment and then check by
carrying out periodic blood tests and prostate examinations.
If you are an athlete, be aware that this product may produce a positive reaction in
anti-doping tests. Testosterone must not be used to increase muscles or improve
physical strength in healthy individuals.
Children
Testim is not indicated in children.

140814

Other medicines and Testim Gel
Tell your doctor if you are using, have recently used or might use any other medicines.

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.
- 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. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Testim Gel is and what it is used for
2. What you need to know before you use Testim Gel
3. How to use Testim Gel
4. Possible side effects
5. How to store Testim Gel
6. Contents of the pack and other information

1. What Testim Gel is and what it is used for
Testim Gel is a clear gel that contains testosterone. Testosterone is a male hormone. The gel
is put on to your skin (shoulders and/or upper arms) and testosterone is absorbed into your
body through your skin. It then enters your bloodstream and helps to raise your testosterone
to normal levels. The type of testosterone delivered into your body by Testim Gel is the
same as the testosterone produced by your body.

Testim Gel may affect how these medicines work and you may need to have your doses
adjusted. This is particularly important if you are taking:
- insulin to control your blood sugar levels (in diabetes): you may need to reduce your dose
of insulin when using in combination with Testim Gel
- drugs to thin your blood (anti-coagulants): Testim Gel may increase the effects of these
drugs
- corticosteroids or drugs which may increase the production of these hormones (ACTH):
both corticosteroids and Testim Gel may cause your body to retain more water.
Other forms of interactions: laboratory test interactions. Treatment with testosterone may
alter the levels of thyroid hormones in your body. The thyroid function is not affected by
these minor changes in levels of thyroid hormones. The thyroid is a gland located in the
neck and is involved in the regulation of the body’s metabolism and growth.
Pregnancy and breast-feeding
Testim Gel is not intended for use by women.
Pregnant women should avoid skin contact with Testim Gel application sites in men as
testosterone can cause the appearance of male secondary sex characteristics in the
female foetus.
Breast-feeding women should also avoid any contact with Testim Gel application sites in
men.
If your partner is or becomes pregnant, you must follow the advice under the heading
‘How to prevent transfer of Testim Gel to someone else’ on the other side of this leaflet.
Testim Gel contains propylene glycol
This product contains propylene glycol which may irritate your skin.

3. How to use Testim Gel

Testim Gel is used to replace testosterone in men who do not produce sufficient natural
testosterone, a condition known as hypogonadism. Testosterone is made naturally in your
body in your testicles. It helps produce sperm and to develop and maintain the male sexual
characteristics such as a deep voice and body hair. It is also necessary for normal sexual
function and sex drive. Testosterone also helps to maintain muscle size and strength.

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

Testim 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

Before you start to use Testim Gel, your doctor will check that you have low testosterone
levels in your blood. Always use Testim Gel exactly as your doctor has told you. Check with
your doctor if you are not sure. Each 5 g tube contains 50 mg of testosterone. The usual
starting dose of Testim Gel is one tube of gel (5 g) each day.

Other medicines may be needed as well as Testim if you are being treated for infertility.

2. What you need to know before you use Testim Gel
Only men can use Testim Gel. Do not allow women or children to come into contact with
the areas of skin to which Testim Gel has been applied. Males under the age of 18 years
should not use this product. This product should also not be used by females of any age.
Do not use Testim Gel:
- if you have or are suspected of having prostate cancer
- if you have or are suspected of having male breast cancer (a rare condition for men)
- if you are allergic to testosterone or soy or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor before using Testim Gel
- if you have difficulty in passing water (urinating) due to an enlarged prostate gland
- if you are suffering from severe heart, liver or kidney disease, treatment with Testim Gel
may cause severe complications in the form of water retention in your body sometimes
accompanied by (congestive) heart failure
- if you have high calcium levels in your blood or urine caused by bone cancer you may
be advised by your doctor to undergo regular blood tests
- if you have high blood pressure or if you are treated for high blood pressure, as
testosterone may cause a rise in blood pressure
- if you suffer from ischaemic heart disease (a condition that affects the supply of blood
to the heart)
- if you have epilepsy
- if you suffer from migraines
- if you have breathing difficulties during sleep; these are more likely to occur if you are
overweight or have chronic lung disease
- if you have or have ever had blood clotting problems; thrombophilia (an abnormality of
blood coagulation that increases the risk of thrombosis - blood clots in blood vessels)
These conditions may be aggravated when using Testim Gel. If you have any of the above
conditions go back to your doctor to seek advice.
If you develop serious reactions on your skin where you applied the Testim Gel, go back to
your doctor to seek advice.
If you have close skin-to-skin contact, testosterone may be transferred to someone else.
For further information, please refer to section 3 (How to use).

Testim Gel is intended for transdermal use, which means application on the skin
(shoulders and/or upper arms).

Some patients may require a higher dose and your doctor may prescribe two tubes of
gel every day. The correct dose of Testim Gel that you need will be decided by regularly
measuring the levels of testosterone that are in your blood, as well as by assessing the
clinical response to Testim Gel treatment. If you have the impression that the effect of
Testim Gel is too strong or too weak, you should talk to your doctor. Signs of irritability,
nervousness, weight gain and prolonged or frequent erections may be suggestive of
excessive use.
It is important that you read and follow these directions on how to use Testim Gel properly.
Apply Testim Gel only to healthy, normal skin. Never apply Testim Gel to your genitals
(penis and testes) or to skin that is broken or damaged and avoid contact with open sores,
wounds or irritations.
1. Apply Testim Gel at the same time each day (preferably every morning).
2. Apply the contents of one (1) or two (2) tube(s) of gel on the shoulders and/or upper
arms, every morning as instructed by your doctor. If you take a bath or shower in the
morning, use Testim Gel after your bath or shower.
3. Make sure that your shoulders and/or upper arms are clean and
completely dry before putting on the gel.

4. Open the Testim Gel aluminium tube by piercing the end of the
tube with the top part of the cap.
5. Squeeze the entire contents of the tube into the palm of your hand.
Squeeze the gel out from the bottom of the tube towards the top.

6. Apply Testim Gel only to your shoulders and/or upper arms as
a thin layer. In this way your body will absorb the right amount of
testosterone.
7. Use a circular motion to rub the gel in to your skin for several
seconds. Do this until no gel is left on the skin area. This process
should be repeated with a second tube of Testim Gel by patients
who have been prescribed a daily dose of testosterone 100 mg.
It is suggested that patients who require two tubes of gel each day
use both shoulders (one tube per shoulder) and/or upper arms as
application sites.

8. Thoroughly wash your hands with soap and water immediately
after application. This will also reduce the chance that the
medicine will spread from your hands to other people.

Tell your doctor as soon as possible if you notice any of the following symptoms while
taking Testim Gel. Your doctor may decide to adjust your treatment:
- too frequent or persistent erections of the penis
- any changes in skin colour
- swelling of the ankles
- unexplained nausea (feeling sick) or vomiting
- any breathing abnormalities including those during sleep

9. Let Testim Gel dry for a few minutes before you dress. This prevents
your clothing from wiping the gel off your skin and ensures that your
body will absorb the correct amount of testosterone.

Other possible side effects
The following side effects have not been reported with Testim Gel, but may occur as with
any other testosterone treatment:
- prostate cancer
- liver problems (which may be associated with altered liver function tests and/or jaundice
(yellowing of the skin/eyes))
- prostate abnormalities (enlargement of the prostate gland, that may cause problems with
urination)
- emotional instability
- generalised pins & needles
- altered blood lipid levels
- anxiety
- decreased sexual desire
- hair loss
- skin seborrhoea (oily skin)
- increased body hair
- feeling sick
- muscle cramps

10. If you wash the application site within 6 hours after applying Testim Gel you may lower
the amount of testosterone that is absorbed by your body. Therefore, wait at least
6 hours after applying the gel before showering or swimming to ensure that the greatest
amount of Testim Gel is absorbed into your body.
Always use this medicine exactly as described in this leaflet or as your doctor has told you.
Check with your doctor if you are not sure.
How to prevent transfer of Testim Gel to someone else
It is important that you do not spread the medicine to others, especially women and
children. If you do not take appropriate precautions, you can transfer testosterone gel to
other persons by close skin-to-skin contact. This may result in increased testosterone
serum levels in the other person. If the contact is repeated or prolonged, this may cause
unwanted side effects such as the growth of facial and/or body hair, acne, deepening of
the voice or changes in the menstrual cycles of women. Similarly, children have naturally
low concentrations of testosterone and could be harmed by higher levels.
To stop the gel being transferred from your skin to someone else, the following precautions
are recommended:
- wash your hands thoroughly with soap and water after applying the gel
- cover the application site with clothing once the gel has dried
- have a bath or shower, or wear clothing to cover the gel application site (e.g. a T-shirt),
before having close skin-to-skin contact with anyone
- leave a long period of time between putting on the gel and having sex or making close
skin to skin contact with anyone.
What to do if someone else is exposed to Testim Gel
If someone else is exposed to Testim Gel either as a result of contact with the gel itself or
because of contact with the application area on your skin, the person should wash their
area of skin contact with soap and water as soon as possible. The longer that the gel is in
contact with the skin before washing, the greater the chance that the person will absorb
some testosterone. This is particularly important for women, especially pregnant or
breastfeeding women, and children.
If they develop signs such as acne or changes in the growth or pattern of hair on their face
or body, they should see their doctor.
If you use more Testim Gel than you should
If you have applied too much Testim Gel by mistake, wash the application area with soap
and water as soon as you realise. For further information about any possible side effects,
please refer to section 4 (Possible side effects).
If you forget to use Testim Gel
If you miss a dose, do not double your dose the next day to catch up. If your next dose is
less than 12 hours away, do not take the missed dose but continue with your next dose as
normal. If it is more than 12 hours until your next dose, take the dose that you have missed.
Continue as normal the following day.
If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or symptoms to look out for - and what to do if you are affected
If you have been told after a clinical examination or periodic blood test that you have
developed any of the following side effects, see a doctor immediately. Your doctor may
review or discontinue your treatment.
The following are common side effects, probably affecting up to 1 in every 10 people
taking Testim Gel:
- worsening of hypertension (increase of blood pressure above the normal range)
- increased Prostatic Specific Antigen (PSA), identified by periodic blood tests. PSA is a
protein produced by the prostate, which can be used to detect prostate disease
- 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.
If you think you have any of the following side effects, see your doctor as soon as
possible. Depending on your doctor’s decision and/or in the case of a severe reaction,
your treatment may be reviewed or discontinued.
The following are common side effects. They probably affect up to 1 in every 10 people
taking Testim Gel:
- redness, rash or other application site reaction
- acne
- headache
The following are uncommon side effects. They probably affect fewer than 1 in every 100
people taking Testim Gel:
- breast enlargement in males.
- hot flushes or flushing
- itching
- water retention
Azoospermia (no sperm count) may occur very rarely (in fewer than 1 in 10,000 people
taking Testim Gel).

In case of prolonged use or excessive dose:
- changes to salt (electrolyte) levels (such as sodium, chloride, potassium, calcium,
inorganic phosphates) in blood may clinically result in oedema (swelling), hypertension
(increase of blood pressure above the normal range) or behavioural disturbances such as
anxiety
- frequent and/or prolonged erections of the penis
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any side effects not listed in
this leaflet. You can also report side effects directly via;
UK: The Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie,
Email: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Testim Gel
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 carton and on the
bottom of each tube. The expiry date stated after EXP refers to the last day of that month.
Do not store above 25°C.
Keep the tubes of Testim Gel away from direct heat and direct sunlight as the contents are
flammable.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Testim Gel contains
- The active substance is testosterone. Each single dose container of 5 g contains
testosterone 50 mg.
- The other ingredients are ethanol, carbomers (980 and copolymer), propylene glycol,
glycerol, macrogol 1000, trometamol, pentadecalactone and purified water. The ethanol
content is approximately 74%.
What Testim Gel looks like and contents of the pack
This medicinal product is presented as a gel in a single dose container. The gel is a clear
to translucent gel. Testim Gel is provided in single dose aluminium tubes with screw caps,
each containing 5 g gel. Testim Gel is available in cartons containing 7, 14, 30 or 90 single
dose containers.
Not all pack sizes may be available in the country where it is purchased.
Marketing Authorisation Holder:
UK: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton UB7 7PS, UK.
PL 03194/0105
Ireland: Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park,
Citywest Road, Dublin 24, Ireland. PA 1009/23/1
Manufacturer:
Ferring GmbH, Wittland 11, 24109 Kiel, Germany
This leaflet was last revised in July 2017.
TESTIM, FERRING and the FERRING Logo are trademarks of Ferring B.V.

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