TESTIM 50MG GEL

Active substance: TESTOSTERONE

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Assessed against UK PIL granted in February 2008
Taking other medicines

PACKAGE LEAFLET: INFORMATION FOR THE USER

Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. 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

‘beta-blocker’ drugs to reduce blood pressure, such as propranolol

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.

TESTIM® 50MG GEL
(testosterone)
Read this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

In
1.
2.
3.
4.
5.
6.

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.

this leaflet
What Testim Gel is and what it is used for
Before you use Testim Gel
How to use Testim Gel
Possible side effects
How to store Testim Gel
Further Information

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.
Important information about some of the ingredients of Testim Gel
This product contains propylene glycol which may irritate your skin.

1. What Testim Gel is and what it is used for

3. How to use Testim Gel

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

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 the 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.
Testim Gel will only be given to you if you are shown to have low testosterone levels in your
blood and clinical signs of low testosterone, which may include the following:

poor erections of the penis and/or loss of sex drive

tiredness and loss of energy

low moods (depression)

loss of muscle mass

partial loss of secondary sex characteristics, such as changes in the voice, changes in the fat
distribution and partial loss of facial and body hair.

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 5g tube contains 50mg of testosterone. The usual starting dose of Testim Gel is
one tube of gel (5g) each day. 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.
2.

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

2. Before you use Testim Gel

3.

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.

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.
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 100mg. 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.

Do not use Testim Gel and tell your doctor




Apply Testim Gel at the same time each day (preferably every morning).
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.
Make sure that your shoulders and/or upper arms are clean and
completely dry before putting on the 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 (hypersensitive) to testosterone or soy or any of the other ingredients of Testim
Gel (see section 6. Further information).

If you have any of the above conditions go back to your doctor to seek advice.

Take special care with Testim Gel and tell your doctor









if you have difficulty in passing water (urinating) due to an enlarged prostate gland
if you have serious liver, kidney or heart disease; you may develop complications such as oedema
(swelling due to fluid or water retention), with or without 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
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.

7.

The following blood checks should be carried out by your doctor before and during the treatment: full
blood count, lipid profile (level of fat in the blood) and liver function tests, as well as testosterone
blood levels.
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.

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.

9.

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).

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.

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.

Page 1 of 2

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 breast-feeding women, and children.

If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.

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 your 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, Testim Gel can have 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 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 and needles

altered blood lipid levels

anxiety

decreased sexual desire

hair loss

skin seborrhoea (oily skin)

increased body hair

feeling sick

muscle cramps.
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 due to fluid), hypertension (increase
of blood pressure above the normal range) or behavioural disturbances such as anxiety

frequent and/or prolonged erections of the penis.

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

Other possible side effects

5. How to Store Testim Gel
Keep out of the reach and sight of children.
Keep the tubes of Testim 50mg Gel away from any direct heat as the contents of each tube are
flammable.
Do not store above 25°C.
Do not use after the expiry date printed on the carton or the tube of medication. The expiry date refers
to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

Important:

If your doctor tells you to stop using the medicine or when you need to dispose of them, please take
them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the
medicine becomes discoloured or show signs of deterioration, you should seek the advice of your
pharmacist.
This leaflet does not contain complete information about your medicine. If you have any questions, or
are not sure about anything, ask your doctor or pharmacist who has access to additional information.

6. Further Information

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.


What Testim Gel contains

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.

Manufacturer

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.




What Testim Gel looks like and contents of the pack

Testim Gel is a clear to translucent gel. A full carton contains 30 tubes of 5g gel. Each 5g contains
50mg testosterone.

Manufactured by Beaufour Ipsen Industrie, Rue Ethe Virton, 28100 Dreux, France
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Parallel Import Product Licence Holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX
POM

PL No: 21828/0160

Leaflet revision date: 09.06.09
Testim® is the registered trademark of Auxilium Pharmaceuticals Inc.

Azoospermia (no sperm count) may occur very rarely (in fewer than 1 in 10, 000 people taking
Testim Gel)


The active substance in Testim Gel is testosterone.
The other ingredients in the gel are: ethanol, carbomers, propylene glycol, glycerol, macrogol
1000, trometamol, pentadecalactone and purified water.

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.

Page 2 of 2

Taking other medicines

PACKAGE LEAFLET: INFORMATION FOR THE USER

Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. 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

‘beta-blocker’ drugs to reduce blood pressure, such as propranolol

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.

TESTIM® 50MG GEL
(testosterone)
Read this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

In
1.
2.
3.
4.
5.
6.

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.

this leaflet
What Testim Gel is and what it is used for
Before you use Testim Gel
How to use Testim Gel
Possible side effects
How to store Testim Gel
Further Information

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.
Important information about some of the ingredients of Testim Gel
This product contains propylene glycol which may irritate your skin.

1. What Testim Gel is and what it is used for

3. How to use Testim Gel

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

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 the 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.
Testim Gel will only be given to you if you are shown to have low testosterone levels in your
blood and clinical signs of low testosterone, which may include the following:

poor erections of the penis and/or loss of sex drive

tiredness and loss of energy

low moods (depression)

loss of muscle mass

partial loss of secondary sex characteristics, such as changes in the voice, changes in the fat
distribution and partial loss of facial and body hair.

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 5g tube contains 50mg of testosterone. The usual starting dose of Testim Gel is
one tube of gel (5g) each day. 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.
2.

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

2. Before you use Testim Gel

3.

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.

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.
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 100mg. 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.

Do not use Testim Gel and tell your doctor




Apply Testim Gel at the same time each day (preferably every morning).
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.
Make sure that your shoulders and/or upper arms are clean and
completely dry before putting on the 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 (hypersensitive) to testosterone or soy or any of the other ingredients of Testim
Gel (see section 6. Further information).

If you have any of the above conditions go back to your doctor to seek advice.

Take special care with Testim Gel and tell your doctor









if you have difficulty in passing water (urinating) due to an enlarged prostate gland
if you have serious liver, kidney or heart disease; you may develop complications such as oedema
(swelling due to fluid or water retention), with or without 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
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.

7.

The following blood checks should be carried out by your doctor before and during the treatment: full
blood count, lipid profile (level of fat in the blood) and liver function tests, as well as testosterone
blood levels.
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.

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.

9.

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).

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.

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.

Page 1 of 2

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 breast-feeding women, and children.

If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.

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 your 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, Testim Gel can have 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 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 and needles

altered blood lipid levels

anxiety

decreased sexual desire

hair loss

skin seborrhoea (oily skin)

increased body hair

feeling sick

muscle cramps.
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 due to fluid), hypertension (increase
of blood pressure above the normal range) or behavioural disturbances such as anxiety

frequent and/or prolonged erections of the penis.

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

Other possible side effects

5. How to Store Testim Gel
Keep out of the reach and sight of children.
Keep the tubes of Testim 50mg Gel away from any direct heat as the contents of each tube are
flammable.
Do not store above 25°C.
Do not use after the expiry date printed on the carton or the tube of medication. The expiry date refers
to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

Important:

If your doctor tells you to stop using the medicine or when you need to dispose of them, please take
them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the
medicine becomes discoloured or show signs of deterioration, you should seek the advice of your
pharmacist.
This leaflet does not contain complete information about your medicine. If you have any questions, or
are not sure about anything, ask your doctor or pharmacist who has access to additional information.

6. Further Information

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.


What Testim Gel contains

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.

Manufacturer

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.




What Testim Gel looks like and contents of the pack

Testim Gel is a clear to translucent gel. A full carton contains 30 tubes of 5g gel. Each 5g contains
50mg testosterone.

Manufactured by Beaufour Ipsen Industrie, Rue Ethe Virton, 28100 Dreux, France
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Parallel Import Product Licence Holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX
POM

PL No: 21828/0160

Leaflet revision date: 09.06.09
Testim® is the registered trademark of Auxilium Pharmaceuticals Inc.

Azoospermia (no sperm count) may occur very rarely (in fewer than 1 in 10, 000 people taking
Testim Gel)


The active substance in Testim Gel is testosterone.
The other ingredients in the gel are: ethanol, carbomers, propylene glycol, glycerol, macrogol
1000, trometamol, pentadecalactone and purified water.

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.

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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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