Assessed against UK PIL granted in February 2008

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 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 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 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)

•    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.

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

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

What Testim Gel contains

•    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.

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.

Manufacturer

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

PL No: 21828/0160

Leaflet revision date: 09.06.09

Testim® is the registered trademark of Auxilium Pharmaceuticals Inc.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 this leaflet

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

2.    Before you use Testim Gel

3.    How to use Testim Gel

4.    Possible side effects

5.    How to store Testim Gel

6.    Further 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 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.

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

2. 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 and tell your doctor

•    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.

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).

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.

Taking other medicines

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.

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.

Important information about some of the ingredients of Testim Gel

This product contains propylene glycol which may irritate your skin.

3. How to use Testim Gel

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

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.    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 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.

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. 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.

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 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 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 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)

•    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.

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

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

What Testim Gel contains

•    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.

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.

Manufacturer

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

PL No: 21828/0160

Leaflet revision date: 09.06.09

Testim® is the registered trademark of Auxilium Pharmaceuticals Inc.

Page 2 of 2