Irisel 16.2 mg/g transdermal gel

• 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.

1. What Irisel gel is and what it is used for
2. What you need to know before you use Irisel gel
3. How to use Irisel gel
4. Possible side effects
5. How to store Irisel gel
6. Contents of the pack and other information

• Only men can use this medicine.
• Young men under the age of 18 years should not use this medicine.
• This medicine should not be used by females at any age.
• Do not allow women (especially women that are pregnant or breast-feeding) or children to come into contact with this medicine or the areas of skin where this medicine has been applied.

• 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).

Talk to your doctor or pharmacist before using this medicine.

Before starting any treatment with this medicine, 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. Your doctor will do the necessary tests before you can use this medicine and do follow-up checks by carrying out periodic blood tests.

If any of the below apply to you (or you are not sure), talk to your doctor before using this medicine as using this medicine may make these conditions worse.

• You have difficulty in passing water (urinating) due to an enlarged prostate gland.
• You have high blood pressure, or if you are treated for high blood pressure, as this medicine may cause a rise in blood pressure.
• You have bone cancer – your doctor will check your calcium levels.
• You have severe heart, liver or kidney disease, as treatment with this medicine may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure (fluid overload in the heart).
• You have ischaemic heart disease (which affects the supply of blood to the heart).
• Blood clotting problems:
  • (thrombophilia an abnormality of blood coagulation that increases the risk of thrombosis, blood clots in blood vessels)
  • factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
  • how to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.
• You have epilepsy.
• You have migraines.
• You have breathing difficulties when you sleep -these are more likely to happen if you are overweight or have long term lung problems.

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 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.

This medicine 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).

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

You will have regular check-ups (at least once a year and twice a year if you are elderly or if your doctor considers you as a risk patient) during treatment.

If you receive testosterone replacement treatment over long periods of time you may develop an abnormal increase in the number of red blood cells in your blood (polycythaemia). You will need regular blood tests to check that this is not happening.

This medicine is not recommended for children, as no clinical information is available for boys under 18 years.

During repeated or prolonged periods of physical contact, this medicine may be transferred to another person. This may cause side-effects such as growth of facial or body hair, deepening of the voice or changes in the menstrual cycle of women, or accelerated height, genital enlargement, and early puberty (including development of pubic hair) in children.

Wearing clothes covering the application area or washing the application area before contact reduces this risk.

The following precautions are recommended to protect against accidental transfer to other persons as well as pets:

• wash your hands thoroughly with soap and water after applying the gel
• once the gel has dried, cover the application area with clothing (such as a T-shirt), after applying this medicine patients should wait at least 1 hour before showering or bathing
• shower and wash the application area(s) thoroughly with soap and water to remove any testosterone residue before any situation in which close contact is foreseen or if not possible wear clothing such as a shirt or a T-shirt covering the application site during the contact period.

Additional care should be taken by patients using this product who may be in close physical contact with children as testosterone may pass through clothing. Please make sure you follow the application technique (see section 3 of this leaflet) when in physical contact with children, including covering the application site with clean clothing once the gel has dried. Additionally, please wash the application site with soap once the recommended time period (at least 1 hour) has passed and cover again with clean clothing before physical contact with children.

If you believe testosterone has been transferred to another person (man, woman or child) this person should:

• immediately wash the area of skin onto which may have been affected with soap and water
• contact a doctor if they get signs such as acne, changes in the growth or pattern of hair on their body or face, deepening of the voice, changes in their menstrual cycle
• for children signs of early puberty and genital enlargement should also be looked out for

You should preferably wait at least 1 hour before showering or bathing after applying this medicine.

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
• medicines used to treat diabetes. It may be necessary to adjust the dose of your blood sugar reducing medicine. Like other androgens, testosterone may increase the effect of insulin. Taking SGLT-2 inhibitors (such as empagliflozin, dapagliflozin or canagliflozin) together with testosterone may increase the number of red blood cells in your blood. Your doctor may need to monitor your blood more regularly.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.

These particular medicines may lead to your dose of this medicine being adjusted.

This medicine is not to be used by women.

Sperm production may be reversibly suppressed with this medicine.

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

Pregnant women must avoid any contact with this medicine’s application sites because this product may have adverse virilising effects on the foetus. In the event of accidental skin-to-skin contact, as recommended above, thoroughly wash the area of contact as soon as possible with soap and water.

This medicine has no influence on the ability to drive or use machines.

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.

This medicine contains 0.9 g alcohol (ethanol) in each dose of 1.25 g of gel.

It may cause burning sensation on damaged skin.

Care should be taken to avoid sources of heat/naked flames when first administering the product, as ethanol is flammable until the gel has dried on the skin.

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
• 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 pumps applied once daily at approximately the same time each day, preferably in the morning. The dose may be adjusted by your doctor, and the maximum dose is 4 pumps actuations per day.

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

Amount of gel (g): 1.25

Quantity of testosterone applied to the skin (mg): 20.25

Number of depressions: 2

Amount of gel (g): 2.5

Quantity of testosterone applied to the skin (mg): 40.5

Number of depressions: 3

Amount of gel (g): 3.75

Quantity of testosterone applied to the skin (mg): 60.75

Number of depressions: 4

Amount of gel (g): 5

Quantity of testosterone applied to the skin (mg): 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.

After priming the pump as described above, the gel is now ready to be used.

The gel should be applied by the patient himself.

1. Press the plunger down once to dispense the gel into the palm of the hand.

2. Select a clean, dry and healthy skin area on the shoulder and upper arm (see marked areas in the picture below).

3. Using your fingers, gently spread the gel evenly across one shoulder and upper arm. Do not rub it into the skin.

4. If you are using 2 pumps, repeat steps 1, 2 and 3 on the other shoulder and upper arm.

5. If you are using 3 or more pumps, apply up to 2 pumps to the first shoulder and upper arm and up to 2 pumps to the other shoulder and upper arm.

6. After having applied the gel, wash your hands with soap and water.

7. You should allow the gel to dry completely before dressing.

Do not apply to the genital areas (penis and testes) as the high alcohol content may cause local irritation.

Patients should be informed that other persons (adult or child) as well as pets should not come in contact with the area of the body where the gel has been applied.

Once the gel has dried, cover the application site with clean clothing (such as a t-shirt). Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 1 hour) has passed and cover again with clean clothing.

The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms.

After applying the gel: wear clothing that covers the application site at all times to prevent accidental transfer to other persons as well as pets.

Seek advice from your doctor or pharmacist. You may be advised to wash the application site immediately and your doctor may advise you to stop treatment. The following signs may indicate you may be taking too much of the product, and you should contact your doctor:

• Irritability
• nervousness
• weight gain
• frequent or prolonged erections

These symptoms may mean that your dose of this medicine is too high and your doctor may need to adjust your dose (see Warnings and precautions, section 2).

Do not use a double dose to make up for a forgotten individual dose. Apply the next dose at the usual time.

You should not stop therapy with this medicine unless told to do so by your doctor.

• The active substance is testosterone.
• The other ingredients are carbomer 980, isopropyl myristate, ethanol, sodium hydroxide and purified water.

This medicine is a colourless gel presented in a multi-dose container with metering pump with 90 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.

This medicine is available in packs containing 1, 2, 3 or 6 containers. Not all pack sizes may be marketed.