Testogel 40.5 mg transdermal gel in sachet – patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

This medicine contains testosterone, a male hormone produced naturally in the body. This medicine is used in adult men for testosterone replacement to treat various health pro-blems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as:

• impotence,
• infertility,
• low sex drive,
• tiredness,
• depressive moods,
• bone loss caused by low hormone levels

2. What you need to know before you use this medicine Who can use this medicine

• 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 of 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.

Do not use this medicine

• if you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6)
• if you have or are suspected of having prostate cancer
• if you have or are suspected of having breast cancer

Warnings and precautions

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.

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/main-tain 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.

Talk to your doctor or pharmacist before taking this medicine.

• you have difficulty in passing water (urinating) due to an enlarged prostate gland
• you have bone cancer – your doctor will check your calcium levels
• 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 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 hypertro-phy) or prostate cancer. Regular examinations of the prostate gland before the beginning and during therapy should be performed to follow your doctor’s recommendations. If you have diabetes and use insulin to control your blood sugar levels, testosterone treat-

ment 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). Information on additional monitoring

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 (polycythae-mia). You will need regular blood tests to check that this is not happening. Children and adolescents

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

Possible transfer of testosterone

During repeated or prolonged periods of physical contact, this medicine may be trans-ferred 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 transfer:

• wash your hands thoroughly with soap and water after applying the gel
• Once the gel has dried, cover the application area with clothing. After applying this medicine 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 re-commended time period (at least 1 hours) 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.

Other medicines and 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 (medicines used to thin the blood)
• corticosteroids (medicines used to reduce inflammation)
• insulin (medicines used to control your blood sugar levels in diabetes). You may need to reduce your dose of insulin when using this medicine.

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. Pregnancy, breast-feeding and fertility

This medicine is not to be used by women.

Sperm production may be reversibly suppressed with this medicine. If your partner is or becomes pregnant or is planning to have a baby you must follow the advice regarding avoiding transfer of the testosterone gel (see “Possible transfer of testosterone” above).

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 contact, your partner must wash the area of contact as soon as possible with soap and water. Driving and using machines

This medicine has no influence on the ability to drive or use machines. This medicine contains alcohol (ethanol)

This medicine contains 1.81 g alcohol (ethanol) in each sachet.

It may cause a 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.

3. How to use this medicine This medicine is for use by adult men only.

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.

The recommended dose is 1 sachet (i.e. 2.5g of gel which contains 40.5 mg of testoste-rone) applied once daily at approximately the same time, preferably in the morning. The daily dose may be adjusted by your doctor, on an individual patient basis, not excee-ding 2 sachets (i.e. 5 g of gel which contains 81 mg of testosterone) per day. because it contains important information for you.

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

How to apply this gel:

• The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms.
• After opening the sachet, the entire contents should be taken out of the sachet and applied immediately onto the skin.
• The gel must be gently spread onto clean, dry, healthy skin.
• Apply as a thin layer on the right and left upper arms and shoulders. 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.

Patients should be informed that other persons (adult or child) should not come in contact with the area of the body where the testosterone 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.

If you use more of this medicine than you should

Seek advice from your doctor or pharmacist. You may be advised to wash 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). If you forget to use this medicine

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

If you stop using this medicine

You should not stop therapy with this medicine unless told to do so by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them:

Common (may affect up to 1 in 10 people)

• mood disorders
• emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido)
• dizziness
• paraesthesia
• amnesia
• hyperaesthesia
• headache
• hypertension
• diarrhoea
• alopecia
• urticaria
• gynaecomastia
• application site reaction
• changes in laboratory tests (polycythaemia, lipids)
• haematocrit increased
• haemoglobin increased
• red blood cell count increased

Uncommon side effects (may affect up to 1 in 100 people)

This medicine may cause:

• malignant hypertension
• hot flushes/flushing
• phlebitis
• oral pain
• abdominal distension
• acne
• hirsutism
• rash
• dry skin
• seborrhoea
• skin lesions
• contact dermatitis
• hair colour changes
• application site hypersensitivity
• application site pruritus
• nipple disorder
• prostate-abnormalities
• testicular pain
• increased frequency of erections
• pitting oedema

• PSA increased

  Rare (may affect up to 1 in 1000 people)

  This medicine may cause:

  • hepatic neoplasm
  • priapism

Very rare (may affect up to 1 in 10’000 people)

This medicine may cause:

• jaundice
• urinary tract obstruction

Frequency not known (cannot be estimated from the available data) This medicine may cause:

• prostate cancer
• asthenia
• nervousness
• depression
• hostility
• sleep apnoea
• urinary tract obstruction
• muscle cramps
• libido changes
• therapy with high dose of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles
• malaise
• oedema
• hypersensitivity reactions
• weight gain
• electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phos-phate and water) during high dose and/or prolonged treatment
• skin reactions (because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin)
• increases the occurrences of water retention and oedema

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store This medicine

This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharma-cist 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 this medicine contains

• The active substance is testosterone. One sachet of 2.5 g contains 40.5 mg of testosterone.
• The other ingredients are Carbomer, isopropyl myristate, ethanol, sodium hydroxide, water.

What this medicine looks like and contents of the pack

This medicine is a colourless transdermal gel presented in a 2.5 g sachet. This medicine is available in boxes of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Besins Healthcare (UK) Ltd

Lion Court, 25 Procter Street

Holborn, London

WC1V 6NY

United Kingdom

Manufacturers

Laboratoires Besins International or Besins Manufacturing Belgium 13, rue Périer Groot Bijgaardenstraat, 128 92120 Montrouge 1620 Drogenbos France Belgium

Distributed in the UK by

Besins Healthcare (UK) Ltd,

Lion Court, 25 Procter Street, Holborn,

London WC1V 6NY – United Kingdom

Tel. +44(0)203862 0920

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium, Luxembourg; Testogel 40,5 mg gel transdermique en sachet Denmark Testogel (40,5 mg transdermal gel i brev)

Finland Testogel 40,5 mg/annos transdermaaligeeli, annospussi Germany TESTOGEL 40,5 mg transdermales Gel im Beutel Iceland Testogel 40,5 mg hlaup til notkunar um húð Ireland, United Kingdom; Testogel 40.5 mg transdermal gel in sachet

Netherlands Testogel 40,5 mg, gel voor transdermaal gebruik in sachet Norway Testogel 40,5 mg transdermalgel i dosepose Sweden Testogel 40,5 mg transdermal gel i dospåseBelgium, Ireland, For further information on this medicine, please contact Medical Information: UK: +44(0)203862 0920

This leaflet was last revised in October 2024.