Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of this medicine is Irisel 16.2 mg/g transdermal gel (called "Irisel gel" or "this medicine" throughout this leaflet). Irisel gel contains testosterone, a male hormone produced naturally in the body. Irisel gel 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 - regression of masculine characteristics - reduced lean body mass - inability to have/maintain an erection.
o Only men can use this medicine. o Young men under the age of 18 years should not use this medicine. o This medicine should not be used by females at any age. o Do not allow women (especially women that are pregnant or breast-feeding) or children to
Do not use Irisel gel - 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). Warnings and precautions 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). 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 (polycythaemia). 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 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. Other medicines and Irisel gel 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. 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 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. Driving and using machines This medicine has no influence on the ability to drive or use machines. Sportsmen and women 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. Irisel gel contains alcohol (ethanol) 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.
- 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 Amount of gel (g) Quantity of testosterone applied to the skin (mg) 1 1.25 20.25 2 2.5 40.5 3 3.75 60.75 4 5.0 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. How to apply the gel: 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. If you use more Irisel gel than you should 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). If you forget to use Irisel gel
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 Irisel gel 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (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): • 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.
- The active substance is testosterone.
Rare (may affect up to 1 in 1000 people): • priapism • hepatic neoplasm. Very rare (may affect up to 1 in 10'000 people): • jaundice • urinary tract obstruction. Not known (frequency cannot be estimated from the available data): • 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 phosphate 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. Because of the alcohol this medicine contains, frequent applications to the skin may cause irritation and skin dryness. 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 Website 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.
- The other ingredients are carbomer 980, isopropyl myristate, ethanol, sodium hydroxide and purified water. What Irisel gel looks like and contents of the pack 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. Marketing Authorisation Holder Exeltis Healthcare S.L. Avda. de Miralcampo, 7 Pol. Ind. Miralcampo 19200-Azuqueca de Henares (Guadalajara) Spain Manufacturer LABORATORIOS LEÓN FARMA S.A., C/La Vallina, s/n, Polígono Industrial Navatejera 24193 Villaquilambre, León Spain If this leaflet is difficult to see or read or you would like it in a different format, please contact Exeltis UK. This leaflet was last revised in April 2026
Irisel 16.2 mg/g transdermal gel comes as gel containing 16.2 mg/g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Irisel 16.2 mg/g transdermal gel is testosterone.
Medicines with the same active substance include: TESTOGEL 40.5 mg, transdermal gel in sachet, TESTOGEL 50 mg, transdermal gel in sachet, Testavan 20 mg/g Transdermal gel, Testogel 16.2mg/g gel, Tostran 20mg/g transdermal gel. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Irisel 16.2 mg/g transdermal gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
This medicine is indicated in adults for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4 Special warnings and precautions for use).
Posology
Adult and elderly men
The recommended dose is two pump actuations of gel (i.e. 40.5 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding four pump actuations or 81 mg testosterone per day. The adjustment of posology should be achieved by increments of one pump actuation of gel.
The dose should be titrated based on the pre-dose morning testosterone blood levels. Steady state blood testosterone levels are reached usually by the second day of treatment with this medicine. In order to evaluate the need to adjust the testosterone dosage, blood testosterone levels should be measured in the morning before application of the product, after the steady state is reached. Testosterone blood levels should be assessed periodically to ensure that the patient is on the correct dose. The dose may be reduced if the testosterone blood levels are raised above the desired level. If the levels are low, the dosage may be increased stepwise, to a daily administration of 81 mg of testosterone (four actuations of gel) per day.
Therapy should be discontinued if the blood testosterone levels consistently exceeds the normal range at the lowest daily dose of 20.25 mg (1.25 g gel, equivalent to one pump actuation) or if blood testosterone levels in the normal range cannot be achieved with the highest dose of 81 mg (5 g gel, equivalent to four pump actuations).
Patient suffering from severe renal or hepatic insufficiency
Please see section 4.4 Special warnings and precautions for use.
Paediatric population
The safety and efficacy of this medicine in males under 18 years have not been established. No data are available.
Use in women
This medicine is not indicated for use in women.
Method of administration
Transdermal use.
Patients should be informed that other persons (including children and adults) should not come in contact with the area of the body where testosterone gel has been applied (see section 4.4.). The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms.
The gel should be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow to dry for at least 3-5 minutes before dressing.
- Wash hands thoroughly with soap and water after applying the gel
- Once the gel has dried, cover the application site(s) with clean clothing (such as a T-shirt).
After applying this medicine patients should wait at least 1 hour before showering or bathing.
Do not apply to the genital areas as the high alcohol content may cause local irritation.
To obtain a full first dose, it is necessary to prime the canister pump. To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose.
After the priming procedure, fully depress the actuator once for delivering 1.25 g of this medicine into the palm of the hand and then apply to the upper arms and shoulders.
Skin to skin contact
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.
Patients should be advised to wear clothing that covers the application site at all times to prevent accidental transfer to other persons as well as pets.
For more information regarding post dose washing see section 4.4. (subsection Skin to skin transfer). 4.2 Posology and method of administration
This medicine is contraindicated:
- hypersensitivity to the active substance or any of the excipients listed in section 6.1.
- known or suspected prostate cancer or breast carcinoma.
Oral anticoagulants
Changes in anticoagulant activity (increased effect of the oral anticoagulant by modification of hepatic synthesis of coagulation factor and competitive inhibition of plasma protein binding) increased monitoring of the prothrombin time and international normalized ratio (INR) determinations are recommended. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped.
Corticosteroids
Concomitant administration of testosterone and ACTH or corticosteroids may increase the risk of developing oedema. As a result, these medicinal products should be administered cautiously, particularly in patients suffering from cardiac, renal or hepatic disease.
Laboratory tests
Interactions with laboratory tests: androgens may decrease levels of thyroxin binding globulin, resulting in decreased T4 serum concentrations and in increased resin uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged and there is no clinical evidence of thyroid insufficiency.
Diabetic medication
Changes in insulin sensitivity, glucose tolerance, glycaemic control, blood glucose and glycosylated haemoglobin levels have been reported with androgens. In diabetic patients, antidiabetic's medication might need dose reduction (see section 4.4).
Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during (name of the product) treatment.
Concomitant use of testosterone replacement therapy and sodium-glucose co-transporter 2 (SGLT-2) inhibitors has been associated with an increased risk of erythrocytosis. Since both substances may independently elevate haematocrit levels, a cumulative effect is possible (see also section 4.4). Monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.
Sunscreens
Application of sunscreen or lotion does not reduce efficacy.
Washing 2 hours after application doesn't have significant effect on blood testosterone levels.
Fertility
Spermatogenesis may be reversibly suppressed with this medicine.
Pregnancy
This medicine is intended for use by men only.
This medicine is not indicated in pregnant or breast-feeding women.
Pregnant women must avoid any contact with this medicine (see section 4.4) because this product may have adverse virilising effects on the foetus. In the event of inadvertent skin-to-skin contact, thoroughly wash with soap and water as soon as possible
Breast-feeding
This medicine is not indicated in women who are breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed
Symptoms
Serum testosterone levels should be measured if clinical signs and symptoms indicative of overexposure to androgen are observed. Application site rash has also been reported in case reports of overdose with this medicine.
Treatment
Treatment of overdosage consists of washing the application site immediately and discontinuing treatment if advised by the treating physician
Ask anything about Irisel 16.2 mg/g transdermal gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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