Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Testogel 16.2mg/g gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Testosterone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 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. 2.
What you need to know before you take it
e 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 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)
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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 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 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. common-uk-ie-pl_andro16.2_cv
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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 transfer:
- 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 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
- 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 becomes pregnant you must follow the advice regarding avoiding transfer of the testosterone gel. common-uk-ie-pl_andro16.2_cv
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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. This medicine contains alcohol (ethanol) This medicine contains 0.9 g alcohol (ethanol) in each dose of 1.25 g 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. 3.
How to take it
this medicine
This medicine is for use by adult men only. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using the pump for the first time 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
Amount of Gel (g)
1 2 3 4
1.25 2.5 3.75 5.0
Quantity of Testosterone Applied to the Skin (mg) 20.25 40.5 60.75 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: common-uk-ie-pl_andro16.2_cv
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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 on 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) 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. If you use more of this medicine 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 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 common-uk-ie-pl_andro16.2_cv
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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 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) 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:
- priapism
- hepatic neoplasm common-uk-ie-pl_andro16.2_cv
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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 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: 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 it
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 pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
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What this medicine contains
- The active substance is testosterone.
- The other ingredients are Carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, purified water. What this medicine looks like and contents of the pack This medicine is a colourless gel presented in a multi-dose container with metering pump with 88 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 one, two, three or six containers. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Besins Healthcare Rue Washington 80 1050 Ixelles Belgium Manufacturer Laboratoires Besins International 13, rue Périer 92120 Montrouge France Besins Manufacturing Belgium Groot-Bijgaardenstraat 128 1620 Drogenbos Belgium Distributed in the UK by Besins Healthcare (UK) Ltd, Lion Court, 25 Procter Street London, Holborn, United Kingdom UKTel. +44(0)203862 0920 This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, France, Iceland, Luxembourg, Romania, The Netherlands, Czech Republic, Hungary: Androgel 16,2 mg/g Denmark: Androgel Germany, Ireland, United Kingdom, Spain: Testogel 16.2 mg/g Gel Finland: Androtopic 16,2 mg/g Poland: Androtop Slovenia: Androtop 20,25 mg/sprožitev gel For information in large print, tape, CD or Braille, telephone +44(0)203862 0920. This leaflet was last revised in October 2024
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Frequently asked questions about Testogel 16.2mg/g gel
How do I take Testogel 16.2mg/g gel?
Testogel 16.2mg/g gel comes as gel containing 16.2mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Testogel 16.2mg/g gel?
The active substance in Testogel 16.2mg/g gel is testosterone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Testogel 16.2mg/g gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Testogel 16.2mg/g gel without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: testosterone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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 4.4 Special warnings and precautions for use).
4.2. Posology and method of administration
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 physician 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.
For more information regarding post dose washing see section 4.4 (subsection Skin to skin transfer).
4.3. Contraindications
This medicine contraindicated:
- Hypersensitivity to the active substance or any of the excipients listed in Section 6.1
- Known or suspected prostate cancer or breast carcinoma.
4.4. Special warnings and precautions for use
This medicine should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone deficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, fatigue, reduced libido, erectile dysfunction etc.) and confirmed by two separate blood testosterone measurements. Currently, there is no consensus about age-specific testosterone reference levels. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.
Due to variability in laboratory values, all measures of testosterone for any given individual should be carried out by the same laboratory.
Prior to testosterone initiation, all patients should undergo a detailed examination in order to exclude a risk of pre-existing prostate cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum prostate specific antigen (PSA)) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial risk factors).
Androgens may accelerate the progression of sub-clinical prostate cancer and benign prostate hyperplasia.
This medicine should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of blood calcium levels is recommended in these patients.
In patients suffering from severe cardiac, hepatic or renal insufficiency, or ischaemic disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately. In addition, diuretic therapy may be required.
Testosterone may cause a rise in blood pressure and this medicine should be used with caution in men with hypertension.
Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.
Testosterone levels should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit (to detect polycythaemia), liver function tests and lipid profile.
Currently, there is no consensus about age specific testosterone reference values. It should be taken into account that physiologically testosterone serum levels are lower with increasing age.
This medicine should be used with caution in patients with epilepsy and migraine as these conditions may be aggravated.
There are published reports of increased risk of sleep apnoea in hypogonadal subjects treated with testosterone esters, especially in those with risk factors such as obesity and chronic respiratory disease.
Improved insulin sensitivity may be observed in patients treated with androgens and may require a decrease in the dose of antidiabetic medications (see section 4.5). Monitoring of the glucose level and HbA1c is advised for patients treated with androgens.
Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.
If the patient develops a severe application site reaction, treatment should be reevaluated and discontinued if necessary.
The attention of athletes should be drawn to the fact that this proprietary medicinal product contains an active substance (testosterone) that may produce a positive result in doping control tests.
With large doses of exogenous androgens, spermatogenesis may be reversibly suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Gynecomastia occasionally develops and occasionally persists in patients being treated with androgens for hypogonadism.
This medicine should not be used by women due to possibly virilising effects.
Skin to skin transfer
If no precautions are taken, testosterone gel can be transferred to other persons by close physical contact at any time after dosing, resulting in increased testosterone serum levels and possibly adverse effects (e.g. growth of facial and/or body hair, deepening of the voice, irregularities of the menstrual cycle in women and premature puberty and genital enlargement in children) in the event of repeated contact (inadvertent androgenisation).
Additional caution should be taken when using this product and in close physical contact with children as secondary transmission of testosterone through clothing cannot be excluded. Consult a physician in case of signs and symptoms in another person that may have been exposed accidentally to testosterone gel. The physician should inform the patient carefully about the risk of testosterone transfer, for instance during contact with another person including children and about safety instructions. The treating physician should give extra attention to patients with a major risk of not being able to follow these instructions in Method of Administration (see Section 4.2). It is essential to adhere to the application technique when in physical contact with another person. 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 the site again with clean clothing. In the event of a person coming into contact with this medicine, the person affected should immediately wash the affected area with soap and water.
This product contains ethanol: in neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).
Pregnant women must avoid any contact with this medicine's application sites. In case of pregnancy of a partner, the patient must pay extra attention to the precautions for use described above (also see section 4.6).
This medicine contains 0.9 g alcohol (ethanol) in each dose of 1.25 g gel.
It may cause a burning sensation on damaged skin.
This medicine contains ethanol to aid transdermal delivery and is flammable.
Care should be taken to avoid sources of heat / naked flames when administering the product, until the gel has dried on the skin.
4.5. Interaction with other medicinal products and other forms of interaction
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).
Sunscreens
Application of sunscreen or lotion does not reduce efficacy.
Washing 2 hours after application doesn't have significant effect on blood testosterone levels.
4.6. Fertility, pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
The adverse reactions listed in the table are based on post-marketing data, clinical trials and class-effects.
a. Summary of the safety profile
The most frequently observed clinical adverse drug reactions at the recommended dosage per day were skin reactions at the application site, (erythema, acne, dry skin), anxiety and asthenia.
b. Tabulated list of adverse reactions
Adverse reactions reported in clinical trials and derived from post-marketing experience via spontaneous reports or literature cases are listed below.
Adverse effects have been ranked under headings of frequency using the following
convention: very common (≥ 1/10); common (≥ 1/100; <1/10); uncommon (≥ 1/1,000;<1/100); rare (≥ 1/10,000;<1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Adverse Reaction Tabulation for Transdermal Testosterone.
MedDRA
System Organ Class
Adverse reactions – preferred term
Common
(≥ 1/100 to <1/10)
Uncommon
(≥ 1/1,000 to ≥ 1/100)
Rare
(≥ 1/10,000 to <1/1,000)
Very Rare
(<1/10,000)
Frequency not known
(cannot be estimated from the available data)
Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Hepatic Neoplasm
Prostate Cancer
Metabolism and nutrition disorders
Weight gain, electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment
Psychiatric disorders
Mood Disorders, Emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido)
Nervousness, Depression, Hostility
Nervous system disorders
Dizziness, Paraesthesia, Amnesia, Hyperaesthesia Headache
Vascular disorders
Hypertension
Malignant hypertension, Hot flushes/flushing, Phlebitis
Respiratory, thoracic and mediastinal disorders
Sleep apnoea
Gastrointestinal disorders
Diarrhoea
Oral pain, Abdominal distension
Hepatobiliary disorders
Jaundice, Liver function test abnormalities
Skin and subcutaneous tissue disorders
Alopecia Urticaria,
Acne, , Hirsutism, Rash, Dry Skin, Seborrhoea, Skin lesions, Contact dermatitis, Hair colour changes, application site hypersensitivity, application site pruritus
skin reactions2
Renal and urinary disorders
Urinary tract obstruction
Musculoskeletal and connective tissue disorders
Muscle Cramps
Reproductive system and breast disorders
Gynaecomastia1
Nipple disorder, Prostate-abnormalities, Testicular pain, Increased frequency of erections
Priapism
Libido changes, therapy with high dose of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles
General disorders and administration site conditions
Application site reaction
Pitting oedema,
Asthenia, Malaise, oedema, hypersensitivity reactions, increases the occurrences of water retention and oedema3
Investigations
Changes in laboratory tests (polycythaemia, lipids), Haematocrit increased, Haemoglobin increased, Red blood cell count increased
PSA increased
Weight gain
1. May develop and persist in patients treated for hypogonadism with testosterone
2. skin reactions, because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin
3. High dose or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ANDROGEL 16,2 mg/g prescriptionTESTOSTERONUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- AndrotopTestosteronum · skin / topical
- TestavanTestosteronum · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Testogel 16.2mg/g 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.