The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16468/0005 .
TESTOGEL® 50 mg transdermal gel in sachet
TESTOGEL 50 mg transdermal gel in sachet will be referred to as “this medicine” throughout this leaflet.
1. What TESTOGEL® is and what it is used for
2. What you need to know before you use TESTOGEL®
3. How to use TESTOGEL®
4. Possible side effects
5. How to store TESTOGEL®
6. Content of the pack and other information
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:
Talk to your doctor 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 carried out in the same laboratory.
This medicine is not recommended for:
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.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
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.
In case of severe skin reactions, treatment should be reviewed and stopped if necessary.
The following may indicate you are taking too much of the product: irritability, nervousness, weight gain, frequent or prolonged erections. Report any of these to your doctor who will adjust the daily dose of this medicine.
Before starting treatment your doctor will perform a full examination. He/she will need to take blood samples on 2 visits to measure your levels of testosterone before you are given this medicine. You will have regular check-ups (at least once a year and twice a year if you are elderly or an at-risk patient) during treatment.
During close and relatively long periods of skin contact testosterone may be transferred to another person unless you cover the treated area and could result in the other person showing signs of increased testosterone such as more hair on the face and body and a deepened voice. It may cause changes in the menstrual cycle of women. Wearing clothes covering the application area or washing the application area before contact protects against such transfer.
The following precautions are recommended:
For the patient:
If you believe testosterone has been transferred to another person (man, woman or child), this person should:
You should preferably wait at least 1 hour before showering or bathing after applying this medicine.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed, but particularly oral anticoagulants (used to thin the blood), insulin or corticosteroids. These particular medicines may lead to your dose of this medicine being adjusted.
This medicine is not to be used by pregnant or breast-feeding women.
Pregnant women must avoid any contact with this medicine’s application sites. This medicine may cause the development of unwanted male characteristics in the developing baby. In the event of contact, as recommended above, wash the area of contact as soon as possible with soap and water.
If your partner becomes pregnant you must follow the advice regarding avoiding transfer of the testosterone gel.
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) which may produce a positive reaction in anti-doping tests.
This medicine contains 3.6 g alcohol (ethanol) in each sachet.
It may cause burning sensation on damaged skin.
This product is flammable until dry.
This medicine is for transdermal use by adult men only.
Always use this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure.
The recommended dose is 5g of gel (i.e. 50mg of testosterone) 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 exceeding 10 g of gel per day.
The gel must be gently spread onto clean, dry, healthy skin as a thin layer on the shoulders, arms or stomach.
After opening the sachet, the entire contents should be taken out of the sachet and applied immediately onto 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.
Seek advice from your doctor.
Do not use a double dose to make up for a forgotten individual dose.
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:
Very common side effects may be experienced by 10 people in every 100
Because of the alcohol this medicine contains, frequent applications to the skin may cause irritation and skin dryness. Moreover, acne may occur.
Common side effects (between 1 and 10 people in every 100)
This medicine may cause headaches, hair loss, development of painful, tender or enlarged breasts, changes to your prostate gland, diarrhoea, dizziness, an increase in blood pressure, changes to your mood, increase in red blood cell count haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen) identified by periodic blood tests, changes in lipid levels, skin hypersensitivity, stinging and loss of memory.
Other side effects have been observed during treatment with oral or injectable testosterone: weight gain, changes of the salt in the blood, muscular pain, nervousness, depression, hostility, breathing problem during sleep, yellowing of the skin (jaundice), changes in the results of tests that check how the liver is working seborrhoea, sex drive changes, reduction in the number of sperm, frequent or prolonged erections, blockages that may make it difficult to pass urine, water retention, hypersensitivity reactions.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected].
By reporting side effects you can help provide more information on the safety of 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 box.
TESTOGEL® 50 mg is a colourless gel presented in a 5 g sachet.
TESTOGEL® 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).
UK Marketing Authorisation Holder
Ireland Marketing Authorisation Holder
Distributed in the UK and in Ireland by
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Norway, Portugal, Spain, Sweden, The Netherlands: TESTOGEL®
For information in large print, tape, CD or Braille, telephone +44(0)203862 0920.
This leaflet was last revised in August 2022