• 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.

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

• If you are allergic to testosterone or to any of the ingredients of this medicine. (listed in section 6),
• If you are suffering from prostate cancer,
• If you are suffering from breast cancer.

Talk to your doctor before using this medicine

• if you are suffering from epilepsy and/or from migraine, as these conditions may be made worse
• if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure
• if you are suffering from severe heart, liver or kidney disease, treatment with this medicine may cause severe complications in the form of water retention in you body sometimes accompanied by (congestive) heart failure
• as worsending of breathing problems during sleep have been reported during treatment with testosterone in some people, particulalry those who are very overweight or are already suffering from breathing difficulties.
• if you have cancer that affects your bones, as you may develop increased levels of calcium in your blood or urine. This medicine may further affect these calcium levels. Your doctor may with to check these calcium levels using blood tests during your treatment with this medicine
• have or ever had 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.

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:

• Children as no clinical information is available for boys under 18 years,
• By women because of possibly developing male characteristics.

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:

• wash your hands with soap and water after applying the gel,
• cover the application area with clothing once the gel has dried,
• wash the application area before making close contact with another person.

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

• wash the area of skin onto which may have been affected immediately with soap and water,
• report any signs such as acne or changes in the growth or pattern of hair on your body or face to your doctor.

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.

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.

United Kingdom

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.

Ireland

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.

• The active substance is testosterone. Each 5 g sachet contains 50 mg testosterone.
• The other ingredients are Carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, purified water.

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

Manufacturers

or

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.