Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Testogel. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Testogel against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TESTOGEL IS USED FOR
Testogel is used to replace the body’s natural hormone testosterone when not enough is made by the body.
Testosterone is a natural hormone, known as an androgen, which controls normal sexual development and function in men.
Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as facial and body hair growth, deep voice, sexual drive, muscle mass and body fat distribution.
Testogel is a testosterone-containing gel that is applied by the patient daily to the skin. The testosterone passes from the gel through the skin and into the bloodstream at a steady rate.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
BEFORE YOU USE TESTOGEL
When you must not use it
Do not use Testogel if you have an allergy to:
- testosterone, the active ingredient in Testogel
- any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not use Testogel if you have or are suspected to have:
- prostate cancer
- male breast cancer.
Testogel must not be used by children under the age of 18 years. The safety of Testogel in children under 18 years of age has not been established.
Testogel must not be used by women.
Do not use this medicine after the expiry date printed on the pack and sachet. The expiry date is printed on the carton and on each sachet after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.
Do not use this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have, or have had, any of the following medical conditions:
- high blood calcium levels associated with tumours (hypercalcaemia)
- high levels of calcium in the urine (hypercalciuria)
- high blood pressure or heart disease
- a tendency to retain fluid (signs may include swollen feet or ankles)
- liver or kidney disease
- sleep apnoea (abnormal pauses in breathing during sleep)
- polycythaemia (a blood disorder where too many red blood cells are being produced).
Testogel may quicken the growth of existing prostatic tumours and benign prostatic hyperplasia (enlargement of the prostate gland). It may also increase the risk of breast cancer in males.
Before treatment, your doctor should conduct tests to check that you do not have existing prostate or breast cancer.
If you use Testogel over long periods of time, you may develop an abnormal increase in the number of red blood cells in the blood (polycythaemia). Your doctor may organise regular blood counts to monitor this.
If you have not told your doctor about any of the above, tell them before you start using Testogel.
Athletes should note that the active substance, testosterone, may produce a positive reaction in anti-doping tests.
Misuse of androgens to enhance your physical ability in sport carries serious health risks and is discouraged. Use of androgens for reasons other than what your doctor prescribed carries a serious health risk and is strongly discouraged.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Testogel may interfere with each other. These include:
- oral anticoagulants, medicines used to thin blood and to treat or prevent blood clots
- corticosteroids or adrenocorticotropic hormone (ACTH), hormones used to control inflammation
- oxyphenbutazone, a medicine used to treat pain and inflammation
- insulin, a medicine used to control blood sugar levels
- bupropion, a medicine used to aid in smoking cessation
- cyclosporin, a medicine used to suppress the immune system
- some herbal products.
These medicines may be affected by Testogel or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
HOW TO USE TESTOGEL
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.
How much to use
The usual starting dose is one 5 g sachet of gel per day. Your doctor or pharmacist will tell you exactly how much to use. You should not use more than 10 g of gel per day.
How to use it
Do not apply Testogel to the testes, scrotum or penis. The high alcohol content may cause local irritation.
Follow these steps when applying Testogel:
- Open the sachet(s).
- Spread a thin layer of Testogel onto clean, dry, healthy skin over the upper arms, shoulders or stomach.
- Allow the gel to dry for at least 3-5 minutes before dressing.
- Wash your hands thoroughly with soap and water after applying the gel.
- Cover the application area with clothing once the gel has dried.
- Do not shower for at least six (6) hours after applying Testogel.
When to use it
Apply Testogel once per day at approximately the same time each day, preferably in the morning. Using it at the same time each day helps maintain a steady level of testosterone in the blood. It will also help you remember when to apply it.
How long to use it
Testogel helps control the symptoms of your condition, but does not cure it. Therefore you must use Testogel every day.
When you have finished a pack, start the next pack on the following day. Never leave a break between packs.
Continue using Testogel for as long as your doctor tells you to.
If you forget to use it
If you forget to apply a dose, apply it as soon as you remember.
If you do not remember to apply the dose until the next dose is due, then just apply one dose. Do not apply a double dose to make up for a forgotten individual dose.
If you use too much (overdose)
Immediately telephone your doctor or the Poisons Information Cen
on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much Testogel. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE USING TESTOGEL
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Testogel.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
Keep all of your doctor’s appointments. Your doctor may monitor your blood pressure, examine your prostate and conduct other tests (including blood tests) from time to time, particularly if you are elderly. This is to make sure the medicine is working and to check for unwanted side effects.
The use of Testogel may affect the results of certain laboratory tests. If you are about to have any tests, tell your doctor that you are using this medicine.
Things you must not do
Do not use Testogel to treat any other complaints unless your doctor tells you to.
Do not give Testogel to anyone else, even if their symptoms seem similar to yours.
Do not stop using Testogel, or change the dosage, without checking first with your doctor. If you stop using it suddenly, your condition may worsen or you may have unwanted side effects.
Things to be careful of
Testosterone may be transferred to another person during close and relatively prolonged skin contact with the gel application area. If contact occurs a number of times or for long periods of time this could cause the other person to show signs of increased testosterone such as more hair on the face and body and a deepened voice. In women, this may also cause changes in the menstrual cycle.
Unwanted transfer of testosterone to another person can be avoided by wearing clothes which cover the application area and/or by showering before contact. You need to ensure that your partner is not put at risk of receiving testosterone by accident.
You should leave a gap of 6 hours between applying Testogel and having intimate physical contact. You should also wear clothing such as a T-shirt to cover the gel application area and/or have a shower or bath beforehand.
You should also follow these precautions before coming into close contact with women and children. If a woman or child does come into contact with Testogel, thoroughly wash the area of skin exposed to the gel with soap and water.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Testogel.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell you doctor if you notice any of the following and they worry you:
- skin reactions such as irritation, redness, dry or stinging skin and/or hives
- prostatic disorders such as difficulty or pain while urinating, frequent urination
- painful, tender or enlarged breasts
- feeling of “pins and needles” or tingling sensation
- memory loss
- heightened senses
- mood changes
- high blood pressure
- hair loss.
These are the common side effects of Testogel.
Tell your doctor immediately, or go to Accident and Emergency department at your nearest hospital if you notice any of the following:
- yellowing of the skin and eyes, also called jaundice.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Your doctor may need to monitor your blood pressure and conduct blood tests, as Testogel can increase your blood pressure and affect your liver function. You may not experience any specific symptoms.
Side effects associated with high doses or long term treatment include:
- increased tendency to retain fluid (signs may include swollen feet or ankles)
- decreased sperm count, which may affect fertility
- unwanted, frequent or prolonged and painful erections. erections
- severe stomach pain or tenderness, which do not disappear within a short time.
Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients.
AFTER USING TESTOGEL
Keep Testogel in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not leave it in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Return any unused medicine to your pharmacist.
What it looks like
Testogel is a clear, colourless gel presented in 5 g sachets.
Packs contain 10 or 30 sachets.
Active ingredient per sachet:
Testogel – 50 mg testosterone in 5 g gel
- carbomer 980
- isopropyl myristate
- sodium hydroxide
- purified water.
Made in Belgium for:
Besins Healthcare Australia Pty Ltd
Level 23 Governor Macquarie Tower
1 Farrer Place Sydney NSW 2000
Australian Registration Numbers
Testogel – AUST R 96131
Date of Preparation
See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.
Published by MIMS September 2016