Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Testosterone Implants. 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 receiving Testosterone Implants against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may wish to read it again.
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.
What Testosterone Implants are used for
Testosterone Implants are used to treat confirmed testosterone deficiency in males.
The active substance of Testosterone Implants is testosterone. In men, testosterone is produced by the testicles. It is necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. It is also necessary for the growth of body hair, the development of bones and muscles, and it stimulates the production of red blood cells It also makes men’s voices deepen. Preparations containing testosterone are used to replace testosterone in a person who has low or no natural testosterone (a condition known as hypogonadism).
Ask your doctor if you have any questions about why this medicine has been prescribed to you. A doctor’s prescription is required to obtain this medicine.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Before you use Testosterone Implants
When you must not be given it
- If you have or have had a tumour of your prostate or breast or are suspected to have one of these tumours.
- If you are allergic to one or more of the ingredients of this medicine. Please see Product Description – Ingredients.
Before you are given it
Before you start using this medicine you must tell your doctor if you have or have ever had any of the following medical conditions:
- Breast cancer which has spread to the bones;
- Kidney or lung cancer;
- heart disease
- kidney disease
- liver disease
- high blood pressure
- prostatic complaints such as problems passing urine
- Diabetes mellitus
- Migraines, headaches
If you have sleep apnoea (temporarily stopping breathing during your sleep), this may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this.
Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.
Children and adolescents
The safety and efficacy of this medicine has not been adequately determined in children and adolescents.
Extra supervision by your doctor is necessary in the treatment of children and adolescents, since testosterone administration in general may cause early sexual development and limits normal growth.
Other medicines and Testosterone Implants
Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines – even those not prescribed.
Other medicines may influence the effects of Testosterone Implants, or Testosterone Implants may affect other medicines. Therefore you must tell your doctor or pharmacist if you are using, or are about to use:
- Insulin and/or other medicines to control blood sugar levels;
- Medicines to reduce the clotting of your blood (anti-coagulants);
The use of androgens like Testosterone Implants may lead to a reduction of the doses of these medicines.
Also tell your doctor or pharmacist if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma). The use of androgens like Testosterone Implant may increase the risk of water retention especially if your heart and liver are not working properly.
Androgens may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.
Using Testosterone Implants with food and drink
This medicine can be implanted without taking consideration of meals and drinks.
Pregnancy, breast-feeding and fertility
Testosterone Implants are not for use in women, therefore this medicine must not be taken by women who are pregnant or think that they are pregnant, or by women who are breast-feeding.
In men, treatment with Testosterone Implants can lead to fertility disorders by repressing sperm formation.
If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).
Additionally, at regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (hemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.
If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as Testosterone Implants can interfere with anti-doping testing.
The misuse of this medicine to enhance ability in sports carries serious health risks and is discouraged.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Testosterone Implants may interfere with each other. These include:
- anticoagulants or medicines used to reduce blood clots
- anti-diabetic medicines such as insulin used to control blood sugar levels and to treat diabetes.
These medicines may influence the effects of Testosterone Implants or Testosterone Implants may affect other medication. You may need different amounts of your medicines, or you may need to take different medicines.
The use of androgens like Testosterone Implant may lead to a reduction of the doses of these medicines.
Do not use this product if it has passed the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Using Testosterone Implants
How much to use
The dose is chosen by your doctor. The recommended dose is 600 – 1200 mg testosterone, depending on individual requirements. In most patients, a dose of 800 mg is enough to maintain the testosterone levels in the blood to the normal male physiological range. The implants are effective for approximately 4 – 5 months.
Use in children and adolescents
The safety and efficacy of this medicine have not been adequately determined in children and adolescents. Pre-pubertal children using this medicine will be monitored by your doctor.
How the implant is inserted
This medicine should only be given by a doctor or nurse.
This medicine is inserted under the skin (for example at the lower abdominal wall or buttock) to facilitate removal should it be necessary. A local anaesthetic is given in the area of implantation before the implants are inserted and the small cut made is dressed with a bandage afterwards.
Dosage should be adjusted by your doctor in response to individual requirements.
If you are given too much (overdose)
Testosterone Implants are given under medical supervision and it is very unlikely that you will be given too much.
Your doctor or nurse will insert this medicine into you. If you have the impression that the effect of this medicine is too strong then please talk to your doctor or nurse immediately.
You should consult your doctor or talk to your nurse if you feel the effect of this medicine are too strong or too weak as side-effects are dependent on dosage, dose interval and your individual sensitivity.
If you forgot to get your Testosterone Implant: Your doctor or nurse will insert this medicine into you. Should you miss a scheduled injection then please talk to your doctor or nurse as soon as possible. No double dose should be injected to make up for forgotten individual doses.
While you are using Testosterone Implants
Keep all of your appointments so that your progress can be checked. Your doctor may do some blood tests at regular intervals to make sure the medicine is working and to prevent unwanted side effects.
As far as known, Testosterone Implants have no influence on driving and using machines.
Side Effects of Testosterone Implants
All medicines can have side effects. Sometimes they are serious, most of the time they are not.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Testosterone Implants.
The side effects which are reported with testosterone therapy in general are:
- changes in sexual desire
- itching (pruritis)
- changes in liver function tests
- depression, nervousness, mood alterations;
- muscle pain (myalgia)
- fluid retention in the tissues, usually marked by swelling of ankles or feet
- high blood pressure (hypertension)
- changes in cholesterol levels (changes in lipid metabolism)
- increase in number of red blood cells (the cells which carry the oxygen in your blood)
- prolonged abnormal, painful erection of the penis
- disturbed formation of sperm
- prostatic growth to a size representative for the concerned age group
- increased growth of a small prostate cancer which had not been detected yet (progression of a sub-clinical prostatic cancer)
- increased levels of a blood marker which is associated with prostate cancer (PSA increased)
- feminisation (gynaecomastia)
- local reaction at the insertion site.
Some side effects have no symptoms. These side effects e.g. changes in cholesterol levels, changes in liver function tests, increase in the number of red blood cells or increased blood pressure can only be found when your doctor does tests to check your progress.
The most frequent reported local side effects of Testosterone Implant experienced by patients include: expulsion of the implant or infection, bruising or bleeding at the implantation site.
Children and adolescents:
The following side effects have been reported in pre-pubertal children using androgens:
- early sexual development;
- penis enlargement;
- an increased frequency of erections;
- growth limitation (limited body height)
Tell your doctor or pharmacist if you notice any other side effects. This includes any possible side effects not listed in this leaflet. Other side effects not listed in this leaflet also occur in some people.
Due to the nature of Testosterone Implants, side effects cannot be quickly reversed by discontinuing medication.
After Using Testosterone Implants
The effects of this medicine do not stop immediately after discontinuation, but gradually subside.
When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Keep Testosterone Implants in the original box in order to protect from light.
Keep it in a cool dark place where the temperature stays below 30°C.
Do not use Testosterone Implants after the expiry date stated on the carton after the term ‘exp.’ The expiry date refers to the last day of that month.
Keep this medicine out of reach and sight of children. A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.
Return any unused medicine to your pharmacist.
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 to protect the environment.
What it looks like
Testosterone Implants are white to pale yellow, opaque or translucent and have a common cylindrical shape with a diameter of 4.5 millimetre and a length of 6mm (100 mg) or a length of 12 millimetre (200 mg).
Each sterile implant is supplied singly in a sealed glass tube, positioned between plugs of non-absorbent wool.
Testosterone Implants consist of pure testosterone without any other ingredients.
The active substance is:
- Testosterone 100 mg per implant
- Testosterone 200 mg per implant
The other ingredients are:
- There are no other ingredients
MERCK SHARP & DOHME (AUSTRALIA) PTY LIMITED
54-68 Ferndell Street
SOUTH GRANVILLE NSW 2142
This leaflet was prepared in:06 June 2013.
100 mg: AUST R 14523
200 mg: AUST R 14524
The information supplied relates only to Testosterone Implants and should not be used in relation to any other product which may also contain the same active ingredients.
For further information please ask your doctor or pharmacist.
Published by MIMS September 2013