Testosterone Implant 50, 100 and 200mg

INFORMATION FOR THE PATIENT

What you should know about your medicine

This leaflet has been written to help you understand your medicine.
If you have any questions or worries, ask your doctor or pharmacist.
At the end of the leaflet you will find a list of things to remember about your medicine. Please keep this leaflet until you have finished your medicine. You may want to read it again.

What Is A Testosterone Implant?

Testosterone implants are pellets containing 50, 100 or 200mg of testosterone and are sold in a glass ampoule.
Each implant is packed in a cardboard carton There are no other ingredients in the pellet. These implants are used in hormone replacement therapy in men and women.
Testosterone is a natural male hormone, known as an
androgen, which controls normal sexual development in men.

The Product Licence Is Held By:

Organon Laboratories Limited, Science Park, Milton Road, Cambridge, CB4 0FL

Testosterone Implants Are Made By:

Organon (Ireland) Ltd
P O Box 2857
Drynam Road
Swords
Co Dublin
Eire

What Are Testosterone Implants Used For?

Testosterone implants are used in testosterone replacement therapy for male sexual problems for example:

• impotence caused by hormonal disorders
• after castration or a similar problem called eunuchoidism
• decreased sex drive and decreased mental and physical activity
• infertility caused by low sperm count
• bone loss caused by low hormone levels.

Implants can also be used in women together with other forms of hormone replacement therapy to relieve symptoms such as decreased sexual drive and loss of energy.

Before Your Implant is Inserted:

Men

• Do you have or think you may have cancer of the prostate or breast?

Women

• Do you think you may be pregnant?
• Are you breast-feeding?

If the answer to any of these questions is YES,

• Did you tell your doctor at the last visit, or an earlier visit?

If NOT, then you should do so as soon as possible.

Even so your doctor may still want you to have the
implant.

What Do You Need To Know Before Having An Implant?

Extra supervision by your doctor may be necessary in some cases particularly the elderly.

Tell your doctor if you have ever had:

• heart disease
• kidney disease
• liver disease
• high blood pressure
• epilepsy
• migraine

Testosterone should be used carefully in women as it can cause hoarseness of the voice. In young boys testosterone can cause early sexual development and delay growth.

What Other Medicines Are You Taking?

Other medicines may affect how the testosterone implant works or testosterone may affect how they work.

Certain types of drugs can cause more enzymes to be made in the liver. These are called "enzyme inducing
drugs" for example medicines used to treat epilepsy; phenobarbitone. These drugs will affect the way
Testosterone works. Tell your doctor if you are taking or intend to take any other medicines.

PSD, Organon Ireland Limited, Swords.

How A Testosterone Implant Is Given?

How much?.

The dose is chosen by your doctor. In men usually a dose of 100-600mg implant is given, but this depends on each individual.
In women a dose of 50-100mg is usual, together with another form of hormone replacement therapy.

How the implant is inserted?

Testosterone implants are inserted under the skin into the lower abdominal wall or buttock by your doctor. You are usually given a local anaesthetic in this area before the implant is inserted and the small cut made is dressed with a bandage afterward. The implant usually lasts for 4-5 months.

What To Do If Someone Is Accidentally Given Too Much?

If the dose is too much it can cause a woman’s voice to deepen and cause frequent erections in men. If this
occurs tell your doctor immediately. He/She may want to remove the implant.

What About Side Effects?

Testosterone may cause side effects in some people. If you have any of the following side-effects tell your doctor.
He may decide to stop treatment for a while.
In men it may cause:

• prolonged painful erection
• increased sexual desire
• decreased amounts of ejaculation fluid
• low sperm count
• water retention

In young boys, early sexual development, erections occurring more often than normal, enlarged penis, delayed growth

In women it may cause hoarseness of the voice and excess hair growth.

Tell your doctor if you have any side effects which are serious or troublesome and if side effects continue.

How Should Testosterone Implants Be Stored?

Testosterone implants should not be used after the ‘use by’ date on the pack. They should be stored below 25°C (room temperature) away from light. Keep out of reach of children.

This information was written in May 1999

Other Things To Remember About Medicines.

1. This medicine has been prescribed for your current medical problems. Do not use it for other medical problems.
2. Do not allow other people to use your medicines and do not use medicines meant for other people.
3. Tell any doctor treating you what medicines you are taking. Always carry a medical information card showing which medicines you are using. This can also
   be very important if you are involved in an accident.
4. Return any medicine that you do not use to the pharmacy, they will dispose of it safely.
5. Make sure that other people you may live with or who look after you read this information.

Ref: UP02Test2a.