Consumer medicine information (CMI) leaflet
Please read this leaflet carefully before you start using PROVIRON.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Proviron.
It does not contain all of 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 taking Proviron 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 with the medicine.
You may need to read it again.
WHAT PROVIRON IS USED FOR
Proviron is used to replace testosterone in men with hypogonadism. Male hypogonadism is a condition when the body does not produce enough testosterone.
Testosterone is a natural male hormone, known as an androgen, which controls normal sexual development in men.
Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as hair growth, deep voice, sexual drive, muscle mass and body fat distribution.
Proviron is for use in male patients only.
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 PROVIRON
When you must not take it
Do not take Proviron if you have an allergy to:
- mesterolone, the active ingredient in Proviron
- 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 take Proviron if you have:
- prostate cancer
- previous or existing liver tumours
- male breast cancer
- high blood calcium levels
Do not use this medicine after the expiry date printed on the pack and blister.
The expiry date is printed on the carton and on each blister 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 taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Before starting Proviron, your doctor will conduct an examination of your prostate. Your doctor will also note your medical history and perform other tests including a blood test.
Tell your doctor if you have or have had any of the following medical conditions:
- prostate disease
- liver disease
- heart or blood vessel disease
- high blood pressure
- kidney disease
- difficulty passing urine
- sleep apnoea (abnormal pauses in breathing during sleep)
- polycythaemia (a blood disorder where too many red blood cells are being produced)
- porphyria a rare metabolising disorder
If you have not told your doctor about any of the above, tell him/her before you start taking Proviron.
Use of androgens for reasons other than what your doctor prescribed carries a serious health risk and is strongly discouraged.
Use of Proviron during puberty can stunt your growth. Your doctor can discuss with you the risks and benefits involved.
Taking other medicines
Tell your doctor if you are taking any other medicines, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Proviron may interfere with each other. These include:
- phenobarbital or phenytoin, medicines used to treat seizures
- cyclosporin, a medicine used to suppress the immune system
- medicines used for diabetes
- thyroxine, a medicine used to replace low thyroid levels
- oral anticoagulants such as warfarin, ‘blood thinning’ medications to treat or prevent blood clots
- neuromuscular blockers such as anaesthetics, medicines used to cause temporary paralysis
These medicines may be affected by Proviron 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 taking this medicine.