PROVIRON® (Pro-VAI-Ron) Mesterolone

PROVIRON® (Pro-VAI-ron) mesterolone

Consumer Medicine Information

WHAT IS IN THIS Proviron is for use in male patients Do not use this medicine after the LEAFLET only. expiry date printed on the pack and blister. Ask your doctor if you have any The expiry date is printed on the This leaflet answers some common questions about why this medicine carton and on each blister after questions about Proviron. has been prescribed for you. "EXP" (e.g. 11 18 refers to Your doctor may have prescribed it It does not contain all of the available November 2018). The expiry date for another reason. information. refers to the last day of that month. If It does not take the place of talking to it has expired return it to your your doctor or pharmacist. pharmacist for disposal. All medicines have risks and BEFORE YOU USE Do not use this medicine if the benefits. Your doctor has weighed PROVIRON packaging is torn or shows signs of the risks of you taking Proviron tampering. against the benefits they expect it If the packaging is damaged, return it will have for you. When you must not take it to your pharmacist for disposal. If you have any concerns about If you are not sure whether you Do not take Proviron if you have should start taking this medicine, talk taking this medicine, ask your an allergy to: doctor or pharmacist. to your doctor. • mesterolone, the active ingredient Keep this leaflet with the medicine. in Proviron Before you start to take it You may need to read it again. • any of the ingredients listed at the end of this leaflet. Tell your doctor if you have allergies to any other medicines, Some of the symptoms of an allergic foods, preservatives or dyes. reaction may include: WHAT PROVIRON IS Before starting Proviron, your doctor • shortness of breath USED FOR will conduct an examination of your • wheezing or difficulty breathing prostate. Your doctor will also note • Proviron is used to replace swelling of the face, lips, tongue your medical history and perform testosterone in men with or other parts of the body other tests including a blood test. hypogonadism. Male hypogonadism • rash, itching or hives on the skin. is a condition when the body does Tell your doctor if you have or Do not take Proviron if you have: have had any of the following not produce enough testosterone. • prostate cancer medical conditions: Testosterone is a natural male • previous or existing liver tumours • prostate disease hormone, known as an androgen, • • liver disease which controls normal sexual male breast cancer • development in men. • high blood calcium levels heart or blood vessel disease • high blood pressure Testosterone is essential for the • development and maintenance of the kidney disease male reproductive organs as well as • difficulty passing urine other male characteristics, such as • migraines hair growth, deep voice, sexual drive, • epilepsy muscle mass and body fat • diabetes distribution.

PROVIRON® Published by MIMS/myDr March 2013 1 • sleep apnoea (abnormal pauses in HOW TO TAKE If you forget to take it breathing during sleep) PROVIRON If it is almost time for your next • polycythaemia (a blood disorder dose, skip the dose you missed and where too many red blood cells Follow all directions given to you take your next dose when you are are being produced) by your doctor or pharmacist meant to. • porphyria a rare metabolising carefully. disorder They may differ from the Otherwise, take it as soon as you information contained in this leaflet. remember, and then go back to If you have not told your doctor taking it as you would normally. about any of the above, tell If you do not understand the him/her before you start taking instructions printed on the pharmacist Do not take a double dose to make Proviron. label, ask your doctor or pharmacist up for the dose that you missed. Use of androgens for reasons other for help. If you are not sure what to do, ask than what your doctor prescribed your doctor or pharmacist. carries a serious health risk and is How much to take If you have trouble remembering strongly discouraged. Your doctor or pharmacist will tell when to take your medicine, ask Use of Proviron during puberty can you how much and how often you your pharmacist for some hints. stunt your growth. Your doctor can should take Proviron. discuss with you the risks and For Proviron to work best it is very If you take too much benefits involved. important to take it exactly as your (overdose) doctor tells you. Taking other medicines Immediately telephone your The usual treatment consists of 1-2 doctor, or the Poisons Information Tell your doctor if you are taking tablets three times per day. After a Centre (telephone 13 11 26), or go any other medicines, including few months of treatment, your doctor to the Accident and Emergency those that you buy without a may decrease the dose to 1 tablet two department at your nearest hospital, if you think you or prescription from your pharmacy, to three times a day. supermarket or health food shop. anyone else may have taken too Do not exceed the recommended much Proviron. Do this even if Some medicines and Proviron may dose your doctor has prescribed for there are no signs of discomfort or interfere with each other. These you as this can increase your risk of poisoning. include: side effects. You may need urgent medical • phenobarbital or phenytoin, attention. medicines used to treat seizures How to take it Excessive use of hormonal • cyclosporin, a medicine used to substances such as Proviron has been suppress the immune system Swallow the tablet whole with associated with liver abnormalities, water. • medicines used for diabetes tumours, changes to blood lipids, • thyroxine, a medicine used to increased risk of heart disease, replace low thyroid levels When to take it reduced glucose tolerance, decreased testosterone levels, enlargement of • oral anticoagulants such as Take your medicine at about the male breast tissue, stunted growth, warfarin, 'blood thinning' same time each day medications to treat or prevent psychiatric disturbances, acute Taking it at the same time each day blood clots withdrawal syndrome, vomiting will have the best effect. It will also blood or blood in stools and tendon • neuromuscular blockers such as help you remember when to take it. It damage. anaesthetics, medicines used to does not matter if you take this cause temporary paralysis medicine before or after food. These medicines may be affected by Proviron or may affect how well it How long to take it works. You may need different amounts of your medicines, or you Continue taking your medicine for as may need to take different medicines. long as your doctor tells you. This medicine helps control your Your doctor and pharmacist have condition, but does not cure it. It is more information on medicines to be important to keep taking your careful with or avoid while taking medicine even if you feel well. this medicine.

PROVIRON® Published by MIMS/myDr March 2013 2 WHILE YOU ARE SIDE EFFECTS Hormonal substances such as TAKING PROVIRON Proviron may quicken the growth of Tell your doctor or pharmacist as existing hormone dependent tissues soon as possible if you do not feel and tumours If you are over 65 years Things you must do well while you are taking Proviron. of age, you may have an increased All medicines can have side effects. risk of developing prostatic If you are about to be started on Sometimes they are serious, most of hyperplasia (enlargement of the any new medicine, remind your the time they are not. You may need prostate) and prostatic cancer. doctor and pharmacist that you medical attention if you get some of are taking Proviron. Tell your doctor or pharmacist if the side effects. you notice anything that is making Tell any other doctors, dentists, you feel unwell. and pharmacists who treat you Do not be alarmed by the following that you are taking this medicine. lists of possible side effects. You Other side effects not listed above may not experience any of them. may also occur in some people. If you are going to have surgery, tell the surgeon or anaesthetist that Ask your doctor or pharmacist to you are taking this medicine. answer any questions you may have. It may affect other medicines used during surgery. Tell your doctor or pharmacist if AFTER TAKING you notice any of the following and PROVIRON Keep all of your doctor's they worry you: appointments so that your progress • headache can be checked. Storage Your doctor may do some tests (such • fluid retention as blood tests and regular • breast enlargement Keep your tablets in the pack until examinations of the prostate) from • increased sexual drive it is time to take them. time to time to make sure the If you take the tablets out of pack, • psychiatric disturbances such as medicine is working and to check for they may not keep well. depression, aggression, increased unwanted side effects. or decreased energy levels, Keep your tablets in a cool dry If you experience prolonged elation or irritability place where the temperature stays stomach pain, blood in the stools or • acne below 30°C. vomit, or yellowing of the skins • excessive hairiness Do not store it or any other and eyes during treatment with • medicine in the bathroom, near a Proviron, tell your doctor premature puberty sink, or on a window-sill. immediately • stunted growth There have been cases reported of Tell your doctor immediately, or Do not leave it in the car. patients developing liver tumours go to Accident and Emergency Heat and dampness can destroy some while taking Proviron. Your doctor department at your nearest medicines. may tell you to stop using Proviron. hospital if you notice any of the Keep it where children cannot following: reach it. Things you must not do • symptoms of an enlarged prostate A locked cupboard at least one-and-a such as changes in urination, or half metres above the ground is a Do not take Proviron to treat any blood in the urine or ejaculate good place to store medicines. other complaints unless your • doctor tells you to. unwanted, frequent or prolonged and painful erections Disposal Do not give your Proviron tablets • severe stomach pain or tenderness to anyone else, even if they have which do not disappear within a If your doctor tells you to stop the same condition as you. short time taking Proviron or the tablets have passed their expiry date, ask your Do not stop taking your medicine You may need urgent medical pharmacist what to do with any or lower the dosage without attention or hospitalisation. that are left over. checking with your doctor. If you stop taking it suddenly, your Return any unused medicine to condition may worsen or you may your pharmacist. have unwanted side effects.

PROVIRON® Published by MIMS/myDr March 2013 3 PRODUCT DESCRIPTION

What it looks like

Proviron tablets are round white scored tablets marked with "AX" inside a hexagon. Each pack contains 50 tablets.

Ingredients

Active ingredient: • 25 mg mesterolone per tablet Inactive ingredients: • lactose • maize starch • povidone • methyl hydroxybenzoate • propyl hydroxybenzoate • magnesium stearate

Supplier

Made in Germany for: Bayer Australia Ltd ABN 22 000 138 714 875 Pacific Highway Pymble NSW 2073 Australian Registration Number Proviron (blister pack) - AUST R 136196 Proviron (bottle) - AUST R 10712

Date of preparation

PROVIRON® Published by MIMS/myDr March 2013 4