Package leaflet · information for the user

Fluoxymesterone 10 mg

Fluoxymesterone

Read all of this leaflet carefully before you start using this medicine

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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.

1.What Fluoxymesterone is and what it is used for

Fluoxymesterone belongs to a group of medicines called androgens. These are man-made forms of testosterone, the main male sex hormone that the body normally makes on its own. Your doctor has prescribed it for you because your body is not making enough of this hormone itself, or to help a boy whose puberty is very late. In some women it is prescribed by a specialist as part of the treatment of certain breast cancers that are affected by hormones. It is a prescription medicine and it has been chosen for your situation only.

2.What you need to know before you use Fluoxymesterone

Read this section carefully before you take the first tablet, and tell your doctor about every illness you have had and every other medicine you take.

Do not use it if

Do not use it if you are allergic to fluoxymesterone or to any of the other ingredients listed on your carton.
Do not use it if you are pregnant, think you may be pregnant or are breastfeeding — it can seriously harm an unborn baby.
Do not use it if you have cancer of the prostate gland or cancer of the male breast.
Do not use it if you have severe liver disease, or if you have ever been told you have a liver tumour.
Do not use it if you have a high level of calcium in your blood, especially if this is caused by a cancer.
Do not use it if you have severe kidney disease with a lot of protein in your urine, or severe heart failure.

Warnings and precautions

Talk to your doctor before using it if you have any liver trouble. Fluoxymesterone is one of the tablet hormones that can damage the liver, so your doctor will take blood tests before you start and at intervals while you are taking it. Tell your doctor straight away if the whites of your eyes or your skin turn yellow, your urine goes dark, or you get pain in the upper right side of your stomach.
Talk to your doctor before using it if you have heart failure, high blood pressure, kidney disease, epilepsy or migraine — this medicine can make your body hold on to salt and water, which can make these worse.
Talk to your doctor before using it if you are an older man or have an enlarged prostate gland. Your doctor will check your prostate and may ask for a blood test before you start and now and then afterwards.
Talk to your doctor before using it if you have high cholesterol or heart disease in the family; this medicine can lower your "good" cholesterol and your doctor will check your blood fats.
If this medicine is for a boy who is still growing, the doctor will check his bones with X-rays regularly, because the medicine can make the bones stop growing too early and reduce his final height.
If you are a woman taking this medicine, tell your doctor promptly if your voice starts to deepen, you grow hair on your face or body, or your periods change — some of these changes may not go away when you stop.
Never take this medicine to build muscle or improve sporting performance, and never give it to anyone else. Used that way it can cause liver tumours, heart disease and lasting damage to your own hormones.

Other medicines and Fluoxymesterone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important for: blood-thinning medicines such as warfarin, because this medicine can make them work far too strongly and cause bleeding, so your clotting tests will need checking more often; medicines for diabetes, including insulin, because your blood sugar may fall and your doses may need changing; steroid medicines such as prednisolone, because together they make your body hold more water; and ciclosporin, used after transplants. Also mention any herbal remedies or supplements you buy yourself.

Pregnancy, breastfeeding and fertility

Do not take this medicine if you are pregnant or trying to become pregnant. It can cause serious harm to an unborn baby, in particular to the sexual development of a baby girl. If you could become pregnant, use a reliable method of contraception and talk to your doctor about which one is suitable. Do not breastfeed while taking this medicine. In men, this medicine lowers the number of sperm you make and can make you temporarily or, rarely, permanently unable to father a child; tell your doctor if you are planning a family.

Driving and using machines

This medicine is not expected to affect your ability to drive or to use tools and machines. A few people get headaches, dizziness or trouble sleeping. If that happens to you, do not drive or use machines until you feel normal again.

3.How to use Fluoxymesterone

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water. How many tablets you take and when you take them is decided by your doctor for you personally and is written on your pharmacy label — never change it yourself and never take more than you have been told. If you forget a dose, take it as soon as you remember, unless it is nearly time for your next one; in that case skip the missed dose. Never take a double dose to make up for a forgotten one. Do not stop taking this medicine without speaking to your doctor first. If you take too many tablets, contact your doctor or your nearest hospital straight away and take the carton with you.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop and get medical help straight away

Yellowing of the skin or the whites of the eyes, dark urine, pale stools or pain in the upper right side of your stomach — these can be signs of liver damage.
Sudden severe stomach pain with feeling faint, very pale skin or collapse — this can mean bleeding inside the liver.
Breathlessness, rapid weight gain or badly swollen legs — this can mean your heart is struggling with the extra fluid.
An erection that is painful or lasts more than four hours — go to hospital, as this needs treatment quickly.
Swelling of the face, lips or throat, a rash with itching, or difficulty breathing — these can be signs of an allergic reaction.
In women, any deepening of the voice or growth of facial hair — tell your doctor as soon as it starts, because these changes can become permanent.

Other possible side effects

acne and oily skin
difficulty sleeping
headache
feeling sick or losing your appetite
swollen ankles, feet or hands from holding water
mood changes, feeling irritable, restless or unusually aggressive
in men: more frequent erections, smaller testicles, fewer sperm, or tender or swollen breast tissue
in women: deeper voice, extra hair on the face and body, hair loss at the temples, irregular or absent periods, enlargement of the clitoris
increased or reduced interest in sex
changes in your blood fats and blood sugar, seen on blood tests

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist — including any not listed in this leaflet. You can also report them directly to us at pv@ergopharm.net or through our reporting form, and to your national reporting system. By reporting side effects you help provide more information on the safety of this medicine.

5.How to store Fluoxymesterone

Keep this medicine out of the sight and reach of children. Store it below 25 °C in the original blister or container, away from light and damp. Do not use this medicine after the expiry date printed on the carton and on the blister; the expiry date is the last day of that month. Do not use a tablet if the blister is torn or the tablet is broken or discoloured. Do not throw medicines away down the toilet or with your household rubbish. Return anything you no longer need to your pharmacist — this helps protect the environment.

6.Contents of the pack and other information

The active substance is fluoxymesterone. The strength of your tablets, in milligrams, is printed on the carton and on the blister. The other ingredients are lactose, maize starch, povidone, magnesium stearate and colloidal silica; the full list is on your carton, so check it if you know you cannot tolerate certain sugars. The tablets are white, round and uncoated. They come in aluminium blister strips inside a carton, or in bulk containers, in pack sizes from 10 to 100 tablets; not all pack sizes may be available in your country. Every carton carries a printed verification code and a GS1 DataMatrix square, which your pharmacist — or you — can check at ergopharm.net/verify to confirm the pack is genuine. Manufactured under GMP conditions by Ergopharm, Vadodara, Gujarat, India.