Package leaflet · information for the user

Oxymetholone 50 mg

Oxymetholone

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 Oxymetholone is and what it is used for

Oxymetholone is a man-made medicine related to testosterone, the main male sex hormone. It works mainly by encouraging your bone marrow — the factory inside your bones — to make more red blood cells, the cells that carry oxygen around your body. Your doctor has prescribed it because your bone marrow is not producing enough red blood cells, a problem called anaemia, which can happen when the marrow fails or is damaged. It is a strong medicine that needs close supervision, and it has been chosen for your situation only.

2.What you need to know before you use Oxymetholone

Read this section carefully before your first tablet — this medicine needs regular blood tests and you should know what to watch for.

Do not use it if

Do not use it if you are allergic to oxymetholone or to any of the other ingredients listed on your carton.
Do not use it if you are pregnant, 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 have ever been told you have a liver tumour.
Do not use it if you have too much calcium in your blood.
Do not use it if you have severe heart failure or severe kidney disease with a lot of protein in your urine.

Warnings and precautions

Talk to your doctor before using it if you have any liver trouble. Of all the hormone tablets of this kind, oxymetholone is the hardest on the liver: it can cause blood-filled spaces in the liver, and rarely liver tumours, which sometimes do not cause any symptoms until they bleed. Your doctor will test your liver before you start and regularly during treatment. Tell your doctor immediately if your skin or eyes turn yellow, your urine goes dark, your stools go pale, 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 or kidney disease. This medicine makes the body hold a lot of salt and water, which can cause sudden swelling and put strain on the heart. Weigh yourself regularly and tell your doctor about rapid weight gain.
Your doctor will take blood counts regularly, both to see whether the anaemia is improving and because this medicine can affect how your blood clots.
Your blood fats and blood sugar will be checked, because this medicine lowers your "good" cholesterol and can unmask or worsen diabetes.
If this medicine is for a child, the doctor will X-ray the bones regularly, because it can close the growing ends of the bones too early and reduce final adult height.
Women should tell the doctor as soon as their voice deepens, hair appears on the face or body, or their periods change — some of these changes can be permanent.
Never take this medicine to build muscle or improve sporting performance and never give it to anyone else; used that way it is particularly dangerous to the liver.

Other medicines and Oxymetholone

Tell your doctor or pharmacist about all other medicines you take, including anything bought without a prescription and herbal products. It especially matters with: blood-thinning medicines such as warfarin — oxymetholone makes them far stronger and can cause serious bleeding, so your doctor will usually reduce the dose and check your clotting tests often; medicines for diabetes, including insulin, because your blood sugar can fall; steroid tablets such as prednisolone, which together with this medicine cause much more swelling; and ciclosporin, used after transplants.

Pregnancy, breastfeeding and fertility

Do not take this medicine if you are pregnant or trying to become pregnant. It can seriously harm an unborn baby, especially the sexual development of a baby girl. Women who could become pregnant must use a reliable method of contraception; ask your doctor which is suitable. Do not breastfeed while taking it. In men, this medicine lowers the number of sperm you make and can make you unable to father a child during treatment, and sometimes for a while afterwards.

Driving and using machines

Oxymetholone is not expected to affect your ability to drive or to use tools and machines. If you feel dizzy, tired or headachy, or you are sleeping badly, do not drive or use machines until you feel normal again.

3.How to use Oxymetholone

Always take this medicine exactly as your doctor has told you; check with your doctor or pharmacist if you are unsure. Swallow the tablets whole with a glass of water, ideally with or just after food to reduce stomach upset. Your doctor decides how many tablets you take and for how long, based on your blood counts, and this is written on your pharmacy label — never change it yourself. It can take three to six months of treatment before the full benefit is seen, so keep taking the tablets even if you do not feel different at first. If you forget a dose, take it when you remember unless the next one is nearly due, in which case skip it; never take a double dose. Do not stop without talking to your doctor. 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 the stomach — possible serious liver damage.
Sudden severe stomach pain with faintness, very pale skin or collapse — this can mean bleeding from the liver and is a medical emergency.
Breathlessness, rapid weight gain over a few days, or badly swollen legs — your heart may not be coping with the extra fluid.
Unusual bruising, nosebleeds, blood in the urine or black stools — tell your doctor the same day.
An erection that is painful or lasts more than four hours — go to hospital.
Swelling of the face, lips or throat, a widespread rash, or difficulty breathing — signs of an allergic reaction.

Other possible side effects

swollen ankles, feet or hands, and weight gain from holding water
feeling sick, being sick or diarrhoea
acne and oily skin
difficulty sleeping and restlessness
headache
in men: tender or swollen breast tissue, smaller testicles, fewer sperm, frequent erections
in women: deeper voice, extra facial and body hair, irregular or absent periods, enlarged clitoris
hair loss or thinning of the scalp hair
cramps in the legs
changes in liver blood tests, blood fats, blood sugar and blood counts

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 Oxymetholone

Keep this medicine out of the sight and reach of children. Store below 25 °C in the original blister or container, protected from light and damp. Do not use this medicine after the expiry date printed on the carton and blister; the expiry date is the last day of that month. Do not use a tablet if the blister is damaged or the tablet is broken or discoloured. Never dispose of medicines down the toilet or with household rubbish — return anything you no longer need to your pharmacist.

6.Contents of the pack and other information

The active substance is oxymetholone. The strength of your tablets, in milligrams, is printed on the carton and on the blister. The other ingredients are lactose, maize starch, povidone, croscarmellose sodium, magnesium stearate and colloidal silica; the full list is on your carton, so check it if you have been told you cannot tolerate certain sugars. The tablets are white to off-white, round, uncoated and scored on one face. 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 can be checked at ergopharm.net/verify to confirm the pack is genuine. Manufactured under GMP conditions by Ergopharm, Vadodara, Gujarat, India.