Package leaflet · information for the user

Oxandrolone 10 mg

Oxandrolone

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 Oxandrolone is and what it is used for

Oxandrolone is a man-made medicine related to testosterone, the main male sex hormone, but it has been changed so that its main effect is on building and keeping body tissue rather than on sexual characteristics. Your doctor has prescribed it to help you put back weight and muscle that you have lost — for example after a serious operation, a bad injury or burn, a long infection, or long-term treatment with steroid tablets. It is sometimes also prescribed to ease the bone pain of thin, weakened bones. It is a prescription medicine, chosen for your situation only.

2.What you need to know before you use Oxandrolone

Read this section before your first tablet, and tell your doctor about every other condition you have and every medicine you take.

Do not use it if

Do not use it if you are allergic to oxandrolone 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 have ever had a liver tumour.
Do not use it if you have a high level of calcium in your blood, particularly if this is caused by breast cancer.
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. Even though oxandrolone is gentler on the liver than some similar tablets, it can still damage it, so your doctor will check your liver with blood tests before and during treatment. Tell your doctor at once if your skin or the whites of your eyes turn yellow, your urine turns dark, or you get pain in the upper right side of your stomach.
Talk to your doctor before using it if you have heart disease, high blood pressure or kidney disease, because this medicine makes the body hold salt and water.
Your doctor will check your blood fats, because oxandrolone can markedly lower your "good" cholesterol and raise the "bad" kind, which over time is bad for your heart and blood vessels.
If this medicine is for a child, the doctor will check the bones with X-rays roughly every six months, because the medicine can make the growing ends of the bones close too early and reduce final adult height. Children may also grow body hair or, in boys, develop early signs of puberty.
Women should tell the doctor promptly if their voice deepens, hair grows on the face or body, or periods change, because some of these changes may not go away after stopping.
Tell your doctor if you have diabetes; your blood sugar may fall and your treatment may need adjusting.
Never take this medicine to build muscle for sport or appearance, and never share it with anyone else.

Other medicines and Oxandrolone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including anything you buy yourself and herbal products. It is especially important with: blood-thinning medicines such as warfarin — oxandrolone strongly increases their effect and your doctor will usually have to lower the dose and check your clotting tests often, because otherwise you can bleed seriously; medicines for diabetes, including insulin, because your blood sugar may fall; steroid tablets such as prednisolone, which cause more swelling when combined with this medicine; 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, in particular the sexual development of a baby girl. If you could become pregnant, use a reliable method of contraception and talk it over with your doctor. Do not breastfeed while taking it. In men, this medicine can reduce the number of sperm you produce and make it harder to father a child while you are taking it.

Driving and using machines

Oxandrolone is not expected to affect your ability to drive or use tools and machines. If you feel dizzy, have a headache or sleep badly, wait until you feel normal again before driving or using machines.

3.How to use Oxandrolone

Always take this medicine exactly as your doctor has told you; ask your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water; taking them with food may help if they upset your stomach. Your doctor decides how many tablets you take, how often and for how long — this is written on your pharmacy label and you should never change it yourself. Treatment is usually given in short courses. If you forget a dose, take it when you remember unless it is nearly time for the next one, in which case skip it; never take a double dose. 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 high on the right side of your stomach — possible liver damage.
Sudden severe stomach pain with faintness, very pale skin or collapse — this can mean bleeding inside the liver and is an emergency.
Breathlessness, sudden weight gain or badly swollen legs — your heart may be struggling with the extra fluid.
An erection that is painful or lasts more than four hours — go to hospital.
Unusual bruising or bleeding, such as nosebleeds or blood in the stools, especially if you also take a blood thinner.
Swelling of the face, lips or throat, a widespread rash, or difficulty breathing — signs of an allergic reaction.

Other possible side effects

acne and oily skin
swollen ankles, feet or hands from holding water
feeling sick, being sick or stomach discomfort
difficulty sleeping
changes in mood, irritability or restlessness
in men: more frequent erections, smaller testicles, fewer sperm, tender or swollen breast tissue
in women: deeper voice, extra facial or body hair, irregular or absent periods, enlarged clitoris
hair loss at the temples or thinning scalp hair
changes in blood fats, especially a fall in "good" cholesterol
changes in liver blood tests and in blood sugar

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 Oxandrolone

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 torn or the tablet is broken or discoloured. Do not put medicines down the toilet or in household rubbish — return anything you no longer need to your pharmacist.

6.Contents of the pack and other information

The active substance is oxandrolone. 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, which matters if you have been told you cannot tolerate certain sugars. The tablets are white, round, uncoated and scored on one face so they can be divided if your doctor asks you to. 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.