Package leaflet · information for the user
Methyltestosterone 25 mg
Methyltestosterone
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 Methyltestosterone is and what it is used for
Methyltestosterone is a man-made form of testosterone, the main male sex hormone that the body normally makes for itself. It is taken by mouth. Your doctor has prescribed it because your body is not producing enough of this hormone — for example after an illness or operation affecting the testicles or the pituitary gland in the brain — or to help a boy whose puberty is very late. It is sometimes prescribed by a specialist for women as part of the treatment of certain hormone-sensitive breast cancers. It is a prescription medicine, chosen for your situation only.
2.What you need to know before you use Methyltestosterone
Read this section before your first tablet and tell your doctor about all your other conditions and medicines.
Do not use it if
- Do not use it if you are allergic to methyltestosterone 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 had 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. Because this hormone has been altered so it can be swallowed, it can damage the liver. Your doctor will do blood tests before you start and regularly afterwards. 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 failure, high blood pressure, kidney disease, epilepsy or migraine, because this medicine makes the body hold salt and water.
- Talk to your doctor before using it if you are an older man or have an enlarged prostate or difficulty passing urine. Your doctor will examine your prostate and may do a blood test before treatment and from time to time during it.
- Your doctor will check your blood count and your blood fats during treatment, because this medicine can thicken the blood and lower your "good" cholesterol.
- If this medicine is for a boy who is still growing, his bones will be X-rayed regularly, because the medicine can close the growing ends of the bones too early and reduce his final height.
- Women taking this medicine should tell the doctor as soon as their voice deepens, extra hair appears on the face or body, or their periods change — these changes may become permanent.
- Never use this medicine for body-building or sport, and never share it with anyone else.
Other medicines and Methyltestosterone
Tell your doctor or pharmacist about any other medicines you take, including ones you buy yourself and herbal products. It especially matters if you take: blood thinners such as warfarin, because this medicine makes them much stronger and can cause dangerous bleeding, so your clotting will be checked more often; medicines for diabetes, including insulin, as your blood sugar may drop and the doses may need lowering; steroid tablets such as prednisolone, which together with this medicine cause more swelling; and ciclosporin, used after transplants.
Pregnancy, breastfeeding and fertility
Do not take this medicine if you are pregnant or planning a pregnancy. It can seriously harm an unborn baby, particularly 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 sperm production and can make it difficult or impossible to father a child during treatment; tell your doctor if you are planning a family.
Driving and using machines
Effects on driving and on using tools or machines are unlikely. Some people get headaches, dizziness or poor sleep. If you are affected, wait until you feel normal again before driving or using machines.
3.How to use Methyltestosterone
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. Your doctor decides how many tablets you take and when, based on your blood tests and how you respond; this is written on your pharmacy label and you should never change it yourself. If you forget a dose, take it when you remember unless your next dose is nearly due — then skip the missed one. Never take a double dose. Do not stop treatment without talking to your doctor, as your symptoms may return. If you take too many tablets, contact your doctor or nearest hospital at once 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 eyes, dark urine, pale stools or pain in the upper right side of the stomach — possible liver damage.
- Sudden severe stomach pain with faintness or collapse — this can mean bleeding inside the liver and is an emergency.
- Breathlessness, rapid weight gain or badly swollen legs — your heart may not be coping with the extra fluid.
- An erection that is painful or lasts more than four hours — go to hospital straight away.
- Being completely unable to pass urine — 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
- acne and oily skin
- difficulty sleeping
- headache
- swollen ankles, feet or hands from holding water
- mood changes, irritability or unusual aggression
- in men: more frequent or longer erections, smaller testicles, fewer sperm, tender or swollen breast tissue
- in men: needing to pass urine more often or difficulty starting to pass urine
- in women: deeper voice, extra facial and body hair, irregular or missed periods, enlarged clitoris
- feeling sick or losing your appetite
- changes in blood fats, blood sugar, blood count and liver 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 Methyltestosterone
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 shown 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 looks broken or discoloured. Never put medicines down the toilet or in household rubbish — hand anything you no longer need to your pharmacist.
6.Contents of the pack and other information
The active substance is methyltestosterone. 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 complete list is on your carton, which matters if you have been told you cannot tolerate certain sugars. The tablets are white to off-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 can be checked at ergopharm.net/verify to confirm the pack is genuine. Manufactured under GMP conditions by Ergopharm, Vadodara, Gujarat, India.