Package leaflet · information for the user

Mesterolone 25 mg

Mesterolone

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 Mesterolone is and what it is used for

Mesterolone is a man-made male sex hormone. It is closely related to the natural hormone that the body makes from testosterone in the skin, the prostate and other tissues. Your doctor has prescribed it because your body is making too little male hormone — this can happen with age, after an illness affecting the testicles, or when tests have shown low hormone levels. Unlike most hormone tablets of this kind, mesterolone is not changed in the body into a female hormone, so breast tenderness is less common with it. It is a prescription medicine, chosen for your situation only.

2.What you need to know before you use Mesterolone

Read this section before you take your first tablet, and tell your doctor about your other conditions and medicines.

Do not use it if

  • Do not use it if you are allergic to mesterolone or to any of the other ingredients listed on your carton.
  • Do not use it if you have cancer of the prostate gland, or a lump or cancer in the male breast.
  • Do not use it if you have a tumour of the liver now or have had one in the past.
  • Do not use it if you have too much calcium in your blood.
  • Do not use it if you are a woman who is pregnant or breastfeeding; this medicine is intended for men.
  • Do not use it if you have severe untreated 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 or have had prostate trouble. Before you start, and regularly during treatment, your doctor will examine your prostate and may take a blood test, because male hormones can make an existing prostate problem or an undetected prostate cancer grow faster.
  • Talk to your doctor before using it if you have heart failure, high blood pressure, kidney or liver disease, epilepsy or migraine, because holding on to water can make these worse. Your doctor will check your liver with blood tests during treatment even though mesterolone is gentler on the liver than most hormone tablets that are swallowed.
  • Talk to your doctor before using it if you have a history of blood clots or if your blood is unusually thick; your blood count will be checked from time to time.
  • Tell your doctor if you snore heavily or stop breathing in your sleep, as male hormones can make sleep apnoea worse, particularly if you are overweight or have a lung condition.
  • If this medicine is for a boy or a young man who is still growing, the doctor will check bone growth with X-rays, because male hormones can stop the bones growing too early.
  • This medicine does not treat infertility and it can lower your own hormone production if used long term; tell your doctor if you are trying to father a child.
  • Never take this medicine to build muscle or improve sporting performance, and never pass it on to anyone else.

Other medicines and Mesterolone

Tell your doctor or pharmacist if you take, have recently taken or may take any other medicine, including ones bought without a prescription and herbal products. It particularly matters if you take: blood-thinning medicines such as warfarin, because male hormones can strengthen their effect and cause bleeding, so your clotting will need checking more often; medicines for diabetes, including insulin, as your blood sugar may fall and your doses may need adjusting; and steroid tablets such as prednisolone, which together with this medicine make you retain more water.

Pregnancy, breastfeeding and fertility

This medicine is for men. It must not be taken by women who are pregnant, who may become pregnant or who are breastfeeding, because male hormones can harm an unborn baby, particularly the development of a baby girl. In men, mesterolone may reduce the number of sperm you make and so make it harder to father a child; if fertility matters to you, discuss this with your doctor before you start.

Driving and using machines

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

3.How to use Mesterolone

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; it is easier on the stomach if you take them after a meal. How many tablets you take and when is decided by your doctor and written on your pharmacy label — never change it yourself. If you forget a dose, take it when you remember unless your next dose is nearly due, in which case skip the missed one. Never take a double dose to make up. Do not stop treatment on your own; your symptoms may come back. If you take too many tablets, contact your doctor or your nearest hospital 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

  • An erection that is painful or lasts longer than four hours — go to hospital, as this needs urgent treatment.
  • Being unable to pass urine at all, or passing blood in your urine — get medical help the same day.
  • Yellowing of the skin or the whites of the eyes, dark urine or pain in the upper right side of your stomach — possible liver problems.
  • Pain and swelling in one leg, chest pain or sudden breathlessness — possible blood clot.
  • 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
  • more frequent or longer-lasting erections, especially early in treatment
  • increased interest in sex
  • needing to pass urine more often, or difficulty starting to pass urine
  • tender or slightly enlarged breast tissue (less common than with other hormone tablets)
  • feeling sick or stomach discomfort
  • headache
  • mood changes, restlessness or difficulty sleeping
  • fluid retention with slightly swollen ankles
  • changes in your blood count or 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 Mesterolone

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

6.Contents of the pack and other information

The active substance is mesterolone. The strength of your tablets, in milligrams, is printed on the carton and on the blister. The other ingredients are lactose, maize starch, povidone, methylcellulose, 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, 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.

This leaflet was last revised in July 2026.

Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For Export Only. This medicine is available on prescription only. The leaflet supplied inside your pack, in the language of the country where it was supplied, is the version that applies to you.