Prospect: information for the user

Proviron 25 mg tablets

mesterolone

1. What isProvironand for what it is used

2. What you need to know before starting to takeProviron

3. How to takeProviron

4. Possible adverse effects

5. Storage ofProviron

6. Contents of the package and additional information

It must be clearly demonstrated that there is a deficiency of androgens/testosterone before starting treatment with androgens (male hormones), excluding previously other diseases that may explain these symptoms.

Proviron is a medication that contains mesterolone, a form of androgen (male hormone).

It is used in men in whom the production of male hormones (androgens) is insufficient.

It is also used in men with fertility problems, having low levels of male hormones due to hypogonadism or inadequate functioning of the testicles.

Do not take Proviron

• If you are allergic to mesterolone or any of the other components of this medication (listed in section 6).
• If you have prostate cancer.
• If you have an enlarged prostate (benign prostatic hyperplasia).
• If you have or have had liver tumors.
• If you are a man with breast cancer.

Proviron is not indicated for use in children and adolescents. There is no available information on the use of Proviron in individuals under 18 years old.

Proviron is not indicated for use in women.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Proviron.

Substance abuse and dependence

Follow exactly the administration instructions for Proviron indicated by your doctor or pharmacist.

Do not use Proviron for bodybuilding, to increase muscle mass in healthy men, or to increase other physical abilities, either alone or with other anabolic androgenic steroids, as this poses serious health risks, including heart and blood vessel problems (which may be fatal) and liver and/or mental health problems, as well as the possibility of developing dependence on these medications.

Proviron is only for use in male patients.

During treatment with Proviron, periodic prostate examinations will be performed to rule out any cancerous processes, as Proviron may increase the growth rate of this type of cancer.

With the use of hormonal substances such as those contained in Proviron, benign liver tumors have been observed in rare cases, and in very rare cases, malignant liver tumors. In isolated cases, these liver tumors have caused intra-abdominal hemorrhage with a risk to life.If you notice a different stomach discomfort or a pain that does not go away, inform your doctor immediately.

Frequent or persistent erections may occur. In some cases, the dose should be reduced or the treatment interrupted to avoid penile injuries.

Use in athletes

This medication contains mesterolone, which may produce a positive result in doping control tests.

Other medications and Proviron

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. Certain medications may interact with mesterolone, so your doctor will need to adjust the dose or discontinue treatment with one of the medications.

This is especially important when taking:

- medications to treat infections (antibiotics such as clarithromycin or erythromycin)

- medications to treat seizures (antiepileptics)

- medications to treat fungal infections (antifungals such as voriconazole, fluconazole)

- medications to treat hypertension such as verapamil

- antidepressants such as fluvoxamine or bupropion

- other androgens

- oral anticoagulants

- medications to treat diabetes (oral hypoglycemics or insulin)

- corticotropin (hormone that stimulates the secretion of corticosteroids) or corticosteroids

- ciclosporin (medication used to prevent organ or bone marrow transplant rejection)

- thyroxine

- neuromuscular blockers (such as vecuronium)

- any hepatotoxic substance (affecting liver function)

Pregnancy, breastfeeding, and fertility

Proviron is not indicated for use in women and should not be used in pregnant women or breastfeeding women.

Proviron improves sperm formation, increasing the chances of reproduction.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery.

Proviron contains lactose, methylparahydroxybenzoate, and propylparahydroxybenzoate

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause allergic reactions (possibly delayed).

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet 3 or 4 times a day.

Tablets should be swallowed whole with a little water.

If you think the effect of Proviron is too intense or very weak, inform your doctor.

When you have been taking Proviron for a few months, depending on your symptoms, your doctor may reduce the number of tablets you need to take per day.

If you take more Proviron than you should

If you have taken more Proviron than you should, consult your doctor or pharmacist immediately. In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Proviron

Do not take a double dose to compensate for the missed doses. Take the dose that corresponds to you and continue with the treatment normally.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor if you notice any change in your general condition during treatment with Proviron.

Unknown: the frequency cannot be estimated with the available data.

• Abdominal pain (discomfort in the stomach)
• Acne
• Alopecia (hair loss)
• Headache
• Benign and malignant liver tumors
• Frequent erections of the penis
• Priapism (prolonged and unwanted erections of your penis)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of thismedication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Proviron

• The active ingredient is mesterolone. Each tablet contains 25 mg of mesterolone.

• The other components are lactose monohydrate, cornstarch, povidone 25000 (E1201), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and magnesium stearate (E572).

Appearance of the product and contents of the packaging

Proviron 25 mg is presented in the form of white, round tablets. Each package contains 20 tablets.

Last review date of this leaflet:01/2023

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/