Proviron 25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Proviron 25 mg tablets

mesterolone

Package leaflet contents

1. What Proviron is and what it is used for
2. What you need to know before taking Proviron
3. How to take Proviron
4. Possible side effects
5. Storage of Proviron
6. Contents of the pack and other information

1. What Proviron is and what it is used for

Proviron contains the active substance mesterolone, which belongs to a group of medicines called androgens (male hormones). Mesterolone acts as a substitute for natural androgens.

Proviron is indicated in adult men for the treatment of signs and symptoms of androgen deficiency.

Androgen deficiency may be due to testicular, pituitary, or hypothalamic disorders.

Proviron is also used in combination with other medications in the treatment of infertility in men when hormone levels indicate a specific cause.

The active substance is Acidum ascorbicum.

Androgen/testosterone deficiency must be clearly demonstrated before initiating treatment with androgens (male hormones), with prior exclusion of other diseases that could explain these symptoms.

Proviron is a medicine containing 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 due to low levels of male hormones caused by hypogonadism or inadequate testicular function.

2. What you need to know before taking Proviron

Do not take Proviron

• If you are allergic to mesterolone or to any of the other ingredients of this medicine (listed in section 6).
• If you have prostate carcinoma.
• If you have an enlarged prostate (benign prostatic hyperplasia).
• If you have or have had a liver tumor.
• 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 of age.

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 given by your doctor or pharmacist.

You must not use Proviron for bodybuilding, to increase muscle mass in healthy men, or to enhance other physical abilities, either alone or in combination with other anabolic androgenic steroids, as this entails serious health risks, such as heart and blood vessel problems (which may be fatal), liver problems, and/or mental health issues, as well as the potential to develop dependence on these drugs.

Proviron is intended for use only in male patients.

During treatment with Proviron, you will undergo periodic prostate examinations 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 the one contained in Proviron, benign liver tumors have rarely been observed, and in very rare cases, malignant liver tumors. In isolated cases, these liver tumors have caused life-threatening intra-abdominal bleeding. If you notice unusual discomfort in your abdomen or persistent pain, inform your doctor immediately.

Frequent or persistent erections may occur. In some cases, the dose may need to be reduced or treatment discontinued to avoid penile injury.

Use in athletes

This medicine contains mesterolone, which may result in a positive outcome in doping control tests.

Other medicines and Proviron

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Certain medicines may interact with mesterolone, and in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines.

This is especially important if you are taking:

• Medicines to treat infections (antibiotics such as clarithromycin or erythromycin)
• Medicines to treat seizures (antiepileptics)
• Medicines to treat fungal infections (antifungals such as voriconazole, fluconazole)
• Medicines to treat hypertension such as verapamil
• Antidepressants such as fluvoxamine or bupropion
• Other androgens
• Oral anticoagulants
• Medicines to treat diabetes (oral hypoglycemics or insulin)
• Corticotropin (a hormone that stimulates corticosteroid secretion) or corticosteroids
• Cyclosporine (a medicine used to prevent rejection of organ or bone marrow transplants)
• 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 must not be used in pregnant or breastfeeding women.

Proviron improves sperm formation, thereby increasing the chances of reproduction.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Proviron contains lactose, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

It may cause allergic reactions (possibly delayed).

3. How to take Proviron

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet three or four times a day.

The tablets should be swallowed whole, with a little water.

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

After several months of treatment with Proviron, depending on your symptoms, your doctor may reduce the number of tablets you need to take each day.

If you take more Proviron than you should

If you have taken more Proviron than you should, contact your doctor or pharmacist immediately. In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Proviron

Do not take a double dose to make up for missed doses. Take the dose you are supposed to take and continue your treatment as normal.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Not known: frequency cannot be estimated from the available data.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Proviron Storage

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Proviron

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

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

Nature of the product and contents of the pack

Proviron 25 mg is presented as white, round tablets. Each pack contains 20 tablets.

Date of the most recent review of this leaflet: 01/2023

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