PROVIRON 25 mg TABLETS
How to use PROVIRON 25 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Proviron 25 mg Tablets
mesterolone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Contents of the pack
- What Proviron is and what it is used for
- What you need to know before you take Proviron
- How to take Proviron
- Possible side effects
- Storage of Proviron
- Contents of the pack and other information
1. What Proviron is and what it is used for
Androgen/testosterone deficiency must be clearly demonstrated before initiating treatment with androgens (male hormones), excluding other diseases that may explain these symptoms.
Proviron is a medicine that contains mesterolone, a form of androgen (male hormone).
It is used in men who have insufficient production of male hormones (androgens).
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 you take Proviron
Do not take Proviron
- If you are allergic to mesterolone or any of the other ingredients of this medicine (listed in section 6).
- If you have prostate cancer.
- If you have an enlarged prostate (benign prostatic hyperplasia)
- If you have or have had a liver tumor.
- If you are a man and have breast cancer
Proviron is not indicated for use in children and adolescents. There is no available information on the use of Proviron in minors 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 of Proviron as 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 carries serious health risks, such as heart and blood vessel problems (which can be fatal) and liver and/or mental health problems, as well as the possibility of developing dependence on these drugs.
Proviron is for use in male patients only.
During treatment with Proviron, you will undergo periodic prostate exams to rule out any cancerous process, as Proviron may increase the growth rate of this type of cancer.
With the use of hormonal substances like the one contained in Proviron, benign liver tumors have been rarely observed, and in very rare cases, malignant liver tumors. In isolated cases, these liver tumors have caused intra-abdominal bleeding with a risk to life. If you notice any unusual discomfort in the stomach or persistent pain, inform your doctor immediately.
Frequent or persistent erections may occur. In some cases, the dose should be reduced or treatment interrupted to avoid penile injury.
Use in athletes
This medicine contains mesterolone, which may produce a positive result in doping tests.
Other medicines and Proviron
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. Certain medicines may interact with mesterolone, so in these cases, your doctor should adjust the dose or interrupt treatment with one of the medicines.
This is especially important when 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 high blood pressure such as verapamil
- antidepressants such as fluvoxamine or bupropion
- other androgens
- oral anticoagulants
- medicines to treat diabetes (oral hypoglycemics or insulin)
- corticotropin (hormone that stimulates the secretion of corticosteroids) or corticosteroids
- cyclosporin (medicine 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 or breastfeeding women.
Proviron improves sperm formation, 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 use machines have been observed.
Proviron contains lactose, methyl parahydroxybenzoate, and propyl parahydroxybenzoate
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
It may cause allergic reactions (possibly delayed).
3. How to take Proviron
Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet 3 or 4 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.
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 Toxicology Information Service, phone 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 forgotten doses. Take the dose that corresponds to you and continue normally with the treatment.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any change in your general condition during treatment with Proviron.
Not known: the frequency cannot be estimated from the available data.
- Abdominal pain (stomach discomfort)
- Acne
- Alopecia (hair loss)
- Headache
- Benign and malignant liver tumors
- Frequent erections of the penis
- Priapism (prolonged and unwanted erections of the penis)
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Proviron
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your usual pharmacy. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are lactose monohydrate, corn starch, povidone 25000 (E1201), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and magnesium stearate (E572).
Appearance and packaging of the product
Proviron 25 mg is presented in the form of white, round tablets. Each pack contains 20 tablets.
Marketing authorisation holder Bayer Hispania, S.L. Av. Baix Llobregat, 3-5 08970 Sant Joan Despí (Barcelona) Spain | Manufacturer Bayer Weimar GmbH & Co KG Weimar 99427 - Germany | Bayer AG Muellerstrasse 178 13353, Berlin-Germany |
Date of last revision of this leaflet:01/2023
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Average pharmacy price4 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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