Proviron 25

1. Name of the product

Proviron 25 — 25 mg/tablet

Uncoated tablet for oral administration.

2. Qualitative and quantitative composition

3. Pharmaceutical form

Uncoated tablet for oral administration. Oral use.

4. Clinical particulars

4.1 Indications

Supplied for professional and research applications only. Any therapeutic application is determined exclusively by a qualified physician on the basis of individual clinical assessment. This product is not intended for self-medication.

4.2 Posology and method of administration

As directed by the physician. Dose and duration of administration are established by the treating clinician. Tablets are taken with water. Do not exceed the regimen prescribed and do not extend administration beyond the period advised.

4.3 Contraindications

• Known hypersensitivity to the active substance or to any of the excipients.
• Carcinoma of the prostate or of the male mammary gland.
• Pre-existing hepatic impairment, cholestasis or hepatic tumours.
• Hypercalcaemia associated with malignancy.
• Pregnancy and breast-feeding.
• Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption (contains lactose).

4.4 Special warnings and precautions for use

• Compounds bearing 17-alpha alkylation undergo hepatic first-pass metabolism and are associated with hepatotoxicity; liver function tests should be obtained before and periodically during administration.
• Administration should be discontinued immediately if jaundice, persistent nausea, abdominal pain or abnormal transaminase values occur.
• Periodic assessment of the lipid profile is advised, as oral androgens may markedly reduce HDL cholesterol.
• Concomitant hepatotoxic agents and alcohol should be avoided.
• Prolonged uninterrupted administration is not advised.

4.5 Interaction with other medicinal products

Potentiation of coumarin anticoagulants with risk of bleeding; prothrombin time must be monitored. Additive hepatotoxicity with other hepatotoxic agents. Reduction of blood glucose may alter insulin and oral antidiabetic requirements. Concurrent corticosteroids increase the risk of fluid retention.

4.6 Fertility, pregnancy and lactation

Contraindicated in pregnancy owing to the risk of virilisation of a female foetus, and during breast-feeding. Suppression of the hypothalamic-pituitary-gonadal axis may impair fertility.

4.7 Effects on ability to drive and use machines

No direct effect on the ability to drive or operate machinery is expected.

4.8 Undesirable effects

• Hepatobiliary: elevated transaminases, cholestatic jaundice, and with prolonged exposure peliosis hepatis.
• Endocrine: suppression of endogenous testosterone, gynaecomastia, menstrual irregularity, virilisation in females.
• Cardiovascular: fluid retention, elevated blood pressure, pronounced reduction of HDL cholesterol.
• Gastrointestinal: nausea, abdominal discomfort, altered appetite.
• Dermatological: acne, seborrhoea, alopecia in predisposed individuals.
• Psychiatric: mood alteration, irritability, disturbed sleep.

If any adverse effect becomes serious, or if an effect not listed in this leaflet is observed, medical advice must be sought without delay.

4.9 Overdose

In the event of acute overdose, discontinue administration immediately and seek medical assistance. Management is symptomatic and supportive, with particular attention to hepatic function.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Mesterolone exerts its pharmacological effects through three principal mechanisms. First, it binds sex hormone-binding globulin (SHBG) with very high affinity — higher than testosterone or DHT — displacing endogenous testosterone from SHBG and dramatically increasing the free testosterone fraction available for androgenic and anabolic activity. Second, it acts as a weak peripheral aromatase inhibitor, reducing conversion of endogenous and exogenous testosterone to estradiol. Third, it directly activates androgen receptors in androgenic target tissues, providing supplemental androgenic tone during suppressed cycles.

Pharmacotherapeutic group: Androgens / anabolic steroid, oral.

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Each production lot is released against the full pharmaceutical testing protocol: identity and purity by HPLC (specification ≥ 98 %), verification of concentration against label claim (± 5 %), sterility in accordance with USP <71>, bacterial endotoxin quantification by LAL assay (< 0.25 EU/mL) and inspection of particulate matter in accordance with USP <788>.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, maize starch, povidone, microcrystalline cellulose, magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months from the date of manufacture. Do not use after the expiry date printed on the carton and blister.

6.4 Special precautions for storage

Store below 30 °C in the original package in order to protect from light and moisture. Keep out of the reach and sight of children.

6.5 Nature and contents of container

Blister strips in a printed outer carton, 100 tablets for oral use.

6.6 Special precautions for disposal

Any unused product or waste material must be disposed of in accordance with local requirements. Do not dispose of via wastewater or household waste.

7. Authentication

Every unit carries a unique authentication code on the outer packaging. The code confirms that the product originates from Biomedica and has not been substituted. Verify it before use.

8. Manufacturer

Biomedica
Pharmaceutical manufacturing — GMP compliant
biomedicapharmacies@protonmail.com
biomedica.it.com