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Proviron (Tablets) Instructions for Use

Marketing Authorization Holder

Schering, AG (Germany)

ATC Code

G03BB01 (Mesterolone)

Active Substance

Mesterolone (Rec.INN registered by WHO)

Dosage Form

Bottle Rx Icon Proviron Tablets 25 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Mesterolone 25 mg

20 pcs. – bottles (1) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Androgenic drug

Pharmacotherapeutic Group

Androgen

Pharmacological Action

Androgenic agent. It stimulates the development of male genital organs and secondary sexual characteristics, activates libido and potency, and has an anabolic effect.

Indications

Psychovegetative disorders, decreased performance, potency disorders, hypofunction of the gonads, male infertility, aplastic anemia.

ICD codes

ICD-10 code Indication
D61.9 Aplastic anemia, unspecified
E29.1 Testicular hypofunction
F45.3 Somatoform dysfunction of the autonomic nervous system
F52.2 Insufficiency of genital response (psychogenic impotence)
N46 Male infertility
N48.4 Impotence of organic origin
Z73.0 Burn-out
ICD-11 code Indication
2A60.40 Transient abnormal myelopoiesis
3A70.1Z Acquired aplastic anemias, unspecified
5A81.1 Testicular hypofunction
6C20.Z Bodily distress disorder, unspecified
CB40.1 Young's syndrome
GB04.Z Male infertility, unspecified
HA01.00 Female sexual arousal dysfunction, lifelong, generalized
HA01.01 Female sexual arousal dysfunction, lifelong, situational
HA01.02 Female sexual arousal dysfunction, acquired, generalized
HA01.03 Female sexual arousal dysfunction, acquired, situational
HA01.0Z Female sexual arousal dysfunction, unspecified
HA01.10 Male erectile dysfunction, lifelong, generalized
HA01.11 Male erectile dysfunction, lifelong, situational
HA01.12 Male erectile dysfunction, acquired, generalized
HA01.13 Male erectile dysfunction, acquired, situational
HA01.1Z Male erectile dysfunction, unspecified
HA01.Z Sexual arousal dysfunctions, unspecified
QD85 Burn-out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take the tablet orally with a sufficient amount of liquid.

For the treatment of male hypogonadism, infertility, and psychovegetative or potency disorders, administer 25 mg one to three times daily.

Continue this therapy for several months as directed by a physician; treatment duration depends on clinical response and laboratory parameters.

For the management of aplastic anemia, administer a higher dose of 50 mg three times daily.

Do not exceed the prescribed daily dosage.

Adjust the dosing schedule based on individual therapeutic needs and tolerability.

Regularly monitor clinical status and relevant biochemical markers during long-term treatment.

Adverse Reactions

Possible undesirable frequent or prolonged erection.

Rarely benign or malignant changes in the liver.

Contraindications

Prostate cancer, liver tumors (including history).

Use in Pregnancy and Lactation

Mesterolone is used only in men.

Use in Hepatic Impairment

Contraindicated in liver tumors (including history).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Mesterolone is used only in men.

Androgens are not intended to stimulate muscle tissue growth in healthy individuals or to enhance their performance.

During use, regular rectal examination of the prostate is recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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