Proviron - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable effects Shelf life and storage Composition and pharmaceutical form

Active ingredients: Mesterolone

PROVIRON 50 mg tablets

Why is Proviron used? What is it for?

Pharmacotherapeutic group

Androgens.

Therapeutic indications

Male infertility

Infertility can result from oligospermia or functional failure of Leydig cells. With the administration of Proviron, the number and quality of nemasperms and the concentration of fructose in the spermatic fluid can be improved and normalized. This has repercussions in an increase in procreative abilities.

Male hypogonadism

Proviron stimulates the growth, development and function of androgen-dependent sexual organs. The preparation promotes the development of secondary sexual characteristics when the androgen deficiency appeared in prepubertal age. The phenomena related to functional deficiency of the male gonads appearing in post-puberty age are also eliminated.

Disturbances of virile power

Proviron is able to eliminate the disturbances of virile potency linked to androgenic increase deficiency. The preparation can however be usefully administered as an adjuvant even when the disturbances of potency have a different genesis.

With advancing age the androgenic increase progressively decreases. Even a modest deficit of androgens often results in the appearance of easy fatigue, decreased power of concentration, memory disturbances, sleep disturbances, mood alterations, circulatory disturbances . These symptoms lessen or disappear using Proviron.

Contraindications When Proviron should not be used

Prostate cancer and breast cancer in men. Hypersensitivity already known to androgens.

Precautions for use What you need to know before taking Proviron

The use of Proviron is reserved exclusively for male patients.

It would be advisable, following the usual rules of preventive medicine, to carry out periodic rectal examinations of the prostate.

In elderly subjects it must be carefully observed that the treatment does not cause undesirable nerve, mental or physical stimulation.

Interactions Which drugs or foods can modify the effect of Proviron

Do not report.

Warnings It is important to know that:

For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.

If symptoms of sexual over-stimulation occur, treatment should be discontinued.

Administer with caution in defected subjects, in patients with renal insufficiency and in epileptics since androgens can aggravate the state of water retention.

Dosage and method of use How to use Proviron: Dosage

For higher dosages, the daily dosage should be divided into 2 or 3 single doses.

Intermediate doses (25 and 75 mg) can be obtained by halving the tablet along the predetermined mark.

At the beginning of the therapy 50-75 mg of Proviron per day; afterwards it goes down to a dosage of 25-50 mg of Proviron per day.

To maintain the therapeutic results obtained, in many cases 25 mg of Proviron per day are sufficient.

Depending on the type and intensity of the disease or disorders it is advisable to administer Proviron for 4-6 weeks or a prolonged and continuous treatment for several months. If necessary, these therapeutic cycles can be repeated several times.

Continuous treatment is essential for hypogonadism: for the development of secondary sexual characteristics, 75-100 mg of Proviron per day are required for several months; for maintenance therapy, 50 mg of Proviron per day is generally sufficient.

In oligospermia a dosage of 50-75 mg of Proviron per day is recommended for the duration of a whole spermiogenic cycle (about 90 days). In patients with reduced gonadotropinuria, an additional treatment with gonadotropins is recommended at the beginning of therapy. It may sometimes be necessary to repeat the Proviron treatment after a break of a few weeks.

Side Effects What are the side effects of Proviron

In case of prolonged treatments, excessive sexual, nervous and psychic stimulation may occur. Rarely, hypercalcaemia, fluid retention and hypersensitivity reactions may occur with the use of androgens.

Any occurrence of any undesirable effect not described in this leaflet during treatment must be promptly reported to the treating physician or pharmacist.

Expiry and Retention

Warning: do not use the medicine after the expiry date shown on the package.

Do not store above 25 ° C.

Composition and pharmaceutical form

Composition

1 Proviron tablet contains 50 mg of mesterolone (17ß hydroxy-1α methyl-5α-androstan-3-one).

Excipients: lactose, corn starch, colloidal silica, polyvinylpyrrolidone 25,000, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, magnesium stearate.

Pharmaceutical form and packaging

Box with 2 blisters of 10 tablets of 50 mg.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information on Proviron can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

PROVIRON

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: mesterolone 50 mg.

03.0 PHARMACEUTICAL FORM

Oral tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Male hypogonadism.

Treatment of male hypogonadism should be carried out when the testosterone deficiency has been confirmed by the clinical picture and biochemical analyzes.

04.2 Posology and method of administration

In particular in hypogonadism, for the development of secondary sexual characteristics, the dosage is 75-100 mg of PROVIRON (1½-2 tablets) per day for several months; 50 mg per day is sufficient for maintenance therapy.

In oligospermia, a dosage of 50-75 mg of PROVIRON (1-1½ tablet) per day is recommended for the duration of a spermiogenic cycle (approximately 90 days). Sometimes it may be necessary to repeat the treatment after a break of a few weeks. In patients with reduced gonadotropinuria, additional initial treatment with gonadotropins is recommended.

Patients with impaired hepatic function

No formal studies have been conducted in patients with hepatic impairment. PROVIRON is contraindicated in men with present or previous liver tumors (see section 4.3).

Patients with impaired renal function

No formal studies have been conducted in patients with impaired renal function.

04.3 Contraindications

Carcinoma of the prostate and breast in men, present or previous liver tumors, already known hypersensitivity to androgens.

04.4 Special warnings and appropriate precautions for use

The use of PROVIRON is reserved exclusively for male patients.

Androgens can accelerate the advancement of subclinical prostate cancer and benign prostatic hyperplasia.

It would be advisable, following the usual rules of preventive medicine, to carry out periodic rectal examinations of the prostate.

PROVIRON should be used with caution in cancer patients who are at risk of hypercalcaemia (and associated hypercalciuria) due to bone metastases. Regular monitoring of serum calcium concentrations should be recommended for these patients.

Cases of benign and malignant liver tumors have been reported in users of hormonal substances such as androgenic compounds. If abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in men using PROVIRON, the possibility of liver cancer should be considered in the differential diagnosis.

Administer with caution in defected subjects, in epileptics and in patients with renal insufficiency, since androgens can aggravate the state of water retention. Caution should be used in patients predisposed to edema as treatment with androgens may lead to increased sodium retention.

In patients suffering from severe heart, liver or kidney failure or ischemic heart disease, treatment with androgens can cause severe complications characterized by edema with or without congestive heart failure. In these cases, the treatment should be stopped immediately.

Androgen therapy can lead to an increase in blood pressure and PROVIRON should be used with caution in hypertensive individuals.

Androgen therapy may be associated with an increase in hematocrit, red blood cell count or hemoglobin. In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored at regular intervals: hemoglobin and hematocrit, liver function parameters and lipid profile.

There is limited experience on the safety and efficacy of the use of PROVIRON in patients over 65 years of age.

In elderly subjects it must be carefully observed that the treatment does not cause unwanted nervous, mental or physical stimulation.

If symptoms of sexual over-stimulation occur, treatment should be discontinued.

04.5 Interactions with other medicinal products and other forms of interaction

There are no known interactions between mesterolone and other substances.

04.6 Pregnancy and lactation

PROVIRON is for male patients only.

04.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No effect on the ability to drive and use machines was observed in users of PROVIRON.

04.8 Undesirable effects

In case of prolonged treatments, excessive sexual, nervous and psychic stimulation can occur. Rarely, with the use of androgens, hypercalcemia, water retention and hypersensitivity reactions can occur.

Following the use of androgens there have been reports of increased hematocrit, increased erythrocyte count, increased hemoglobin.

04.9 Overdose

There is no news of any morbid situations caused by overdose. Should this occur, no treatment will normally be required; however, if the overdose is discovered within the first two or three hours and is of such a magnitude as to require treatment, gastric lavage may be performed.

However, there are no specific antidotes and any further treatment must be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Mesterolone is an orally active synthetic steroid, characterized, chemically, by being the 1-methyl derivative of dihydrotestosterone, the biologically active form of the physiological hormone, of which it possesses all the pharmacological characteristics.

Mesterolone, at therapeutic doses, does not inhibit pituitary gonadotropic function and therefore does not depress testicular augmentation, as well as spermiogenetic activity.

05.2 Pharmacokinetic properties

After oral administration, mesterolone is absorbed from the gastrointestinal tract and reaches the circulation without undergoing hepatic inactivation.

The maximum blood concentration, which is added to that of endogenous testosterone, is reached in about 3 hours with a half-life of about 8 hours.

Mesterolone binds to the same globulin as testosterone, but more firmly.

The active substance follows metabolic pathways very similar to those of testosterone, but, unlike the latter, it is not aromatized into estrogen; excretion occurs mainly in the urine and the main metabolite is a 17-ketosteroid.

05.3 Preclinical safety data

Acute, sub-acute or chronic toxicity could not be determined even after oral administration of very high doses of PROVIRON in experimental animals (mouse, rat, guinea pig, rabbit, dog).The absence of a methyl group in position 17 probably motivates the excellent hepatic tolerability of mesterolone.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Lactose, corn starch, colloidal silica, polyvinylpyrrolidone 25,000, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, magnesium stearate.

06.2 Incompatibility

Not known.

06.3 Period of validity

5 years.

06.4 Special precautions for storage

Do not store above 25 ° C.

06.5 Nature of the immediate packaging and contents of the package

PVC / Aluminum blister

Box with 20 divisible tablets of 50 mg.

06.6 Instructions for use and handling

Not relevant.

07.0 MARKETING AUTHORIZATION HOLDER

Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 021938055

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

01.03.1971/01.06.2010

10.0 DATE OF REVISION OF THE TEXT

01/2015

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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