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.
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
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