Proviron® - 50tabs / 25mg - Mesterolon - Bayer Schering

Proviron® Mesterolon Bayer Schering

Proviron tablets

Approval number: 14 393
Approval holder: Bayer Austria, Vienna.
Manufacturer: Bayer Schering Pharma, Berlin, Germany and Schering, Weimar, Germany.

Composition
1 tablet contains 25 mg of mesterolone. Other ingredients: lactose, maize starch, povidone 25 000, methyl-4-hydroxybenzoate (E218), propyl-4-
hydroxybenzoate (E216), magnesium stearate.
Properties and efficacy

Mesterolone is an orally applicable androgen. It has only a small central inhibitory effect. Autonomic disturbances and psychotic symptoms with
Drop in performance in middle-aged and elderly, which often occur at the stage age-related decreases testosterone levels can, by Proviron
be eliminated or reduced.

Mesterolone makes oral treatment androgeninefficency more or less pronounced forms of hypogonadism.
The promotional Androgeneffekte with low central inhibitory effect of mesterolone can use in patients with infertility therapy.
Mesterolone is characterized by a good liver tolerance. Laboratory tests, conducted during the high dose and prolonged treatment
were, gave no evidence for a detrimental effect.

Pharmacokinetics
Mesterolone is protected from rapid degradation in the liver by the 5α-H configuration and the 1α-methyl group. It resembles, in his metabolic
Behavior largely to testosterone. Mesterolone is mainly excreted in the urine and only a small part in the stool. It is the man
not, e.g. Testosterone metabolizes to estrogen.

Applications
Reduced performance in middle and old age:
Attributable to androgen deficiency symptoms such as decreased energy, rapid fatigability, weakening of memory and
Concentration, disturbances of libido and potency, irritability, sleep disturbances, depressive moods, general vegetative complaints
be eliminated or ameliorated by mesterolone.
Erectile dysfunction:
Based on androgen potency problems are eliminated by mesterolone. If other causes play a role alone or in addition, may
It can be administered to support other therapeutic measures.

Hypogonadism:
Growth, development and function of androgen target organs are stimulated by Proviron. When androgen deficiency before completion of the
Puberty it promotes the development of secondary male sex characteristics.
Deficits due to loss of gonadal function after puberty can be cleaned by mesterolone.

Infertility:
Oligozoospermia and Leydig cell insufficiency may be the cause of infertility. By mesterolone can sperm count and quality and the
Fructose concentration in seminal plasma or better normalize and thus increasing the chances of procreation.
Type of Application
The tablets are swallowed whole with liquid.
Dosage
Power reduction and erectile dysfunction:

Beginning of treatment:
1 Proviron tablet 3 times a day. If a satisfactory improvement is achieved, can be tried to reduce this dose.

Further treatment:
1 Proviron tablet 2 - 1 times a day. Depending on the type and intensity of disturbance or discomfort is the dose for further treatment to the individual
Needed basis. It is recommended that a continuous treatment over several months.
When hypogonadism continuous treatment is required:
For the formation of secondary sex characteristics 1 - 2 tablets 3 times daily for several months Proviron.
As maintenance dose is often one Proviron tablet 2 to 3 times daily is sufficient.

When infertility to improve sperm count and sperm quality: 1 Proviron tablet 2 - 3 times daily for a spermatogenic, ie about
For 90 days. The treatment is necessary after several weeks of rest repeated.

To increase the concentration of fructose in the ejaculate at postpuberaler Leydig cell insufficiency:
1 Proviron tablet 2 times daily for several months.
Contraindications
Hypersensitivity to any component of the product; prostate and / or male breast cancer, prior or existing
Liver tumor.

Pregnancy and lactation
Due to the application areas is unnecessary statement.

Side effects
Should it be in individual cases, too frequent or persistent erections occur, the dose is reduced or treatment stopped for
To avoid damage from a permanent erection.
In rare cases, after use of hormonal agents, as it contains Proviron, benign, even more rarely malignant changes in the liver
been observed, which have occasionally led to life-threatening bleeding into the abdominal cavity.
If severe upper abdominal complaints, liver enlargement or signs of intraabdominal haemorrhage occur, a liver tumor in the
included differential diagnosis and, if the drug should be discontinued.
This also applies for mesterolone, although it has been found in long-term and high doses to be extremely well tolerated liver and a
Liver tumor formation by mesterolone is not accepted.

Interactions
Enzyme inducers (eg barbiturates) can accelerate the metabolism lead to a reduction of effect of mesterolone.
Special warnings for safe use
Androgens are not suitable to promote healthy people in the muscle attachment or increase physical performance.
Proviron is exclusively intended for use in male patients.
Since a clinically manifest carcinoma of the prostate and / or breasts may deteriorate by androgens, is Proviron application before the existence
exclude a malignant prostate or breast cancer. During therapy, rectal, and are regularly - if to confirm the diagnosis
perform biopsy examinations, as required in the context of screening in men - is necessary.
Pack sizes: 50.
Shelf life: 60 months.

Storage: Protect from light.
Deadline: Recipe and pharmacies.
SPC: 11 October 1989.
Information as at: April 1998.
PKZ: 50 * ST (EKO: N) [20.75]

Source: paper included in package, translated from german language