PROVIRON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MESTEROLONE

Available from:

BAYER ISRAEL LTD

ATC code:

G03BB01

Pharmaceutical form:

TABLETS

Composition:

MESTEROLONE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Therapeutic group:

MESTEROLONE

Therapeutic area:

MESTEROLONE

Therapeutic indications:

Androgen therapy. Androgen deficiency or male infertility when associated with primary or secondary male hypogonadism.

Authorization date:

2012-06-30

Patient Information leaflet

PROVIRON
®
TABLETS
In the event of an erection - a sign of overdosage
(rare): consult your doctor immediately!
In the event that you experience side effects not
mentioned in this leaflet, or if there is a change
in your general health, consult your doctor
immediately.
DOSAGE:
Dosage is according to doctor‘s instructions only.
Do not exceed the recommended dosage.
THIS MEDICINE IS NOT USUALLY INTENDED FOR USE IN
CHILDREN AND INFANTS.
This medicine is to be taken at specific time intervals
as determined by the attending doctor.
If you forget to take this medicine at the specified
time, take the dose as soon as you remember, but
never take a double dose to compensate for a missed
one!
DIRECTIONS FOR USE:
Do not chew! Swallow the medicine with a small
amount of water.
Do not halve the tablet.
HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF THE
TREATMENT?
Complete the full course of treatment as instructed
by the doctor.
Even if there is an improvement in your health,
do not discontinue use of this medicine without
consulting your doctor.
AVOID POISONING!
This medicine, and all other medicines, must be
stored in a safe place out of the reach of children
and/or infants, to avoid poisoning.
If you have taken an overdose, or if a child has
accidentally swallowed the medicine, proceed
immediately to a hospital emergency room and
bring the package of the medicine with you.
Do not induce vomiting unless explicitly instructed
to do so by a doctor!
This medicine has been prescribed for the treatment
of your ailment; in another patient it may cause
harm.
DO NOT GIVE THIS MEDICINE TO YOUR RELATIVES,
NEIGHBOURS OR ACQUAINTANCES.
Do not take medicines in the dark! Check the label
and the dose each time you take your medicine. Wear
glasses if you need them.
STORAGE:
No special storage conditions are required.
Even if kept in their original container and stored as
recommended, medicines may be kept for a limited
period only. Please note the expiry date of the medicine!
In case of doubt, consult the pharmacist who dispensed
the medicine

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
PROVIRON
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg mesterolone.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Androgen deficiency or male infertility when associated with primary
or secondary male hypogonadism.
•
REDUCED EFFICIENCY IN MIDDLE AND ADVANCED AGE
Complaints attributable to androgen-deficiency, such as reduced
efficiency, easy fatigability, lack of
concentration, weak memory, disturbances of libido and potency,
irritability, disturbances of sleep,
depressive moods, and general vegetative complaints, can be overcome
or improved by the use of Proviron
tablets.
•
POTENCY DISTURBANCES
Potency disorders based on an androgen deficiency are eliminated by
administration of Proviron. If other
factors are the sole cause or if they contribute to the disorders,
Proviron may be administered in support of
other therapeutic measures.
•
HYPOGONADISM
Growth, development and function of androgen-dependent target organs
are stimulated by Proviron. It
promotes development of secondary male sex characteristics in cases of
prepuberal androgen-deficiency.
Proviron eliminates deficiency symptoms in cases where a loss of
gonadal function has occurred
postpuberally.
•
INFERTILITY
Oligozoospermia and deficient Leydig-cell secretion may be the cause
of infertility. With Proviron, sperm
count and sperm quality as well as the fructose concentration in the
ejaculate can be improved or
normalized, thus increasing the chances of procreation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole with some liquid.
The following dosages are recommended:
•
REDUCED EFFICIENCY AND POTENCY DISTURBANCES:
_Commencement of treatment:_
1 Proviron tablet 3 times per day.
After satisfactory clinical improvement, it can be tried to reduce the
dose.
_Continuation of treatment:_
1 Proviron tablet twice or once per day.
According to the type and severity of the complain