UTROGESTAN 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROGESTERONE

Available from:

CTS LTD

ATC code:

G03DA04

Pharmaceutical form:

CAPSULES

Composition:

PROGESTERONE 100 MG

Administration route:

PER OS, VAGINAL

Prescription type:

Required

Manufactured by:

LABORATORIES BESINS INTERNATIONAL, FRANCE

Therapeutic group:

PROGESTERONE

Therapeutic area:

PROGESTERONE

Therapeutic indications:

Vaginal or oral addministration: Disorders related to progesterone deficit in particular menopause ( in association with estrogen therapy).Vaginal administration: Progesterone substitution for ovary deprived women in situation of total progesterone deficiency. Supplementation of the luteal phase during in vitro fertilization cycles. Supplementation of the luteal phase during spontaneous or induced cycles, in cases of hypofertility or primary or secondary ovarain failure, particulary through dysovulation. In cases of threatning abortion or prevention of repeated abortions due to proven luteal insufficiency. For all other progesterone indications, in the case of : Adverse events due to progesterone, contraindication of the oral route of administration hepatopathy.

Authorization date:

2015-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
UTROGESTAN 100 capsules for oral or vaginal administration
UTROGESTAN 200 capsules for oral or vaginal administration
The active ingredient and its quantity:
Utrogestan 100: Each capsule contains progesterone (micronized) 100 mg
Utrogestan 200: Each capsule contains progesterone (micronized) 200 mg
Inactive and allergenic ingredients in the preparation - see the
section “Important
information about some of the ingredients of the medicine” and
Section 6.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Oral administration: Treatment of disorders arising from progesterone
deficiency such as:
premenstrual syndrome, irregular menstruation, and during menopause -
combined
therapy with estrogens.
Vaginal administration: In addition to the above activity, for
hormonal support during in
vitro fertilization, spontaneous fertilization or in treatment to
induce ovulation in patients
with fertility problems or impaired ovarian function, for prevention
of repeated
miscarriages, and in cases where oral administration is
contraindicated or caused side
effects in the past.
Therapeutic group: The active ingredient belongs to a group of
hormones called
progestogens.
2. BEFORE USING THE MEDICINE
x Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients contained in the medicine (see Section 6).
•
Your liver function is severely impaired.
•
You have a neoplasm (tumour) of the breast or genital organs,
suspected or
confirmed.
Utrogestan increases the amount of proges

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT:
Utrogestan 100
Utrogestan 200
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Utrogestan 100: Each soft gelatin capsule contains 100 mg of
progesterone in a
micronized form.
Utrogestan 200: Each soft gelatin capsule contains 200 mg of
progesterone in a
micronized form.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
oral or vaginal capsule.
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Vaginal or oral administration:
Disorders related to progesterone deficit in particular menopause ( in
association with
estrogen therapy).
Vaginal administration:
Progesterone substitution for ovary deprived women in situation of
total progesterone
deficiency.
Supplementation of the luteal phase during in vitro fertilization
cycles. Supplementation
of the luteal phase during spontaneous or induced cycles, in cases of
hypofertility or
primary or secondary ovarain failure, particulary through
dysovulation. In cases of
threatning abortion or prevention of repeated abortions due to proven
luteal
insufficiency. For all other progesterone indications, in the case of
: Adverse events due
to progesterone, contraindication of the oral route of administration
hepatopathy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosages should be strictly observed.
Whatever the indication and route of administration (oral or vaginal),
the dosage should
never exceed 200mg per dose.
Oral administration
This medicinal product should be taken on an empty stomach preferably
in the evening
before going to bed.
Usually, the dosage is 200 to 300 mg of progesterone daily in two
intakes: one in the
morning, preferably 2 hours after breakfast, another one to two in the
evening (at
bedtime) , on an empty stomach.
IN LUTEAL INSUFFICIENCY (premenstrual syndrome, benign mastopathy,
menstrual
irregularities), dose is from 200 to 300 mg daily:
- either 200 mg in one intake at bedtime,
- or 300 mg in two intakes.
for 10 days per cycle, usually from the 17th to the