Utrogestan 100 mg capsules, soft

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Progesterone

Dostupné z:

Laboratoires Besins International

ATC kód:

G03DA04

INN (Medzinárodný Name):

Progesterone

Dávkovanie:

100 milligram(s)

Forma lieku:

Capsule, soft

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

progesterone

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2006-07-14

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
Utrogestan
®
100mg Capsules
progesterone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Utrogestan is and what it is used for
2.
What you need to know before you take Utrogestan
3.
How to take Utrogestan
4.
Possible side effects
5.
How to store Utrogestan
6.
Contents of the pack and other information
1.
WHAT UTROGESTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Utrogestan 100mg Capsules(called
Utrogestan in this leaflet). Utrogestan contains a
female hormone called progesterone and is to be used with another
medicine called estrogen. The combination of
Utrogestan and estrogen belongs to a group of medicines called hormone
replacement therapy (HRT).
WHAT UTROGESTAN IS USED FOR
Utrogestan in combination with an estrogen is used to reduce the
symptoms of the menopause (change of life).
•
It is used only in women who still have a womb (uterus). Utrogestan is
not a contraceptive.
HOW UTROGESTAN WORKS
•
As you get near to the menopause, the amount of the female hormones
estrogen and progesterone in your
body goes down.
•
HRT replaces these hormones and helps reduce the symptoms of the
menopause.
WHY UTROGESTAN IS TAKEN WITH ESTROGEN
•
If your HRT contains only estrogen the lining of the womb could build
up. This can cause problems.
•
By taking Utrogestan as well, this makes you shed the womb lining.
This prevents these problems happening.
•
You might get some bleeding at the end of each month, rather like a
period.
2.
WHAT Y

Súhrn charakteristických

Health Products Regulatory Authority
08 June 2022
CRN00CYF7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Utrogestan 100 mg capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg micronized progesterone as the active
ingredient.
Excipients with known effect: Contains 1.0 mg Soybean lecithin.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule (capsules)
Round and slightly yellow soft capsules, containing whitish oily
suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Utrogestan is indicated for adjunctive use with estrogen in
post-menopausal women with an intact uterus, as hormone
replacement therapy (HRT).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In women receiving estrogen replacement therapy there is an increased
risk of endometrial cancer which can be countered by
progesterone administration.
The recommended dose is 200 mg daily at bedtime, for 12 days in the
last half of each therapeutic cycle (beginning on Day 15
of the cycle and ending on Day 26). Withdrawal bleeding may occur in
the following week.
Alternatively, 100 mg can be given at bedtime from Day 1 to Day 25 of
each therapeutic cycle, withdrawal bleeding being less
with this treatment schedule.
_Paediatric population_
There is no relevant use of Utrogestan in the paediatric population.
_Older people_
As for adults
Method of Administration:
Oral
Utrogestan 100 mg Capsules should not be taken with food and should be
taken at bedtime.
Concomitant food ingestion increases the bioavailability of micronized
progesterone.
4.3 CONTRAINDICATIONS
When used in conjunction with estrogens, Utrogestan should not be used
in patients with any of the following conditions

Known hypersensitivity to the active substances, soya lecithin, peanut
or to any of the excipients listed in section
6.1

Known, past or suspected breast cancer

Known or suspected estrogen-dependent malignant tumours (_e.g.
_genital tract carcinoma)

Undiagnosed genital