Utrogestan 100 mg Capsules, Soft

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Progesterone

Dostopno od:

Besins Healthcare S.A.

Koda artikla:

G03DA; G03DA04

INN (mednarodno ime):

Progesterone

Odmerek:

100 milligram(s)

Farmacevtska oblika:

Capsule, soft

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Pregnen (4) derivatives; progesterone

Status dovoljenje:

Not marketed

Datum dovoljenje:

1988-02-09

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
Utrogestan
®
100mg Soft Capsules
progesterone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.

If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Utrogestan is and what it is used for
2.
Before you take Utrogestan
3.
Safety of HRT
4.
How to take Utrogestan
5.
Possible side effects
6.
How to store Utrogestan
7.
Further information
1.
WHAT UTROGESTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Utrogestan 100mg Soft Capsules
(called Utrogestan in this leaflet). Utrogestan contains a
hormone called progesterone and is to be used with another
medicine called oestrogen. The combination of Utrogestan and
oestrogen belongs to a group of medicines called hormone
replacement therapy (HRT).
WHAT UTROGESTAN IS USED FOR
Utrogestan 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 used with another hormone called oestrogen.
Utrogestan is not a contraceptive.
HOW UTROGESTAN WORKS

As you get near to the menopause, the amount of the
female hormones oestrogen and progesterone in your body
goes down.

HRT like Utrogestan replaces these hormones and helps
reduce the symptoms of the menopause.
WHY UTROGESTAN IS TAKEN WITH OESTROGEN

If your HRT contains only oestrogen 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.
BEFORE YOU TAKE UTROGESTAN
DO NOT TAKE UTROGES

Lastnosti izdelka

Health Products Regulatory Authority
18 January 2019
CRN008NZ8
Page 1 of 9
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 progesterone as the active ingredient.
Excipient(s) with known effect: contains 1.0mg soya bean lecithin.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule (capsules)
Oblate, spheroid, white, opaque soft gelatin capsules containing a
white paste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As the progesterone component in hormonal replacement therapy for the
menopause.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is 200 mg at bedtime, for 12 days in the last
half of each
therapeutic cycle (beginning on Day 15 and ending on Day 26).
4.3 CONTRAINDICATIONS

Confirmed pregnancy (see Section 4.6);

Lactation;

Severe disturbances of liver function (including porphyria) or past
history
as long as liver function tests have not returned to normal, previous
or
existing liver tumours;

Rotor syndrome;

Dubin-Johnson syndrome;

Severe cardiac disease,

Severe renal disease;

Jaundice or general pruritus during a previous pregnancy;

Active or past deep venous thrombosis;
Health Products Regulatory Authority
18 January 2019
CRN008NZ8
Page 2 of 9

Arterial thromboembolic disorders or a past history of these
conditions;

Sickle cell anaemia;

Severe diabetes with vascular changes;

Suspected or existing hormone dependent disorders or tumours of the
uterus, breast or ovaries;

Past history of breast cancer

Undiagnosed irregular vaginal bleeding;

Disturbances of lipid metabolism;

History of herpes gestations; untreated endometrial hyperplasia,

Porphyria, otosclerosis with deterioration in previous pregnancies;

Endometriosis;

Hypersensitivity to soya lecithin and any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For the treatment of post menopaus