Utrogestan 100mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Progesterone

Dostupno od:

Besins Healthcare (UK) Ltd

ATC koda:

G03DA04

INN (International ime):

Progesterone

Doziranje:

100mg

Farmaceutski oblik:

Oral capsule

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 06040102; GTIN: 5060139530217

Uputa o lijeku

4
Manufactured by Cyndea Pharma, S.L., Poligono Industrial Emiliano
Revilla Sanz, Avenida de Agreda, 31, Olvega 42110 (Soria) - Spain.
Procured from within the EU and repackaged by the Product Licence
Holder Beachcourse Ltd., Unit 2-3, Townsend Industrial Estate, Waxlow
Road, London, NW10 7NU.
Revision date: 17.01.2023
PLGB 16378/1179 POM
Utrogestan
®
is a registered trademark of Besins Healthcare Luxembourg
S.A.R.L.
Blind or partially sighted?
Is this leaflet hard to see or read?
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Tel: [phone] for help.
Ref. number: 1179
1
Package Leaflet: Information for the User
UTROGESTAN
® 100 MG CAPSULES
(progesterone)
Your medicine is known by the above name, but will be referred to as
Utrogestan
®
throughout this leaflet.
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
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

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Utrogestan 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg micronised progesterone.
Excipients with known effect: Soyabean lecithin
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsules, soft
White
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Utrogestan is indicated for adjunctive use with oestrogen in
post-menopausal
women with an intact uterus, as hormone replacement therapy (HRT).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
In women receiving oestrogen replacement therapy there is an increased
risk
of endometrial cancer which can be countered by progesterone
administration.
The recommended dose is 200mg daily at bedtime, for twelve 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 100mg 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 100mg Capsules should not be taken with food and should be
taken at bedtime.
Concomitant
food
ingestion
increases
the
bioavailability
of
micronised
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, soybean 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 bleeding
•
Previous or current thromboembolism disorders (_e.g_. deep venous
thrombosis,
pulmonary embolism) or thrombophlebitis
•
Known thrombophilic disorders
•
Acute liver disease, o