Utrogestan 100mg Capsules

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Micronised progesterone

Available from:

Besins Healthcare

ATC code:

G03D

INN (International Name):

Micronised progesterone

Dosage:

100 mg

Pharmaceutical form:

Capsules, soft

Administration route:

Oral use

Units in package:

Pack size: 30 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Besins Manufacturing Belgium

Therapeutic indications:

Adjunctive use with estrogen in post-menopausal women with an intact uterus. (HRT)

Authorization status:

Authorised

Authorization date:

2003-01-10

Patient Information 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.  Content 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 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 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,

Summary of Product characteristics

Utrogestan 100mg Capsules
Summary of Product Characteristics Updated 11­Jun­2014 | Besins Healthcare (UK) Ltd
1. Name of the medicinal product
UTROGESTAN 100MG CAPSULES
2. Qualitative and quantitative composition
Each capsule contains 100 mg micronised progesterone (INN). For excipients, see 6.1.
3. Pharmaceutical form
Capsules, soft
White
4. Clinical particulars
4.1 Therapeutic indications
Adjunctive use with estrogen in post­menopausal women with an intact uterus. (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 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 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.
_Children: _Not applicable.
_Elderly: _As for adults
_Method of Administration: _Oral. Utrogestan 100mg Capsules should not be taken with food
4.3 Contraindications
Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsules contain arachis oil (peanut
oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction. Undiagnosed vaginal
bleeding. Mammary or genital tract carcinoma. Thrombophlebitis. Thromboembolic disorders. Cerebral haemorrhage.
Porphyria.
4.4 Special warnings and precautions for use
_Warnings:_
Utrogestan 100mg Capsules are not a treatment for premature labour.
Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis.
Utrogestan 100mg