Utrogestan 200mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Progesterone

Available from:

Besins Healthcare (UK) Ltd

ATC code:

G03DA04

INN (International Name):

Progesterone

Dosage:

200mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040102; GTIN: 5060139530224

Patient Information leaflet

PATIENT INFORMATION LEAFLET
UTROGESTAN 200MG 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 include 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 200mg 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, rather like
a period.
2.
What you need to know before you take Utro

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Utrogestan 200mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg micronised progesterone.
Excipients with known effect: Soybean 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 200mg 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 oestrogens, the following apply:
•
Known, past or suspected breast cancer
•
Known or suspected estrogen-dependent malignant tumours (_e.g_ genital
tract carcinoma)
•
Undiagnosed genital bleeding
•
Thrombophlebitis
•
Previous or current thromboembolism disorders (_e.g_. deep venous
thrombosis, pulmonary
embolism)
•
Known thrombophilic disorders
•
Acute liver disease, or a history of liver disease as long as liver
function tests have failed to
return to normal
•
Known hypersensitivity to the active substances, soybean lecithin,
peanut or to any of