Duphaston 10mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

G03DB01

INN (International Name):

DYDROGESTERONE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DYDROGESTERONE 10 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2007-10-01

Patient Information leaflet

Package Leaflet: Information for the user
DUPHASTON
®
10MG FILM-COATED TABLETS
dydrogesterone
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, pharmacist or
nurse.
• 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, pharmacist or
nurse. This includes any side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1 What Duphaston is and what it is used for
2 What you need to know before you take Duphaston
3 How to take Duphaston
4 Possible side effects
5 How to store Duphaston
6 Contents of the pack and other information
1. What Duphaston is and what it is used for
WHAT DUPHASTON IS
Duphaston contains a medicine called “dydrogesterone”.
Dydrogesterone is a man-made hormone. It is very similar to the
hormone “progesterone” made by your body. Medicines like Duphaston
are called “progestogens”
WHAT DUPHASTON IS USED FOR
Duphaston can be used alone or with an estrogen. Whether you take an
estrogen as well, depends on what you are taking the
medicine for.
DUPHASTON IS USED:
FOR PROBLEMS YOU MAY GET WHEN YOUR BODY DOES NOT PRODUCE ENOUGH
PROGESTERONE:
to relieve painful periods
to relieve the symptoms of endometriosis (a problem caused by growth
of the womb lining outside the womb)
to treat infertility due to low level of progesterone
to control irregular periods (that come at the wrong time or not at
all)
to relieve the symptoms of premenstrual syndrome (PMS).
to re-start periods that have stopped before the menopause
(amenorrhoea)
to stop or prevent unusually heavy or long periods (often due to the
start of the menopause).
TO TREAT THE SIGNS OF YOUR MENOPAUSE – THIS TREATMENT IS CALLED
HORMONE REPLACEMENT THERAPY OR ‘HRT’.
Duphaston is used wit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duphaston 10 mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone.
Excipients: each tablet contains 111.1mg lactose monohydrate. For a
full list of excipients, see
section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A round, biconvex, scored, white film-coated tablet, one side with
inscription “155” on either side of
the score.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the management of conditions associated with progesterone
insufficiency: dysmenorrhoea,
endometriosis, infertility, irregular menstrual cycles and
pre-menstrual syndrome.
The drug may be used with an estrogen in the management of
dysfunctional bleeding or secondary
amenorrhoea, or in association with estrogen in hormone replacement
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosages, treatment schedule and duration of treatment may be adapted
to the severity of the
dysfunction and the clinical response.
Dysfunctional uterine bleeding:
When treatment is started to
_ _
arrest a bleeding episode Duphaston 10 mg b.d.(twice a day) for five
to
seven days.
For continuous treatment
Duphaston 10 mg b.d. from day 11 to day 25 of the cycle.
Withdrawal bleeding occurs if the endometrium has been adequately
primed with either endogenous
or exogenous estrogen.
Secondary amenorrhoea:
Duphaston 10 mg b.d. from day 11 to 25 to produce an optimum secretory
transformation of an
endometrium that has been adequately primed with either endogenous or
exogenous estrogen.
Pre-menstrual syndrome:
Duphaston 10 mg b.d. from day 12 to 26 of the cycle. The dosage may be
increased if necessary.
Endometriosis:
Duphaston 10 mg two to three times daily from day 5 to 25 of the
cycle, or continuously.
Dysmenorrhoea:
Duphaston 10 mg b.d. from day 5 to 25 of the cycle.
Irregular cycles:
Duphaston 10 mg b.d. from day 11 to