Dydrogesterone 10mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Vara einkenni Vara einkenni (SPC)
17-05-2024

Virkt innihaldsefni:

Dydrogesterone

Fáanlegur frá:

Special Order

ATC númer:

G03DB01

INN (Alþjóðlegt nafn):

Dydrogesterone

Skammtar:

10mg

Lyfjaform:

Oral tablet

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06040102

Vara einkenni

                                PRESCRIBING INFORMATION
DUPHASTON
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Duphaston10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A round, biconvex, scored, white film-coated tablet, one side with
inscription ‘155’ on either
side of the score (size 7 mm).
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
Cases where progesterone supplement is needed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The
following
dosage
regimens
are
recommended
for
treatment
with
Duphaston.
The
quantities can be adjusted according to the seriousness of the
disorder to be treated and the
individual patients’ responses to the treatment.
_Regulation of the cycle _
It is possible to achieve a cycle lasting 28 days by giving 1 tablet
of Duphaston a day from the
11
th
to the 25
th
day of the cycle.
_Endometriosis _
1 to 3 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle or for the entire
cycle.
Dosages
of
10
mg
several
times
a
day
should
be
spread
over
the
day.
It
is
recommended that treatment should start at the highest dose.
_Dysmenorrhoea _
1 to 2 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle. Dosages of 10 mg
several times a day should be spread over the day. It is recommended
that treatment should
start at the highest dose.
_Infertility as a result of corpus luteum insufficiency _
1 tablet of Duphaston a day from the 14
th
to the 25
th
day of the cycle.
Treatment should be continued for at least 6 consecutive cycles. It is
advisable to continue
this treatment for the first months of any pregnancy at dosages as
indicated for habitual
abortion.
_Threatened abortion _
Starting dose: 4 tablets of Duphaston at once followed by 1 tablet of
Duphaston mg every 8
hours. Dosages of 10 mg several times a day should be spread 
                                
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