Cerazette Tablet 75 microgram
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
17-12-2013
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Active ingredient:
Desogestrel
Available from:
MSD PHARMA (SINGAPORE) PTE. LTD.
ATC code:
G03AC09
Dosage:
0.075mg
Pharmaceutical form:
TABLET, FILM COATED
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
N.V. Organon
Authorization date:
2013-06-19
Patient Information leaflet
RA 0390 EU S6 (REF 5.0)
CERAZETTE® 75 MICROGRAM FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Cerazette 75 microgram film-coated tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient: lactose < 65 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The tablet is white, round, biconvex and 5 mm in diameter.
On one side it is coded KV
above 2 and on the reverse side Organon*.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indication
Contraception.
4.2
Posology and method of administration
4.2.1 How to take Cerazette
Tablets must be taken
every day at about the same time so that the interval between
two tablets always is 24 hours. The first tablet should
be taken on the first day of
menstrual bleeding. Thereafter one tablet each day is to be
taken continuously,
without taking any notice on possible bleeding. A new blister
is started directly the day
after the previous one.
1.4.3_Proposed Cerazette PI_Clean_20 Nov 2013
4.2.2 How to start Cerazette
No preceding hormonal contraceptive use [in the past month]
Tablet-taking has to start on day 1 of the woman’s natural
cycle (day 1 is the first day
of her menstrual bleeding). Starting
on days 2-5 is allowed, but during the first cycle a
barrier method is recommended for the first 7 days
of tablet-taking.
Following first-trimester abortion
After first-trimester abortion it is recommended to
start immediately. In that case there
is no need to use an additional method of contraception.
Following delivery or second-trimester abortion
Contraceptive treatment with Cerazette after delivery can
be initiated before the
menstruations have returned. If more than 21 days have elapsed pregnancy ought
to
be ruled out and an additional met
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