QLAIRA FILM-COATED TABLET
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
09-07-2014
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Active ingredient:
(dark red tablets) Estradiol valerate, micro 20
Available from:
BAYER (SOUTH EAST ASIA) PTE LTD
ATC code:
G03AB08
Dosage:
1.000 mg
Pharmaceutical form:
TABLET, FILM COATED
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
BAYER WEIMAR GMBH UND CO. KG (WEIMAR PLANT)
Authorization date:
2010-08-13
Patient Information leaflet
Qlaira_SG_Approved PI_CCDS8_4 June 2014
1. NAME OF THE MEDICINAL PRODUCT
Qlaira film-coated tablets
Estradiol valerate/Dienogest
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
26 hormone-containing film-coated tablets in the
following order:
2 dark yellow tablets each containing 3mg estradiol valerate
5 medium red tablets each containing 2mg estradiol valerate and
2mg dienogest
17 light yellow tablets each containing 2mg estradiol valerate
and 3mg dienogest
2 dark red tablets each containing 1mg estradiol valerate
2 hormone-free white film-coated tablets
For excipients, see ‘PHARMACEUTICAL PARTICULARS’.
3. PHARMACEUTICAL FORM
Film-coated tablets
The hormone-containing tablet is dark yellow, medium red,
light yellow or dark red and round with
convex faces, one side is embossed with
the letters ‘DD’, ‘DJ’, ‘DH’ or ‘DN’, in a
regular hexagon,
respectively.
The hormone-free tablet is white, round with convex faces, one
side is embossed with the letter ‘DT’
in a regular hexagon.
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
Oral contraception
Treatment of heavy menstrual bleeding in women without
organic pathology who desire oral
contraception.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Oral Use
4.2.2 DOSAGE REGIMEN
HOW TO TAKE QLAIRA
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1% per
year. The failure rate may increase when pills are missed or taken
incorrectly._ _
Tablets must be taken in the order directed on the package
every day at about the same time with
some liquid as needed. Tablet taking is continuous. One tablet is to be taken
daily for 28
consecutive days. Each subsequent pack is started the day after
the last tablet of the previous
Qlaira_SG_Approved PI_CCDS8_4 June 2014
calendar pack.
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