QLAIRA FILM-COATED TABLET

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE

Disponible des:

BAYER CO. (MALAYSIA) SDN. BHD.

Designació comuna internacional (DCI):

DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE

Unidades en paquete:

84Tablet Tablets; 168Tablet Tablets; 28Tablet Tablets

Fabricat per:

Bayer Weimar GmbH und Co. KG

Informació per a l'usuari

Not Applicable

Fitxa tècnica

Reference : Qlaira film -coated tablets/ CCDS Version 11.0/12 Dec 2018 , Qlaira film -coated tablets/ xCCDS Version 11.0/ 03 Jun 201 9
Qlaira ®
Film -Coated Tablets 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 t ablets 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 estrad iol valerate
2 hormone -free white film -coated tablets.
3. PHARMACEUTICAL FORM
Film -coated tablet
4. CLINICAL PARTICULARS
4.1 Therapeutic indications Oral contraception . Tre atment of heavy menstrual bleeding in women wit hout organic pathology who d esire to use oral contraception.
4.2 Dosage and method of administration
Method of administration
Oral use
Dosage regimen
How to take Qlaira
Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The fa ilure 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 2 8 consecutive days. Each subsequent pack is started the day
after the last tablet of the previous calendar pack. Withdrawal bleeding usually starts during the intake of the last tablets of a
calendar pack and may not have finished before the next calendar pack is started. In some women, the bleeding starts after
the first tablets of the new calendar pack are taken.
How to start Qlaira
► No preceding hormonal contraceptive use (in the past month)
Tablet -taking has to start on day 1 of the woman’s natural cy cle (i.e. the first day of her menstrual bleeding).
► Changing from a combined hormonal contraceptive (combined oral contraceptive /COC