QLAIRA estradiol valerate / dienogest tablets composite pack in wallet pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol valerate, Quantity: 3 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Dienogest,estradiol valerate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; povidone; purified talc; maize starch

Administration route:

Oral

Units in package:

3 x 28 film-coated tablets, 1 x 28 film-coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral contraception. Treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.

Product summary:

Visual Identification: White, round, biconvex film-coated tablet, one side embossed with the letters "DT" in a regular hexagon.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-05-14

Patient Information leaflet

Qlaira CMI VX1.0
Page 1 of 10
QLAIRA
®
Contraceptive tablets for women
_estradiol valerate and dienogest _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about Qlaira.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Qlaira against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS, OR
ARE UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST FOR MORE ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT QLAIRA IS
USED FOR
Qlaira is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
Qlaira is used to prevent
pregnancy. It is also used for the
treatment of heavy and/or
prolonged menstrual bleeding
(not caused by any underlying
disease) in women who wish to
use oral contraception.
While taking Qlaira you may also
experience the following
benefits:
•
More regular and lighter
periods – potentially resulting
in a decrease in anaemia (iron
deficiency)
•
a decrease in period pain
Some conditions such as pelvic
inflammatory disease, ovarian
cysts, ectopic pregnancy (where
the foetus is carried outside of
your womb), lumpy breasts and
cancer of the uterus (womb) and
ovaries may be less common in
women taking Qlaira.
Qlaira contains two female sex
hormones called estradiol
valerate (an estrogen) and
dienogest (a progestogen).
The estrogen in Qlaira (estradiol
valerate) is broken down in the
body into a hormone called 17β-
estradiol, which is identical to the
natural estrogen produced by the
female body. The estrogen in
Qlaira is therefore different from
the synthetic estrogen (known as
ethinylestradiol) usually used in
other forms of the Pill.
When taken correctly, Qlaira
prevents you from
becoming pregnant by:
•
inhibiting ovulation (egg
release)
•
changing the cervical mucus
consistency, making it more
di

Summary of Product characteristics

QLAIRA PI VX1.0; CCDS 11
1
RESTRICTED
AUSTRALIAN PRODUCT INFORMATION
QLAIRA (ESTRADIOL VALERATE / DIENOGEST) TABLET
1
NAME OF THE MEDICINE
Estradiol valerate / dienogest
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QLAIRA is a combined oral contraceptive (COC) pill containing the
estrogen estradiol valerate and the
progestogen dienogest.
Each dark yellow active tablet contains 3 mg estradiol valerate.
Each medium red active tablet contains 2 mg estradiol valerate and 2
mg dienogest.
Each light yellow active tablet contains 2 mg estradiol valerate and 3
mg dienogest.
Each dark red active tablet contains 1 mg estradiol valerate.
Excipients with known effect:
All QLAIRA active and placebo tablets contain lactose monohydrate. For
the full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets
Each wallet contains 28 tablets consisting of:
•
2 dark yellow, round, biconvex film-coated tablet, one side embossed
with the letters “DD” in
a regular hexagon;
•
5 medium red, round, biconvex film-coated tablet, one side embossed
with the letters "DJ" in
a regular hexagon;
•
17 light yellow, round, biconvex film-coated tablet, one side embossed
with the letters "DH"
in a regular hexagon;
•
2 dark red, round, biconvex film-coated tablet, one side embossed with
the letters "DN" in a
regular hexagon; and
•
2 white, round, biconvex film-coated placebo tablet, one side embossed
with the letters "DT"
in a regular hexagon.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
QLAIRA is indicated for use as:
•
Oral contraception
QLAIRA PI VX1.0; CCDS 11
2
RESTRICTED
•
Treatment
of
heavy
and/or
prolonged
menstrual
bleeding
in
women
without
organic
pathology who desire oral contraception.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives (COCs), when taken correctly, have a
failure rate of approximately 1%
per year. The failure rate may increase when pills are missed or taken
incorrectly.
Treatment of heavy and/or prolonged menstrual bleeding with QLAIRA has
been