Qlaira

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol valerate 3mg; Dienogest 2mg; Estradiol valerate 2mg; Dienogest 3mg; Estradiol valerate 2mg; Estradiol valerate 1mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Estradiol valerate 3 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Estradiol valerate 3mg Excipient: Hypromellose Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Pregelatinised maize starch Purified talc Titanium dioxide Active: Dienogest 2mg Estradiol valerate 2mg Excipient: Hypromellose Iron oxide red Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Pregelatinised maize starch Purified talc Titanium dioxide Active: Dienogest 3mg Estradiol valerate 2mg Excipient: Hypromellose Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Pregelatinised maize starch Purified talc Titanium dioxide Active: Estradiol valerate 1mg Excipient: Hypromellose Iron oxide red Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Pregelatinised maize starch Purified talc Titanium dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Povidone Pregelatinised maize starch Purified talc Titanium dioxide

Units in package:

Blister pack, PVC/Al blister, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Oral contraception.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al blister - 28 tablets - 5 years from date of manufacture stored at or below 30°C - Blister pack, PVC/Al blister, 3 x 28 tablets - 84 tablets - 5 years from date of manufacture stored at or below 30°C

Authorization date:

2009-07-28

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

210723 Qlaira DS
Page 1 of 25
RESTRICTED
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
QLAIRA
®
3 mg; 2 mg / 2 mg; 2 mg / 3 mg; 1 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dark yellow tablet contains: 3 mg estradiol valerate
Each medium red tablet contains: 2 mg estradiol valerate and 2 mg
dienogest
Each light yellow tablet contains: 2 mg estradiol valerate and 3 mg
dienogest
Each dark red tablet contains: 1 mg estradiol valerate
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
QLAIRA active tablets have 4 presentations: dark yellow film coated
tablets, medium red film
coated tablets, light yellow film coated tablets and dark red film
coated tablets.
QLAIRA placebo tablets are white film coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of heavy and/or prolonged menstrual bleeding in women
without organic
pathology who desire oral contraception.
4.2 DOSE 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 shown to
result in a rapid normalisation of excessive menstrual blood losses.
If QLAIRA has been
taken according to the directions provided under “How to take
QLAIRA” and the patient does
not experience a reduction of her menstrual bleeding after 3 treatment
cycles then treatment
with QLAIRA should be ceased and other treatment options should be
considered.
HOW TO TAKE QLAIRA
Tablets must be taken in the order directed on the wallet pack 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 wallet. Withdrawal bleeding usually starts during the intake
of the last tablets of a
wallet and may not have finished before t