Qlaira, film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIENOGEST; ESTRADIOL VALERATE

Available from:

Bayer PLC

ATC code:

G03AB08

INN (International Name):

DIENOGEST; ESTRADIOL VALERATE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DIENOGEST 4.41 mg; ESTRADIOL VALERATE

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2009-01-07

Patient Information leaflet

Page 1 of 21
PACKAGE LEAFLET: INFORMATION FOR THE USER
QLAIRA FILM-COATED TABLETS
Estradiol valerate/Dienogest
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly
•
They slightly increase the risk of having a blood clot in the veins
and arteries,
especially in the first year or when restarting a combined hormonal
contraceptive
following a break of 4 or more weeks
•
Please be alert and see your doctor if you think you may have symptoms
of a blood
clot (see section 2 “Blood clots”)
WHAT IS IN THIS LEAFLET:
1. What Qlaira is and what it is used for
...................................................2
2. What you need to know before you take
Qlaira.....................................2
WHEN NOT TO TAKE QLAIRA
4
WARNINGS AND PRECAUTIONS
4
BLOOD CLOTS
5
QLAIRA AND CANCER
9
BLEEDING BETWEEN PERIODS
10
WHAT TO DO IF NO BLEEDING OCCURS ON DAY 26 OR THE
FOLLOWING DAY(S)
10
OTHER MEDICINES AND QLAIRA
10
QLAIRA WITH FOOD AND DRINK
11
LABORATORY TESTS
11
PREGNANCY AND BREAST-FEEDING
11
DRIVING AND USING MACHINES
11
QLAIRA CONTAINS LACTOSE
11
3. How to take Qlaira
...............................................................................11
PREPARATION OF THE WALLET
12
Page 2 of 21
WHEN CAN YOU START WITH THE FIRST WALLET?
12
IF YOU TAKE MORE QLAIRA THAN YOU SHOULD
13
IF YOU FORGET TO TAKE QLAIRA
13
USE IN CHILDREN
15
WHAT TO DO IF YOU VOMIT OR HAVE SEVERE DIARRHOEA
15
IF YOU STOP TAKING QLAIRA
15
4. Possible side effects
..

Summary of Product characteristics

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Qlaira, film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each wallet (28 film-coated tablets) contains in the following order:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and 2 mg
dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3
mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets do not contain active substances
Excipient with known effect: lactose (not more than 50 mg per tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dark yellow film-coated tablet, round with biconvex faces, one side is
marked with
the letters “DD” in a regular hexagon
Medium red film-coated tablet, round with biconvex faces, one side is
marked with
the letters “DJ” in a regular hexagon
Light yellow film-coated tablet, round with biconvex faces, one side
is marked with
the letters “DH” in a regular hexagon
Dark red film-coated tablet, round with biconvex faces, one side is
marked with the
letters “DN” in a regular hexagon
White film-coated tablet, round with biconvex faces, one side is
marked with the
letters “DT” in a regular hexagon
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
Treatment of heavy menstrual bleeding in women without organic
pathology who
desire oral contraception.
The decision to prescribe Qlaira should take into consideration the
individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Qlaira compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
Page 2 of 22
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral use
POSOLOGY
HOW TO TAKE QLAIRA
Tablets must be taken in the order directed on the package every day
at about the
same time with some liquid as needed. Tablet