Yasminelle 0.02mg/3mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DROSPIRENONE, ETHINYLESTRADIOL

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

G03AA12

INN (International Name):

ETHINYLESTRADIOL 0.02 mg DROSPIRENONE 3 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETHINYLESTRADIOL 0.02 mg DROSPIRENONE 3 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2006-07-31

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
YASMINELLE 0.02 MG/3 MG FILM-COATED TABLETS
ethinylestradiol/drospirenone
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 Yasminelle is and what it is used for
..............................................................................
2
2.
What you need to know before you take Yasminelle
.............................................................. 2
When you should not use Yasminelle
.......................................................................................
2
Warnings and precautions
.........................................................................................................
4
Blood clots
................................................................................................................................
5
Yasminelle and cancer
..............................................................................................................
9
Psychiatric disorders
......................................................................................

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Yasminelle 0.02 mg/3 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex
clathrate) and 3 mg drospirenone.
Excipient with known effect: lactose 46 mg (as lactose monohydrate
48.18 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light pink, round tablets with convex faces, one side marked with the
letters "DS" in a regular hexagon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Yasminelle should take into consideration
the individual woman’s current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with
Yasminelle compares with other combined hormonal
contraceptives (CHCs), see sections 4.3 and 4.4.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_: oral use
_POSOLOGY _
HOW TO TAKE YASMINELLE
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order shown on the blister
pack. One tablet is to be taken daily for 21 consecutive days. Each
subsequent pack is started after a 7-day tablet-free interval,
during which time a withdrawal bleed usually occurs. This usually
starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
HOW TO START YASMINELLE
•
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual bleeding).
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Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring, or transdermal
patch
The woman should start with Yasminelle preferably on the day after the
last active tablet (the last tablet containing the active
substances) of her previous COC, but at the latest on the day
following th