Yasmin film-coated Tablets 0.03mg/3mg

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

DROSPIRENONE; ETHINYLESTRADIOL

Disponible depuis:

Bayer PLC

Code ATC:

G03AA12

DCI (Dénomination commune internationale):

DROSPIRENONE; ETHINYLESTRADIOL

forme pharmaceutique:

FILM-COATED TABLET

Composition:

DROSPIRENONE 3 mg; ETHINYLESTRADIOL 0.03 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Statut de autorisation:

Authorised

Date de l'autorisation:

2007-07-25

Notice patient

PACKAGING TECHNOLOGY BERLIN SGQWX
Bayer AG
client: 0021
item-no.: 85674552
PZ: 2536A-4D
code-no.: 161
name: LF-BRO-YASMIN FTB 21
country: GB/-/BAG
colors: BLACK
version: 06.03.2017/02
Restricted Document
dimension: 103 X 38 MM
page U1 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C
PACKAGE LEAFLET:
INFORMATION FOR THE USER
0.03 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
52_02.indd cover:1
3/6/2017 9:05:40 AM
PACKAGING TECHNOLOGY BERLIN SGQWX
Bayer AG
client: 0021
item-no.: 85674552
PZ: 2536A-4D
code-no.: 161
name: LF-BRO-YASMIN FTB 21
country: GB/-/BAG
colors: BLACK
version: 06.03.2017/02
Restricted Document
dimension: 103 X 38 MM
page U2 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C
52_02.indd cover:2
3/6/2017 9:06:06 AM
PACKAGING TECHNOLOGY BERLIN SGQWX
Bayer AG
client: 0021
item-no.: 85674552
PZ: 2536A-4D
code-no.: 161
name: LF-BRO-YASMIN FTB 21
country: GB/-/BAG
colors: BLACK
version: 06.03.2017/02
Restricted Document
dimension: 103 X 38 MM
page U3 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C
52_02.indd cover:3
3/6/2017 9:06:06 AM
PACKAGING TECHNOLOGY BERLIN SGQWX
Bayer AG
client: 0021
item-no.: 85674552
PZ: 2536A-4D
code-no.: 161
name: LF-BRO-YASMIN FTB 21
country: GB/-/BAG
colors: BLACK
version: 06.03.2017/02
Restricted Document
dimension: 103 X 38 MM
page U4 / PANTONE 1375 C / PANTONE 116 C / PANTONE 233 C / PANTONE 1788 C
85674552
52_02.indd cover:4
3/6/2017 9:06:06 AM
PACKAGING TECHNOLOGY BERLIN SGQWX
Bayer AG
client: 0021
item-no.: 85674552
PZ: 2536A-4D
code-no.: 161
name: LF-BRO-YASMIN FTB 21
country: GB/-/BAG
colors: BLACK
version: 06.03.2017/02
Restricted Document
dimension: 103 X 38 MM
page 1
BLACK / PANTONE 233 C
1
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
R Keep this booklet. You may need to read it again.
R If you have any further questions, ask your doctor or pharmacist.
R This medicine has been prescribed for you only. Do not pass it on

Résumé des caractéristiques du produit

V025.0
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Yasmin, film-coated tablets, 0.03 mg/3 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg drospirenone and 0.030 mg ethinylestradiol.
Excipient with known effect: lactose 46 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Light yellow, round tablets with convex faces, one side embossed with
the letters "DO" in a
regular hexagon
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Yasmin should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk
of VTE with Yasmin compares with other combined hormonal
contraceptives (CHCs), see
sections 4.3 and 4.4.
V025.0
Page 2 of 24
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION_
Oral use
_POSOLOGY_
HOW TO TAKE YASMIN
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 YASMIN
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).

Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring, or transdermal patch)
The woman should start with Yasmin 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 the usual tablet-free or placebo tablet interval of her
previous COC. In case a
vaginal ring or transdermal patch has been used, the