YASMIN

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

DROSPIRENONE; ETHINYLESTRADIOL

Διαθέσιμο από:

BAYER ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

G03AA12

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

DROSPIRENONE 3 MG; ETHINYLESTRADIOL 0.03 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

BAYER AG, GERMANY

Θεραπευτική ομάδα:

DROSPIRENONE AND ESTROGEN

Θεραπευτική περιοχή:

DROSPIRENONE AND ESTROGEN

Θεραπευτικές ενδείξεις:

Oral contraception.

Ημερομηνία της άδειας:

2021-04-30

Φύλλο οδηγιών χρήσης

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: 0021,GV15
material-no.: 89280362
PZ: 2536A-4D
code-no.: 64
name: LF-BRO YASMIN TAFI 21
country: IL/MULI/BAG
colors: BLACK
version: 05.09.2022/04
Restricted Document
dimension: 103 X 38 MM
page 1 /
1
YASMIN®
drospirenone 3 mg
ethinylestradiol 0.03 mg
89280362_04.indd 1
05.09.2022 06:39:41
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: 0021,GV15
material-no.: 89280362
PZ: 2536A-4D
code-no.: 64
name: LF-BRO YASMIN TAFI 21
country: IL/MULI/BAG
colors: BLACK
version: 05.09.2022/04
Restricted Document
dimension: 103 X 38 MM
page 2 /
2
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
YASMIN®
FILM-COATED TABLETS
89280362_04.indd 2
05.09.2022 06:39:41
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: 0021,GV15
material-no.: 89280362
PZ: 2536A-4D
code-no.: 64
name: LF-BRO YASMIN TAFI 21
country: IL/MULI/BAG
colors: BLACK
version: 05.09.2022/04
Restricted Document
dimension: 103 X 38 MM
page 3 /
3
Each film-coated tablet contains:
drospirenone 3 mg
ethinylestradiol 0.03 mg
Inactive ingredients and allergens: see section 6 “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them
even if it seems to you that their medical condition is similar.
89280362_04.indd 3
05.09.2022 06:39:42
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: 0021,GV15
material-no.: 89280362
PZ: 2536A-4D
code-no.: 64
name: LF-BRO YASMIN TAFI 21
country: IL/MULI/BAG
colors: BLACK
version: 05.09.2022/04
Restricted Document
dimension: 103 X 38 MM
page 4 /
4
Yasmin is not intended for women or adolescent girls who still have
not had their first
menstrual period.
ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND
ABOUT THE MEDIC

Αρχείο Π.Χ.Π.

1. NAME OF THE MEDICINAL PRODUCT
Yasmin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg drospirenone and 0.030 mg
ethinylestradiol.
Excipient with known effect: lactose monohydrate 48.17 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.
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 woman should start using Yasmin preferably on the day
of removal, but