YAZ

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

DROSPIRENONE; ETHINYLESTRADIOL

Tilgjengelig fra:

BAYER ISRAEL LTD

ATC-kode:

G03AA12

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

DROSPIRENONE 3 MG; ETHINYLESTRADIOL 0.02 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Terapeutisk gruppe:

DROSPIRENONE AND ESTROGEN

Terapeutisk område:

DROSPIRENONE AND ESTROGEN

Indikasjoner:

- Oral contraception. - Treatment of moderate acne vulgaris in women who seek oral contraception. - Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who have chosen oral contraceptives as their method of birth control. The efficacy of Yaz for PMDD was not assessed beyond 3 cycles. Yaz has not been evaluated for treatment of PMS ( premenstrual syndrome ).

Autorisasjon dato:

2014-07-31

Informasjon til brukeren

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 89115582
PZ: 2642A-4B
code-no.:
name: LF-BRO YAZ TAFI 3X28
country: IL/MULI/BAG
colors: BLACK
version: 07.09.2022/06
Restricted Document
dimension: 90 X 65 MM
page 69 / PANT389C
69
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
YAZ
FILM-COATED TABLETS
Each pink tablet contains:
Drospirenone 3 mg
Ethinylestradiol (as betadex clathrate) 0.02 mg
The white tablets do not contain active ingredients.
Inactive ingredients and allergens: see section 2 under ‘Important
information about
some of this medicine’s ingredients’, and 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.
89115582_06.indd 69
07.09.2022 10:32:44
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 89115582
PZ: 2642A-4B
code-no.:
name: LF-BRO YAZ TAFI 3X28
country: IL/MULI/BAG
colors: BLACK
version: 07.09.2022/06
Restricted Document
dimension: 90 X 65 MM
page 70 / PANT389C
70
ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND
ABOUT THE MEDICINE
•
When used properly, combined hormonal contraceptives are considered
one of
the most reliable reversible methods of contraception.
•
They slightly increase the risk of a blood clot in the veins and
arteries, especially
in the first year or when resuming treatment with a combined hormonal
contraceptive following a break of 4 or more weeks.
•
You must be alert and refer to the doctor if you think you have
symptoms of a
blood clot (see “Blood clots” in section 2).
1) WHAT IS THE MEDICINE INTENDED FOR?
Yaz is intended to prevent pregnancy and to treat moderat

Preparatomtale

1. NAME OF THE MEDICINAL PRODUCT
YAZ
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
24 light pink film-coated tablets:
Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex
clathrate) and 3 mg
drospirenone.
Excipient with known effect: lactose monohydrate 48.18 mg
4 white placebo (inactive) film-coated tablets:
The tablet does not contain active substances.
Excipient with known effect: lactose monohydrate 23.205 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
The active tablets are light pink, round with convex faces; one side
embossed with the letters "DS"
in a regular hexagon.
The placebo tablets are white, round with convex faces, one side
embossed with the letters "DP"
in a regular hexagon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Oral contraception.
•
Treatment of moderate acne vulgaris in women who seek oral
contraception.
•
Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in
women who have
chosen oral contraceptives as their method of birth control. The
efficacy of YAZ for PMDD was
not assessed beyond 3 cycles. YAZ has not been evaluated for treatment
of PMS
(premenstrual syndrome).
The decision to prescribe YAZ should take into considerat
ion the individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with YAZ
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 YAZ
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. 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
pack. Withdrawal bleeding usually starts on day 2-3 after starting the
placebo tablets (last row) and
may not have finished before the next pack is started.