YAZ PLUS

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

DROSPIRENONE; ETHINYLESTRADIOL AS BETADEX CLATHRATE; LEVOMEFOLATE CALCIUM; LEVOMEFOLATE CALCIUM

MAH:

BAYER ISRAEL LTD

ATC_code:

G03CA53

pharmaceutical_form:

FILM COATED TABLETS

composition:

LEVOMEFOLATE CALCIUM 0.451 MG; ETHINYLESTRADIOL AS BETADEX CLATHRATE 0.02 MG; DROSPIRENONE 3 MG; LEVOMEFOLATE CALCIUM 0.451 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

therapeutic_area:

ESTRADIOL, COMBINATIONS

therapeutic_indication:

- Oral contraception. - Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in women who choose to use an oral contraceptive as their method of birth control.- Treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. - In women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

authorization_date:

2019-09-30

PIL

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 89354609
PZ: 2701A-4
code-no.:
name: LF-BRO YAZ PLUS TAFI 3X28
country: IL/MULI/BAG
colors: BLACK /
version: 03.01.2023/02
Restricted Document
dimension: 95 X 66 MM
page 54
colors: BLACK /
54
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
YAZ PLUS
FILM-COATED TABLETS
Each pink tablet contains:
Drospirenone 3 mg
Ethinylestradiol (as betadex clathrate) 0.02 mg
Levomefolate calcium 0.451 mg
Each light-orange tablet contains:
Levomefolate calcium 0.451 mg
Inactive ingredients and allergens: See section 6 “Additional
information” and
section 2 “Important information regarding some of the ingredients
of the
medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 89354609
PZ: 2701A-4
code-no.:
name: LF-BRO YAZ PLUS TAFI 3X28
country: IL/MULI/BAG
colors: BLACK /
version: 03.01.2023/02
Restricted Document
dimension: 95 X 66 MM
page 55
colors: BLACK /
55
This medicine has been prescribed for you to prevent pregnancy. Do not
pass it
on to others. It may harm them even if it seems to you that the
purpose of use
is similar.
ESSENTIAL INFORMATION ABOUT THE MEDICINE
•
Do not use Yaz Plus if you smoke and are over 35 years of age. Taking
birth
control pills while smoking increases your risk of developing serious
cardiac
side effects (cardiovascular problems), including death due to heart
attack,
blood clots or stroke. This risk increases with age and the number of
cigarettes
you smoke.
•
Birth control pills lower the chance of becoming pregnant if taken
according to
the instructions. They do not protect against contraction of AIDS or
any other
sexually transmitted disease.
1)
WHAT IS THIS MEDICINE INTENDED FOR?
Yaz Plus is i

SPC

1
YAZ PLUS
Film coated tablets
Drospirenone
3 mg
Ethinylestradiol as betadex calthrate
0.02 mg
Levomefolate calcium
0.451 mg
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION
ORAL CONTRACEPTIVES (COC) USE. THIS RISK INCREASES WITH AGE,
PARTICULARLY IN WOMEN OVER
35 YEARS OF AGE, AND WITH THE NUMBER OF CIGARETTES SMOKED. FOR THIS
REASON, COCS SHOULD
NOT BE USED BY WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE _[SEE
CONTRAINDICATIONS (4)]_.
1 INDICATIONS AND USAGE
- Oral contraception.
- Treatment of symptoms of premenstrual dysphoric disorder (PMDD ) in
women who choose to use an oral contraceptive
as their method of birth control.
- Treatment of moderate acne vulgaris in women at least 14 years of
age, who have no known contraindications to oral
contraceptive therapy and have achieved menarche.
- In women who choose to use an oral contraceptive as their method of
contraception, to raise folate levels for the purpose
of reducing the risk of a neural tube defect in a pregnancy conceived
while taking the product or shortly after
discontinuing the product.
2 DOSAGE AND ADMINISTRATION
2.1 HOW TO TAKE YAZ PLUS
Take one tablet by mouth at the same time every day. The failure rate
may increase when pills are missed or taken
incorrectly.
To achieve maximum contraceptive and PMDD effectiveness, Yaz Plus must
be taken as directed, in the order directed on
the blister pack. Single missed pills should be taken as soon as
remembered.
2.2 HOW TO START YAZ PLUS
Instruct the patient to begin taking Yaz Plus either on the first day
of her menstrual period (Day 1 Start) or on the first
Sunday after the onset of her menstrual period (Sunday Start).
_Day 1 Start _
During the first cycle of Yaz Plus use, instruct the patient to take
one pink Yaz Plus daily, beginning on Day 1 of her
menstrual cycle. (The first day of menstruation is Day 1.) She should
take one pink Yaz Plus daily for 24 consecutive
days, followed by one light orange tablet