YASMIN PLUS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

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

متاح من:

BAYER ISRAEL LTD

ATC رمز:

G03CA53

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LEVOMEFOLATE CALCIUM 0.451 MG; ETHINYLESTRADIOL AS BETADEX CLATHRATE 0.03 MG; DROSPIRENONE 3 MG; LEVOMEFOLATE CALCIUM 0.451 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAYER AG, GERMANY

المجال العلاجي:

ESTRADIOL, COMBINATIONS

الخصائص العلاجية:

Oral contraceptive. 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.

تاريخ الترخيص:

2019-09-30

نشرة المعلومات

PACKAGING TECHNOLOGY BERLIN SGSMZ
page 2
Bayer AG
client: 0021,GV15
material-no.: 89283558
PZ: 2688A-3A
code-no.:
name: LF-INS YASMIN PLUS TAFI 28
country: IL/MULI/BAG
colors: BLACK
version: 27.10.2022/01
Restricted Document
dimension: 355 X 594 MM
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
E
ach orange tablet contains:
drospirenone 3 mg
ethinylestradiol (as betadex clathrate) 0.03 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.
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 Yasmin 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 HIV
(AIDS) or
any other sexually transmitted disease.
1) WHAT IS THIS MEDICINE INTENDED FOR?
Yasmin Plus is intended to prevent pregnancy and also as a folate
supplement
in women who chose to use a birth control pill.
THERAPEUTIC GROUP: Yasmin Plus belongs to a group of medicines called
birth
control pills. Yasmin Plus contains 2 types of female hormones:
synthetic
estrogen (ethinylestradiol) an

خصائص المنتج

1
YASMIN PLUS
Film coated tablets
Drospirenone
3 mg
Ethinylestradiol as betadex calthrate
0.03 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 Contraceptive
- Yasmin Plus is indicated 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 YASMIN 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 effectiveness, Yasmin 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 YASMIN PLUS
Instruct the patient to begin taking Yasmin 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 Yasmin Plus use, instruct the patient to
take one orange Yasmin Plus daily, beginning on Day 1
of her menstrual cycle. (The first day of menstruation is Day 1.) She
should take one orange Yasmin Plus daily for 21
consecutive days, followed by one light orange tablet, containing
levomefolate alone, daily on Days 22 through 28.
Yasmin Plus should be taken in the order directed on the package at
the same time each day, preferably after the evening
meal or at bedtime with some liquid, as needed. Yasmin Plus can be
taken without regard to