Yaz plus tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)

Available from:

Bayer Weimar GmbH & Co. KG

ATC code:

G03AA12

INN (International Name):

pink tablet-drospirenone, ethinyl estradiol, levomefolate (levomefolate calcium); light orange tablet-levomefolate (levomefolate calcium)

Dosage:

pink tablet-3mg+ 0,02mg+ 0,451mg

Pharmaceutical form:

tablets film-coated

Units in package:

light orange tablet-0,451mg; (28/24 pink tablet+4 light orange tablet/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-09-05

Summary of Product characteristics

NDA 22532 Yaz Plus FDA Approved Clean 14Aug2017
1
RESTRICTED
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION
NEEDED TO USE YAZ PLUS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR YAZ PLUS.
YAZ PLUS (DROSPIRENONE/ETHINYL ESTRADIOL/
LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE
CALCIUM TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND SERIOUS
CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._

WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE YAZ PLUS.
(4)

CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR
EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
----------------------------INDICATIONS AND
USAGE---------------------------
Yaz Plus is an estrogen/progestin COC containing a folate, indicated
for use
by women to:

Prevent pregnancy. (1.1)

Treat symptoms of premenstrual dysphoric disorder (PMDD) for women
who choose to use an oral contraceptive for contraception. (1.2)

Treat moderate acne for women at least 14 years old only if the
patient
desires an oral contraceptive for birth control. (1.3)

Raise folate levels in women who choose to use an oral contraceptive
for
contraception. (1.4)
----------------------DOSAGE AND ADMINISTRATION-----------------------

Take one tablet daily by mouth at the same time every day. (2.1)

Tablets must be taken in the order directed on the blister pack. (2.1)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Yaz Plus consists of 28 film-coated, biconvex tablets in the following
order
(3):

24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg
ethinyl estradiol (EE) as betadex clathrate and 0.451 mg levomefolate
calcium

4 light orange tablets, each containing 0.451 mg levomefolate calcium
-------------------------------CONTRAINDICATIONS------------------------------

Renal impairment (4)

Adrenal insufficiency (4)

A high risk of arterial or venous thrombotic diseas