Yaz plus

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

INN (International Name):

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

Dosage:

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

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Summary of Product characteristics

1
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
1.1
ORAL CONTRACEPTIVE
Yaz Plus
®
is indicated for use by women topreventpregnancy.
1.2
PREMENSTRUAL DYSPHORIC DISORDER (PMDD)
Yaz Plusis also indicated for the treatment of symptoms of
premenstrual dysphoric disorder (PMDD) in women who
chooseto use an oral contraceptive as their method of contraception.
The effectiveness ofYaz Plusfor PMDD when used
for morethan three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and
Statistical Manual-4th edition (DSM-IV)
includemarkedly depressed mood, anxiety or tension, affective
lability, and persistent anger or irritability. Other features
includedecreased interest in usual activities, difficulty
concentrating, lack of energy, change in appetite or sleep, and
feeling out
ofcontrol. Physical symptoms associated with PMDD include breast
tenderness, headache, joint and muscle pain, bloatingand
weight gain. In this disorder, these symptoms occur regularly during
the luteal phase and remit within a few daysfollowing
onset of menses;the disturbance markedly interferes with work or
school, or with usual social activities andrelationships with
others. Diagnosis is made by healthcare providers according to
DSM-IVcriteria, with symptomatologyassessed prospectively
over at least two menstrual cycles. In making the diagnosis, care
should be taken to rule out othercyclical mood disorders.
Yaz Plushas not been evaluated for the treatment of premenstrual
syndrome (PMS).
1.3
ACNE
Yaz Plusis indicated for the treatment of moderate acne vulgaris in
women at least 14 years of age, who have no
knowncontraindications to oral contraceptive therapy and have achieved
menarche.Yaz Plusshould be used for the
treatment ofacne only if the patient desires an oral contraceptive for
birth control.
1.4
FOLATE SUPPLEMENTATION
Yaz Plusis indicatedin women who choose to use an oral contraceptive
as their method of contraception,to
raisefolatelevels for the purpose of reducing the risk of a neural
t