Yaz

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Drospirenone 3mg (micro 15); Ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg)

Tilgængelig fra:

Bayer New Zealand Limited

INN (International Name):

Drospirenone 3 mg (micro 15)

Dosering:

3mg/0.02mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Drospirenone 3mg (micro 15) Ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) Excipient: Lactose monohydrate Magnesium stearate Maize starch Opadry pink 02A34744 Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Titanium dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Titanium dioxide

Enheder i pakken:

Blister pack, PVC/aluminium (starter pack), 28 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Bayer AG

Terapeutiske indikationer:

YAZ is indicated for use as: - an oral contraceptive. - 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).

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC/aluminium (starter pack) - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/aluminium - 84 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisation dato:

2008-02-22

Indlægsseddel

Yaz CMI VX1.0
1
YAZ
®
Contraceptive tablets for women
_drospirenone and ethinylestradiol (as betadex clathrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about YAZ. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking YAZ
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS, OR ARE
UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST FOR MORE ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT YAZ IS USED
FOR
YAZ is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
YAZ is used to prevent
pregnancy.
It is also used to treat moderate
acne and symptoms of
premenstrual dysphoric disorder
(PMDD) in women seeking oral
contraception.
You may also experience the
following benefits:
•
more regular and lighter periods
– potentially resulting in a
decrease in anaemia (iron
deficiency)
•
a decrease in period pain
•
improvement in symptoms like
bloating, swelling or weight
gain related to fluid retention
Some conditions such as pelvic
inflammatory disease, ovarian
cysts, ectopic pregnancy (where
the foetus is carried outside of
your womb), lumpy breasts and
cancer of the uterus (womb), and
ovaries may be less common in
women taking the Pill.
When taken correctly, it prevents
you from becoming pregnant in
several ways, including:
•
inhibiting the egg release by
stopping it maturing
•
changing the cervical mucus
consistency, making it more
difficult for the sperm to reach
the egg.
YAZ has 24 active (hormone)
tablets and 4 inactive tablets,
rather than the traditional 21
active tablets and 7 inactive
tablets. This means that with
YAZ, you take the active
(hormone) tablets for three more
days. This helps your hormone
levels to stay even.
When the Pill is taken by women
under close observation in clin

Produktets egenskaber

YAZ DS VX1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
YAZ
®
20 micrograms / 3 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active light pink tablet contains:
Ethinylestradiol (as betadex clathrate)
20 micrograms
Drospirenone
3 mg
For full list of excipients, see section _6.1 List of excipients_.
3.
PHARMACEUTICAL FORM
YAZ ACTIVE TABLET
Light pink round film-coated tablets marked on one side with the
letters "DS" in a regular
hexagon, each containing drospirenone 3 mg and ethinylestradiol 20
µg.
YAZ PLACEBO TABLET
White round film-coated tablets marked on one side with the letters
"DP" in a regular
hexagon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
YAZ is indicated for use as:
•
an oral contraceptive.
•
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). See _5.1 Pharmacodynamic
properties_.
4.2
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1%
per year. The failure rate may increase when pills are missed or taken
incorrectly.
Tablets must be taken in the order directed on the package every day
at about the same time
with some liquid as needed. Tablet-taking is continuous. One tablet is
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 white
placebo tablets and may not have finished before the next pack is
started.
YAZ DS VX1.0
2
HOW TO START YAZ
•
NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH)
Tablet-taking has to start on Day 1 of the woman’s natural cycle
(i.e. the first day of her
menstrual bleeding). The woman should be instructed to take a