Yasmin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Drospirenone 3mg; Ethinylestradiol 30ug

Available from:

Bayer New Zealand Limited

INN (International Name):

Drospirenone 3 mg

Pharmaceutical form:

Tablet

Composition:

Active: Drospirenone 3mg Ethinylestradiol 30ug Excipient: Hypromellose Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Starch Titanium dioxide Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Titanium dioxide Hypromellose Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Titanium dioxide

Units in package:

Blister pack, 21 active tabs + 7 placebo tab (sample), 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Oral contraception

Product summary:

Package - Contents - Shelf Life: Blister pack, 21 active tabs + 7 placebo tab (sample) - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, 3 strips x (21 active tabs + 7 placebo tab) - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2000-08-29

Patient Information leaflet

YASMIN CMI VX1.0
1
YASMIN
®
(YAZ
⋅
MIN)
Contraceptive tablets for women
_drospirenone and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Yasmin. 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
Yasmin 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 YASMIN IS
USED FOR
Yasmin is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
Yasmin is used to prevent
pregnancy.
You may also experience the
following benefits:
•
improvement in symptoms like
bloating, swelling or weight
gain related to fluid retention
•
more regular and lighter
periods – potentially resulting
in a decrease in anaemia (iron
deficiency)
•
a decrease in period pain.
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.
When the Pill is taken by women
under close observation in
clinical trials, it is more than
99% effective in preventing
pregnancy. However, in real life
the Pill is around 92% effective.
This is because pills might be
missed, or taken with medicines
that may interfere with their
effectiveness, or may not be
absorbed due to vomiting and
diarrhoea.
Like all oral contraceptives,
Yasmin is intended to prevent
pregnancy. It does not protect
aga

Summary of Product characteristics

YASMIN DS VX1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
YASMIN
®
30 micrograms / 3 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active light yellow tablet contains:
Ethinylestradiol
30 micrograms
Drospirenone
3 mg
For full list of excipients, see section _6.1 List of excipients_.
3.
PHARMACEUTICAL FORM
YASMIN ACTIVE TABLET
Light yellow round film-coated tablets marked on one side with the
letters “DO” in a regular
hexagon, each containing drospirenone 3 mg and ethinylestradiol 30
µg.
YASMIN PLACEBO TABLET
White, round placebo film-coated tablets, marked on one side with the
letters “DP” in a
regular hexagon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
4.2
DOSE AND METHOD OF ADMINISTRATION
YASMIN is to be taken regularly in order to achieve the therapeutic
efficacy and the required
contraceptive protection.
HOW TO TAKE YASMIN
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.
HOW TO START YASMIN
Start with the first tablet from the green section marked with that
day of the week, in
accordance with one of the following:
YASMIN DS VX1.0
2
•
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 women should be instructed to take a light
yellow active tablet
from the green section of the pack, corresponding to that day of the
week. If started on Day
1 in this way, protection against