ISABELLE TABLETS 3 mg/30 micrograms drospirenone/ethinylestradiol 3 mg/30 micrograms tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

ethinylestradiol, Quantity: 30 microgram; drospirenone, Quantity: 3 mg

から入手可能:

Lupin Australia Pty Limited

INN（国際名）:

Drospirenone,ethinylestradiol

医薬品形態:

Tablet

構図:

Excipient Ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400

投与経路:

Oral

パッケージ内のユニット:

4 x 28 Tablets (21 active and 7 placebo), 3 x 28 Tablets (21 active and 7 placebo), 1 x 28 Tablets (21 active and 7 placebo), 2 x 28 Tablets (21 active and 7 placebo)

処方タイプ:

(S4) Prescription Only Medicine

適応症:

For use as an oral contraceptive

製品概要:

Visual Identification: White to off-white coloured, round, biconvex, film coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2012-01-20

情報リーフレット

CONSUMER MEDICINE INFORMATION
ISABELLE
(DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Isabelle. 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
Isabelle 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 ISABELLE IS USED FOR
Isabelle is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the Pill’.
Isabelle 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 oral
contraceptives.
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 oral contraceptives are
taken by women under close
observation in clinical trials, it is
more than 99% effective in
preventing pregnancy. However,
in real life the oral
contraceptives are 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,
Isabelle is intended to prevent
pregnancy. It does not protec

製品の特徴

AUSTRALIAN PRODUCT INFORMATION – ISABELLE
(DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET
1
NAME OF THE MEDICINE
Drospirenone and Ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isabelle is a combined oral contraceptive tablet containing the
synthetic progestogen, drospirenone and
the synthetic estrogen, ethinylestradiol.
Each yellow active tablet contains drospirenone 3 mg and
ethinylestradiol 30 µg.
List of excipients with known effects: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ACTIVE TABLETS: Yellow coloured, round, biconvex, film coated tablets,
debossed with 'DR2' on one side
and plain on the other side.
PLACEBO TABLETS: White to off-white coloured, round, biconvex, film
coated tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isabelle is indicated for use as an oral contraceptive.
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 to 3 after starting the white placebo tablets and may
not have finished before the next
pack is started.
HOW TO START ISABELLE
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on Day 1 of the woman's natural cycle (ie.
the first day of her menstrual
bleeding). The women should be instructed to take a yellow active
tablet from the pink section of the
Isabelle v3.0
Page 2 of 22
(drospirenone and ethinylestradiol) film coated tablet
pack, corresponding to that day of the week. If started on Day 1 in
this way, protection against pregnancy
is i