PETIBELLE ethinylestradiol 30 microgram/ drospirenone 3 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 0.03 mg; drospirenone, Quantity: 3 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; purified talc; lactose monohydrate; magnesium stearate; hypromellose; microcrystalline cellulose

Administration route:

Oral

Units in package:

1 x 28 tablets: 21 active with 7 placebo, 3 x 28 tablets: 21 active with 7 placebo

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: Petibelle is indicated for use as an oral contraceptive.

Product summary:

Visual Identification: Small, round white tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-08-04

Patient Information leaflet

2003 PETIBELLE
CMI AU
1
PETIBELLE
®
(PE-TI-BELL)
Contraceptive tablets for women
_drospirenone and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
PETIBELLE. 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
PETIBELLE 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 PETIBELLE IS
USED FOR
PETIBELLE is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
PETIBELLE 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,
PETIBELLE is intended to
prevent pregnancy

Summary of Product characteristics

180925 PETIBELLE PI
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
PETIBELLE
® (DROSPIRENONE & ETHINYLESTRADIOL) TABLET
1
NAME OF THE MEDICINE
PETIBELLE (drospirenone and ethinylestradiol)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each light yellow active tablet contains ethinylestradiol 30 µg and
drospirenone 3
mg.
Excipients with known effect:
Each light yellow active tablet contains 48.17 mg of lactose
monohydrate.
Each white placebo tablet contains 23.21 mg of lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each PETIBELLE active tablet is light yellow, round and marked on one
side with
the letters "DO" in a regular hexagon.
Each PETIBELLE placebo tablet is white, round and marked on one side
with the
letters “DP” in a regular hexagon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PETIBELLE is indicated for use as an oral contraceptive.
4.2
DOSE AND METHOD OF ADMNISTRATION
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.
180925 PETIBELLE PI
Page 2 of 27
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 PETIBELLE
_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 pregnancy is
immediate
and no additional methods o