Bella ethinylestradiol/drospirenone 20 microgram/3 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

4 x 28 tablets, 2 x 28 tablets, 1 x 28 tablets, 3 x 28 tablets, 6 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bella is indicated for use:,? as an oral contraceptive.,? for the treatment of moderate acne vulgaris in women who seek oral contraception.,? for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ethinylestradiol/drospirenone 20 microgram/3 mg tablets for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/drospirenone 20 microgram/3 mg tablets have not been evaluated for treatment of PMS (premenstrual syndrome) (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials).

Product summary:

Visual Identification: White to off-white round, biconvex film coated tablets, plain on both the sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-09-11

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
BELLA
(DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Bella.
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
Bella 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 BELLA IS USED FOR
Bella is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the Pill’.
Bella is used to prevent
pregnancy.
It is also used to treat 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 breaks and
cancer of the uterus (womb),
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.
_HOW BELLA IS DIFFERENT FROM _
_OTHER CONTRACEPTIVE PILLS _
Bella has 24 active (hormone)
tablets and 4 inactive tablets,
rather than the traditional 21
active tablets and 7 inactive
tablets.
This means that with Bella, 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
clini

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – BELLA
(DROSPIRENONE AND ETHINYLESTRADIOL) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Drospirenone and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bella is a combined oral contraceptive tablet containing the synthetic
progestogen, drospirenone and
the synthetic oestrogen, ethinylestradiol
Each pink active tablet contains 20 µg ethinylestradiol and 3 mg
drospirenone.
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: Pink, round, biconvex film-coated tablets, plain on
one side and "DR1" on the other side.
PLACEBO TABLETS: White to off-white round, biconvex film-coated
tablets, plain on both the sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bella is indicated for use as:
•
An oral contraceptive.
•
Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in
women who have chosen
oral contraceptives as their method of birth control. The efficacy of
ethinylestradiol/drospirenone
20 µg / 3 mg tablet for PMDD was not assessed beyond 3 cycles.
Ethinylestradiol/drospirenone
20 µg / 3 mg tablet has not been evaluated for treatment of PMS
(premenstrual syndrome) (see
SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
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. A withdrawal bleed usually
starts on Day 2-3 after starting the white placebo tablets (last row)
and may not have finished before
the next pack is started.
Bella v2.0
Page 2 of 26
(drospirenone and ethinylestradiol) film-coa