NEXTSTELLIS estetrol (as monohydrate) 14.2 mg / drospirenone 3 mg tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

estetrol monohydrate, Quantity: 15 mg (Equivalent: estetrol, Qty 14.2 mg); drospirenone, Quantity: 3 mg

Հասանելի է:

Mayne Pharma International Pty Ltd

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: magnesium stearate; titanium dioxide; hypromellose; hyprolose; purified talc; hydrogenated cottonseed oil; lactose monohydrate; maize starch

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

1 x 28 tablets (24 active and 4 placebo tablets), 6 x 28 tablets (144 active and 24 placebo tablets), 3 x 28 tablets (72 active and 12 placebo tablets)

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

NEXTSTELLIS is indicated for use by women of reproductive potential to prevent pregnancy.

Ապրանքի ամփոփագիր:

Visual Identification: White tablets embossed with a drop shaped logo on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2021-11-26

Տեղեկատվական թերթիկ

NEXTSTELLIS
®
1
NEXTSTELLIS
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING NEXTSTELLIS?
NEXTSTELLIS is a birth control tablet (oral contraceptive) used by
women to prevent pregnancy. NEXTSTELLIS contains the
active ingredients estetrol (as estetrol monohydrate) and
drospirenone. The estetrol (also called E4) in NEXTSTELLIS is made
from a plant source to match the naturally occurring estrogen in the
body and has selective activity.
For more information, see Section 1. Why am I using NEXTSTELLIS?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEXTSTELLIS?
Do not use if you have ever had an allergic reaction to E4,
drospirenone or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NEXTSTELLIS?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NEXTSTELLIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE NEXTSTELLIS?
Take one tablet every day at the same time. Take the tablets in the
order directed on the blister pack. Both the pink tablets and
white tablets should be swallowed whole.
More instructions can be found in Section 4. How do I use NEXTSTELLIS?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEXTSTELLIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NEXTSTELLIS.
•
Tell your doctor, dentist or pharmacist about all of your medical
conditions.
•
Tell your doctor, dentist or pharmacist about all the medicines you
take.
THINGS YOU
SHOULD NOT DO
•
Do not use NEXTSTELLI

Ապրանքի հատկությունները

v 2.0
1
This medicinal product is subject to additional monitoring in
Australia. This will
allow quick identification of new safety information. Healthcare
professionals are asked
to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
NEXTSTELLIS
® (ESTETROL (AS MONOHYDRATE) AND
DROSPIRENONE) TABLETS
1.
NAME OF THE MEDICINE
Estetrol (as monohydrate) and drospirenone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estetrol (E4) is a synthetic analogue of a native human estrogen and
drospirenone is a
synthetic progestational compound.
Each active tablet contains 14.2 mg estetrol (equivalent to 15 mg of
estetrol
monohydrate) and 3 mg of drospirenone.
Excipients with known effect: lactose.
For the full list of excipients, see
_section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Active tablet: Pink tablet embossed with a drop-shaped logo on one
side.
Inactive tablet: White tablet embossed with a drop-shaped logo on one
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NEXTSTELLIS is indicated for use by women of reproductive potential to
prevent
pregnancy.
▼
v 2.0
2
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
NEXTSTELLIS is dispensed in a blister pack. NEXTSTELLIS should be
started using
instructions for starting or switching in Table 1.
TABLE 1:
INSTRUCTIONS FOR STARTING OR SWITCHING NEXTSTELLIS
STARTING NEXTSTELLIS IN
WOMEN WITH NO CURRENT USE
OF HORMONAL CONTRACEPTION
IMPORTANT:
•
Consider the possibility of pregnancy prior to initiation of this
product.
•
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual bleeding). If not starting on the
first day of menses for any reason, use a non-hormonal
contraceptive (condom) as back-up until tablets have been taken
for 7 days in a row.
1.
Take the first tablet from the purple area on the blister pack
corresponding to the day of the week.
2.
Follow the direction of the arrows on the blister pack until all the
tablets have been take