ZOELY nomegestrol acetate 2.5 mg and estradiol 1.5 mg tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

nomegestrol acetate, Quantity: 2.5 mg; estradiol hemihydrate, Quantity: 1.55 mg (Equivalent: estradiol, Qty 1.5 mg)

Tersedia dari:

Theramex Australia Pty Ltd

INN (Nama Internasional):

estradiol hemihydrate,Nomegestrol acetate

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; purified talc; lactose monohydrate; colloidal anhydrous silica; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black

Rute administrasi :

Oral

Unit dalam paket:

1 x 28 tablets (24 active and 4 placebo) Sample Pack, 1 x 28 tablets (24 active and 4 placebo), 3 x 28 tablets (each blister strip contains 24 active and 4 placebo tablets)

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Oral contraception.

Ringkasan produk:

Visual Identification: Round, yellow tablet, diameter of 5.5 mm, debossed 'p' on each side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2011-08-15

Selebaran informasi

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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.
1.
WHY AM I USING ZOELY?
ZOELY contains the active ingredient nomegestrol acetate and
estradiol. ZOELY is an oral contraceptive, used to prevent
pregnancy.
For more information, see Section 1. Why am I using ZOELY? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZOELY?
Do not use if you have ever had an allergic reaction to nomegestrol
acetate, estradiol 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
ZOELY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZOELY 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 ZOELY?
•
ZOELY needs to be taken every day at the same time, to ensure it works
effectively. Follow all instructions given to you by your
doctor.
More instructions can be found in Section 4. How do I use ZOELY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZOELY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ZOELY.
•
Monitor your health and contact your doctor if you notice any changes.
•
Keep all of your doctor’s appointments and go for regular checkups.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly without telling your doctor.
•
Do not use this medicine if you are pregnant, or fall pregnant while
taking this medicine.
DRIVING
OR USING
MACHINES
•
ZOELY is not expected to affect your ability to drive or operate
machinery. If you experience any
side effects which impact your ability to drive or operate machinery
when taking this medicine, act
appropr

Karakteristik produk

Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
ZOELY

(NOMEGESTROL ACETATE AND ESTRADIOL (AS HEMIHYDRATE))
TABLETS
1
NAME OF THE MEDICINE
Nomegestrol acetate and estradiol (as hemihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each blister strip consists of 24 white active tablets each containing
2.5 mg nomegestrol
acetate and 1.5 mg estradiol (as hemihydrate) and 4 yellow placebo
tablets that do not contain
active substances.
List of excipients with known effect:
-
Lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each blister of ZOELY contains:
•
24 white, round, active film-coated tablets coded with ‘ne’ on
both sides, each
containing 2.5 mg nomegestrol acetate and 1.5 mg estradiol.
•
4 yellow, round, placebo film-coated tablets coded with ‘p’ on
both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
How to take ZOELY
Tablet intake instructions are the same for all users.
Tablets must be taken every day at about the same time without regard
to meals. Take tablets
with some liquid as needed, and in the order as directed on the
package. One tablet is to be
taken daily for 28 consecutive days. Each pill pack starts with 24
white active tablets, followed
by 4 yellow placebo tablets; (see Figure 1). A subsequent pack is
started immediately after
finishing the previous pack, without a break in daily tablet intake
and irrespective of presence
or absence of withdrawal bleeding. Withdrawal bleeding usually starts
on day 2-3 after intake
of the last white tablet and may not have finished before the next
pack is started. See also
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, CYCLE CONTROL.
How to start ZOELY
_No preceding hormonal contraceptive use _
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her
menstrual bleeding). When doing so, no additional contraceptive
measures are necessary.
Page 2 of 22
Starting on days 2-5 is allowed, but durin