Zoely 2.5mg/1.5mg Film-Coated Tablets

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

ESTRADIOL HEMIHYDRATE; NOMEGESTROL ACETATE

Mevcut itibaren:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Adı):

ESTRADIOL HEMIHYDRATE; NOMEGESTROL ACETATE

Paketteki üniteler:

28tablet Tablets; 3 X 28tablet Tablets

Tarafından üretildi:

ORGANON (IRELAND) LTD

Bilgilendirme broşürü

_ Consumer Medication Information Leaflet (RiMUP) _
ZOELY
®
FILM-COATED TABLETS
Nomegestrol Acetate/Estradiol (2.5mg/1.5mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_ZOELY_
is used for
2.
How
_ZOELY_
works
3.
Before you take
_ZOELY_
4.
How to take
_ZOELY_
_5._
_ _
While you are taking
_ZOELY _
6.
Side effects
_7._
_ _
Storage and Disposal of
_ZOELY _
8.
Product Description
9.
Product Manufacturer and
Product Registration Holder
10.
Date of revision
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE.
–
Keep this leaflet. You may
need to read it again.
–
If you have any further
questions, ask your doctor or
pharmacist.
–
This medicine has been
prescribed for you. Do not pass
it on to others. It may harm
them.
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
WHAT _ZOELY_ IS USED FOR
_ZOELY_
is a contraceptive pill that is
used to prevent pregnancy.
•
All 24 white tablets are
active tablets that contain a
small amount of two
different female hormones.
These are nomegestrol
acetate (a progestagen) and
estradiol (the natural
estrogen).
•
The 4 yellow tablets do not
contain hormones and are
called placebo tablets.
•
Contraceptive pills that contain
two hormones, like
_ZOELY_
, are
called ‘combined pills’.
•
If you were previously using
the pill, please note that
_ZOELY_
contains estradiol, the
estrogen which is identical to
the natural hormone produced
by your ovaries, as opposed to
the commonly used synthetic
estrogen ethinylestradiol.
•
Nomegestrol acetate, the
progestogen in
_ZOELY_
, is
derived from the hormone
progesterone. Progesterone is
produced by your ovaries.
When
_ZOELY_
is taken correctly
(without missing active white
tablets), the chance of becoming
pregnant is very low.
HOW _ZOELY_ WORKS_ _
_ZOELY_
releases two female sex
hormones that prevent the release of
an egg cell from the ovaries. If no
egg is released you cannot become
pregnant.
In addition,
_ZOELY _
causes changes in the

Ürün özellikleri

ZOELY Film -coated tablet LPC -MK8175A -T-
11 2018 082016 (nomegestrol acetate/estradiol)
1. NAME OF THE MEDICINAL PRODUCT
Zoely 2.5 mg/1.5 mg film -coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
White active film -coate d tablets: Each film -coated tablet contains 2.5 mg nomegestrol
acetate and 1.5 mg estradiol (as hemihydrate).
Yellow placebo film -coated tablets: The tablet does not contain active substances.
Excipient with known effect :
Each white active film -coa ted ta blet contains 57.71 mg of lactose monohydrate.
Each yellow placebo film -coated tablet contains 61.76 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet (tablet).
Active film -coated tablet s: white, round and coded ‘ne’ on both sides.
Placebo film -coated tablets: yellow, round and coded ‘p’ on both sides.
4. CLINICAL PARTICUL ARS
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Zoely should take into conside ration the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE
with Zoely compares with other combined hormonal contraceptives ( CHCs ) (see sections 4.3
and 4.4).
4.2 Posology and method of admini stration
Posology
One tablet is to be taken daily for 28 consecutive days. Each pack starts with 24 white active
tablets, followed by 4 yellow placebo tablets. A subsequent pack is started immediately after
finishing the previous pack, without a br eak 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 b efore the next pack is started. See ‘Cycle
control’ in secti on 4.4.
Special populations
Renal impairment
Although data in renal impaired patients are not available, renal impairment is unlikely to
affect the elimination of nomegestrol acetate and estradiol .
Hepatic impairment
No clinical studies have been perfor med