Zoely
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
16-12-2022
Fachinformation
(SPC)
16-12-2022
Öffentlichen Beurteilungsberichts
(PAR)
17-05-2016
Wirkstoff:
Nomegestrol acetate, estradiol
Verfügbar ab:
Theramex Ireland Limited
ATC-Code:
G03AA14
INN (Internationale Bezeichnung):
nomegestrol, estradiol
Therapiegruppe:
Sex hormones and modulators of the genital system,
Therapiebereich:
Contraception
Anwendungsgebiete:
Oral contraception,
Produktbesonderheiten:
Revision: 23
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2011-07-26
Gebrauchsinformation
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOELY 2.5 MG/1.5 MG FILM-COATED TABLETS
nomegestrol acetate/estradiol
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the
first year or when restarting a combined hormonal contraceptive
following a break of 4 or more
weeks.
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoely is and what it is used for
2.
What you need to know before you use Zoely
3.
How to use Zoely
4.
Possible side effects
5.
How to store Zoely
6.
Contents of the pack and other information
1.
WHAT ZOELY IS AND WHAT IT IS USED FOR
Zoely is a contraceptive pill that is used to prevent pregnancy.
•
All 24 white film-coated tablets are active tablets that contain a
small amount of two different
female hormones. These are nomegestrol acetate (a progestogen) and
estradiol (an oestrogen).
•
The 4 yellow film-coated tablets are inactive tablets that do not
contain hormones and are called
placebo tablets.
•
Contraceptive pills that contain two different hormones, like Zoely,
are called ‘combined pills’.
•
•
Nomegestrol acetate (the progestogen in Zoely) and estradiol (the
oestrogen in Zoely) work
together to prevent ovulation (release of an egg from the ovary)
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoely 2.5 mg/1.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5
mg estradiol (as hemihydrate).
Each yellow placebo tablet does not contain active substances.
Excipients with known effect
Each white active tablet contains 57.7 mg of lactose monohydrate.
Each yellow placebo tablet contains 61.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The active tablet is white, round and coded ‘ne’ on both sides.
The placebo tablet is yellow, round and coded ‘p’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Zoely should take into consideration 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 ADMINISTRATION
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 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
‘Cycle control’ in section 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 performed in patients with hepatic
insufficiency. Since the metabolism
of steroid hormones might be impaired in patients with severe hepatic
disease, the use of
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