Ioa
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
26-08-2014
Karatteristiċi tal-prodott
(SPC)
26-08-2014
Rapport ta 'Valutazzjoni Pubblika
(PAR)
26-08-2014
Ingredjent attiv:
Nomegestrol acetate, estradiol
Disponibbli minn:
N.V. Organon
Kodiċi ATC:
G03AA14
INN (Isem Internazzjonali):
nomegestrol acetate, estradiol
Grupp terapewtiku:
Sex hormones and modulators of the genital system,
Żona terapewtika:
Contraception
Indikazzjonijiet terapewtiċi:
Oral contraception.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-11-16
Fuljett ta 'informazzjoni
B. PACKAGE LEAFLET
27
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
IOA 2.5 MG/1.5 MG FILM-COATED TABLETS
Nomegestrol acetate/estradiol
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 IOA is and what it is used for
2.
What you need to know before you use IOA
When you should not use IOA
When to take special care with IOA
When should you contact your doctor
Blood clots
Cancer
Laboratory tests
Children and adolescents
Other medicines and IOA
Pregnancy and breast-feeding
Driving and using machines
IOA contains lactose
3.
How to use IOA
When and how to take the tablets
Starting your first pack of IOA
If you take more IOA than you should (overdose)
If you forget to take IOA
If you vomit or have severe diarrhoea
If you want to delay your period
If you want to change the starting day of your period
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Karatteristiċi tal-prodott
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
IOA 2.5 mg/1.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
White active film-coated 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.
Excipients with known effect
:
Each white active film-coated tablet contains 57.71 mg of lactose
monohydrate.
Each yellow placebo film-coated tablet contains 61.76 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Active film-coated tablets: white, round and coded ‘ne’ on both
sides.
Placebo film-coated tablets: yellow, round and coded ‘p’ on both
sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe IOA should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with IOA
compares with other 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 rena
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