Evra
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-11-2022
Charakterystyka produktu
(SPC)
09-11-2022
Sprawozdanie z oceny publicznego
(PAR)
25-07-2017
Składnik aktywny:
norelgestromin, Ethinyl estradiol
Dostępny od:
Gedeon Richter Plc.
Kod ATC:
G03AA13
INN (International Nazwa):
norelgestromin, ethinyl estradiol
Grupa terapeutyczna:
Sex hormones and modulators of the genital system,
Dziedzina terapeutyczna:
Contraception
Wskazania:
Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Podsumowanie produktu:
Revision: 25
Status autoryzacji:
Authorised
Data autoryzacji:
2002-08-22
Ulotka dla pacjenta
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVRA 203 MICROGRAMS/24 HOURS + 33.9 MICROGRAMS/24 HOURS TRANSDERMAL
PATCH
norelgestromin/ethinyl 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 get 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 EVRA is and what it is used for
2.
What you need to know before you use EVRA
3.
How to use EVRA
4.
Possible side effects
5.
How to store EVRA
6.
Contents of the pack and other information
1.
WHAT EVRA IS AND WHAT IS IT USED FOR
EVRA contains two types of sex hormones, a progestogen called
norelgestromin and an oestrogen
called ethinyl estradiol.
Because it contains two hormones, EVRA is called a ‘combined
hormonal contraceptive’.
It is used to prevent pregnancy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EVRA
GENERAL NOTES
Before you start using EVRA you should read the information on blood
clots in section 2. It is
particularly important to read the symptoms of a blood clot - see
section 2 “Blood clots”.
WHEN YOU SHOULD NOT USE EVRA
You should not use EVRA if you have any of the conditions listed
below. If you do have any of the
conditions liste
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EVRA
203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 cm
2
transdermal patch contains 6 mg norelgestromin (NGMN) and 600
micrograms ethinyl
estradiol (EE).
Each transdermal patch releases an average of 203 micrograms of NGMN
and 33.9 micrograms of EE
per 24 hours. Medicinal product exposure is more appropriately
characterised by the pharmacokinetic
profile (see section 5.2).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Thin, matrix-type transdermal patch consisting of three layers.
The outside of the backing layer is beige and heat-stamped “EVRA”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Female contraception
EVRA is intended for women of fertile age. The safety and efficacy has
been established in women
aged 18 to 45 years.
The decision to prescribe EVRA should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with EVRA
compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve maximum contraceptive effectiveness, patients must be
advised to use EVRA exactly as
directed. For initiation instructions see ‘How to start EVRA’
below.
Only one transdermal patch is to be worn at a time.
Each used transdermal patch is removed and immediately replaced with a
new one on the same day of
the week (Change Day) on Day 8 and Day 15 of the cycle. Transdermal
patch changes may occur at
any time on the scheduled Change Day. The fourth week is transdermal
patch-free starting on Day 22.
A new contraceptive cycle begins on the next day following transdermal
patch-free week; the next
EVRA transdermal patch should be applied even if there has been no
withdrawal bleeding or if
withdrawal bleeding has not yet stopped.
Under no circumstances should there be more than a 7-da
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