Evra transdermal patches

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Norelgestromin; Ethinylestradiol

Boleh didapati daripada:

Janssen-Cilag Ltd

Kod ATC:

G03AA13

INN (Nama Antarabangsa):

Norelgestromin; Ethinylestradiol

Dos:

203microgram/24hour ; 33.9microgram/24hour

Borang farmaseutikal:

Transdermal patch

Laluan pentadbiran:

Transdermal

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 07030100; GTIN: 5012674901052

Risalah maklumat

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 listed below, you must tell yo

Ciri produk

OBJECT 1
EVRA TRANSDERMAL PATCH
Summary of Product Characteristics Updated 30-Jun-2017 | Janssen-Cilag
Ltd
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.
Und