Evorel Sequi patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Available from:

Theramex HQ UK Ltd

ATC code:

G03FB05

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 06040101; GTIN: 5012946314160

Patient Information leaflet

Package Leaflet: Information for the User
EVOREL
® SEQUI TRANSDERMAL PATCHES
(ESTRADIOL/NORETHISTERONE ACETATE)
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 or pharmacist

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 5.
WHAT IS IN THIS LEAFLET
1. What Evorel Sequi is and what it is used for
2. What you need to know before you use Evorel Sequi
3. Safety of HRT
4. How to use Evorel Sequi
5. Possible side effects
6. How to store Evorel Sequi
7. Contents of the pack and other information
The name of your medicine is Evorel Sequi. It belongs to a group of
medicines called hormone replacement therapy (HRT).
Evorel Sequi contains two medicines:

An oestrogen (estradiol)

A progestogen (norethisterone)
They are both female hormones.
Evorel Sequi comes in a ‘memory pack’. This can be used to help
you
remember when to change your patches. Each pack contains eight
patches:

Four ‘Evorel 50’ patches marked CE50 (containing estradiol only)

Four ‘Evorel Conti’ patches marked CEN1 (containing estradiol and
norethisterone)
The hormones are spread evenly in each patch. They pass slowly into
your body through the skin.
WHAT EVOREL SEQUI IS USED FOR
Evorel Sequi is used:

For the symptoms of the menopause (see ‘What is the menopause?’).
It is only used in women who still have a womb. It is suitable for
women who have had the menopause (postmenopausal) or who are
around the time of the menopause (perimenopausal)

To prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. Evorel Sequi
is only used if other m

Summary of Product characteristics

OBJECT 1
EVOREL SEQUI
Summary of Product Characteristics Updated 24-Jun-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
EVOREL SEQUI
_International non-proprietary names_
estradiol
norethisterone acetate
2. Qualitative and quantitative composition
EVOREL SEQUI is a transdermal therapy comprising
a) 4 EVOREL 50 TDSs, each containing:
3.2 mg of estradiol hemihydrate
b) 4 EVOREL CONTI TDSs, each containing:
3.2 mg of estradiol hemihydrate
11.2 mg of norethisterone acetate
3. Pharmaceutical form
EVOREL SEQUI is composed of EVOREL 50 and EVOREL CONTI. Both EVOREL 50
and EVOREL
CONTI are a Transdermal Delivery System (TDS), or transdermal patch,
composed of a flat two-layer
laminate which is 0.1 mm in thickness. The first layer is a flexible,
translucent, and nearly colourless
backing film. The second layer is a monolayer adhesive film (matrix)
composed of acrylic adhesive and
guar gum and contains the hormones. This system is protected by a
polyester foil release liner, which is
affixed to the adhesive matrix and is removed prior to application of
the patch to the skin. The polyester
foil used is coated with silicone on both sides. The release liner has
an S-shaped opening to facilitate its
removal prior to use. Each TDS is enclosed in a protective,
hermetically-sealed sachet.
EVOREL CONTI has a surface area of 16 sq cm and contains 3.2 mg of
estradiol corresponding to a
nominal release of 50 micrograms of estradiol per 24 hours and 11.2 mg
of norethisterone acetate
corresponding to a nominal release of 170 micrograms of norethisterone
acetate per 24 hours. Each
EVOREL Conti patch is marked in the centre of the lower margin on the
outside of the backing film:
CENI.
EVOREL 50 has a surface area of 16 sq cm and contains 3.2 mg of
estradiol corresponding to a nominal
release of 50 micrograms of estradiol per 24 hours. The release liner
of EVOREL 50 is aluminised on one
side. Each EVOREL 50 patch is marked in the centre of the lower margin
of the outside of the backing
film: CE50.
4. Clinical particulars
4.1 The