Estraderm MX 50 patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol

Available from:

Norgine Pharmaceuticals Ltd

ATC code:

G03CA03

INN (International Name):

Estradiol

Dosage:

50microgram/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5010678539103 5010678547801

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRADERM
® MX 25, 50, 75 AND 100
(OESTRADIOL (AS HEMIHYDRATE))
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 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT ESTRADERM MX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRADERM MX
3.
HOW TO USE ESTRADERM MX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ESTRADERM MX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ESTRADERM MX IS AND WHAT IT IS USED FOR
Estraderm MX is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Estraderm MX is used in postmenopausal women with at least 12 months
since their last natural
period.
Estraderm MX is a patch that is applied to the skin. The patch
contains a supply of oestradiol which
is released from the patch and absorbed through the skin into your
blood stream. This is called a
transdermal patch.
Estraderm MX is used for:
RELIEF OF SYMPTOMS OCCURING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can
cause symptoms such as hot face, neck and chest (hot flushes).
Estraderm MX alleviates these
symptoms after menopause. You will only be prescribed Estraderm MX if
your symptoms seriously
hinder your daily life.
PREVENTION OF OSTEOPOROSIS (FOR ESTRADERM MX 50 AND 75 ONLY)
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable f

Summary of Product characteristics

OBJECT 1
ESTRADERM MX 50
Summary of Product Characteristics Updated 17-Oct-2016 | Merus Labs
Luxco S.a.R.L.
1. Name of the medicinal product
Estraderm MX
®
50
2. Qualitative and quantitative composition
The active ingredient is estra-1, 3,5(10)-triene-3,17ß-diol
(oestradiol hemihydrate).
Patches contain 1.50 mg active substance corresponding to a surface
area of 22cm².
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Estraderm MX is a square-shaped, self-adhesive, transparent,
transdermal patch for application to the skin
surface. Each patch comprises an impermeable polyester backing film,
an adhesive matrix containing
oestradiol and an oversized protective liner which is removed prior to
application of the patch to the skin.
Estraderm MX releases oestradiol into the circulation via intact skin
at a low rate for up to 4 days.
_Cross section:_
DOSAGE STRENGTHS
ESTRADERM MX 50
Nominal rate of estradiol release
50 micrograms /day
Oestradiol content
1.50mg
Drug-releasing area
22 cm²
Imprint
(on backing film)
Product logo
CG GSG
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant
of, or contraindicated for, other medicinal products approved for the
prevention of osteoporosis (See also
section 4.4).
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
Estraderm MX 50 is an oestrogen only patch.
In women with an intact uterus oestrogen should be supplemented by
sequential administration of a
progestagen (e.g. medroxyprogesterone acetate 10mg, norethisterone
5mg, norethisterone acetate 1-5mg
or dydrogesterone 20mg per day) to be taken at least on the last 12
days of each 4-week treatment cycle.
Withdrawal bleeding usually occurs following 12 days or more of
progesterone administration. Unless
there is a previous diagnosis of endometriosis, it is not rec