Elleste Solo MX 80 transdermal patches

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Estradiol

Mevcut itibaren:

Viatris UK Healthcare Ltd

ATC kodu:

G03CA03

INN (International Adı):

Estradiol

Doz:

80microgram/24hour

Farmasötik formu:

Transdermal patch

Uygulama yolu:

Transdermal

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 06040101; GTIN: 5012882007539

Bilgilendirme broşürü

INFORMATION FOR THE PATIENT
ELLESTE SOLO
TM MX 80 MICROGRAMS TRANSDERMAL PATCH
Transdermal Matrix Patch
2.50 mg estradiol (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, please 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, even if their signs of illness are
the same as yours.
• 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 ELLESTE SOLO IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELLESTE SOLO
3. HOW TO USE ELLESTE SOLO
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ELLESTE SOLO
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. What Elleste Solo is and what it is used for
Elleste Solo is a Hormone Replacement Therapy (HRT). It contains
the female hormone oestrogen. Elleste Solo is a transdermal patch
containing estradiol as the active ingredient. The estradiol in
Elleste
Solo is a synthetic version of the body’s natural oestrogen. It is
made
from plant materials. Elleste Solo is used in menopausal women.
The estradiol gradually comes out of the sticky side of the patch
and goes through your skin while you are wearing it. You will get
about 80 micrograms of estradiol a day from Elleste Solo.
Elleste Solo is used for:
Relief of symptoms occurring 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”). Elleste Solo alleviates
these
symptoms after menopause. You will only be prescribed Elleste
Solo if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss a

Ürün özellikleri

OBJECT 1
ELLESTE SOLO MX80 MICROGRAMS TRANSDERMAL
PATCH
Summary of Product Characteristics Updated 13-May-2016 | Meda
Pharmaceuticals
1. Name of the medicinal product
Elleste Solo MX 80 micrograms Transdermal Patch.
2. Qualitative and quantitative composition
Elleste Solo MX 80 contains 2.50 mg of estradiol (as hemihydrate) and
each patch delivers approximately
80 micrograms of estradiol per 24 hours.
For excipients, see 6.1.
3. Pharmaceutical form
Transdermal patch.
Elleste Solo MX 80 is a self-adhesive, flexible transdermal patch
comprising a layer of clear adhesive
sandwiched between a translucent patch and a metallised polyester
backing. Elleste Solo MX 80 is a
rectangular shape with rounded corners and has an active surface area
of 28.5 cm
2
.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
peri-menopausal and post-
menopausal 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 of treating women older than 65 years is limited.
4.2 Posology and method of administration
Elleste Solo MX 80 Transdermal Patch is an oestrogen-only product for
transdermal use.
Adults
_Climacteric Symptoms:_
For initiation and continuation of treatment of peri- and
postmenopausal symptoms, the lowest effective
dose for the shortest duration (see also Section 4.4) should be used.
Therapy should be initiated with
Elleste Solo MX 40 in women who have menopausal symptoms. The dosage
may be increased if required
by using Elleste Solo MX 80.
_Prevention of Osteoporosis_
Treatment should be with Elleste Solo MX 80.
_Dosage Schedule (for both indications):_
Therapy may start at any time in women with established amenorrhoea or
who are experiencing long
intervals between spontaneous menses. In women who are menstruating,
it is advised that therapy starts
within five days of the