Estradot 25micrograms/24hours patches

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Estradiol

Disponível em:

Sandoz Ltd

Código ATC:

G03CA03

DCI (Denominação Comum Internacional):

Estradiol

Dosagem:

25microgram/24hour

Forma farmacêutica:

Transdermal patch

Via de administração:

Transdermal

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06040101; GTIN: 5010678905182

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRADOT 25 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
ESTRADOT 37.5 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
ESTRADOT 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
ESTRADOT 75 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
ESTRADOT 100 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
(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, 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 ESTRADOT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRADOT
3.
HOW TO USE ESTRADOT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ESTRADOT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ESTRADOT IS AND WHAT IT IS USED FOR
Estradot is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Estradot is used in postmenopausal women with at least 12 months since
their last natural period.
Estradot comes as a patch that is applied to the skin.
Estradot is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot face, neck and chest ("hot flushes"). Estradot
alleviates these symptoms after
menopause. You will only be prescribed Estradot if your symptoms
seriously hinder your daily life.
PREVENTION OF OSTEOPOROSIS
(for Estradot 50, 75 and 100 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

Características técnicas

OBJECT 1
ESTRADOT 25 MICROGRAMS/24 HOURS, TRANSDERMAL
PATCHES
Summary of Product Characteristics Updated 23-Jun-2016 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Estradot
®
25 micrograms/24 hours, transdermal patch
2. Qualitative and quantitative composition
2.5 cm
2
patch containing 0.39 mg estradiol (as hemihydrate) with a release
rate 25 micrograms estradiol
per 24 hours.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch.
Rectangular patch with rounded corners, comprising a
pressure-sensitive adhesive layer containing
estradiol, with a translucent polymeric backing on one side and a
protective liner on the other.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women.
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
Dosage
The transdermal patch is applied twice weekly, i.e. every three to
four days.
_Oestrogen deficiency symptoms: _
Estradot is available in five strengths: 25, 37.5, 50, 75 and 100. For
initiation and continuation of
treatment of postmenopausal symptoms, the lowest effective dose for
the shortest duration (see also
section 4.4) should be used. Depending on the clinical response the
dose can then be adjusted to the
patient's individual needs. If, after three months, there is
insufficient response in the form of alleviated
symptoms, the dose can be increased. If symptoms of overdose arise
(e.g. tender breasts) the dose must be
decreased.
General instructions
Estradot is administered as continuous therapy (uninterrupted
application twice weekly).
In women with an intact uterus, Estradot should be combined with a
progestagen approved for addition to
oestrogen treatment in a continuous sequential dosing scheme: the
oestrogen is dosed continuously. The
progestagen is added for at least 12 to 14 days of every 28-day cycle,
in a sequential manner.
Unless there is a previous diagnosis of endometrios