Estradot 25 micrograms/24 hours, transdermal patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol hemihydrate

Available from:

Novartis Ireland Limited

ATC code:

G03CA; G03CA03

INN (International Name):

Estradiol hemihydrate

Dosage:

25 microgram(s)/24 hours

Pharmaceutical form:

Transdermal patch

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Natural and semisynthetic estrogens, plain; estradiol

Authorization status:

Not marketed

Authorization date:

2005-05-24

Patient Information leaflet

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").
Estra
dot 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
oth

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2022
CRN00CZRG
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
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 of 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, Special warnings and precautions for use)_
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 endometriosi