DERMESTRIL-Septem 50 micrograms/24hours Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol

Available from:

Rottapharm Ltd

ATC code:

G03CA; G03CA03

INN (International Name):

Estradiol

Dosage:

50 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:

1999-08-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DERMESTRIL-SEPTEM 25 MICROGRAMS/24HOURS
DERMESTRIL-SEPTEM 50 MICROGRAMS/24HOURS
DERMESTRIL-SEPTEM 75 MICROGRAMS/24HOURS
ESTRADIOL
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 further questions, please ask your doctor or your
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 DERMESTRIL-Septem is and what it is used for
2.
What you need to know before you use DERMESTRIL-Septem
3.
How to use DERMESTRIL-Septem
4.
Possible side effects
5.
How to store DERMESTRIL-Septem
6.
Contents of the pack and other information
1. WHAT DERMESTRIL-SEPTEM IS AND WHAT IT IS USED FOR
DERMESTRIL-Septem is a Hormone Replacement Therapy (HRT). It contains
17-

estradiol.
DERMESTRIL-Septem is used in postmenopausal women with at least 6
months since their last
natural period.
DERMESTRIL-Septem 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”).
DERMESTRIL-Septem alleviates these
symptoms after menopause. You will only be prescribed
DERMESTRIL-Septem if your symptoms
seriously hinder your daily life.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DERMESTRIL-SEPTEM
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking it,
or whether to carry on taking it.
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The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is
limited. If you have a premature menopause the risks of using

Summary of Product characteristics

Health Products Regulatory Authority
29 October 2020
CRN009XGZ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DERMESTRIL-Septem 50 micrograms/24hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains:
5.16 mg of estradiol hemihydrate equivalent to 5.0 mg estradiol/22.50
cm
2
delivering 50 micrograms of estradiol in 24 hours.
Excipient(s):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch. Each patch is transparent, colourless, slightly
opaque with an elliptical shape and a printed identification
code, and covered by a rectangular, transparent protective liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
women at least 6 months since last menses.
The experience treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
DERMESTRIL-Septem is an oestrogen-only patch applied to the skin once
weekly in order to ensure a continuous supply of
estradiol to the body; thus each used system is removed after seven
days and replaced by a new one.
Three strengths of DERMESTRIL-Septem are available, i.e.
DERMESTRIL-Septem 25, 50, 75.
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.
Treatment is usually initiated with DERMESTRIL-Septem 25.
If after a treatment of 1-2 months with DERMESTRIL-Septem 25 applied
once weekly the symptoms of estrogen deficiency
appear not to be neutralised, a higher dosage can be given.
In case of undesirable effects or symptoms of overdose (e.g. breast
tenderness and/or vaginal bleeding), the dose should be
reduced.
_ _
In
women
with
an
intact
uterus,
a
progestagen
approved
for
addition
to
oestrogen
treatment
must
be
additionally
administered for at least 12-14 days every month/28 day cycle to
oppose the development of an oestrogen-stimulated
hyperplasia of the