DERMESTRIL-Septem 75 micrograms/24 hours 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:

75 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 75 micrograms/24 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains:
7.74 mg of estradiol hemihydrate equivalent to 7.5 mg estradiol/33.75
cm
2
delivering 75 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 oestrogen 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