Estradot 50 mikrogram/24 timmar Depotplåster

Country: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

estradiolhemihydrat

Fáanlegur frá:

2care4 ApS

ATC númer:

G03CA03

INN (Alþjóðlegt nafn):

estradiol hemihydrate

Skammtar:

50 mikrogram/24 timmar

Lyfjaform:

Depotplåster

Samsetning:

estradiolhemihydrat 0,81 mg Aktiv substans

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

Förpacknings: Påse, 24 x 1 depotplåster

Leyfisstaða:

Avregistrerad

Leyfisdagur:

2018-10-31

Upplýsingar fylgiseðill

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
other medicines ar

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
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
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.
3.75 cm
2
patch containing 0.585 mg estradiol (as hemihydrate) with a release
rate of 37.5 micrograms
estradiol per 24 hours.
5 cm
2
patch containing 0.78 mg estradiol (as hemihydrate) with a release
rate of 50 micrograms estradiol
per 24 hours.
7.5 cm
2
patch containing 1.17 mg estradiol (as hemihydrate) with a release
rate of 75 micrograms
estradiol per 24 hours.
10 cm
2
patch containing 1.56 mg estradiol (as hemihydrate) with a release
rate 100 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.
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 (for Estradot 50, 75 and 100 only).
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 shor