Vagifem 10 micrograms vaginal Tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

ESTRADIOL

Verfügbar ab:

NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark

ATC-Code:

G03CA03

INN (Internationale Bezeichnung):

ESTRADIOL 10 µg

Darreichungsform:

VAGINAL TABLET

Zusammensetzung:

ESTRADIOL 10 µg

Verschreibungstyp:

POM

Therapiebereich:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2011-04-08

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VAGIFEM 10 MICROGRAMS VAGINAL TABLETS
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 any 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, ‘Possible side
effects’.
WHAT IS IN THIS LEAFLET
1.
What Vagifem is and what it is used for
2.
What you need to know before you use Vagifem
3.
How to use Vagifem
4.
Possible side effects
5.
How to store Vagifem
6.
Contents of the pack and other information
1.
WHAT VAGIFEM IS AND WHAT IT IS USED FOR
Vagifem contains estradiol
•
Estradiol is a female sex hormone.
•
It belongs to a group of hormones called oestrogens.
•
It is exactly the same as the estradiol produced by the ovaries of
women.
Vagifem belongs to a group of medicines called vaginal Hormone
Replacement Therapy (HRT).
IT IS USED TO
relieve menopausal symptoms in the vagina such as dryness or
irritation. In medical
terms this is known as ‘vaginal atrophy’. It is caused by a drop
in the levels of oestrogen in your
body. This happens naturally after the menopause.
VAGIFEM WORKS BY
replacing the oestrogen which is normally produced in the ovaries of
women. It
is inserted into your vagina, so the hormone is released where it is
needed. This may relieve
discomfort in the vagina.
The experience of treating women older than 65 years is limited.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VAGIFEM
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.
The experience in treating women with a premature menopa

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vagifem 10 micrograms vaginal tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains: Estradiol hemihydrate equivalent to
estradiol 10 micrograms.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal tablet.
White, film-coated, biconvex tablet, engraved with NOVO 278 on one
side. Diameter 6 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of vaginal atrophy due to oestrogen deficiency in
postmenopausal women (see section
5.1).
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vagifem is administered intravaginally as a local oestrogen therapy by
use of an applicator.
Initial dose: One vaginal tablet daily for two weeks.
Maintenance dose: One vaginal tablet twice a week.
Treatment may be started on any convenient day.
If a dose is forgotten, it should be taken as soon as the patient
remembers. A double dose should be
avoided.
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.
For oestrogen products for vaginal application of which the systemic
exposure to the oestrogen
remains
WITHIN
the normal postmenopausal range, such as Vagifem, it is not
recommended to add a
progestagen (but see section 4.4, ‘Special warnings and precautions
for use’, ‘Endometrial
hyperplasia and carcinoma’).
Vagifem may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the Vagifem
therapy.
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Administration:
1.
Open the blister pack at the plunger end.
2.
Insert the applicator in the vagina until resistance is met (8-10 cm).
3.
Release the tablet by pressing the plunger.
4.
Withdraw the applicator and discard.
4.3
CONTRAINDICATIONS
•
Known, past or suspected breast cancer
•
Known, past or suspected oestrogen-dependent malignant tumours (e.g.
endometrial can