Vagirux 10 microgram vaginal tablets.

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESTRADIOL HEMIHYDRATE

Available from:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC code:

G03CA03

INN (International Name):

ESTRADIOL HEMIHYDRATE 10 µg

Pharmaceutical form:

VAGINAL TABLET

Composition:

ESTRADIOL HEMIHYDRATE 10 µg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-07-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VAGIRUX 10 MICROGRAM 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.
WHAT IS IN THIS LEAFLET
1.
What Vagirux is and what it is used for
2.
What you need to know before you use Vagirux
3.
How to use Vagirux
4.
Possible side effects
5.
How to store Vagirux
6.
Contents of the pack and other information
1.
WHAT VAGIRUX IS AND WHAT IT IS USED FOR
Vagirux contains estradiol.
-
Estradiol is a female sex hormone.
-
It belongs to a group of hormones called estrogens.
-
It is exactly the same as the estradiol produced by the ovaries of
women.
Vagirux belongs to a group of medicines called vaginal Hormone
Replacement Therapy (HRT).
VAGIRUX 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 estrogen in
your body. This happens naturally after the menopause.
VAGIRUX WORKS BY
replacing the estrogen, 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VAGIRUX
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 menopause (due to
ovarian failure or surgery) is
limited. If you have a premature menopause the risks of using HRT may
be d

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Vagirux 10 microgram vaginal tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains estradiol hemihydrate equivalent to 10
microgram estradiol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal tablet.
White, round, film-coated tablets embossed with "E" in one side. The
diameter of the tablet is
approximately 6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of vaginal atrophy due to estrogen deficiency in
postmenopausal women (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vagirux may be used in women with or without an intact uterus.
Posology
Vaginal infections should be treated before start of the Vagirux
therapy.
Treatment may be started on any convenient day.
_Initial dose_
One vaginal tablet daily for two weeks.
_Maintenance dose_
One vaginal tablet twice a week.
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 estrogen products for vaginal application of which the systemic
exposure to the estrogen remains
_within_
the normal postmenopausal range, such as Vagirux, it is not
recommended to add a progestagen
(see section 4.4 'Endometrial hyperplasia and carcinoma').
If a dose is forgotten, it should be taken as soon as the patient
remembers. A double dose should be
avoided.
Method of administration
Vagirux is administered intravaginally as a local estrogen therapy by
use of an applicator.
_How to administer_
Vagirux
_:_
1.
The applicator should be removed from its sealing foil.
2.
While holding the tube, the plunger of the applicator should be pulled
until it comes to a stop.
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One vaginal tablet should be placed firmly into the holder (wide end)
of the applicator tube.
3.
The applicator should be carefully inserted into the vagina up to the
point when some resistance
is being felt (8-10 cm).
4.
To release the vaginal tablet, the plunger should be p