Vagirux 10 microgram vaginal tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Estradiol

Sẵn có từ:

Gedeon Richter Plc

Mã ATC:

G03CA03

INN (Tên quốc tế):

Estradiol

Liều dùng:

10 microgram(s)

Dạng dược phẩm:

Vaginal tablet

Khu trị liệu:

estradiol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2021-01-29

Tờ rơi thông tin

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

Đặc tính sản phẩm

Health Products Regulatory Authority
04 May 2022
CRN00CV10
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
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. One vaginal tablet
should be placed firmly into the holder (wide end) of the applicator
tube.
Health Products Regulatory Authority
04 May 2022
CRN00CV10
Page 2 of 9
3.
The applicator should be carefully