Estradiol SUN 10 micrograms vaginal tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Estradiol

Saadav alates:

Sun Pharmaceutical Industries Europe B.V.

ATC kood:

G03CA03

INN (Rahvusvaheline Nimetus):

Estradiol

Annus:

10 microgram(s)

Ravimvorm:

Vaginal tablet

Terapeutiline ala:

estradiol

Loa andmise kuupäev:

2021-08-13

Infovoldik

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V003
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRADIOL SUN 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 Estradiol SUN is and what it is used for
2.
What you need to know before you use Estradiol SUN
3.
How to use Estradiol SUN
4.
Possible side effects
5.
How to store Estradiol SUN
6.
Contents of the pack and other information
1.
WHAT ESTRADIOL SUN IS AND WHAT IT IS USED FOR
Estradiol SUN 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.
Estradiol SUN 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.
Estradiol SUN 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 ESTRADIOL SUN
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 expe

Toote omadused

Health Products Regulatory Authority
21 March 2022
CRN00CT7X
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estradiol SUN 10 micrograms vaginal tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains: estradiol hemihydrate equivalent to 10
microgram estradiol.
Excipient with known effect
Each vaginal tablet contains 18 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal tablet
White to off white color, 6 mm circular, biconvex film coated vaginal
tablets, 3 mm thick, debossed with "7" on one side and
plain on other side.
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
Estradiol 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 Estradiol SUN, it is not recommended to
add a progestagen (but see section 4.4, 'Special
warnings and precautions for use', 'Endometrial hyperplasia and
carcinoma').
Estradiol may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the estradiol
therapy.
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 plung