Ovestin 1mg per gram Vaginal Cream

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Estriol

Доступно од:

Aspen Pharma Trading Limited

АТЦ код:

G03CA; G03CA04

INN (Међународно име):

Estriol

Дозирање:

1 milligram(s)

Фармацеутски облик:

Vaginal cream

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Natural and semisynthetic estrogens, plain; estriol

Статус ауторизације:

Not marketed

Датум одобрења:

1993-08-16

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
OVESTIN 1MG PER GRAM, VAGINAL CREAM
Estriol
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 further questions, please 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 Ovestin is and what it is used for
2.
What you need to know before you use Ovestin
3.
How to use Ovestin
4.
Possible side effects
5.
How to store Ovestin
6.
Contents of the pack and other Information
1.
WHAT OVESTIN IS AND WHAT IT IS USED FOR
Ovestin belongs to a group of medicines called vaginal Hormone
Replacement Therapy
(HRT). It contains the female hormone estriol (an estrogen). Ovestin
is used in
postmenopausal women with at least 12 months since their last period.
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.
The active substance of Ovestin is estriol, one of the natural
estrogens produced by the
body (female sex hormones). Estrogens are mainly produced in the
ovaries. They are
necessary for the normal sexual development of women and for the
regulation of the
menstrual cycle during the childbearing years. When women get older
the ovaries
gradually produce less estrogen. The period in which this happens
(usually around the
age of 50) is called the menopause. If the ovaries are removed
surgically (ovariectomy)
before the menopause, the decrease in estrogen production occurs very
abruptly.
The shortage of estrogens during menopause may cause the vaginal w

Карактеристике производа

Health Products Regulatory Authority
20 November 2023
CRN00DXV6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ovestin 1mg per gram Vaginal Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vaginal cream containing 1 mg estriol in 1 g of cream.
Excipient(s) with known effect:
Cetyl alcohol 36.7 mg per 1 g cream and stearyl alcohol 88.4 mg per 1g
cream
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal cream with applicator.
Ovestin cream is a homogeneous, smooth, white to nearly white mass of
creamy consistency.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF VAGINAL OESTROGEN DEFICIENCY SYMPTOMS:

Treatment of symptoms of vaginal atrophy due to oestrogen deficiency
in postmenopausal women.

Pre and post operative therapy in post-menopausal women undergoing
vaginal surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION

For atrophy of the lower urogenital tract:
1 application per day for the first weeks (maximally 4 weeks),
followed by a gradual reduction, based on relief of
symptoms, until a maintenance dosage (e.g. 1 application twice a week)
is reached.

As pre- and postoperative therapy in postmenopausal women undergoing
vaginal surgery:
1 application per day in the 2 weeks before surgery: 1 application
twice a week in the 2 weeks after surgery.
A missed dose should be administered as soon as remembered, unless the
missed dose is noticed at the day of the next dose.
In the latter case the missed dose should be skipped and the regular
dosing scheme continued. Two doses must never be
administered on the same day.
Method of administration
Ovestin Cream should be administered intravaginally by means of a
calibrated applicator before retiring at night.
1 applicator-dose (applicator filled to the ring mark) contains 0.5 g
Ovestin Cream which corresponds to 0.5 mg estriol.
The following 'Instructions for Use' should be given to the patient
and are included in the package leaflet:
INSTRUCTIONS FOR USE
1. Remove the cap from the tube,