Estring 7.5micrograms/24hours vaginal delivery system

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Estradiol hemihydrate

Disponible desde:

Pfizer Ltd

Código ATC:

G03CA03

Designación común internacional (DCI):

Estradiol hemihydrate

Dosis:

7.5microgram/24hour

formulario farmacéutico:

Vaginal delivery system

Vía de administración:

Vaginal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 07020100; GTIN: 5013457025996

Información para el usuario

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRING 7.5 MICROGRAM/24 HOURS, VAGINAL DELIVERY SYSTEM
Estradiol Hemihydrate
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 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 any of the side effects gets serious, 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 Estring is and what it is used for
2.
What you need to know before you use Estring
3.
How to use Estring
4.
Possible side effects
5
How to store Estring
6.
Contents of the pack and other information
1.
WHAT ESTRING IS AND WHAT IT IS USED FOR
Estring vaginal delivery system is a vaginal ring which contains the
active ingredient estradiol
hemihydrate, which is a naturally occurring form of the main female
sex hormone, oestrogen.
Women’s ovaries gradually produce less oestrogen as they approach
menopausal age (also
referred to as “the change”). Low levels of oestrogen can cause
symptoms such as vaginal
dryness, inflammation or itching, and this in turn can lead to sore or
painful sexual
intercourse, and an increased susceptibility to vaginal or urinary
infections.
Estring vaginal delivery system is part of hormone replacement therapy
(HRT) that acts
locally in the vagina to maintain the adequate levels of oestrogen to
relieve these symptoms in
post menopausal women. It does not treat other symptoms of menopause
such as hot flushes
and sweats. Tell your doctor if you also have these problems.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRING
MEDICAL CHECK-UP
Estring may not be suitable for all women. Before you start using
Estring, your doctor should
ask about your own and your family’s med

Ficha técnica

OBJECT 1
ESTRING
Summary of Product Characteristics Updated 06-Jun-2018 | Pfizer
Limited
1. Name of the medicinal product
Estring 7.5 microgram/24 hours, vaginal delivery system
2. Qualitative and quantitative composition
Each vaginal ring contains:
Estradiol Hemihydrate 2.0 mg, corresponding to 1.94 mg estradiol.
Each ring releases estradiol at an average amount of 7.5 microgram per
24 hours, over a period of 90
days.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Vaginal delivery system.
A slightly opaque ring, made of a silicone elastomer, with a whitish
core, containing a drug reservoir of
Estradiol Hemihydrate. The product has the following dimensions. Outer
diameter - 55 mm; cross
sectional diameter - 9 mm; core diameter - 2 mm.
4. Clinical particulars
4.1 Therapeutic indications
Treatment for atrophic vaginitis, (due to oestrogen deficiency) in
postmenopausal women.
4.2 Posology and method of administration
Estring vaginal delivery system is an oestrogen-only product for
vaginal use.
ADULTS INCLUDING ELDERLY PEOPLE (≥ 65 YEARS OLD)
One ring to be inserted into the upper third of the vagina. Once
inserted it is left in the vagina
continuously for 90 days and replaced by a new ring as appropriate.
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. The maximum recommended duration of
continuous therapy is two years.
Therapy may start at any time in women with established amenorrhoea or
who are experiencing long
intervals between spontaneous menses. Patients changing from a
cyclical or continuous sequential
preparation should complete the cycle, after a withdrawal bleed, and
then change to Estring vaginal
delivery system. Patients changing from a continuous combined
preparation may start therapy at any
time.
Estring vaginal delivery system is a local therapy and in women with
an intact uterus, progestogen
treatment is _not_ necessary (however see Section 4.4, Special
Warni