Estrofem

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Estradiol hemihydrate 2.07mg (adjustment for water content 3.2%);  ;  ;  ; Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)

Commercializzato da:

Novo Nordisk Pharmaceuticals Ltd

INN (Nome Internazionale):

Estradiol hemihydrate 2.07 mg (adjustment for water content 3.2%)

Dosaggio:

2 mg

Forma farmaceutica:

Tablet

Composizione:

Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2%)       Excipient: Hyprolose Hypromellose Indigo carmine Lactose monohydrate Macrogol 400 Magnesium stearate Maize starch Purified talc   Purified water Titanium dioxide Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)

Confezione:

Calendar pack, 28 tablets

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Aspen Oss B.V

Dettagli prodotto:

Package - Contents - Shelf Life: Calendar pack, - 28 tablets - 48 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

1992-11-02

Foglio illustrativo

Estrofem NZ PIL 23.02.2022.doc
Page 1 of 10
PACKAGE LEAFLET
ESTROFEM
®
1 MG AND 2 MG FILM-COATED TABLETS
Estradiol hemihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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 Estrofem
®
is and what it is used for
2.
What you need to know before you take Estrofem
®
3.
How to take Estrofem
®
4.
Possible side effects
5.
How to store Estrofem
®
6.
Contents of the pack and other information.
1.
WHAT ESTROFEM
® IS AND WHAT IT IS USED FOR
Estrofem
®
is a Hormone Replacement Therapy (HRT). It contains the female hormone
estradiol.
Estrofem
®
is used in postmenopausal women, particularly in women who have had
their womb
removed (have had a hysterectomy) and therefore do not require
combined oestrogen/progestagen
therapy.
Estrofem
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot face, neck and chest (‘hot flushes’).
Estrofem
®
alleviates these symptoms after
menopause. You should only be prescribed Estrofem
®
if your symptoms seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
(thinning of the bones), if you are at high risk of future fracture
and if
you are unable to take other medications for this purpose.
There is only limited experience of treating women older than 65 years
with Estrofem
®
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESTROFEM
®
_ _
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when de

Scheda tecnica

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
ESTROFEM
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
17ß-oestradiol 1 mg and 2 mg tablets.
3 PHARMACEUTICAL FORM
ESTROFEM 1 MG calendar dial pack contains 28 tablets as described
below:
28 red, round, film coated tablets with diameter 6mm and stamped
“Novo 282" on one side.
The other side is plain. Each tablet contains 1mg of 17ß-oestradiol
and weighs about 80mg.
ESTROFEM 2 MG calendar dial pack contains 28 tablets as described
below:
28 blue, round, film coated tablets with diameter 6mm and stamped
“Novo 280" on one side.
The other side is plain. Each tablet contains 2mg of 17ß-oestradiol
and weighs about 80mg.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Estrofem is indicated for treatment of oestrogen deficiency syndrome,
including prevention of
bone mineral content loss in postmenopausal women at increased risk of
developing fractures.
Estrofem is particularly for women who have been hysterectomised and
therefore do not
require combined oestrogen/progestagen therapy. In women with an
intact uterus, use of
opposed therapy must be considered.
The experience treating women older than 65 years is limited.
4.2 Dose and method of administration
Estrofem is an oestrogen-only product for hormonal replacement.
Estrofem is administered
orally, one tablet daily without interruption. For initiation and
continuation of treatment of
menopausal symptoms, the lowest effective dose for the shortest
duration (see also section
4.4) should be used.
A switch to a higher dose or a lower dose of Estrofem could be
indicated if the response after
3 months is insufficient for satisfactory symptom relief or if the
tolerability is not satisfactory.
Prevention of bone mineral content loss is normally achieved with 1-2
mg estradiol daily,
therefore higher doses are not usually used for long term prophylaxis
of osteoporosis.
In women without a uterus, Estrofem may be started on any convenient
day. In women with a
uterus who present amenorrhoea and are being transferred from a
sequential