ESTROFEM 2 MG

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

ESTRADIOL AS HEMIHYDRATE

Saadav alates:

NOVO NORDISK LTD., ISRAEL

ATC kood:

G03CA03

Ravimvorm:

FILM COATED TABLETS

Koostis:

ESTRADIOL AS HEMIHYDRATE 2 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

NOVO NORDISK A/S, DENMARK

Terapeutiline rühm:

ESTRADIOL

Terapeutiline ala:

ESTRADIOL

Näidustused:

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of , or contraindicated for other medicinal products approved for the prevention of osteoporosis. Estrofem is particularly for women who have been hysterectomized and therefore do not require combined estrogen/progestagen therapy.The experience treating women older than 65 years is limited.

Loa andmise kuupäev:

2023-07-31

Infovoldik

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
ESTROFEM 1 MG
ESTROFEM 2 MG
FILM-COATED TABLETS
FILM-COATED TABLETS
ACTIVE INGREDIENT:
ESTRADIOL AS HEMIHYDRATE 1 MG
ESTRADIOL AS HEMIHYDRATE 2 MG
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important
information about some of this medicine’s ingredients’ and section
6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist. This medicine has been prescribed
to treat you.
Do not pass it on to others. It may harm them, even if it seems to you
that their
medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Estrofem is a hormone replacement therapy (HRT) that is used to treat
symptoms of estrogen deficiency in postmenopausal women.
•
Estrofem is used to prevent osteoporosis (bone thinning) in
postmenopausal
women who are at high risk of future fractures and who cannot be
treated with
other medicines for this condition.
Estrofem is used in women who have had their womb removed and
therefore do not
require combined estrogen-progestagen therapy.
There is only limited experience of treating women older than 65 years
with Estrofem.
THERAPEUTIC GROUP: natural and semi-synthetic estrogens.
When a woman’s period stops during menopause, the amount of estrogen
produced by her
body drops. This can cause symptoms such as hot face, neck and chest
(‘hot flushes’).
Estrofem alleviates these symptoms after menopause. Only take Estrofem
if your
symptoms seriously hinder your daily life.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are SENSITIVE (allergic) to ESTRADIOL or to any of the other
ingredients in
this medicine (listed in section 6 ‘Additional information’)
•
you have or have ever had BREAST CANCER, or if

Toote omadused

Estrofem IL SPC Dec23- Notification
1
1
NAME OF THE MEDICINAL PRODUCT
Estrofem
®
1 mg
Estrofem
®
2 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains estradiol 1 mg or 2 mg (as estradiol
hemihydrate).
Excipient with known effect:
Estrofem 1 mg: Each film-coated tablet contains lactose monohydrate
37.3 mg.
Estrofem 2 mg: Each film-coated tablet contains lacotse monohydrate
36.8 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Estrofem 1 mg: Red, film-coated, round, biconvex tablets, engraved
with NOVO 282.
Diameter 6 mm.
Estrofem 2 mg: Blue, film-coated, round, biconvex tablets, engraved
with NOVO 280.
Diameter 6 mm.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal
women.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures, who are
tolerant of, or contraindicated for other medicinal products approved
for the prevention of
osteoporosis.
Estrofem is particularly for women who have been hysterectomised and
therefore do not require
combined oestrogen/progestagen therapy.
The experience treating women older than 65 years is limited.
4.2
Posology 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.
Estrofem IL SPC Dec23- Notification
2
A switch to a higher dose or a lower dose of Estrofem could be
indicated if the response after three
months is insufficient for satisfactory symptom relief or if the
tolerability is not satisfactory.
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
HRT, Estrofem may be initiated
on day 5 of bleeding and only in co