ESTROFEM TABLET 2 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

ESTRADIOL HEMIHYDRATE 2.07 mg EQV ESTRADIOL ANHYDROUS

Commercializzato da:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Codice ATC:

G03CA03

Dosaggio:

2 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

ESTRADIOL HEMIHYDRATE 2.07 mg EQV ESTRADIOL ANHYDROUS 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Novo Nordisk A/S

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

1991-06-03

Foglio illustrativo

Estrofem 1mg 2 mg professional insert   
1 
ESTROFEM® 1 MG 
ESTROFEM® 2 MG 
FILM-COATED TABLETS 

ESTROFEM® 1 MG   
Each film-coated tablet contains estradiol 1 mg (as estradiol
hemihydrate).   
ESTROFEM® 2MG     
Each film-coated tablet contains estradiol 2 mg (as estradiol
hemihydrate).   

TABLET CORE CONTAINS:   
Lactose monohydrate, maize
starch, hydroxypropylcellulose, talc, magnesium stearate.   

FILM-COATING:  
Estrofem® 1 mg: Hypromellose, talc, titanium dioxide (E171),
propylene glycol and red iron 
oxide (E172). The tablets are red, film-coated, round, biconvex,
engraved with NOVO 282. 
Diameter 6 mm. 
Estrofem® 2 mg: Hypromellose, talc, titanium dioxide (E171),
macrogol 400 and indigo carmine 
(E132). The tablets are blue, film-coated, round, biconvex tablets,
engraved with NOVO 280. 
Diameter 6 mm.   

MANUFACTURER  
Novo Nordisk A/S   
Novo Allé 
DK-2880 Bagsværd   
Denmark 

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 
intolerant 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 of treating women older than 65 years is
limited.   

POSOLOGY AND METHOD OF ADMINISTRATION   
Estrofem® is an oestrogen-only product for hormonal
replacement. Estrofem® is administered 
orally, one tablet daily without interruption, and should not be
administered to women with an 
intact uterus unless combined with a suitable progestagen for
at least 12-14 days every 
month/28 day cycle.    For initiation and continuation
of treatment of menopausal symptoms, the 
Estrofem 1mg 2 mg profes

Scheda tecnica

1
1
Name of the medicinal product
Estrofem
®
1 mg
Estrofem
®
2 mg
Film-coated tablets
2
Qualitative and quantitative composition
Each film-coated tablet contains estradiol 1 mg (as estradiol
hemihydrate).
Each film-coated tablet contains estradiol 2mg (as estradiol
hemihydrate).
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3
Pharmaceutical form
Film-coated tablets.
Estrofem
®
1mg: Red, film-coated, round, biconvex tablets, engraved with NOVO
282. Diameter 6 mm.
Estrofem
®
2mg: 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 intolerant 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 of 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, and should not be administered to women
with an intact uterus unless combined
with a suitable progestagen for at least 12-14 days every month/28 day
cycle. 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 three 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 osteoporosi