VAGIFEM VAGINAL TABLET 25 mcg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Estradiol (as hemihydrate)

Commercializzato da:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Codice ATC:

G03CA03

Dosaggio:

25 mcg

Forma farmaceutica:

TABLET

Via di somministrazione:

VAGINAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Novo Nordisk A/S

Data dell'autorizzazione:

1991-05-27

Foglio illustrativo

8-2790-00-036-1.1 STF Q1 2013 
VAGIFEM® 
25 micrograms 
Vaginal tablets 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vaginal tablet contains estradiol hemihydrate equivalent to
estradiol 
25 micrograms. 

LIST OF EXCIPIENTS 
Tablet core: Hypromellose, lactose monohydrate, maize starch and
magnesium stearate. 
Film-coating: Hypromellose and macrogol 6000. 

PHARMACEUTICAL FORM 
Vaginal tablet. 
White, film-coated, biconvex tablet, engraved with NOVO 279 on
one side. Diameter 6 mm. 

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

THERAPEUTIC INDICATIONS 
Treatment of vaginal atrophy due to oestrogen deficiency in
postmenopausal women (see 
_Pharmacodynamic properties_). 
The experience of treating women older than 65 years is limited. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Vagifem® is administered intravaginally as a local
oestrogen therapy by use of an applicator.   

Initial dose: One vaginal tablet daily for two weeks. 
Maintenance dose: One vaginal tablet twice a week. 
Treatment may be started on any convenient day. 
If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should 
be avoided. 
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective 
dose for the shortest duration (see also _Special warnings and
precautions for use_) should be 
used. 
Vagifem® is a local vaginal therapy and in women
with an intact uterus, progestagen treatment 
is not necessary (however see _Special warnings and precautions
for use, Endometrial hyperplasia _
_and carcinoma_). 
Vagifem® may be used in women with or without an intact
uterus. 
Vaginal infections should be treated before start of the Vagifem®
treatment. 
8-2790-00-036-1.1 STF Q1 2013 

ADMINISTRATION 
1.  Open the blister pack at the plunger end. 
2.  Insert the applicator in the vagina until resistance is
m