VAGIFEM 10 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESTRADIOL HEMIHYDRATE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

G03CA03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ESTRADIOL HEMIHYDRATE 10 MCG

Administration route:

VAGINAL

Prescription type:

Not required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

ESTRADIOL

Therapeutic area:

ESTRADIOL

Therapeutic indications:

Treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.The experience treating women older than 65 years is limited.שינוי משטר מינון: 1/7/2019שינויים בעלון לרופא בסעיף Posology:4.2 Posology and method of administrationVagifem 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 section 4.4) should be used.For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as Vagifem, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’).

Authorization date:

2016-11-30

Patient Information leaflet

Page 1 of 12
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITHOUT A DOCTOR'S PRESCRIPTION
VAGIFEM
® 10 MICROGRAMS
FILM-COATED VAGINAL TABLETS
ACTIVE INGREDIENT:
ESTRADIOL 10 MCG (AS HEMIHYDRATE)
Inactive ingredients and allergens in this medicine: see 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.
Use this medicine according to the instructions in the section about
dose in this
leaflet. Consult your pharmacist if you need further information.
Consult your
doctor if your symptoms of illness get worse or do not improve after 2
to 4
weeks, or if other symptoms occur.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Vagifem 10 micrograms in intended to treat vaginal atrophy that is
caused by
estrogen deficiency in women after the menopause.
The experience of treating women older than 65 years is limited.
THERAPEUTIC GROUP:
estrogens, natural and semi-synthetic, simple.
Vagifem 10 mcg contains estradiol which is a female sex hormone that
belongs
to a group of hormones called estrogens. The estradiol in Vagifem 10
mcg is
exactly the same as the estradiol produced in the ovaries of women.
Vagifem 10 mcg belongs to a group of medicines called vaginal hormone
replacement therapy (HRT).
Vagifem 10 mcg is used to relieve menopausal symptoms in the vagina
such
as dryness and irritation. This condition is called ‘vaginal
atrophy’, it is caused
by a drop in the levels of estrogen in your body. This happens
naturally after
the menopause.
Vagifem 10 mcg works by replacing the estrogen which is normally
produced in
the ovaries of women. It is inserted into your vagina, so the hormone
is
released where it is needed. This may relieve discomfort in the
vagina.
Page 2 of 12
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
MEDICAL HISTORY AND ROUTINE MEDICAL CHECK UPS

Summary of Product characteristics

1 NAME OF THE MEDICINAL PRODUCT
Vagifem
®
10 micrograms
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains:
estradiol hemihydrate equivalent to estradiol 10 micrograms.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal tablet.
White, film-coated, biconvex tablet, engraved with NOVO 278 on one
side. Diameter 6 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of atrophic vaginitis due to oestrogen deficiency in
postmenopausal women.
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vagifem
10 mcg 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 section 4.4) should be used.
For oestrogen products for vaginal application of which the systemic
exposure to the oestrogen
remains
WITHIN
the normal postmenopausal range, such as Vagifem 10 mcg, it is not
recommended to
add a progestagen (but see section 4.4, ‘Special warnings and
precautions for use’, ‘Endometrial
hyperplasia and carcinoma’).
Vagifem
10 mcg may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the Vagifem
10 mcg
therapy.
Administration:
1.
Open the blister pack at the plunger end.
2.
Insert the applicator in the vagina until resistance is met (8-10 cm).
3.
Release the tablet by pressing the plunger.
4.
Withdraw the applicator and discard.
4.3
CONTRAINDICATIONS
•
Known, past or suspected breast cancer
•
Known, past or suspected oestrogen-dependent malignant tumours (e.g.
endometrial cancer)
•
Undiagnosed genital bleeding
•
Untreated endometria