NOVOFEM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE ACETATE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

G03CA53

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ESTRADIOL AS HEMIHYDRATE 1 MG; NORETHISTERONE ACETATE 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

ESTRADIOL, COMBINATIONS

Therapeutic area:

ESTRADIOL, COMBINATIONS

Therapeutic indications:

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with an intact uterus. 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.The experience treating women older than 65 years is limited.

Authorization date:

2022-11-30

Patient Information leaflet

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
NOVOFEM
®
FILM-COATED TABLETS
ACTIVE INGREDIENTS:
THE RED TABLETS CONTAIN:
ESTRADIOL AS HEMIHYDRATE 1MG
THE WHITE TABLETS CONTAIN:
ESTRADIOL AS HEMIHYDRATE 1MG AND
NORETHISTERONE ACETATE 1 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?
Novofem is intended for:
•
relief of symptoms which are caused by the drop in the level of the
hormone estrogen in
postmenopausal women whose womb is intact
•
prevention of osteoporosis (bone thinning) in postmenopausal women at
high risk of future fractures,
who cannot be treated with other medicines for this condition.
The experience treating women older than 65 years is limited.
THERAPEUTIC GROUP: sequential estrogen and progestagen products.
Novofem is a sequential combined hormone replacement therapy (HRT)
which is taken every day without
interruption. Novofem is used in postmenopausal women with at least 6
months since their last natural
period.
Novofem contains 2 hormones, estrogen (estradiol) and a progestagen
(norethisterone acetate). The estradiol
in Novofem is identical to the estradiol produced in the ovaries of
women and is classified as a natural
estrogen. Norethisterone acetate is a synthetic progestagen, which
acts in a manner similar to progesterone,
another important female sex hormone.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you a

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Novofem
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One red film-coated tablet contains:
estradiol 1 mg (as estradiol hemihydrate).
One white film-coated tablet contains:
estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 1
mg.
Excipient with known effect: lactose monohydrate:
Each red film-coated tablet contains lactose monohydrate 37.3 mg
Each white film-coated tablet contains lactose monohydrate 36.8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Red film-coated, biconvex tablets engraved with NOVO 282. Diameter: 6
mm.
White film-coated, biconvex tablets engraved with NOVO 283. Diameter:
6 mm.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
with an intact uterus.
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.
The experience treating women older than 65 years is limited.
4.2
Posology and method of administration
Novofem is a continuous sequential HRT product for oral use. The
oestrogen is dosed continuously.
The progestagen is added for 12 days of every 28 day cycle, in a
sequential manner.
One tablet is taken daily in the following order: oestrogen therapy
(red film-coated tablet) over
16 days, followed by 12 days of oestrogen/progestagen therapy (white
film-coated tablet).
After intake of the last white tablet, treatment is continued with the
first red tablet of a new pack on
the next day. A menstruation-like bleeding usually occurs at the
beginning of a new treatment cycle.
In women who are not taking HRT or women in transition from a
continuous combined HRT product,
treatment with Novofem may be started on any convenient day. In women
in transition from another
sequential HRT regimen, treatment should begin the day following
completion of the preced