Novofem, filmomhulde tabletten 1 mg/1 mg

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

ESTRADIOL 0,5-WATER SAMENSTELLING overeenkomend met ; ; ESTRADIOL ; NORETHISTERONACETAAT

Tillgänglig från:

Novo Nordisk B.V. Flemingweg 18 2408 AV ALPHEN A/D RIJN

ATC-kod:

G03FB05

INN (International namn):

ESTRADIOL 0,5-WATER COMPOSITION corresponding to ; ; ESTRADIOL ; norethisterone acetate

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

GLYCEROLTRIACETAAT (E 1518) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; PROPYLEENGLYCOL (E 1520) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administreringssätt:

Oraal gebruik

Terapiområde:

Norethisterone And Estrogen

Produktsammanfattning:

Hulpstoffen: GLYCEROLTRIACETAAT (E 1518); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; PROPYLEENGLYCOL (E 1520); TALK (E 553 B); TITAANDIOXIDE (E 171);

Tillstånd datum:

2002-07-26

Bipacksedel

21
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOFEM, FILMOMHULDE TABLETTEN 1 MG/1 MG
Estradiol/norethisterone acetate
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Novofem is and what it is used for
2.
What you need to know before you take Novofem
3.
How to take Novofem
4.
Possible side effects
5.
How to store Novofem
6.
Contents of the pack and other information
1.
WHAT NOVOFEM IS AND WHAT IT IS USED FOR
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, an oestrogen (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 oestrogen. Norethisterone acetate is a
synthetic progestagen, which acts in a
similar manner as progesterone, another important female sex hormone.
Novofem is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can
cause symptoms such as hot face, neck and chest (‘hot flushes’).
Novofem alleviates these symptoms
after menopause. You will only be prescribed Novofem if your symptoms
seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your docto

Produktens egenskaper

3
1.
NAME OF THE MEDICINAL PRODUCT
Novofem, filmomhulde tabletten 1 mg/1 mg
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 at least 6 months since last menses.
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 (see also section 4.4).
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
4
sequential HRT regimen, tr