Novofem film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol; Norethisterone acetate; Estradiol

Available from:

Novo Nordisk A/S

ATC code:

G03FA; G03FA01

INN (International Name):

Estradiol; Norethisterone acetate; Estradiol

Dosage:

%v/v

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Progestogens and estrogens, fixed combinations; norethisterone and estrogen

Authorization status:

Marketed

Authorization date:

2002-02-08

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOFEM FILM-COATED TABLETS
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 doctor.
If you ar

Summary of Product characteristics

Health Products Regulatory Authority
14 July 2023
CRN00CT48
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Novofem film-coated tablets
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 starte