NOLVADEX-D TABLET 20MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TAMOXIFEN CITRATE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

TAMOXIFEN CITRATE

Unit dalam pakej:

30 mcg/mL

Dikeluarkan oleh:

ASTRAZENECA UK LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NOLVADEX-D TABLET
Tamoxifen (20mg)
1
WHAT IS IN THIS LEAFLET
1.
What Nolvadex-D Tablet
is used for
2.
How Nolvadex-D Tablet
works
3.
Before you use Nolvadex-
D Tablet
4.
How to use Nolvadex-D
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Nolvadex-D Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT NOLVADEX-D TABLET IS
USED FOR
Nolvadex-D Tablet is used to
treat breast cancer.
HOW NOLVADEX-D TABLET
WORKS
Nolvadex-D Tablet contains a
medicine called tamoxifen.
This belongs to a group of
medicines called ‘anti-
oestrogens’. Oestrogen is a
natural substance in your body
known as a ‘sex hormone’.
Nolvadex-D Tablet works by
blocking the effects of
oestrogen.
BEFORE YOU USE NOLVADEX-D
TABLET_ _
-
_When you must not use it _
Do not use Nolvadex-D Tablet
•
if you are allergic to
tamoxifen or any of the
ingredients in Nolvadex-D
Tablet.
•
if you are pregnant, are
trying to become pregnant
or are breastfeeding.
Nolvadex-D Tablet should not
be given to children.
_ _
-
_Before you start to use it _
Take special care with
Nolvadex-D Tablet
•
if you have a history of
hereditary angioedema as
Nolvadex-D Tablet may
cause or worsen symptoms
of hereditary angioedema.
If you experience
symptoms such as
swelling of the face, lips,
tongue and/or throat with
difficulty in swallowing or
breathing, contact a doctor
immediately.
•
on what contraceptive
precautions you should
take, as some may be
affected by Nolvadex-D
Tablet. Please see your
doctor for advice.
•
if you have any unusual
vaginal bleeding or other
gynaecological symptoms
(such as pelvic pain or
pressure) when you are
taking Nolvadex-D Tablet
or anytime afterwards.
This is because a number
of changes to the lining of
the womb (the
endometrium) may occur,
some of which may be
serious and could include
cancer.
•
if you go into hospital. Let
the medical staff know
you are taking Nolvadex-
D Tablet.
•
In dela

Ciri produk

Page 1 of
9
NOLVADEX_-_D_ _
_TAMOXIFEN CITRATE _
TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
White to off-white, octagonal, biconvex, film coated tablets,
intagliated on one face with
NOLVADEX D and plain on the reverse.
NOLVADEX-D contains Tamoxifen Citrate Ph. Eur. 30.4 mg (equivalent to
20 mg of
tamoxifen).
PHARMACEUTICAL FORM
Film-coated tablet.
THERAPEUTIC INDICATION
NOLVADEX is indicated for the treatment of breast cancer.
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
ADULTS (INCLUDING ELDERLY):
The dosage range is 20 to 40 mg daily, given either in divided
doses twice daily or as a single dose once daily.
_ _
USE IN CHILDREN_ _
The use of NOLVADEX is not recommended in children, as safety and
efficacy have not
been established (see Pharmacodynamic and Pharmacokinetics
properties).
CONTRAINDICATIONS
_PREGNANCY:_
NOLVADEX must not be given during pregnancy. Premenopausal patients
must
be carefully examined before treatment to exclude the possibility of
pregnancy (see also
Pregnancy and Lactation).
NOLVADEX should not be given to patients who have experienced
hypersensitivity to the
product or any of its ingredients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Menstruation is suppressed in a proportion of premenopausal women
receiving NOLVADEX.
An increased incidence of endometrial cancer and uterine sarcoma
(mostly malignant mixed
Mullerian tumours) has been reported in association with
NOLVADEX treatment. The
underlying mechanism is unknown, but may be related to the
oestrogen-like effect of
NOLVADEX. Any women receiving or having previously received NOLVADEX,
who report
abnormal
gynaecological
symptoms,
especially
vaginal
bleeding,
should
be
promptly
investigated.
Page 2 of
9
In patients with hereditary angioedema, NOLVADEX may induce or
exacerbate symptoms of
angioedema.
A number of second primary tumours, occurring at sites other than the
endometrium and the
opposite breast, have been reported in clinical trials, following the
treatment of breast cancer
patients with tamoxifen. N