Tamoxifen 20mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Tamoxifen citrate

Διαθέσιμο από:

Teva UK Ltd

Φαρμακολογική κατηγορία (ATC):

L02BA01

INN (Διεθνής Όνομα):

Tamoxifen citrate

Δοσολογία:

20mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08030401; GTIN: 5017007410119

Φύλλο οδηγιών χρήσης

TAMOXIFEN 10 MG AND 20 MG TABLETS
READ ALL OF THIS 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.
1. WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN
3. HOW TO TAKE TAMOXIFEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TAMOXIFEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR
•
The name of y
our medicine is Tamoxifen Tablets and
they belong to a group of drugs called anti-oestrogens.
•
Tamoxifen is used to treat:
•
breast cancer
•
certain forms of infertility
•
Tamoxifen can also reduce the risk of developing
breast cancer occurring in those women who have
an increased likelihood of developing
breast
cancer (your risk). It is important that your
healthcare professional calculates your risk of
developing breast cancer and discusses the
result with you before commencing treatment.
There are a number of specific tools available to
calculate breast cancer risk, based on information
such as your age, family history, genetics,
reproductive factors (e.g. age when periods
started and stopped, had children or not, taken or
taking hormonal replacement therapy
and/or oral
contraceptive pill) and history of breas
t disease.
Although the tools can estimate your risk, it
doesn’t mean you will get breast cancer, being at
increased risk means you have a higher chance
of developing breast cancer. If you and your
healthcare professional are considering using
Tamoxifen for this, it is important to understand
the benefits as well as the side effects of taking
Tam

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30.4 mg of tamoxifen citrate equivalent to 20 mg
of tamoxifen.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round biconvex white coated tablets 9.5 mm diameter with one face
blank, the reverse face marked '20'
above score line and 'T' below.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tamoxifen is used for the treatment of breast cancer and is also used
to stimulate
ovulation in the treatment of anovulatory infertility.
Tamoxifen is also used in the primary prevention of breast cancer in
women at
moderate or high risk (see section 5.1).
Women aged less than 30 years old were excluded from primary
prevention trials
so the efficacy and safety of tamoxifen treatment in these younger
women is
unknown.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
_ _
_Breast Cancer _
The recommended daily dose of tamoxifen is normally 20 mg. No
additional
benefit, in terms of delayed recurrence or improved survival in
patients, has been
demonstrated with higher doses. Substantive evidence supporting the
use of
treatment with 30-40 mg per day is not available, although these doses
have been
used in some patients with advanced disease.
_ _
_Anovulatory Infertility_
Before commencing any course of treatment, whether initial or
subsequent, the
possibility of pregnancy must be excluded. In women who are
menstruating
regularly, but with anovular cycles, the initial course of treatment
consists of 20
mg daily in single or divided doses, given on the second, third,
fourth and fifth
days of the menstrual cycle. If unsatisfactory basal temperature
records or poor
pre-ovulatory cervical mucus indicates that this course of treatment
has been
unsuccessful, further courses may be given during subsequent menstrual
periods,
increasing the dose to 40 mg and then to 80 mg daily in single or
divided doses.
In women who are not menstruatin