Tamoxifen 10mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TAMOXIFEN

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

L02BA01

INN (International Name):

TAMOXIFEN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TAMOXIFEN 10 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMOXIFEN 10MG, 20MG AND 40MG FILM-COATED TABLETS
Tamoxifen Citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
The name of your medicine is Tamoxifen 10mg, 20mg or 40mg Film-Coated
Tablets.
In the rest of this leaflet it is called Tamoxifen Tablets.
WHAT IS IN THIS LEAFLET:
1. What Tamoxifen Tablets are and what they are used for
2. What you need to know before you take Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Contents of the pack and other information
1. WHAT TAMOXIFEN TABLETS ARE AND WHAT THEY ARE USED FOR
Tamoxifen Tablets contain a medicine called tamoxifen. This belongs to
a group of
medicines called ‘anti-oestrogens’.
WHAT TAMOXIFEN TABLETS ARE USED FOR

Tamoxifen Tablets are used to treat breast cancer.

Tamoxifen Tablets also to treat infertility in women caused by a
failure to produce and
release eggs (ovulate) properly.

Tamoxifen Tablets 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 10mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tamoxifen Citrate 15.20mg, equivalent to 10mg of tamoxifen.
Excipient with known effect
Lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
'Tamoxifen' is indicated for:
1. The treatment of breast cancer.
2. The treatment of anovulatory infertility.
3. 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
_1._
_ _
_BREAST CANCER:_
ADULTS:
The recommended daily dose of tamoxifen is normally 20mg. 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 30-40mg per day is not available,
although these doses have been used in some patients with advanced
disease.
_ _
_ELDERLY PEOPLE:_
Similar dosing regimens of tamoxifen have been used in
older people with breast cancer and in some of these patients it has
been used
as sole therapy.
_2. 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 given daily on the second, third, fourth
and fifth
days of the menstrual cycle. If unsatisfactory basal temperature
records or
poor pre-ovulatory cervical mucus indicate that this initial course of
treatment has been unsuccessful, further courses may be given during
subsequent menstrual periods, increasing the dosage to 40mg and then
80mg
daily.
In women who are not menstruating regularly, the initial course m