Tamoxifen 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamoxifen citrate

Available from:

A A H Pharmaceuticals Ltd

ATC code:

L02BA01

INN (International Name):

Tamoxifen citrate

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401; GTIN: 5025903002062

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMOXIFEN 20MG 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.
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 is one of a group of medicines called anti-oestrogens.
Tamoxifen Tablets may be used for:

treatment of breast cancer

some forms of female infertility caused by a failure to produce and
release eggs
(ovulate) properly.

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 breast 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
professi

Summary of Product characteristics

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