Tamoxifen 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamoxifen citrate

Available from:

Accord-UK 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: 5012617022158

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 TABLETS BP 20mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Tamoxifen Citrate PhEur equivalent to 20mg
tamoxifen.
Excipient with known effect
Each 20mg tablet contains 228.80mg of Lactose PhEur.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Indicated for the treatment of breast carcinoma, particularly in
oestrogen
receptor positive patients.
2) For 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
_ _
_Breast carcinoma_
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 patients_
Similar dosage regimens of tamoxifen have been used in elderly
patients with
breast cancer and in some of these pateints it has been used as sole
therapy_. _
_ _
_Anovulatory infertility_
Before commencing any course of treatment, whether initial or
subsequent, the
possibility of pregnancy must be excluded. In women with regular
menstruation but anovular cycles, treatment should be initiated with
20mg
daily given on the second, third, fourth and fifth days of the
menstrual cycle.
If treatment is unsuccessful (unsatisfactory basal temperature records
or poor
pre-ovulatory cervical mucus), further courses may be given during
subsequent menstrual periods, increasing the dosage to 40mg and then
80mg
daily.
In women with irregular