Tamoxifen 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamoxifen citrate

Available from:

DE Pharmaceuticals

ATC code:

L02BA01

INN (International Name):

Tamoxifen citrate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401

Patient Information leaflet

Pharma code 760 (
011111001
)
First bar is 105mm from the top edge of the leaflet.
Top of page cut-off to middle of registration mark: 44 mm.
WHAT IS IN THIS LEAFLET
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 your 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 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15.2 mg of tamoxifen citrate equivalent to 10 mg
of
tamoxifen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round biconvex white coated tablets 7 mm diameter with one face blank,
the
reverse face marked `10' and `T'.
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 menstruating regularly, the initia