Tamoxifen 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamoxifen citrate

Available from:

Waymade Healthcare Plc

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

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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