Tamoxifen 10mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Tamoxifen citrate

Disponível em:

Mawdsley-Brooks & Company Ltd

Código ATC:

L02BA01

DCI (Denominação Comum Internacional):

Tamoxifen citrate

Dosagem:

10mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 08030401

Folheto informativo - Bula

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Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Tamoxifen Citrate 15.20mg (equivalent to 10mg
tamoxifen)
Excipient with known effect: Each tablet contains 129.800mg of
lactose.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White, convex tablets with an approximate diameter of 8mm, printed
T10on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tamoxifen tablets are 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 the elderly
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
20mg 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 of treatment may be given during
subsequent
menstrual periods, increasing