Tamoxifen 40mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Tamoxifen citrate

Commercializzato da:

Waymade Healthcare Plc

Codice ATC:

L02BA01

INN (Nome Internazionale):

Tamoxifen citrate

Dosaggio:

40mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 08030401

Foglio illustrativo

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Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:Tamoxifen Citrate 60.80mg
Excipient with known effect:
Each tablet contains 519.20mg of lactose.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
White, convex tablets with an approximate diameter of 12.5mm, printed
T40on 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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: The same dosage regimens of tamoxifen have been used in
elderly
patients with breast cancer and in some of these patients it has been
used as
sole therapy.
ANOVULATORY INFERTILITY
The possibility of pregnancy must be excluded before commencing any
course
of treatment whether initial or subsequent.
The initial course of treatment in women menstruating regularly but
with
anovular cycles, consists of 20mg of tamoxifen daily in the second,
third,
fourth and fifth days of the menstrual cycle.
Should the initial course of treatment, as judged by unsatisfactory
basal
temperature records and poor pre-ovulatory cervical mucus, prove
unsuccessful, further courses of treatment may be given during
subsequent
menstrual periods, increasing the dosage to 40mg and then 80mg daily.
In women with irregular menstrual cycle, the initial course of
treatment may
begin on any day. Should there be no sign of ovulation, then a
subsequent
course of treatment may begin 45 days later with dosage increased to
40mg
and then 80mg daily. If a patien