Tamoxifen 40mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Tamoxifen citrate

MAH:

DE Pharmaceuticals

ATC_code:

L02BA01

INN:

Tamoxifen citrate

dosage:

40mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 08030401

PIL

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SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen Tablets BP 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains 60.80 mg of tamoxifen citrate.
Excipient with known effect:
Each tablet contains 519.20 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, normal convex tablets printed with the company logo on one face
and A390
on the other face
.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tamoxifen Tablets BP 40 mg is indicated for:
1.
The treatment of breast cancer.
2.
The treatment of anovulatory infertility.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1. Breast Cancer
_Adults_
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.
_Elderly_
Similar dosing regimens of tamoxifen have been used in elderly with
breast cancer
and in some of these patients it has been used as sole therapy.
2. _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 20 mg of tamoxifen daily on the second, third,
fourth and fifth
days of the menstrual cycle. If unsatisfactory basal temperature 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 the dosage to 40 mg and then 80 mg
daily.
In women with irregular menstrual cycle, the initial course of
treatment may begin
on any day. If no signs of ovulation are demonstrable, then a
subsequent course of
treatment may begin 45 days later with dosa