Tamoxifen 20mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Tamoxifen citrate

제공처:

Tillomed Laboratories Ltd

ATC 코드:

L02BA01

INN (International Name):

Tamoxifen citrate

복용량:

20mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 08030401; GTIN: 5024655001866

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMOXIFEN 10MG AND 20MG TABLETS
(TAMOXIFEN CITRATE)
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.
WHAT IS IN THIS LEAFLET:
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
1 WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR
Tamoxifen belongs to a group of medicines called anti−oestrogens.
Oestrogen is a natural substance
in your body and some breast cancers need oestrogen to grow. Tamoxifen
works by blocking the
effects of oestrogen.
Tamoxifen is used to:
•
Treat breast cancer
•
Treat infertility in women caused by a failure to produce and release
eggs (ovulate) properly
•
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
canc

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Tamoxifen Citrate 30.40mg (equivalent to 20mg
tamoxifen)
Excipient with known effect: Each tablet contains 259.60mg of lactose
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White, convex tablets with an approximate diameter of 9.5mm printed
T20on
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