Tamoxifen 20 mg Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Tamoxifen citrate

제공처:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC 코드:

L02BA; L02BA01

INN (International Name):

Tamoxifen citrate

복용량:

20 milligram(s)

약제 형태:

Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Anti-estrogens; tamoxifen

승인 상태:

Marketed

승인 날짜:

1986-03-14

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMOXIFEN 20 MG TABLETS
(as 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
The name of your medicine is Tamoxifen 20 mg Tablets (referred to as
Tamoxifen in this leaflet).Your
medicine comes as a tablet containing the active ingredient tamoxifen
which is an ANTI-
OESTROGEN. It is used in the treatment of breast cancer. Some tumours
are dependent on female
sex hormones, oestrogens, in order to grow. As an anti-oestrogen,
tamoxifen can prevent naturally
occurring oestrogens attaching to tumour cells, which are dependent on
them to grow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN
DO NOT TAKE TAMOXIFEN:

If you are allergic (hypersensitive) to tamoxifen or any of the other
ingredients of this medicine
(listed in section 6).

If you are pregnant or think you might be pregnant (see ‘Pregnancy
and breast-feeding’ in section 2
of this leaflet for further information). If you are a woman of
child-bearing age, a pregnancy test
should normally be taken to confirm if you are pregnant before
starting treatment.

If you have had blood clots in the past and the doctor did not know
what caused them.

If someone in your family has had blood clots with the cause not
k

제품 특성 요약

Health Products Regulatory Authority
16 June 2022
CRN00CXSC
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains tamoxifen citrate equivalent to 20 mg of
tamoxifen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Tamoxifen 20mg Tablet:
White, round, biconvex tablet debossed with 'TN' above the score and
'20' below the score on one side of the tablet and 'G' on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tamoxifen is indicated in the treatment of breast cancer_._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
BREAST CANCER: Adults (including the elderly): The dosage range is 20
to 40 mg daily, given either in divided doses twice daily
or as a single dose once daily.
In early disease, it is currently recommended that treatment is given
for not less than 5 years. The optimal duration of
tamoxifen therapy remains to be determined.
_Paediatric population: _The use of tamoxifen is not recommended in
children, as safety and efficacy have not been established
(see sections 5.1 and 5.2).
Method of administration
For administration by the oral route.
4.3 CONTRAINDICATIONS
Tamoxifen should not be used in the following:

pregnancy. There have been a small number of reports of spontaneous
abortions, birth defects and foetal deaths
after women have taken tamoxifen, although no causal relationship has
been established (see also section 4.6).

hypersensitivity to the active substance, or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Menstruation is suppressed in a proportion of premenopausal women
receiving tamoxifen for the treatment of breast cancer.
A small number of cases of endometrial hyperplasia, endometrial polyps
andan increased incidence of endometrial cancer and
uterine sarcoma (mostly malignant mixed Mullerian tumours) have been
reported in association with tamoxifen treatment. The
underlying mec