Tamoxifen 20mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Tamoxifen citrate

Հասանելի է:

Relonchem Ltd

ATC կոդը:

L02BA01

INN (Միջազգային անվանումը):

Tamoxifen citrate

Դոզան:

20mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 08030401; GTIN: 05055144200897

Տեղեկատվական թերթիկ

TAMOXIFEN 20MG TABLETS
Tamoxifen
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 20MG TABLETS ARE AND
WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TAMOXIFEN 20MG TABLETS
3. HOW TO TAKE TAMOXIFEN 20MG TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TAMOXIFEN 20MG TABLETS
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT TAMOXIFEN 20MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Tamoxifen belongs to a group of medicines
called 'anti-oestrogens'. Oestrogen is a natural
substance in your body known as a 'sex
hormone'. Some breast cancers need oestrogen
to grow and Tamoxifen works by blocking the
effects of oestrogen.
WHAT TAMOXIFEN IS USED FOR
•
Tamoxifen is used to treat breast cancer
•
It is also used to 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

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 30.4mg tamoxifen citrate (equivalent to 20mg
tamoxifen).
3
PHARMACEUTICAL FORM
Tablets
Round, white, biconvex tablets with a score line and ‘20’ embossed
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tamoxifen 20mg 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
trails 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 30-40 mg per day is not available, although these
doses have
been used in some patients with advanced disease.
ELDERLY
Similar dosing regimens of Tamoxifen 20mg Tablets have been used in
elderly
patients 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 daily in single or divided doses, given on the second, third,
fourth and
fifth days of 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 may be given during subsequent
menstrual periods, increasing the dosage to 40mg and then to 80 mg
daily in
single or divided doses.
In women who are no