Tamoxifen 20mg tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Tamoxifen citrate

Disponibbli minn:

DE Pharmaceuticals

Kodiċi ATC:

L02BA01

INN (Isem Internazzjonali):

Tamoxifen citrate

Dożaġġ:

20mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 08030401

Fuljett ta 'informazzjoni

NOT KNOWN (cannot be estimated from the
available data):
•
swelling of the face, lips, tongue or
throat, difficulty in swallowing or
breathing (angioedema). Tamoxifen may
cause or worsen symptoms of hereditary
angioedema.
These side effects are serious. You may
need medical attention.
The following side effects generally occur
after long-term use with Tamoxifen and
include a range of menstrual disorders (see
below). If you still have periods you may
notice that your cycles are disturbed, or
may completely stop.
VERY COMMON (may affect more than 1 in 10
people):
•
vaginal discharge
•
hot flushes
•
skin rash
•
feeling sick
•
swollen arms or legs (fluid retention in
the body)
•
feeling tired
•
depression
COMMON (may affect up to 1 in 10 people):
•
reduction in red blood cells which can
make the skin pale and cause weakness
or breathlessness (anaemia)
•
increase in blood fat (triglyceride) levels
•
light-headedness, headache
•
tingling or pins and needles sensations in
the hands and feet
•
changes in taste, being sick, diarrhoea,
constipation
•
hair loss
•
tumour pain
•
visual disturbance such as cataracts
(when the lens of your eye lets through
less light)
•
changes in liver enzyme levels (which
may be seen in blood tests),
development of “fatty liver” where fatty
deposits are seen in the liver
•
leg cramps, muscle pain
•
genital itching
•
uterine fibroids or polyps (non-cancerous
growths of the womb), thickening of the
womb lining
UNCOMMON (may affect up to 1 in 100
people):
•
blood disorders which may cause you to
bruise or bleed more easily or without
explanation
•
scarring of the liver (cirrhosis), normally
due to liver damage
•
high levels of calcium in your blood
•
changes to your vision and difficulty
seeing.
RARE (may affect up to 1 in 1,000 people):
•
short-lived falls in platelet counts
(platelets are blood cells)
•
changes to the cornea (the outer
covering of your eye).
•
abnormal or interrupted menstrual cycle
(periods) in premenopausal women
•

Karatteristiċi tal-prodott

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