Tamoxifen 20mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Tamoxifen citrate

Доступно од:

Viatris UK Healthcare Ltd

АТЦ код:

L02BA01

INN (Међународно име):

Tamoxifen citrate

Дозирање:

20mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 08030401; GTIN: 5016695460024

Информативни летак

pharmacode
reading direction
•
inflammation of the lungs
(pneumonitis) may occur, which
may cause a dry cough, progressive
difficulty in breathing, swelling
of the ends of the fingers, bluish
discolouration of the skin and fever
RARE (may affect up to 1 in 1,000 people):
•
the cancer of womb
•
swelling of the optic nerve behind
the eye, which can cause increasingly
blurred vision.
•
damage to, or loss of, nerve cells in the
optic nerve, which can lead to loss of
vision
•
liver disorders such as cholestasis (when
the flow of bile is blocked), injury,
inflammation, death of liver cells or liver
failure. You may notice yellowing of the
skin or eyes, pale stools, dark urine or
pain in the stomach and abdomen.
•
Reddish non-elevated, target-like or
circular patches on the trunk, often with
central blisters, skin peeling, ulcers of
mouth, throat, nose, genitals and eyes.
These serious skin rashes can be preceded
by fever and flu-like symptoms [Stevens-
Johnson syndrome, toxic epidermal
necrolysis] – these side effects occur rarely.
VERY RARE (may affect up to 1 in
10,000 people):
•
condition in which the body’s own
immune system becomes overactive
and attacks normal healthy tissue
including that of the skin (cutaneous
lupus erythematosus)
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):
•
redu

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30.4 mg tamoxifen Citrate equivalent to tamoxifen
20 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
The tablets are white, round, biconvex tablets marked TN|20 on one
side and G on
reverse with an approximate diameter of 9.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an orally active anti-oestrogen in the treatment of breast cancer.
Also used
to stimulate ovulation in anovulatory infertility.
It is also indicated for 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
_Adults:_
I) BREAST CANCER: 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.
II) ANOVULATORY INFERTILITY: The possibility of pregnancy must be
excluded
before the commencement of treatment, whether initial or subsequent.
In
women with regular menstruation but with anovular cycles, treatment
should
commence with 20 mg daily in either one or two doses administered on
the
second, third, fourth and fifth days of the menstrual cycle. In
unsuccessful
cases further courses may be given during subsequent menstrual
periods,
increasing the dosage to 20 mg then 40 mg twice daily.
In women with irregular menstruation, the commencement of treatment
may
take place on any day. If this initial course is not successful then a
further
course may be initiated after an interval of 45 days with the higher
dosage