Diethylstilbestrol 5mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Diethylstilbestrol

Beschikbaar vanaf:

Teva UK Ltd

ATC-code:

L02AA01

INN (Algemene Internationale Benaming):

Diethylstilbestrol

Dosering:

5mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 08030100; GTIN: 5017007131458

Bijsluiter

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms 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.
1. WHAT DIETHYLSTILBESTROL IS AND WHAT IT IS USED
FOR
2. BEFORE YOU TAKE DIETHYLSTILBESTROL
3. HOW TO TAKE DIETHYLSTILBESTROL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DIETHYLSTILBESTROL
6. FURTHER INFORMATION
WHAT DIETHYLSTILBESTROL IS AND
WHAT IT IS USED FOR
Diethylstilbestrol is a synthetic non-steroidal
oestrogen hormone.
Diethylstilbestrol is used to treat:
• prostate cancer in men
• breast cancer in post-menopausal women.
BEFORE YOU TAKE DIETHYLSTILBESTROL
DO NOT TAKE DIETHYLSTILBESTROL IF YOU:
• are allergic (hypersensitive) to
diethylstilbestrol or any of the other
ingredients of this medicine
• are currently suffering from liver disease
• have moderate or severe high blood pressure
• have any heart problems
• have a history of blood clots
• have any disorder of the blood vessels in the
brain
• have hyperlipoproteinaemia (an excess of
lipoproteins in the blood)
• untreated polycythaemia (increased
production of red blood cells), or sickle cell
anaemia (altered shape of red blood cells)
which causes anaemia
• have porphyria (a deficiency of specific
enzymes within the body, causing an increase
of substances called porphyrins).
FEMALE PATIENTS ONLY:
• have not yet reached your menopause
• have an oestrogen dependant cancer,
especially of the genital tract
• have endometrial hyperplasia (thickening of
the womb lining)
• have uterine fibroids (fibrotic lesions in the
uterus)
• have vaginal bleeding where the cause has
not been diagnosed by your doctor
• have a history of herpes gestationis, a rare

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diethylstilbestrol 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of diethylstilbestrol.
For excipients see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, biconvex, film-coated tablets, plain on one side and inscribed
APS over 1314 on
the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diethylstilbestrol tablets are indicated for the treatment of
carcinoma of the prostate
and metastatic post-menopausal carcinoma of the breast.
Diethylstilbestrol is a synthetic non-steroidal oestrogen hormone. It
has been in use
for many years. However, due to its carcinogenic potential, the use of
Diethylstilbestrol is now only justified in the management of
malignant disease.
It may be used to suppress androgenic hormonal activity in the
management of
androgen¬dependent carcinomas such as carcinoma of the prostate in
males and some
post-menopausal carcinomas such as breast cancer in females.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults: _
Management of prostatic carcinoma: 1 - 3 mg daily.
Management of post-menopausal breast carcinoma: 10 - 20 mg daily.
_Children: _
Diethylstilbestrol should not be used in children.
_Elderly: _
The recommended adult dose is appropriate.
4.3
CONTRAINDICATIONS
Diethylstilbestrol is contra-indicated in those who are pregnant (it
is not suitable for
pre-menopausal women); and children. It is also contra-indicated in
the following
conditions; oestrogendependent neoplasms especially of the genital
tract; pre-
menopausal carcinoma of the breast; endometrial hyperplasia or uterine
fibromyomata (fibroids). Diethylstilbestrol should not be given where
there is
undiagnosed vaginal bleeding; a history of herpes gestationis;
porphyria; moderate to
severe hypertension; severe or active liver disease;
hyperlipoproteinaemia; any
cardiovascular or cerebrovascular disorder or a history of
thrombo-embolism or
conditions predisposing to it such as sickle cell