Diethylstilbestrol 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diethylstilbestrol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

L02AA01

INN (International Name):

Diethylstilbestrol

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030100; GTIN: 5037563004102

Patient Information leaflet

PAGE 1: FRONT FACE
PAGE 2: REAR FACE
Pharma code: 1323
Pharma code: 1323
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. 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.
1. WHAT DIETHYLSTILBESTROL IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIETHYLSTILBESTROL
3. HOW TO TAKE DIETHYLSTILBESTROL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DIETHYLSTILBESTROL
6. CONTENTS OF THE PACK AND OTHER 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIETHYLSTILBESTROL
DO NOT TAKE DIETHYLSTILBESTROL:
• if you are allergic to diethylstilbestrol or any
of the other ingredients of this medicine
(listed in section 6)
• if you are currently suffering from liver disease
• if you have moderate or severe high blood
pressure
• if you have any heart problems
• if you have a history of blood clots
• if you have any disorder of the blood vessels
in the brain
• if you have hyperlipoproteinaemia (an excess
of lipoproteins in the blood)
• if you have untreated polycythaemia
(increased production of red blood cells), or
sickle cell anaemia (altered shape of red
blood cells) which causes anaemia
• if you have porphyria (a deficiency of specific
enzymes within the body, causing an increase
of substances called porphyrins).
FEMALE PATIENTS ONLY:
• if you have not yet reached your menopause
• if you have an oestrogen dependant cancer,
especi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diethylstilbestrol 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 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 1313 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
Posology
_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._ _
Method of administration
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
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;
oestrogen-dependent
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;
hyperlipo