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DIETHYLSTILBESTROL 5MG TABLETS

Active substance(s): DIETHYLSTILBESTROL

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TEVA UK Ref: 40432-V LEA DIETHYLSTILBESTROL A/S TABS TUK
3

11 June 2015

PAGE 1: FRONT FACE

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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
skin disorder of pregnant women.

Version 1.4

Approved

swallowed any of the tablets contact your
nearest hospital casualty department or your
doctor immediately.
The most common symptoms of overdose are
feeling or being sick.
Please take this leaflet, any remaining tablets,
and the container with you to the hospital or
doctor so that they know which tablets were
consumed.

increased risk of malignant tumours in the
lining of the uterus
• in women, high calcium levels in the blood
causing nausea, vomiting, loss of appetite,
weakness, headache, bone pain, sleepiness or
apathy
• in men, increased size of male breasts,
reduction in size of testes, inability to get or
maintain an erection.

If you forget to take Diethylstilbestrol
If you forget to take a tablet, take one as soon
as you remember, unless it is nearly time to
take the next one. DO NOT take a double dose
to make up for a forgotten dose.

If you have a thyroid function test while you are
taking this medicine, make sure you have told
the doctor that you are taking Diethylstilbestrol,
as it may affect the results.

If you stop taking Diethylstilbestrol
You should continue to take these tablets for as
long as your doctor tells you to. DO NOT stop
taking your medicine without talking to your
doctor first even if you feel better.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

Taking other medicines
Talk to your doctor if you are taking any of the
following:
• diuretics or water tablets
• medicines used for high blood pressure.

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POSSIBLE SIDE EFFECTS

Like all medicines, Diethylstilbestrol can cause
side effects, although not everybody gets them.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Stop taking the tablets and tell your doctor
immediately or go to the casualty department
at your nearest hospital if the following
happens:
• an allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or hives)
• blood clots (causing redness, swelling and
pain in the affected area).
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.

Important information about some of the
ingredients of Diethylstilbestrol
• Patients who are intolerant to lactose should
note that Diethylstilbestrol tablets contain a
small amount of lactose. If your doctor has
told you that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
• Your medicine contains the colouring agent
E110 (sunset yellow) which may cause allergic
reactions.

Tell your doctor immediately if the following
happens:
• gallstones and associated jaundice (causing
yellowing of the skin or whites of the eyes).

Pregnancy and breast-feeding
• Diethylstilbestrol should not be used by
women of child bearing age.

The following side effects have been reported:
• aches and pains
• breast discomfort, breast tenderness
• darkening of the skin
• fluid retention
• headache
• increased incidence of migraine
• high blood pressure
• feeling sick (nausea) and being sick (vomiting)
• skin rashes
• weight gain
• sodium retention causing symptoms such as
increased thirst, dry mouth, loss of skin
elasticity, irritability, muscle twitching
• above normal glucose levels in the blood,
which may increase the risk of diabetes
• fluctuating moods (both elation and
depression)
• tender inflamed skin marked by red nodules
• discomfort of the eyes in patients wearing
contact lenses
• enlargement and secretion of milk like fluid
from the breasts in both men and women
• in women, withdrawal bleeding, excessive
production of cervical mucous, thickening of
the lining of the uterus and uterine tumours.
With prolonged use there may be an

Driving and using machines
• Diethylstilbestrol is not known to affect your
ability to drive or operate machinery.

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If you have any further questions on the use of
this product, ask your doctor or pharmacist.

HOW TO TAKE DIETHYLSTILBESTROL

Always take Diethylstilbestrol exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably
with a drink of water.
The usual dose is:
Adults, including the elderly
• Prostate cancer
One to three 1 mg tablets per day.
• Post-menopausal breast cancer
Two to four 5 mg tablets per day.
Children
Diethylstilbestrol should not be used in
children.
If you take more Diethylstilbestrol than you
should
If you (or someone else) take too many tablets
all together, or if you think a child has

Page 1 of 2

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HOW TO STORE DIETHYLSTILBESTROL

Keep out of the reach and sight of children.
These tablets should be stored in a dry place
below 25°C, protected from light.
Do not use Diethylstilbestrol after the expiry
date that is stated on the outer packaging. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

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FURTHER INFORMATION

What Diethylstilbestrol tablets contain:
• The active ingredient is either 1 mg or 5 mg
of diethylstilbestrol.
• The other ingredients are, anhydrous lactose,
magnesium stearate (E572), maize starch,
talc, polyvinyl alcohol, macrogol and the
colouring agents E110 (sunset yellow), E127
(erythrosine), E132 (indigo carmine) and E171
(titanium dioxide).
What Diethylstilbestrol tablets look like and
contents of the pack:
• Diethylstilbestrol 1 mg tablets are pink
biconvex, film-coated tablets, plain on one
side and inscribed APS 1313 on the reverse.
• Diethylstilbestrol 5 mg tablets are pink
biconvex, film-coated tablets, plain on one
side and inscribed APS 1314 on the reverse.
• The product is available in packs of 10, 28, 30,
56, 60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG
This leaflet was last revised: June 2015
PL 00289/5188R-5189R

Code 1732
51731378
40432-V

Pharma code: 1732

IN THIS LEAFLET:

REG0061685

11 June 2015

Take special care with Diethylstilbestrol
Tell your doctor before you start to take this
medicine if you:
• suffer from kidney problems
• have ever had any liver problems or have
suffered from jaundice (yellowing of the skin
or whites of the eyes)
• suffer from mild high blood pressure
• have diabetes
• suffer from epilepsy
• suffer from migraine
• suffer from depression
• wear contact lenses
• suffer from gallstones
• suffer from thyroid problems.
Pharma code: 1732

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.

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PAGE 2: REAR FACE

DIETHYLSTILBESTROL
1 mg AND 5 mg TABLETS

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Version:

TEVA UK Ref: 40432-V LEA DIETHYLSTILBESTROL A/S TABS TUK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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