TEVA UK Ref: 40432-V LEA DIETHYLSTILBESTROL A/S TABS TUK<HAU	Version: 3 11 June 2015

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DIETHYLSTILBESTROL 1 mg AND 5 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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.

IN THIS LEAFLET:

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

OWHAT 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.

0 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.

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.

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.

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.

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

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.

Pregnancy and breast-feeding

•    Diethylstilbestrol should not be used by women of child bearing age.

Driving and using machines

•    Diethylstilbestrol is not known to affect your ability to drive or operate machinery.

HOWTO 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

TEVA UK Ref: 40432-V LEA DIETHYLSTILBESTROL A/S TABS TUK<HAU	Version: 3 11 June 2015

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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.

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 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.

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

Q POSSIBLE SIDE EFFECTS

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

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.

Tell your doctor immediately if the following happens:

•    gallstones and associated jaundice (causing yellowing of the skin or whites of the eyes).

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 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.

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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Q HOWTO 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.

Q 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

TEUZD

TEVA UK LIMITED