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PAGE 1: FRONT FACE (INSIDE OF REEL)

ALLOPURINOL 100 mg AND 300 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start

using 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please teli your doctor or pharmacist.

INTHIS LEAFLET:

1. What Allopurinol is and what it is used for

2.    Before you take Allopurinol

3.    How to take Allopurinol

4.    Possible side effects

5.    Howto store Allopurinol

6.    Further information

O WHAT ALLOPURINOL IS AND WHAT IT IS USED FOR

_ • Allopurinol belongs to a group of medicines

called enzyme inhibitors, which act to control the speed at which special chemical changes occur in the body.

• Allopurinol tablets are used for the long term, preventative treatment of gout and may be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease.

Q BEFORE YOU TAKE ALLOPURINOL

DO NOT take Allopurinol and talk to your doctor if you:

• are intolerant or allergic (hypersensitive) to Allopurinol or any of the other ingredients of this medicine (see section 6)

• are currently having an attack of gout or have just had an attack of gout.

Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms).The rash may progress to widespread blistering and peeling of the skin.

These serious skin reactions can be more common in people of Han Chinese orThai origin.

If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

Take special care with Allopurinol:

Talk to your doctor before you start to take this medicine if you:

• are suffering from, or have previously suffered from any form of liver or kidney disease.Your doctor may give you a lower dose or ask you to take it less often than each day.They will also monitor you closely • have heart problems or have high blood pressure

• are pregnant or trying to become pregnant.

If you develop a rash or these skin symptoms, stop taking Allopurinol, seek urgent advice from a doctor and tell him that you are taking this medicine:

• Potentially life-threatening skin rashes

(Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Allopurinol, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk • Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes)

• These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.

• The highest risk for occurrence of serious skin reactions is within the first weeks of treatment

•    If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Allopurinol, you must not be re-started on Allopurinol at any time.

Taking other medicines

Tell your doctor before you start to take this

medicine if you are taking:

•    other medication to treat gout e.g. probenecid

•    large doses of aspirin-type drugs (salicylates)

•    medicines for high blood pressure or heart disease such as diuretics ("water tablets") e.g. furosemide, or ACE inhibitors e.g. fosinopril, captopril

•    any medicines used to thin your blood (anticoagulants) e.g. warfarin

•    mercaptopurine (used to treat leukaemia)

•    ciclosporin or azathioprine (used to suppress the immune system)

•    didanosine (used to treat HIV infections)

•    chlorpropamide (used to treat diabetes)

•    vidarabine (adenine arabinoside), used in the treatment of herpes

•    phenytoin (used to treat epilepsy)

•    theophylline (used for respiratory problems)

•    the antibiotics amoxicillin or ampicillin

•    cyclophosphamide, doxorubicin, bleomycin, procarbazine, mechloroethamine or any other anti-cancer medication.

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

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

AllopurinolTablets can cause dizziness, drowsiness and can affect your coordination. If you are affected DO NOT drive, operate machinery or participate in dangerous activities.

Important information about some of the ingredients of Allopurinol

Patients who are intolerant to lactose should note that Allopurinol 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.

Q HOWTO TAKE ALLOPURINOL

Always use Allopurinol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole, preferably with a drink of water. You should take your tablets after a meal. You should drink plenty of fluids (2 - 3 litres a day) while you are taking this medicine.

The usual dose is:

•    Adults (including the elderly)

Starting dose: 100 - 300 mg/day When you start your treatment, your doctor may also prescribe an anti-inflammatory medicine or colchicine for a month or more, to prevent attacks of gouty arthritis.

Your dose of allopurinol may be adjusted depending on the severity of the condition.

The maintenance dose is:

•    mild conditions, 100 - 200 mg/day

•    moderately severe conditions, 300 - 600 mg/day

•    severe conditions, 700 - 900 mg/day.

Your dose may also be altered by your doctor if you have reduced kidney and liver function, particularly if you are elderly.

If the daily dose exceeds 300 mg/day and you are suffering from gastro-intestinal side effects such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce these effects.

•    Children (under 15 years)

100 - 400 mg/day.

Treatment may be started together with an anti-inflammatory medicine or colchicine, and the dose adjusted if you have reduced kidney and liver function, or divided to reduce gastro-intestinal side effects, as for Adults above.

If you take more Allopurinol than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

An overdose is likely to cause effects including nausea, vomiting, diarrhoea, or dizziness.

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 Allopurinol

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.Take the remaining doses at the correct time.

If you stop taking Allopurinol

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.

Ask your doctor or pharmacist if you have any further questions on the use of this product.

POSSIBLE SIDE EFFECTS

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

Stop taking Allopurinol and contact your doctor immediately if you experience:

• an unexpected skin reaction (possibly in association with fever, swollen glands, joint pain, unusual blistering or bleeding, kidney problems (blood in the urine) or a sudden onset of fits).

Skin rashes are the most common side effect with allopurinol (affecting fewer than one person in 10 but more than one person in 100). Stop taking your tablets and tell your doctor immediately or go to your nearest hospital casualty department if you experience any of the following symptoms:

•    swelling of the face, hands, lips, tongue or throat

•    difficulty swallowing or breathing

•    sudden wheeziness.

A few people may develop a severe allergic reaction to allopurinol, this is an uncommon side effect (affecting less than one person in 100 but more than one person in 1,000) but is a very serious side effect.

If you experience any of the following while you are taking Allopurinol, stop taking your tablets and tell your doctor as soon as possible:

The following uncommon side effects have been reported (affecting less than one person in 100 but more than one person in 1,000):

•    any changes to your skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling

•    nausea, vomiting (very rarely, blood may be present) and diarrhoea

•    serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder)

•    fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell.

The following rare side effects have been reported (affecting less than one person in 1,000 but more than one person in 10,000):

•    jaundice (yellowing of the skin and whites of the eyes)

•    may affect your liver or kidney function (diagnosed by blood and/or urine tests)

•    formation of stones in the urinary tract, symptoms may include blood in the urine and pain in the abdomen, flank, or groin.

The following very rare side effects have been reported (affecting less than one person in 10,000):

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2)

•    reduction in the number of white blood cells, which makes infections more likely

•    serious allergic reaction which causes swelling of the face or throat

•    reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

•    high temperature

•    lethargy

•    blood in the urine (haematuria)

•    a change in your normal bowel habit, or unusual foul-smelling bowel movements

•    high fat levels in the blood (diagnosed by blood tests)

•    a general feeling of being unwell

•    weakness, numbness, unsteadiness on feet, inability to move muscles (paralysis) or loss of consciousness, pins and needles

•    sleepiness

•    difficulty in controlling movements (ataxia)

•    convulsions, fits or depression

•    coma

•    headache, feeling of dizziness or spinning, drowsiness or disturbance of vision

•    chest pain, high blood pressure or a slow pulse

•    vomit blood (Haematemesis)

•    retention of fluid leading to swelling (oedema) particularly of the ankles

•    male infertility (inability to achieve a pregnancy after one year of regular contraceptive-free intercourse)

•    inability to get or maintain an erection, or ejaculation during sleep ("wet dreams")

•    enlargement of the breasts, in men as well as women

•    a change in taste perception, inflammation in the mouth

•    cataracts (clouding of the lens of the eye)

•    boils (small tender red lumps on the skin)

•    hair loss or discolouration

•    feeling thirsty, tired and losing weight (these may be symptoms of diabetes), your doctor may wish to measure the level of sugar in your blood to decide if this is happening

•    muscle pain.

You may occasionally feel sick, but this can usually be avoided by taking allopurinol after meals.Tell your doctor if this problem persists. Occasionally, allopurinol may affect your blood or lymphatic system.These effects have usually occurred in people with liver or kidney problems. Tell your doctor as soon as you can if you notice that you are bruising more easily than usual, or if you develop a sore throat or other signs of an infection.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOWTO STORE ALLOPURINOL

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package. Do not use Allopurinol after the expiry date that is stated on the carton.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.

FURTHER INFORMATION

What Allopurinol contains:

•    Each 100 mg tablet contains 100 mg of Allopurinol

•    Each 300 mg tablet contains 300 mg of Allopurinol

•    The other ingredients are lactose monohydrate, colloidal anhydrous silica, maize starch, powdered cellulose, sodium starch glycolate, sodium lauryl sulphate, povidone and magnesium stearate.

What Allopurinol looks like and contents of the pack:

•    Allopurinol 100 mg Tablets are white, round, biconvex tablets, debossed "4K1" on one side and plain on the other

•    Allopurinol 300 mg Tablets are white, round, biconvex tablets, debossed either "2K1" or "BERK 2K1" on one side and plain on the other.

•    The 100 mg tablets are available in pack sizes of 7, 10, 14, 21,28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150,160,168, 250 and 500 tablets.

•    The 300 mg tablets are available in packs of 28 and 84.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder isTEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG.

Company responsible for manufacture:Teva Pharmaceutical Works Private Limited Company, 4042 Debrecen, Pa Magi ut 13, Hungary.

This leaflet was last revised: September 2012

PL 00289/0951 and PL 00289/017 5    86304-V

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