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Allopurinol 200mg Tablets

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Allopurinol 100mg, 200mg & 300mg Tablets PL 00289/1093, 1094 & 1095

UK/H/1313/01-03/DC

PACKAGE LEAFLET: INFORMATION FOR THE USER Allopurinol 100 mg, 200 mg and 300 mg Tablets

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 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.

IN THIS 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.    How to store Allopurinol

6.    Further information

1.    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.

2.    BEFORE YOU TAKE ALLOPURINOL

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

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

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

Take special care with Allopurinol

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

•    have problems with your liver and kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely.

•    have heart problems or high blood pressure.

•    are currently having an attack of gout.

If you are not sure if any of the following applies to you, talk to your doctor or pharmacist before taking allopurinol.

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 or Thai origin.

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

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Taking other medicines

Tell your doctor before you start to take this medicine if you are taking:

•    6-mercaptopurine ( used to treat blood cancer)

•    azathioprine, cyclosporine (used to suppress the immune system)

Please note, cyclosporine side effects may occur more frequently.

•    vidarabine (used in the treatment of herpes)

Please note, vidarabine side effects can occur more frequently. Take special care if these occur.

•    salicylates (used to reduce pain, fever or inflammation e.g. Aspirin)

•    probenecid ( used to treat gout)

•    chlorpropamide (used to treat diabetes)

Chlorpropamide dose reduction may be necessary, particularly in patients with reduced kidney function.

•    warfarin, phenprocoumon, acenocoumarol (used to thin the blood)

Your doctor will monitor your blood clotting values more frequently and if necessary, reduce the dose of these medicines.

•    phenytoin (used to treat epilepsy )

•    theophylline (used to treat asthma and other breathing diseases)

Your doctor will measure theophylline blood levels, particularly when treatment with Allopurinol begins, or following any dosage changes.

•    ampicillin or amoxicillin (used to treat bacterial infections)

Patients should receive other antibiotics where possible, as allergic reactions are more likely to occur.

•    Medicines to treat aggressive tumours, such as

-    cyclophosphamide

-    doxorubicin

-    bleomycin

-    procarbazine

-    mechloroethamine

Your doctor will monitor your blood counts frequently.

•    didanosine (used to treat HIV infection)

•    captopril (used to treat high blood pressure)

The risk of skin reactions can be raised, especially if your kidney function is chronically reduced.

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 any medicine.

Driving and using machines

•    Allopurinol Tablets 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

•    This medicinal product contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO 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.

If you have a serious kidney problem

•    you may be asked to take less than 100 mg each day

•    or you may be asked to take 100 mg at longer intervals than one day

If you have dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg which is to be taken straight after your dialysis.

•    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.

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.

4. POSSIBLE SIDE EFFECTS

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

   If you experience any of the following, stop your tablets and tell your doctor immediately: an

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

Skin rashes are the most common side effect with allopurinol (affecting less than one person in 10 but more than one person in 100).

Rare (affects less than 1 in 1000 people)

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

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

•    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).

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking allopurinol and see a doctor straight away. The signs may include:

•    skin rash, flaking skin, boils or sore lips and mouth.

•    Swelling of the face, hands, lips, tongue or throat.

•    Difficulty swallowing or breathing.

•    very rarely signs may include sudden wheeziness, fluttering or tightness of the chest and collapse.

Do not take any more tablets unless your doctor tells you to do so.

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):

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

•    symptoms of allergic reactions including itchy rash

•    increase in results of liver function tests

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

•    joint pain or painful swelling in the groin, armpits or neck

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

•    may affect your liver or kidney function.

•    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):

•    high temperature

•    blood in the urine

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

•    high fat levels in the blood

•    a general feeling of being unwell

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

•    convulsions, fits or depression

•    headache, dizziness, drowsiness or disturbance of vision

•    chest pain, high blood pressure or a slow pulse

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

• male infertility or 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) and other problems with sight

•    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

•    swollen glands, usually goes away once treatment with allopurinol ends

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.

5. HOW TO STORE ALLOPURINOL Keep out of the reach and sight of children.

Do not use Allopurinol after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

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.

6. FURTHER INFORMATION

What Allopurinol Tablets contain:

•    The active substance is allopurinol.

Each 100 mg tablet contains 100 mg of allopurinol.

Each 200 mg tablet contains 200 mg of allopurinol.

Each 300 mg tablet contains 300 mg of allopurinol.

•    The other ingredients are lactose monohydrate, silica colloidal anhydrous, maize starch, powdered cellulose, sodium starch glycolate, sodium laurilsulfate, povidone K30 and magnesium stearate (E470b).

What Allopurinol Tablets look 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 200 mg Tablets are white, round, biconvex tablets, debossed “3K1” on one side and plain on the other

•    Allopurinol 300 mg Tablets are white, round, biconvex tablets, debossed “2K1” on one side and plain on the other

The product is available in transparent aluminium blisters in the following pack sizes :

Allopurinol 100 mg Tablets: 20, 25, 28, 30, 50, 60, 90, 98, 100 and 500 tablets and Hospital Pack of 50

Allopurinol 200 mg Tablets: 20, 28, 30, 50, 60, 100 and Hospital Pack of 50

Allopurinol 300 mg Tablets: 20, 28, 30, 50, 60, 90, 98, 100 and 500 tablets and Hospital Pack of 50

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

This leaflet was last revised in August 2012. PL00289/1093-1095

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