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ALLOPURINOL 200MG TABLETS

Active substance(s): ALLOPURINOL

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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.
x Keep this leaflet. You may need to read it again.
x If you have any further questions, ask your doctor or pharmacist.
x 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.
x 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.
x
x

2.

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.

BEFORE YOU TAKE ALLOPURINOL

DO NOT take Allopurinol and talk to your doctor if you:
x are allergic (hypersensitive) to Allopurinol or any of the other ingredients of this medicine
x 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:
x 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.
x have heart problems or high blood pressure.
x 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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Allopurinol 100mg, 200mg & 300mg Tablets
PL 00289/1093, 1094 & 1095
UK/H/1313/01-03/DC

Version 2d1

Taking other medicines
Tell your doctor before you start to take this medicine if you are taking:
x 6-mercaptopurine ( used to treat blood cancer)
x azathioprine, cyclosporine (used to suppress the immune system)
Please note, cyclosporine side effects may occur more frequently.
x vidarabine (used in the treatment of herpes)
Please note, vidarabine side effects can occur more frequently. Take special care if these occur.
x salicylates (used to reduce pain, fever or inflammation e.g. Aspirin)
x probenecid ( used to treat gout)
x chlorpropamide (used to treat diabetes)
Chlorpropamide dose reduction may be necessary, particularly in patients with reduced kidney function.
x 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.
x phenytoin (used to treat epilepsy )
x 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.
x ampicillin or amoxicillin (used to treat bacterial infections)
Patients should receive other antibiotics where possible, as allergic reactions are more likely to occur.
x Medicines to treat aggressive tumours, such as
- cyclophosphamide
- doxorubicin
- bleomycin
- procarbazine
- mechloroethamine
Your doctor will monitor your blood counts frequently.
x didanosine (used to treat HIV infection)
x 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
x 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
x 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
x 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.

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Allopurinol 100mg, 200mg & 300mg Tablets
PL 00289/1093, 1094 & 1095
UK/H/1313/01-03/DC

Version 2d1

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:
x

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:
x mild conditions, 100-200 mg/day
x moderately severe conditions, 300-600 mg/day
x 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
x you may be asked to take less than 100 mg each day
x 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.
x

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.

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Allopurinol 100mg, 200mg & 300mg Tablets
PL 00289/1093, 1094 & 1095
UK/H/1313/01-03/DC

Version 2d1

x

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)
x fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell
x any changes to your skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red
and swollen eyes), widespread blisters or peeling
x 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:
x skin rash, flaking skin, boils or sore lips and mouth.
x Swelling of the face, hands, lips, tongue or throat.
x Difficulty swallowing or breathing.
x 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):
x nausea , vomiting (very rarely, blood may be present) and diarrhoea
x symptoms of allergic reactions including itchy rash
x 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):
x joint pain or painful swelling in the groin, armpits or neck
x jaundice (yellowing of the skin and whites of the eyes)
x may affect your liver or kidney function.
x 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):
x high temperature
x blood in the urine
x a change in your normal bowel habit, or unusual foul-smelling bowel movements
x high fat levels in the blood
x a general feeling of being unwell
x weakness, numbness, unsteadiness on feet, inability to move muscles (paralysis) or loss of
consciousness, pins and needles
x convulsions, fits or depression
x headache, dizziness, drowsiness or disturbance of vision
x chest pain, high blood pressure or a slow pulse
x retention of fluid leading to swelling (oedema) particularly of the ankles
x male infertility or inability to get or maintain an erection, or ejaculation during sleep ("wet dreams")
x enlargement of the breasts, in men as well as women
x a change in taste perception, inflammation in the mouth
x cataracts (clouding of the lens of the eye) and other problems with sight
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Allopurinol 100mg, 200mg & 300mg Tablets
PL 00289/1093, 1094 & 1095
UK/H/1313/01-03/DC
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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:
x 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.
x 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:
x Allopurinol 100 mg Tablets are white, round, biconvex tablets, debossed “4K1” on one side and plain on
the other.
x Allopurinol 200 mg Tablets are white, round, biconvex tablets, debossed “3K1” on one side and plain on
the other
x 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
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Allopurinol 100mg, 200mg & 300mg Tablets
PL 00289/1093, 1094 & 1095
UK/H/1313/01-03/DC

Version 2d1

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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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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