ZYLORIC 100MG TABLETS

Active substance: ALLOPURINOL

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Package Leaflet: Information for the User

Zyloric® 100 mg and 300 mg tablets
allopurinol
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or
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pharmacist.
•  his medicine has been prescribed for you. Do not pass it
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onto others. It may harm them, even if their symptoms are
the same as yours.
• f any of the side effects gets serious, or if you notice any
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side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1 What Zyloric is and what it is used for
2 Before you take Zyloric
3 How to take Zyloric
4 Possible side effects
5 How to store Zyloric
6 Further information

1 What Zyloric is and what it is used for
Zyloric tablets contain a medicine called allopurinol. It works by
slowing down the speed of certain chemical reactions in your body.
Zyloric is used:
•  o prevent gout. This is a disease where your body produces
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too much of a substance called ‘uric acid’. The uric acid
builds up in your joints and tendons as crystals. These
crystals cause an inflammatory reaction. The inflammation
causes the skin around certain joints to become swollen,
tender and sore when only slightly touched. You can also
find you get severe pain when the joint is moved.
•  o prevent other conditions where there is a build up of uric
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acid in the body. These include kidney stones and certain
other types of kidney problem and when you are having
treatment for cancer.

2 Before you take Zyloric
Do not take Zyloric if:
•  ou are allergic (hypersensitive) to allopurinol or any of the
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other ingredients of Zyloric (listed in Section 6).
Do not take Zyloric if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Zyloric.
Take special care with Zyloric
Check with your doctor or pharmacist before taking your
medicine if:
•  ou have problems with your liver or kidneys. Your doctor
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may give you a lower dose or ask you to take it less often
than each day. They will also monitor you more closely
• You have heart problems or high blood pressure
• you are currently having an attack of gout
•  ou have been told by your doctor that you have an
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intolerance to lactose. Zyloric tablets contain a small amount
of lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
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.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Zyloric.



Taking other medicines
Tell your doctor or pharmacist if you are taking any of the
following:
• aspirin
• theophylline, used for breathing problems







medicines used for fits (epilepsy)
antibiotics
didanosine, used to treat HIV infection
medicines for cancer
m
 edicines used to reduce your immune response
(immunosuppressants)
• medicines used to treat diabetes
•  edicines for heart problems or high blood pressure such as
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‘ACE inhibitors’ or water tablets (diuretics)
•  edicines used to thin your blood (anticoagulants), such as
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warfarin
• any other medicine to treat gout.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines. This
is because Zyloric can affect the way some medicines work. Also
some other medicines can affect the way Zyloric works.
Taking Zyloric with food and drink
Take Zyloric with food and water.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, might become pregnant or are breast-feeding.
Driving and using machines
You may feel drowsy, giddy or have problems with your coordination. If this happens, do not drive or use any tools or
machines.

3 How to take Zyloric
Always take Zyloric exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Swallow the tablet with a drink of water.
• Take with or just after food.
Children (under 15 years)
• The usual dose ranges from 100 to 400 mg each day.
Adults (over 18 years)
•  he usual dose ranges from 100 to 900 mg each day. You
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will usually start on a dose of 100 to 300 mg each day.
Elderly (over 65 years)
•  our doctor will prescribe the lowest dose of Zyloric tablets
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that best controls your symptoms.
If you have a serious kidney problem
• you may be asked to take less than 100 mg each day
•  r you may be asked to take 100 mg at longer intervals than
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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.
If you take more Zyloric than you should
If you take more Zyloric than you should, talk to a doctor or go
to hospital straight away. Take the medicine pack with you.
If you forget to take Zyloric
• f you forget a dose, take it as soon as you remember it.
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However, if it is nearly time for the next dose, skip the
missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Zyloric
Do not stop taking your Zyloric without talking to your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4 Possible side effects
Like all medicines, Zyloric can cause side effects, although not
everybody gets them. The following side effects may happen
with this medicine:
Allergic reactions (affects less than 1 in 10,000 people)
If you have an allergic reaction, stop taking Zyloric and see a
doctor straight way. The signs may include:
• skin rash, flaking skin, boils or sore lips and mouth
•  ery rarely signs may include sudden wheeziness, fluttering
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or tightness in 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, stop your tablets
and tell your doctor as soon as possible:
Rare (affects less than 1 in 1000 people)
• joint pain or painful swelling in your groin, armpits or neck
• yellowing of the skin and eyes (jaundice)
• liver or kidney problems
•  eeling sick (nausea) or being sick (vomiting), occasionally
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with blood
• bleeding in the lips, eyes, mouth, nose or genitals
•  ever and chills, headache, aching muscles (flu-like
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symptoms) and generally feeling unwell
•  ny changes to your skin, for example ulcers of the mouth,
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throat, nose, genitals and conjunctivitis (red and swollen
eyes), widespread blisters or peeling
•  erious hypersensitivity reactions involving fever, skin rash,
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joint pain, and abnormalities in blood and liver function tests
(these may be signs of a multi-organ sensitivity disorder).

What Zyloric looks like and contents of the pack
Zyloric tablets contain 100 or 300 mg allopurinol. Each 100 mg
tablet is white, round and marked with a score line, Z1.
Each 300 mg tablet is white, round and marked with a score
line, Z3.
Zyloric 100 mg tablets come in 4 strips of 25 tablets.
Zyloric 300 mg tablets come in 2 strips of 14 tablets.
Marketing Authorisation Holder
Aspen Pharma Trading Limited
12/13 Exchange PlaceI.F.S.C, Dublin 1, Ireland
Service-Tel: +800 00404142
Manufacturer
Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
D 23843 Bad Oldesloe
Germany
Leaflet date: November 2012
Zyloric is a registered trademark of the Aspen

Very rare (affects less than 1 in 10,000 people)
•  ruising more easily than usual, or you may develop a sore
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throat or other signs of an infection. Tell your doctor as soon
as possible. Occasionally Zyloric tablets may affect your
blood or lymph system. These effects usually occur in people
with liver or kidney problems
• high temperature
• blood in your urine (haematuria)
• high levels of cholesterol in your blood (hyperlipidaemia)
• a general feeling of being unwell
•  eakness, numbness, unsteadiness on your feet, feeling
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unable to move muscles (paralysis) or loss of consciousness
•  eadache, dizziness, drowsiness or disturbance of your vision
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• chest pain, high blood pressure or a slow pulse
• male infertility or erectile dysfunction
• enlargement of the breasts, in men as well as women
• a change in your normal bowel habit
• a change in taste
• cataracts
• hair loss or discolouration
• fits (convulsions)
• depression
•  uild up of fluid leading to swelling (oedema) particularly of
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your ankles
•  eeling thirsty, tired and losing weight; these may be
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symptoms of diabetes. Your doctor may wish to measure the
level of sugar in your blood to check if this is happening.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5 How to store Zyloric
• Keep out of the reach and sight of children.
•  o not use Zyloric after the expiry date which is stated on
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the carton after 'EXP'. The expiry date refers to the last day
of that month.
• Keep your tablets in the original packaging.
• Do not store above 25°C.
•  edicines should not be disposed of via wastewater or
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household waste.
•  eturn any unused or unwanted tablets to your pharmacist
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for disposal. Only keep them if your doctor tells you to.
These measures will help to protect the environment.

6 Further information
What Zyloric contains
• The active substance is allopurinol.
•  he other ingredients are lactose, maize starch, povidone
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and magnesium stearate.



12000000103184

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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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