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PACKAGE LEAFLET: INFORMATION FORTHE USER

I Allopurinol Tablets 100mg I Allopurinol Tablets 300mg

[Read all of this leaflet carefully before you start

taking this medicine because it contains

limportant information for you.

• Keep this leaflet. You may need to read it again.

|> If you have any further questions, ask your doctor or pharmacist or nurse.

|> This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

|> If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

^hat is in this leaflet:

1.    What Allopurinol Tablets are and what they are used for

2.    What you need to know before you take Allopurinol Tablets

3.    How to take Allopurinol Tablets

[4. Possible side effects

5. How to store Allopurinol Tablets

|6. Contents of the pack and other information

1. WHAT ALLOPURINOL TABLETS ARE AND WHAT THEY ARE USED FOR

Allopurinol Tablets contain a medicine called ^llopurinol. It works by slowing down the speed of certain chemical reactions in your body.

Allopurinol Tablets are used:-|* To prevent gout. This is a disease where your body produces too much of a substance called 'uric acid'. The uric acid builds up in yourjoints and tendons and forms crystals. These cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. Severe pain may also be felt on slight movement i of the joint

• To prevent other conditions where there is a build i up of uric acid in the body. This includes kidney stones.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TABLETS

iDo not take Allopurinol Tablets ifyou:

•    Are hypersensitive (allergic) to allopurinol or any i of the other ingredients of Allopurinol Tablets

¹ (listed in section 6)

|* Are currently suffering from an attack of gout.

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before taking Allopurinol Tablets if you:

L Have liver or kidney problems. Your doctor may I    give you a lower dose or ask you to take it less

'    often each day. You will also be monitored more

I closely

l Have heart problems or high blood pressure

•    Have been told by your doctor that you have an I intolerance to some sugars as this medicine

contains lactose.

Serious skin rashes (hypersensitivity syndrome, Stevens- Johnson syndrome, toxic epidermal have been reported with the use of

necrolysis)

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 i people of Han Chinese or Thai origin. If you develop a¹ rash or these skin symptoms, stop taking allopurinol i and contact your doctor immediately.

Other medicines and Allopurinol Tablets

Tell your doctor or pharmacist if you are taking, have i recently taken or might take any other medicines.    ¹

In particular tell your doctor if you are taking any of i the following:    ¹

•    Azathioprine (to treat rheumatoid arthritis and after

organ transplants)    ¹

•    Ciclosporin (to treat psoriasis, rheumatoid arthritis i

or after organ transplants)    '

•    6-mercaptopurine (used to treat some cancers    i

and bowel diseases)    '

•    Cyclophosphamide, doxorubicin, bleomycin or    i

procarbazine (drugs used to treat leukaemias and ' some cancers)    .

•    Adenine arabinoside    I

•    Probenecid (used in gout)    ,

•    Phenytoin (used in epilepsy)    I

•    Theophylline (to treat asthma)    ,

•    Ampicillinoramoxicillin(antibiotics)    I

•    Aspirin or related medicines (salicylates)    ,

•    Drugs to prevent blood from clotting (such as    I

warfarin)    ,

•    Chlorpropamide (used in diabetes)    I

•    Didanosine (antiviral)    ,

•    Diuretics (water tablets) or ACE inhibitors such as I

captopril (used in high blood pressure)    .

•    Indigestion remedies (should not be taken within 3l

hoursoftakingallopurinol).    .

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnantorare breastfeeding. Please check with your doctor if you are taking these tablets and want to breastfeed your baby.    I

Driving and using machines

These tablets can cause some people to feel drowsy, giddy or have problems with co-ordination. If you are I affected do not drive or operate machinery as your alertness may be impaired.

Allopurinol Tablets contain lactose

Allopurinol Tablets contain 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.

3. HOW TO TAKE ALLOPURINOL TABLETS

Always take Allopurinol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Swallow the tablet with a drink ofwater Take with orjust after food.

Adults:

The usual starting dose is 100 to 200mg each day. Your doctor will monitor the uric acid levels in your blood or urine at regular intervals and will adjust the dose to suit you as necessary. The maintenance dose is usually 200mg to 600mg daily. The maximum single dose is 300mg. It is unlikely that you will be prescribed more than 900mg per day.

Children:

The dose in children is based on 10mg to 20mg/kg of body weight/day. Your doctor will prescribe the correct dosage. Use in children is mainly for certain types of cancers and enzyme disorders.

Elderly patients:

Your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your symptoms.

Ipatients with severe kidney problems:

You may be asked to take less than 100mg a day, or you may be asked to take 100mg at a longer interval than each day. The exact dose will be prescribed by your doctor.

Ilf you are receiving kidney dialysis two or three times a week, your doctor may prescribe a dose of 300 or koOmg which will be to take straight away after your dialysis.

•    high temperature, a general feeling of

being unwell, headache    I

•    high blood pressure

•    enlarged breasts in men and women] difficulty maintaining erection, infertility.

Other (frequency cannot be estimated from the data):

• worsening of gout, dizziness, diarrhoea, stomach pain, kidney stones, 'we! dreams'.

Many ofthe above mentioned side effects should disappear when treatment is stopped.

Patients with liver problems:

A reduced dose will be prescribed by your doctor.

Ilfyou take more Allopurinol Tablets than you should

Ilf you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Ilfyou stop taking Allopurinol Tablets

Do not stop taking Allopurinol Tablets without bonsulting your doctor.

|lf you forget to take Allopurinol Tablets

If you have forgotten to take a dose, take it as soon as ^ou remember it. However, if it is almost time to take your next dose, skip the missed dose. Do not take a double dose. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOWTOSTORE ALLOPURINOL TABLETS

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side Effects, although not everyone gets them.

|lf you experience any of the following, stop your tablets and tell your doctor immediately:

|b allergic reactions:

. itchy orflaky skin rash, blistered, peeling skin or |    sore lips and mouth

. swelling of the face, lips, tongue or throat, or |    difficulty breathing or swallowing

. changes in the amounts of blood cells; causing increased bruising, nosebleeds, sore throats or infections

|b fever, swollen lymph glands, joint pain, swollen blood vessels, inflammation of the liver (hepatitis),

| jaundice (yellowing ofthe skin or whites ofthe eyes), kidney damage (blood in the urine) or fits |b fever, increase in white blood cells (seen in blood tests), enlargement of lymph nodes (Drug Rash with | Eosinophilia and Systematic Symptoms (DRESS))

•    rare (affects less than 1 in 1000 people)

. fever and chills, headache, aching muscles (flulike 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), idespread 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).

^ell your doctor if you notice any of the following side effects or notice any other effects not listed: uncommon (occurs in less than 1 in 100 users): b feeling or being sick (occasionally with blood)

•    changes in liverfunction tests.

^ery rare (occurs in less than 1 in 10,000 users): b weakness, numbness, 'pins and needles', 'spinning' sensation, unable to move muscles (paralysis), i    drowsiness, loss of consciousness

•    feeling thirsty, tired and losing weight; these may be i signs of diabetes, taste changes, build up of fluid ' leading to swelling (oedema)

b high levels of cholesterol in the blood ' (hyperlipidaemia)

» depression L hair loss

» cataracts, changes in vision L blood in the urine, a change in bowel habit

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Blister packs: Do not store above 25°C. Keep the blister in the outer carton to protect from light and moisture.

Securitainers: Store in a cool, dry place and protect from light.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Allopurinol Tablets contain:

Allopurinol Tablets 100mg and 300mg contain the active substance Allopurinol 100mg and 300mg respectively in each tablet.

The other ingredients are: lactose, maize starch, povidone, magnesium stearate and sodium starch glycollate.

What Allopurinol Tablets look like and contents of the pack

Allopurinol Tablets 100mg are white, circular biconvex, uncoated tablets, with A1 embossed on one side. Diameter: 9.5mm.

Allopurinol Tablets 300mg are white, circular, biconvex, uncoated tablets, with ‘A’ & ‘2’ debossed on either side of score line on one side and plain on other side. Diameter: 11.00mm.

Allopurinol Tablets 100mg are supplied in packs of 28, 30, 56, 60, 84, 90 or 250 tablets.

Allopurinol Tablets 300mg are packed into packs of 28, 30, 56, 60, 84, 90 or 250 tablets.

Marketing Authorisation Holderand Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in April 2014.