PACKAGE LEAFLET: INFORMATION FOR THE USER ALLOPURINOL10Omg TABLETS ALLOPURINOL 300mg TABLETS ACTIVE SUBSTANCE - ALLOPURINOL Read this leaflet carefully before you start to take 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 gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further Information_

1. What this medicine is and _what it is used for_

•    Allopurinol Tablets belong to a group of medicines called ‘enzyme inhibitors’ which act to control the speed at which special chemical changes occur in the body.

•    This medicine is used to prevent gout and other

conditions associated with excess uric acid in the body, including kidney stones and certain types of kidney disease._

|    2. Before you take this medicine |

Do not take this medicine if you:

•    have ever had an allergic reaction (rash, itching, shortness of breath) to allopurinol or any of the other ingredients (these are listed in Section 6, Further Information)

•    are having, or have recently had, an acute gout attack

Take special care with this medicine:

Check with your doctor or pharmacist before taking your medicine if:

•    you have problems with your liver or 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.

•    you have heart problems or high blood pressure

•    you are currently having an attack of gout.

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

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as they may interact with this medicine.

It is important to let your doctor know if you are taking ANY of the following medicines:

•    aspirin

•    theophylline, used for breathing problems

•    antibiotics

•    didanosine, used to treat HIV infection

•    medicines for cancer such as mercaptopurine

•    medicines used to reduce your immune response (immunosuppressants) such as azathioprine and ciclosporin

•    medicines used to treat diabetes such as chlorpopamide

•    medicines for heart problems or high blood pressure such as ‘ACE inhibitors’ or water tablets (diuretics)

•    medicines used to thin your blood (anticoagulants), such as warfarin

•    any other medicine to treat gout Pregnancy and Breastfeeding

•    Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using Machines

•    If you experience giddiness, weakness,drowsiness

or problems with your eyesight while taking allopurinol, DO NOT drive or operate machines.

Important information about some of the

ingredients of these Tablets

•    This medicine contains LACTOSE.

•    Allopurinol 100mg Tablets: Each 100mg tablet contains 138.5mg of lactose.

•    Allopurinol 300mg Tablets: Each 300mg tablet contains 70.08mg of lactose.

•    If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor or pharmacist before taking this medicine.

•    Allopurinol tablets 300mg also contains SODIUM

STARCH GLYCOLATE. Sodium may be harmful to people on a low sodium diet._

|    3. How to take this medicine    |

•    Always take this medicine exactly as prescribed by your doctor. You should check with your doctor or pharmacist if you are unsure.

•    The whole tablets should be swallowed with plenty of water. If Allopurinol Tablets make you feel sick or vomit, this may be avoided by taking the tablets after meals.

•    Check the label to see how often you should take your tablets.

•    If you are changing from an alternative uricosuric medicine to allopurinol, 1 to 3 weeks overlap of treatment is recommended.

•    You may also be prescribed an anti-inflammatory pain killer or colchicine over the first few weeks in case you get an acute attack of gouty arthritis.

Dosage

Adults and the elderly:

•    The initial starting dose is 100mg to 200mg. 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.    I

•    It is unlikely that you will be prescribed more than

Allopurinol tablets insert two

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900mg per day.

•    Elderly patients will be given the minimum necessary dose to maintain uric acid levels In the blood and urine.

Children:

•    The dose Is 10mg to 20mg per kilogram of the child's body weight, per day.

If you have liver or kidney problems:

•    Patients with liver disease or kidney problems will be given a reduced dosage.

•    If you are having frequent kidney dialysis, you may be given 300mg to 400mg of allopurinol after each dialysis instead of the usual dosage schedules.

If you take more Allopurinol Tablets than you

should

•    If you have accidentally taken one extra dose, this is unlikely to be a cause for concern. However if you or someone else has taken a large overdose, contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take Allopurinol Tablets

•    If you have forgotten to take your medicine and your next dose is not due for another 12 hours or more, take a dose now and take the next one on time. Otherwise, skip the missed dose, and take your next dose at the correct time. If you are concerned, consult your doctor or pharmacist.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A

FORGOTTEN DOSE.

If you stop taking Allopurinol Tablets

•    Do not suddenly stop taking these tablets without talking to your doctor. Your symptoms may recur if you stop taking them suddenly. Treatment should continue for as long as your doctor feels it is needed. If you have any further questions on the use of this product, ask your doctor or pharmacist.

_4. Possible Side Effects_

Like all other medicines, Allopurinol Tablets may cause

side effects, although not everybody gets them. STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:

•    sudden wheeziness and chest pain or dizziness

•    swelling of eyelids, face or lips,

•    skin rash , flaking skin, boils, red spots or hives (skin lumps)

•    collapse

The above symptoms may mean that you are allergic to Allopurinol. Do not take more tablets unless your doctor tells you to do so.

If you experience any of the following rare side effects, tell your doctor as soon as possible:

•    Gastrointestinal: feeling or being sick, vomiting blood, diarrhoea, changes in bowel habits, swollen mouth and changes in taste

•    Nervous system: headache, general tiredness, dizziness, depression, coma, nerve disorders including lack of muscle control, paralysis, weakness and numbness, “pins and needles”, sleepiness

•    Heart: chest pain (angina), slow heart beat, oedema (water retention) particularly of the ankles, high blood pressure

•    Other effects: fever, worsening of acute gout attacks, cataract, diabetes, hair loss, changes in hair colour, boils, changes in blood chemistry and blood cells, disturbances of vision, difficulty maintaining an erection, “wet dreams”, infertility, blood in the urine, high levels of fat or urea in the blood.

Occasionally Allopurinol tablets may affect your blood or lymphatic system. These effects have usually occurred in people with liver or kidney problems. However, 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 gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

_5. How to store this medicine_

•    Keep the medicines in a safe place where children

can not see or reach it.

•    Do not use Allopurinol Tablets after the expiry date shown on the label or carton after EXP.

•    The expiry date refers to the last day of that month

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

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

•    If you have any leftover tablets take them back to

your pharmacist for safe disposal._

_6. Further Information_

What Allopurinol Tablets contain

•    Each tablet contains Allopurinol as the active ingredient

•    Each Allopurinol 100mg Tablet contains 100mg of Allopurinol

•    Each Allopurinol 300mg Tablet contains 300mg of Allopurinol

•    The other ingredients are: lactose, maize starch, povidone and magnesium stearate. The 300mg tablets also contain sodium starch glycollate.

What Allopurinol Tablets look like and contents of the pack:

•    Allopurinol 100mg Tablets come in packs of 28, 30, 56, 60, 84, 90 and 250

•    Allopurinol 300mg Tablets come in packs of 28, 30, 56, 60, and 100

Marketing Authorisation Holder and Batch Release Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside,

Northbridge Road,

Berkhamsted, Hertfordshire, United Kingdom, HP41 EG.

01442 200922 01442 873717 info @ bristol-labs.co.uk This leaflet was last approved in February 2009 To request a copy of this leaflet in Braille, large print >< or audio format, contact the licence holder at the £ address (or telephone, fax, email) above.

Telephone:

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