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PACKAGE LEAFLET: INFORMATION FOR THE USER Allopurinol Tablets BP 100mg and 300mg [Allopurinol]

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 gets 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 Tablets are and what they are used for

2.    Before you take Allopurinol Tablets

3.    How to take Allopurinol Tablets

4.    Possible side effects

5.    How to store Allopurinol Tablets

6.    Further information

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

Allopurinol is used in adults to treat conditions caused by

too much uric acid in your body such as:

•    Gout (swelling of the joints caused by build-up of uric acid)

•    Gouty Arthritis (a form of arthritis caused by deposits of uric acid)

•    Skin Tophi (deposit of urates in the skin leaving lumps beneath the skin)

•    Treatment and prevention of calcium renal lithiasis (kidney stones)

•    During cancer chemotherapy to prevent uric acid build up.

In children, Allopurinol is used to treat:

•    Leukaemia

•    Enzyme disorders.

2.    BEFORE YOU TAKE ALLOPURINOL TABLETS

Do not take Allopurinol Tablets if you are:

•    Allergic (hypersensitive) to allopurinol or any of the other ingredients of Allopurinol Tablets.

Take special care with Allopurinol Tablets if you:

•    Have high uric levels in your body (identified in blood tests) but do not have any symptoms

•    Currently have an attack of gout (allopurinol should not be started until the attack has finished)

•    Are taking allopurinol for leukaemia or enzyme disorders; as a substance called Xanthine may build up in the body; therefore plenty of fluids should be drunk. Discuss this with your doctor before starting Allopurinol Tablets

•    Are suffering with kidney disorders as the dose may need to be reduced

•    Are suffering with liver disorders as the dose may need to be reduced

•    Are elderly as your dose may need to be reduced

•    Are receiving treatment for high blood pressure or heart problems

•    Have a flare up of gout whilst taking allopurinol your

doctor may prescribe an anti-inflammatory medicine to reduce the inflammation

•    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.

Taking other medicines:

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

In particular, any of the following medicines as your dose of Allopurinol Tablets may need to be adjusted:

•    6-mercaptopurine (used to treat cancer)

•    Azathioprine (used to reduce your immune system after transplant)

•    Didanosine (used to treat patients with HIV)

•    Capecitabine, 5-Fluorouracil, Cyclophosphamide, Doxorubicin, Bleomycin, Procarbazine or Mechloroethamine (chemotherapy drugs for cancer patients

•    Ciclosporin (used in rheumatoid arthritis)

•    ACE inhibitors (used to treat high blood pressure)

•    Ampicillin or amoxicillin (used to treat infections)

•    Coumarin anti-coagulants such as warfarin (used to thin the blood and prevent blood clots)

•    Theophylline (used to treat asthma and other breathing disorders)

•    Phenytoin (used to treat epilepsy)

•    Vidarabine (used in treatment of herpes)

•    Probenecid (used in treatment of gout)

•    Salicylates (used as painkillers or anti-inflammatories)

•    Chlorpropamide (used in the treatment of Type 2 diabetes).

Taking Allopurinol Tablets with food and drink:

Taking your tablets after food can help reduce side effects such as nausea and vomiting.

Pregnancy and breast-feeding:

Allopurinol should only be taken during pregnancy if your doctor has said it is necessary.

Ask your doctor or pharmacist for advice before taking any medicine whilst pregnant or breast-feeding.

Driving and using machines:

Allopurinol Tablets may cause tiredness, visual disturbances, dizziness and co-ordination disturbances; do not drive or use machinery if you are affected.

Important information about some of the ingredients of Allopurinol Tablets:

Do not take these tablets if you have been told by your doctor that you have an intolerance to some sugars, as Allopurinol Tablets contain lactose.

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 not sure.

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Adults

Your doctor should start you on a low dose (e.g 100mg daily) this will reduce the chance of experiencing side effects. Your doctor will increase the dose until a satisfactory response is achieved.

Doses above 300mg should be taken in divided doses.

Children

The usual dose is 10-20mg/kg bodyweight/day.

If you take more Allopurinol Tablets than you should:

If you take more Allopurinol Tablets than you should, please contact your doctor or nearest hospital casualty department.

If you forget to take Allopurinol Tablets:

If you forget to take a dose, take it as soon as you remember and then carry on as normal. Do not take a double dose to make up for a forgotten tablet.

4. POSSIBLE SIDE EFFECTS

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

Allergic reactions

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

Rare (affects less than 1 in 1000 people)

•    Fever and chills, headache, aching muscles (flu like symptoms) and generally 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 rashes, joint pain, and abnormalities in blood and liver function tests (these may be signs of multi-organ sensitivity disorder).

If you experience increased bruising, frequent infections, weakness and pale skin, contact your doctor immediately, as these may be signs of problems with your blood cells.

You may experience skin reactions such as rash, itchy and flaky skin, blistering or bruising; if the skin rash becomes severe, painful or if you are worried contact your doctor immediately.

If you experience any of the following contact your doctor:

•    Hepatitis (inflammation of the liver leading to yellowing

of the skin and eyes, stomach cramp and loss of appetite)

•    Diabetes

•    Fits (seizures)

•    Nerve disorder (leading to muscle weakness, cramps, and spasms)

•    Angina (pain in the chest due to narrowing of the blood vessels of the heart)

•    Slow heart rate

•    High blood pressure

•    Kidney problems, including blood in the urine

•    Coma

•    Paralysis (loss of muscle function in one or a number of muscles).

Your doctor may identify the following through tests:

•    Reduction in blood cells

•    Increased liver enzymes

•    Increased fat levels in the blood

•    Inflammation of the blood vessels (vasculitis).

Other possible side effects include:

•    Skin infections

Depression Lack of co-ordination Pins and needles Tiredness Headache Taste disturbances Cataracts and visual disturbances Vertigo (which is a balance disorder and may make you feel dizzy and sick)

Feeling sick or being sick Blood in your vomit Fat deposits in your faeces (poo)

Stomatitis (inflammation of the membranes of the mouth, gums, mouth and lips)

Change in bowel habits Swelling (of any part of the body)

Hair loss or hair changing colour Joint pain

General feeling of being unwell Weakness Fever

Infertility in men Erectile dysfunction in men Breast enlargement in men.

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.    HOW TO STORE ALLOPURINOL TABLETS

Keep out of the sight and reach of children.

Do not store above 25°C. Store in a dry place.

Do not use Allopurinol Tablets after the expiry date which is stated on the carton.

Do not use Allopurinol Tablets if you notice any visible signs of deterioration.

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 contains:

The active substance is Allopurinol.

The other ingredients are lactose, maize starch, povidone, stearic acid, sodium starch gylcollate.

What Allopurinol Tablets look like and contents of the pack:

Polypropylene tablet container and cap Pack sizes: 21, 100, 250, 500 and 1000 tablets. Aluminium/PVC blister strips enclosed in outer carton Pack sizes: 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer:

Co-Pharma Ltd Unit 4 Metro Centre Tolpits Lane Watford Hertfordshire WD18 9SS

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This medicinal product is authorised in the Member States of the EEA under the following names:

Not applicable

This leaflet was last revised in 03/2015.

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