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Allopurinol Tablets Bp 300mg

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Allopurinol 100mg and 300mg tablets


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.

Index

T| What Allopurinol tablets are and what they are used for

2    Before you take

3    How to take

4| Possible side effects

|5| How to store

6| Further information

T| What Allopurinol tablets are and what they are used for

Allopurinol tablets are used in:

•    the management of gout and other conditions associated with too much uric acid in the body, such as kidney disease, metabolic disorders, certain skin diseases, cancer and treatment with diuretic ("water tablets").

•    certain types of kidney stones.

2 Before you take

Do not take Allopurinol tablets and tell your doctor ifyou:

•    are allergic (hypersensitive) to Allopurinol tablets or any of the other ingredients (see section 6).

•    are currently suffering from an acute attack of gout.

Check with your doctor or pharmacist before taking Allopurinol tablets if you:

•    have severe liver or kidney disease or kidney problems, you may be given a lower dose.

•    have a condition which causes increased levels of urate in the body (eg Lesch-Nyhan syndrome).

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 Continued top of next column

or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

Taking other medicines

Please tell your doctor or pharmacist if you are taking

or have recently taken any other medicines, including

medicines obtained without a prescription. Especially:

•    azathioprine (to treat rheumatoid arthritis and after organ transplants)

•    ciclosporin (to treat psoriasis, rheumatoid arthritis or after organ transplants)

•    6-mercaptopurine (used to treat some cancers and bowel diseases)

•    cyclophosphamide, doxorubicin, bleomycin or procarbazine (drugs used to treat leukaemias and some cancers)

•    adenine arabinoside

•    probenecid (used in gout)

•    phenytoin (used in epilepsy)

•    theophylline (to treat asthma)

•    ampicillin or amoxicillin (antibiotics)

•    aspirin or related medicines (salicylates)

•    drugs to prevent blood from clotting (such as warfarin)

•    chlorpropamide (used in diabetes)

•    didanosine (antiviral)

•    diuretics (water tablets) or ACE inhibitors such as captopril (used in high blood pressure)

•    indigestion remedies (should not be taken within 3 hours of taking allopurinol)

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Allopurinol tablets may make you feel dizzy, affect your co-ordination or make you sleepy. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

^ How to take

Always take Allopurinol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You should swallow the tablets with a little water after meals, if possible.

Drink plenty of fluids while you are on this medicine. Before starting treatment with allopurinol your doctor may give you an anti-inflammatory drug or colchicine, this helps prevent you getting acute gout attacks.

If you are taking allopurinol for cancer then treatment with allopurinol will begin before treatment with cancer drugs.

Continued over page


Doses:

Adults:

Starting dose of 100-300mg once a day, this may be increased to 200-600mg a day in divided doses. A maximum dose of over 900mg a day is rarely needed.

Children (usually restricted to metabolic disease or cancer):

10-20mg per kg of body weight a day.

Elderly or patients with kidney disease:

Your doctor may prescribe a smaller dose.

If you take more Allopurinol tablets than you should:

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Allopurinol tablets:

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Possible side effects

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

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

•    allergic reactions:

•    itchy or flaky 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.

•    fever, swollen lymph glands, joint pain, swollen blood vessels, inflammation of the liver (hepatitis), jaundice (yellowing of the skin or whites of the eyes), kidney damage (blood in the urine) or fits.

•    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 (flu-like 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), widespread 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).

•    high levels of cholesterol in the blood (hyperlipidaemia)

•    depression

•    hair loss

•    cataracts, changes in vision

•    blood in the urine, a change in bowel habit

•    high temperature, a general feeling of being unwell, headache

•    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, 'wet dreams.

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.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Allopurinol tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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.

Further information

What Allopurinol tablets contain

•    The active substance (the ingredient that makes the tablets work) is Allopurinol. Each tablet contains either 100mg or 300mg of the active ingredient.

•    The other ingredients are maize starch, carmellose sodium, cellulose, sodium lauryl sulphate, lactose, magnesium stearate.

What Allopurinol tablets look like and contents of the pack

Allopurinol tablets are circular, biconvex, white, uncoated tablets.

Pack sizes are 28 tablets.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

Continued top of next column


Tell 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):

•    feeling or being sick (occasionally with blood)

•    changes in liver function tests.

Very rare (occurs in less than 1 in 10,000 users):

•    weakness, numbness, 'pins and needles, 'spinning' sensation, unable to move muscles (paralysis), drowsiness, loss of consciousness

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

This leaflet was last revised in June 2014

If you would like a leaflet with larger % text, please contact 01271 311257.

^actavis

Actavis, Barnstaple, EX32 8NS, UK

AAAH0531 50813384