Allopurinol 100mg Tablets
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Please read this leaflet carefully before you start to take this medicine.
• Keep this leaflet; you may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should 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.
If you take more of your medicine than you should
If you, or anyone else, has swallowed a lot of tablets at the same time contact your doctor or nearest hospital emergency department immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, unless it is nearly time to take your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further queries on the use of this product, ask your doctor or pharmacist.
IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. Storing your medicine
6. More information
Allopurinol belongs to a group of medicines called enzyme inhibitors, which act to control the speed at which certain chemical changes occur in the body.
Allopurinol is used to:
• prevent and treat kidney stones
• prevent gout (a build up of uric acid in the body)
• treat excess uric acid in the body associated with various other conditions, including some forms of cancer and their treatment, enzyme disorders and kidney problems
Do not take Allopurinol and talk to your doctor if you:
• are allergic (hypersensitive) to allopurinol or any of the other ingredients in this medicine
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.
Take special care with Allopurinol and talk to your doctor or pharmacist if you:
• have severe kidney or liver problems
• suffer from high blood pressure or heart problems
• are currently having an attack of gout
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.
Tell your doctor or pharmacist if you are taking any of the following:
• Anticoagulants (medicines used to thin the blood e.g. Warfarin)
• Medicines for the treatment of high blood pressure (hypertension) or heart problems (e.g. ACE inhibitors or diuretics (‘water tablets'))
• Immunosuppressive drugs (medicines used to prevent rejection in organ transplants e.g. azathioprine and ciclosporin and medicines used to prevent leukaemia e.g. 6-mercaptopurine)
• Antiviral drugs (e.g. adenine arabinoside used to treat herpes simplex)
• Other medicines to treat gout (e.g. probenecid and aspirin)
• Chlorpropamide (medicine used to treat diabetes)
• Phenytoin (medicine used for epilepsy (fits))
• Theophylline (medicine used for breathing problems)
• Antibiotics (medicines used to kill bacteria e.g. ampicillin and amoxicillin)
• Medicines for cancer treatment e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, capecitabine and mechloroethamine
• Didanosine (medicine used in the treatment of HIV infection)
• Antacids (e.g. aluminium hydroxide). Intake of antacids and allopurinol should be separated by 3 hours.
Pregnancy and breast-feeding
You must not use Allopurinol during pregnancy unless clearly indicated by your doctor. Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to have a baby in the near future.
Driving and using machines
Allopurinol may cause drowsiness, dizziness or affect your co-ordination. If affected by any of these side effects do not drive or operate machinery.
Important information about some of the ingredients in your medicine
Allopurinol Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Like all medicines, Allopurinol can cause side effects, although not everybody gets them. The possible side effects that may happen with this medicine are listed below.
Stop taking Allopurinol and tell your doctor immediately, or go to your nearest accident and emergency department if you notice any of the following:
• skin rash, itching, blistering or flaking of the skin, hives, ulcers of the lips and mouth, swelling of the lips, face, throat or tongue, sudden wheeziness, tightness of the chest or collapse. These may be signs of an allergic reaction.
Stop taking your tablets and tell your doctor immediately if you experience any of the following: Rare (affects less than 1 in 1,000 people)
• liver problems (e.g. hepatitis (inflammation of the liver) or jaundice (symptoms include yellowing of skin and whites of the eyes))
• 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)
Very rare (affects less than 1 in 10,000 people)
• high temperature
• fever
• a general feeling of being unwell
• weakness
• dizziness
• enlargement of the breasts (in men and women)
• male infertility
• erectile dysfunction (impotence)
• change in your normal bowel habit
• pass pale coloured faeces
• diarrhoea
• high blood pressure (hypertension)
• angina (chest pain)
• slow pulse rate
• blood in the urine (haematuria)
• kidney problems or kidney failure
• abdominal pain
• cataracts (clouding over the lens of the eye)
• visual disturbances
• headache
• drowsiness
• paralysis (unable to move muscles)
• tingling sensation in the hands or feet, ‘pins and needles' (paraesthesia)
• lack of co-ordination
• numbness or unsteadiness on your feet
• coma (loss of consciousness)
• depression
• change in taste
• diabetes (symptoms may include feeling thirsty, tired and weight loss)
• high levels of fats in your blood (hyperlipidaemia)
• hair loss
• hair discolouration
• boils caused by infection of skin follicles
• fluid retention leading to swelling (oedema) particularly of the ankles
• low blood cell count (e.g. anaemia, thrombocytopenia, agranulocytosis - symptoms include bruising more easily, nose bleeds and bleeding gums, more susceptible to infections, feeling weak and tired)
• lymph node disorders (symptoms may include extreme tiredness)
Uncommon (affects less than 1 in 100 people)
• nausea (feeling sick)
• vomiting (in some cases blood may be present)
• liver problems which may lead to increase in liver function tests
If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Do not use your medicine after the expiry date shown on the package. The expiry date refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Keep the container tightly closed. Store in the original container.
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.
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist, if you are not sure.
Dosage
Swallow the tablets with a drink of water after a meal. Do not take the tablets on an empty stomach. Adults
The usual starting dose is 100mg daily. Your doctor will gradually increase the dose to between 200mg-900mg daily over 1-3 weeks depending on your condition. Do not take more than 300mg in a single dose.
Elderly
Your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your condition. Children under 15 years (to treat tumours and certain enzyme disorders)
The dose is worked out by your doctor and will depend on the weight of your child. A dose of 10-20mg per kg body weight per day should be given. The maximum daily dose is 400mg.
Dosage for severe kidney problems
If you have serious kidney problems, your doctor may prescribe less than 100mg per day, or tell you to take a single dose of 100mg at intervals of longer than one day.
If you have dialysis two or three times a week, your doctor may prescribe a dose of 300-400mg which you should take immediately after dialysis.
Dosage for liver problems
Your doctor will prescribe the lowest dose of allopurinol that best controls your condition. Your doctor will arrange for you to have liver function tests during the early stages of your treatment with allopurinol.
CPALL.JNT.T.V1P5
What your medicine contains
The active substance is allopurinol.
The other inactive ingredients are lactose monohydrate, maize starch, povidone, crospovidone and magnesium stearate.
What your medicine looks like
Allopurinol 100mg Tablets are white, circular tablets with ‘230' and a breakline on one side and plain on the other side.
Allopurinol 300mg Tablets are white, circular tablets with ‘242' and a breakline on one side and plain on the other side.
The tablets are available in packs of 28, 100, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing authorisation holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland Distributor
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K.
Product licence numbers
Allopurinol 100mg Tablets: PL 30464/0007 Allopurinol 300mg Tablets: PL 30464/0008
This leaflet was last revised February 2013.
CP ALL.JNTT. V1P5
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Product: Allopurinol 100mg & 300mg Tablets Dimensions: 148mm x 400mm Item Code: CP.ALL.JNT.T.V1P5 Proof No and Date: 5 22/02/2013
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Pantone Blue 280 C
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