Allopurinol 100mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Allopurinol 100mg and 300 mg Tablets
(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 are they 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. Further information
1. WHAT ALLOPURINOL TABLETS ARE AND WHAT ARE THEY USED FOR
Allopurinol belongs to a group of medicines called enzyme inhibitors. These medicines inhibit the amount of uric acid production in your body.
Allopurinol works by slowing down the speed of certain chemical reactions in your body.
Allopurinol Tablets are used to treat the following conditions:
• Gout (increased uric acid quantity in the body). The uric acid builds up in your joints and tendons as crystals causing an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You may also get severe pain when the joint is moved.
• Kidney stones formation and certain other types of kidney diseases due to increase in the amount of uric acid in the body
• Some types of Cancer due to increase in the amount of uric acid in the body
• Enzyme disorders due to increase in the amount of uric acid in the body
2. WHAT YOU NEED TO KNOW 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 (see section 6)
Do not take Allopurinol tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Allopurinol tablets.
Warnings and precautions:
Talk to your doctor or pharmacist before taking your medicine if:
• you have problems with your kidneys or liver. Your doctor may give you a lower dose or ask you to take it less often than each day. They will monitor you more closely.
• you suffer from high blood pressure or have heart problems
• you are currently having an attack of gout
• you suffer from rare inherited forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption. Allopurinol tablets contain a small amount of 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.
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 patients with chronic renal impairment and 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Allopurinol tablets.
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.
The following medicines can be affected by treatment with Allopurinol Tablets:
• medicines used to treat high blood pressure (ACE inhibitors e.g. captopril).
• medicines used to treat problems with stomach acid (e.g. aluminium hydroxide).
• medicines used to treat bacterial infections (antibiotics e.g. ampicillin and amoxicillin).
• medicines used to thin the blood (anticoagulants e.g. dicoumarol, phenprocoumon, warfarin).
• medicines used to treat diabetes ( e.g. chlorpropamide and tolbutamide).
• medicines used to treat epilepsy (e.g. phenytoin, carbamazepine).
• medicines used for chemotherapy (e.g. azathioprine, mercaptopurine, cyclophosphamide).
• ciclosporin - a medicine used to suppress the immune system following organ transplant and in immune related disorders.
• theophylline - a medicine used in asthma and breathing disorders.
• thiazide diuretics - medicines used to get rid of excess fluid from the body and in high blood pressure.
• uricosurics - medicines that are used to reduce uric acid levels (e.g. probenecid, salicylate).
• vidarabine (adenine arabinoside) is a anti-viral drug which is used to treat herpes simplex.
• didanosine used to treat HIV infection.
Taking Allopurinol Tablets with food and drink
Allopurinol Tablets should be taken with food and water.
Pregnancy and breast-feeding
Contact your doctor before taking this medicine if you are pregnant, planning to become pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Allopurinol Tablets may make some people feel drowsy, giddy or have problems with co-ordination. Do not drive or operate dangerous machinery if you are affected.
Important information about some of the ingredients of Allopurinol tablets:
Allopurinol Tablets contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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.
Swallow the tablet with a glass of water after meal.
Adults (Over 18 years)
The initial dose is usually 100mg daily, after food, but this can be gradually increased over one to three weeks according to the levels of uric acid in your blood and urine. The following dosages are administered depending on the severity of the disease.
100mg to 200mg average daily dose for mild gout 300 to 600mg daily for moderately severe gout 700 to 900mg daily for severe gout.
Up to 300mg can be taken as a single dose; larger doses should be divided throughout the day.
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Patients with liver disease:
Your dose may need to be reduced ; this is determined by monitoring the levels of uric acid in your body.
Patients with kidney disease:
• You may be asked to take less than 100 mg each day
• or you may be asked to take single dose of 100 mg at longer intervals than one day.
If you are receiving frequent dialysis for kidney disease then your dose may need to be adjusted or else a single dose of 300 to 400mg following dialysis may be given.
Elderly (Over 65 years):
Your doctor will prescribe a lower dose of Allopurinol tablets that best controls your symptoms.
Children under 15 years (for use in enzyme disorders and with chemotherapy)
The daily dose is calculated based on body weight and is usually 10 to 20 mg/Kg body weight.
The usual dose ranges from 100 to 400mg daily.
Treatment of high uric acid levels in chemotherapy:
Treatment commences from one to two days before chemotherapy and take 600 to 800mg daily in divided doses for 2 to 3 days.
The maintenance dose is then decided depending on your response to treatment.
While taking this medicine the dose of your chemotherapy may be reduced as this medicine can increase its effects. Note: While you are taking allopurinol tablets your doctor may ask you to undergo regular blood tests to check your levels of uric acid and in some cases monitor your liver and kidneys function.
If you take more Allopurinol Tablets than you should
If you or someone else swallows several of these tablets all together, or if you think a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately. Always take any tablets left over with you ,also the box and leaflet as this will allow easier identification of the tablets.
If you forget to take Allopurinol Tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Allopurinol Tablets
Keep taking the medicine for as long as your doctor has told you, even if you are feeling better. If you stop the medicine too soon, your condition may become worse again.
Do not stop taking your tablets without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Allopurinol can cause side effects, although not everybody gets them.
The following side effects may occur with Allopurinol tablets:
Allergic reactions (affects less than 1 in 10,000 people) If you have an allergic reaction, stop taking Allopurinol Tablets and see a doctor straight way. The signs may include:
• skin rash, flaking skin, boils or sore lips and mouth
• very rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse.
Do not take any more tablets unless your doctor tells you to do so.
If you experience any of the following, stop taking your tablets and contact your doctor as soon as possible:
Rare (affects less than 1 in 1000 people)
• joint pain or painful swelling in your groin, armpits or neck
• yellowing of the skin and eyes (jaundice)
• liver or kidney problems
• feeling sick (nausea) or being sick (vomiting), occasionally with blood
• bleeding in the lips, eyes, mouth, nose or genitals
• 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)
• bruising more easily than usual or you may develop a sore throat or other signs of an infection. Contact your doctor as soon as possible. Occasionally Allopurinol Tablets may affect your blood or lymph system. These effects usually occur in people with liver or kidney problems
• high temperature
• blood in your urine (haematuria)
• high levels of cholesterol in your blood (hyperlipidaemia)
• a general feeling of being unwell
• weakness, numbness, unsteadiness on your feet, feeling unable to move muscles (paralysis) or loss of consciousness
• headache, dizziness, drowsiness or disturbance of your vision
• chest pain, high blood pressure or a slow pulse
• male infertility or erectile dysfunction
• enlargement of the breasts, in men as well as women
• a change in your normal bowel habit
• a change in taste
• cataracts
• hair loss or discolouration
• fits (convulsions)
• depression
• build up of fluid leading to swelling (oedema) particularly of your ankles
• feeling thirsty, tired and losing weight; these may be symptoms of diabetes. Your doctor may wish to measure the level of sugar in your blood to check if this is happening.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
Do not store above 25°C. Store in the original package. Keep the container tightly closed.
Keep out of the reach and sight of children.
Do not use your tablets after the expiry date stated on the carton or label.
Medicines should not be disposed of via waste water 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 contain The active substance is Allopurinol.
The other ingredients are Lactose monohydrate, crospovidone, maize starch, povidone K-30 and magnesium stearate (see section 2 for Important information about some of the ingredients of Allopurinol tablets).
What Allopurinol Tablets look like and contents of the pack
Allopurinol 100 mg Tablets are white to off white, round, biconvex, uncoated, marked with "AW" on one side and plain on the other side.
Allopurinol 300 mg Tablets are white to off white, round, biconvex, uncoated, marked with "AX' on one side and plain on the other side.
Allopurinol tablets are available in container packs of 28, 100, 500 and 1000 tablets. They are also available in blister pack of 28 tablets (Not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
This leaflet was last approved in {07/2014}.
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