Allopurinol 300mg Tablets
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Patient information leaflet
ALLOPURINOL 100MG & 300MG TABLETS
In this leaflet:
1. What Allopurinol is and what it is used for
2. What you need to know before you take Allopurinol
3. How to take Allopurinol
4. Possible side effects
5. How to store Allopurinol
6. Contents of the pack and other information
1. What Allopurinol is and what it is used for
2. What you need to know before you take Allopurinol_
3. How to take Allopurinol
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Allopurinol belongs to a group of medicines called xanthine oxidase inhibitor. Allopurinol is used to prevent gout and other conditions associated with excess uric acid in the body including calcium stones and certain other types of cancer and kidney diseases.
Do not take Allopurinol Tablets if:
• you are suffering with an acute attack of gout
• you are hypersensitive (allergic) to allopurinol or any of the other ingredients of Allopurinol tablets
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• are taking or likely to be taking any other medicine, whilst you are taking Allopurinol
• have heart problems or high blood pressure
• are about to start taking Allopurinol for gout treatment for the very first time
• suffer from any kidney or liver disease
• are pregnant or trying to become pregnant
• are breast feeding
• suffer from rare inherited forms of galactose deficiency or glucose-galactose malabsorption
Other medicines and Allopurinol
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. The following medicines can be affected by treatment with Allopurinol:
• medicines used to treat bacterial infections (antibiotics e.g. ampicillin and amoxicillin)
• medicines used to thin the blood (e.g. dicoumarol, phenprocoumon, warfarin)
• medicines used to treat diabetes (e.g. chlorpropamide)
• medicines used to treat epilepsy (e.g. phenytoin, carbamazepine)
• medicines used for chemotherapy (e.g. azathioprine, mercaptopurine)
• ciclosporin (immunosuppressants)
• medicines used to treat high blood pressure (ACE inhibitors e.g. captopril)
• medicines used to treat breathing problems (e.g. theophylline and other xanthines)
• 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
• aspirin, used to treat pain
• cyclophosphamide, doxorubicin, bleomycin, procarbazine, mechloroethamine
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. 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.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
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 may make some people feel drowsy. Do not drive a car or operate dangerous machinery until you know how it affects you.
Allopurinol tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The tablet should be swallowed with half a tea cup of water after a meal (not on an empty stomach).
Dosage:
Adult: The starting dose is between 100mg to 300mg per day which may be taken as a single dose. Doses above 300mg should be taken in divided doses. Your doctor will adjust the dose according to the level of uric acid present in your blood. The maintenance dose is usually 200mg to 600mg daily. It is unlikely that you will be prescribed more than 900mg per day.
Children: 10-20mg/kg body weight/day.
Elderly: The dose should be maintained at the normal serum and urinary levels. If you have previously had a gout attack your doctor will prescribe another treatment (anti-inflammatory) to take with your Allopurinol. You should drink enough fluid to make sure that you pass at least two litres of water every day.
The dose may need to be reduced for patients with liver or kidney disease.
If you take more tablets than you should
If you accidentally take too much or if a child has swallowed any of your tablets, contact your nearest hospital or tell your doctor immediately. Bring any remaining tablets with you to show the doctor. The most likely overdose reaction will be stomach upset, nausea, vomiting and dizziness.
5. How to store Allopurinol
If you forget to take a dose
Take your tablets as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Allopurinol can cause side effects in some people, although not everybody gets them. Allergic reactions (may affect up to 1 in 10,000 people). If you have an allergic reaction, stop taking Allopurinol and see a doctor straight way. The signs may include:
• skin rash, boils or sore lips and mouth. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with Allopurinol
• 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 your tablets and tell your doctor immediately:
Common (may affect up to 1 in 10 people)
• rash
Uncommon (may affect up to 1 in 100 people)
• feeling sick (nausea) or being sick (vomiting)
• changes in liver function tests
Rare (may affect up to 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 multiorgan sensitivity disorder).
• joint pain or painful swelling in your groin, armpits or neck
• yellowing of the skin and eyes (jaundice)
• liver or kidney problems
• bleeding in the lips, eyes, mouth, nose or genitals Very rare (may affect up to 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 may affect your blood or lymph system. These effects usually occur in people with liver or kidney problems
• reduction in numbers of red blood cells, white blood cells and blood platelets
• serious illness with blistering of the skin
• fever, night sweats
• bradycardia (slower heart beat)
• vomiting of blood, excess of fats in stools, stomatitis
• angioedema (swelling of face or throat), fixed drug eruption
• general malaise, asthenia
• high temperature
• blood in your urine, kidney failure
• high levels of cholesterol in your blood
• a general feeling of being unwell
• weakness, numbness, unsteadiness on your feet, paralysis or loss of consciousness
• headache, dizziness, drowsiness or disturbance of your vision, depression
• chest pain, high blood pressure
• male infertility or erectile dysfunction
• enlargement of the breasts, in men as well as
• a change in your normal bowel habit
• a change in taste
• cataracts
• hair loss or discolouration
• fits (convulsions)
• swelling of 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, 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.
Keep all your medicine out of reach of children.
• Do not use the tablets after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.
• Store in cool and dry place protected from light.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Allopurinol tablets contain
• The active substance is either 100mg or 300mg of Allopurinol.
• The other ingredients are Lactose, Starch, Polyethylene Glycol 4000, Povidone, Magnesium Stearate, Colloidal Silicon Dioxide,
Microcrystalline Cellulose and Sodium Starch Glycollate.
See end of section 2 for further information on lactose.
What Allopurinol tablets looks like and contents of the pack
• Allopurinol 100mg tablets are white, biconvex tablets. Embossed ‘PV’ on one face and ‘A’ and ‘100’ on the other.
• Allopurinol 300mg tablets are white, biconvex tablets. Embossed ‘PV’ on one face and ‘A’ and ‘300’ on the other.
• Allopurinol tablets are available in packs containing 14, 28, 30, 50, 56, 100, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444 Fax: 0208 997 5433
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL: 04556/0005 & 04556/0006 PoM
Ref: 0005061114/02
The leaflet was last revised in November 2014
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