Patient leaflet - Allopurinol tablets BP 300 mg
1. WHAT ALLOPURINOL TABLETS IS AND WHAT IT IS USED FOR
These tablets contain Allopurinol and are available in strengths of 100mg and 300mg. Allopurinol works by slowing down the speed of certain chemical reactions in your body.
Allopurinol is used to treat high levels of uric acid in the body, which can cause gouty arthritis, skin and kidney problems. Some people may not get any symptoms. Allopurinol is also used to prevent and treat kidney stones in patients who have high uric acid levels.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL
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 or Korean origin. Chronic kidney disease may increase the risk in these patients additionally. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately. Do not take Allopurinol Tablets
- If you are allergic (hypersensitive) to Allopurinol or any of the other ingredients of these tablets (listed in section 6). The symptoms of an allergic reaction include itching, nettle rash, wheezing or swelling of the hands, throat, mouth, or eyelids.
- During an attack of gout.
If you think any of the points above apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine
- If you are of Han Chinese, African or Indian origin.
- If you have kidney problems
- If you have thyroid problems.
- If you suffer from high blood pressure or heart problems
- If you are currently having an acute attack of gout
- If you suffer from hepatic or renal impairment
- If you suffer from rare inherited forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption
- If you suffer with conditions like Lesch-Nyhan syndrome or malignant disease where rate of urate formation is greatly increased
Take special care with Allopurinol:
Talk to your doctor before taking Allopurinol if you:
- are suffering from or have previously suffered from any form of liver or kidney disease. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you closely
- have heart problems or have high blood pressure
are pregnant or trying to become pregnant If you develop a rash or these skin symptoms, stop taking Allopurinol, seek urgent advice from a doctor and tell him that you are taking this medicine:
Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Allopurinol, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
- Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
- These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
- The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
- If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Allopurinol, you must not be re-started on Allopurinol at any time. Serious skin rashes have been reported with the use of allopurinol that can be more common in patients with chronic renal impairment and in people of Han Chinese, Thai or Korean origin. Chronic kidney disease may increase the risk in these patients additionally.
Date : 2
Artist : A
Product : Allopurinol Tablets 100 & 300 mg PIL Actual Size : W 170 x L 400 mm Customer : Rudipharm (Common) Text Area : Front/Back
170 mm
8 mm These serious skin rashes can include hypersensitivity syndrome, Stevens- Johnson syndrome and toxic epidermal necrolysis. All 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. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately. If you have cancer or Lesch-Nyhan syndrome the amount of uric acid may increase in your urine. To prevent this, you need to assure to drink sufficiently to dilute your urine. In case you have kidney stones, the kidney stones will become smaller and may enter your urinary tract.
Other medicines and Allopurinol Tablets
Tell your doctor or pharmacist if you are taking any of the following:
Medicines to treat gout or other medicines to control
uric acid levels e.g. probenecid
- Anticoagulants used to thin the blood e.g. warfarin
- Chlorpropamide used to control blood sugar levels
- Aspirin or other salicylates
Immunosuppressive drugs such as mercaptopurine,
azathioprine and cyclosporin
- Didanosine (used to treat HIV infections)
- Anti-cancer drugs such as doxorubicin and bleomycin
Vidarabine used to treat viruses such as herpes, chicken
pox and shingles
Theophylline used to treat breathing problems
including asthma
- Phenytoin used to treat epilepsy
Medicines for heart problems or high blood pressure
such as 'ACE inhibitors' or water tablets (diuretics)
- Ampicillin and amoxycillin antibiotics
If aluminium hydroxide is taken concomitantly, allopurinol
may have an attenuated effect. There should be an interval of at least 3 hours between taking both medicines.
With administration of allopurinol and cytostatics (e.g.
cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood dyscrasias occur more frequently than when these active substances are administered alone. Blood count monitoring should therefore be performed at regular intervals. Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes medicines obtained without a prescription, including herbal medicines. This is because Zyloric can affect the way some medicines work. The co-administration of 6-mercaptopurine or azathioprine with allopurinol should be avoided. When 6-mercaptopurine or azathioprine is given concurrently with [allopurinol product name], the dose of 6-mercaptopurine or azathioprine should be reduced because their activity will be prolonged. This could increase the risk of serious blood disorders. In this case, your doctor will closely monitor your blood count during treatment.
Seek medical advice immediately if you notice that you have any unexplained bruising, bleeding, fever or sore throat.
Allopurinol Tablets with food and drink
Take Allopurinol tablets with food and water. Pregnancy, breast-feeding and fertility
If you are pregnant, trying to become pregnant or are breast feeding, ask your doctor or pharmacist for advice before taking allopurinol.
Allopurinol is excreted in the human breast milk. Allopurinol during breastfeeding is not recommended. Driving and using machines
You may feel drowsy, giddy or have problems with your co-ordination. If this happens, do not drive or use any tools or machines.
Allopurinol Tablets contain 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.
3. HOW TO TAKE ALLOPURINOL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Swallow the tablet with a drink of water.
- Take with or just after food.
You should drink plenty of fluids (2-3 litres a day)
while you are taking this medicine.
Dosage in Adults
The usual starting dose in adults is between 100mg and 300mg a day taken as a single dose.
The doctor may alter this dose depending on your response to treatment. The usual maintenance dose is between 200mg and 600mg a day, this dose may be split up and taken at separate times during the day
Your doctor will usually start with a low dose of allopurinol (e.g. 100 mg/day), to reduce the risk of possible side effects. Your dose will be increased if necessary. When you start your treatment, your doctor may also prescribe an anti-inflammatory medicine or colchicine for a month or more, to prevent attacks of gouty arthritis.
Your dose may also be altered by your doctor if you have reduced kidney and liver function, particularly if you are elderly. If the daily dose exceeds 300 mg/day and you are suffering from gastro-intestinal side effects such as nausea or vomiting (see section 4), your doctor may prescribe allopurinol in divided doses to reduce these effects. Children (under 15 years)
Treatment may be started together with an anti-inflammatory medicine or colchicine, and the dose adjusted if you have reduced kidney and liver function, or divided to reduce gastro-intestinal side effects, as for adults above.
Dosage in the Elderly and in patients with kidney or liver problems
Patients with kidney or liver problems and the elderly may be prescribed a lower dose. The correct dose for you will be on the label.
Check the label and if you are not sure ask your doctor or pharmacist.
Sometimes, starting treatment with allopurinol can trigger an attack of gout. To prevent this, your doctor may prescribe another treatment for the first month. Cancer treatment
Sometimes Allopurinol is used in patients with cancer to prevent problems due to high uric acid levels. In this case you should be given Allopurinol tablets before the cancer treatment begins.
If you take more Allopurinol Tablets than you should
An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately. An overdose is likely to cause effects including nausea, vomiting, diarrhoea, or dizziness. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed. If you forget to take Allopurinol Tablets
If you forget to take a dose, take it as soon as you remember. But do not take two doses at the same time. If you stop taking Allopurinol Tablets
Do not stop taking your Allopurinol tablet without talking to 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, these tablets can cause side effects, although not everybody gets them. The following side effects may happen with Allopurinol Tablets: The following very rare side effects (may affect up to 1 in 10,000 people):
potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2)
- serious allergic reaction which causes swelling of the face or throat
- serious potentially life-threatening allergic reaction. 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.
The signs of a serious allergic reaction can also include:
- an unexpected skin reaction (possibly in association with fever, swollen glands, joint pain, unusual blistering or bleeding, kidney problems (blood in the urine) or a sudden onset of fits)
- swelling of the hands, lips, tongue
- difficulty swallowing or breathing
The following not known side effects (cannot be estimated from available data):
- Aseptic meningitis (inflammation of the membranes that surround the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever or consciousness clouding. Seek medical attention immediately if these occur.
- Lichenoid skin rash (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
If you experience any of the following while you are taking Allopurinol, stop taking your tablets and tell your doctor as soon as possible:
Common (may effect up to 1 in 10 people)
- Increased level of thyroid stimulating hormone in the blood.
Rare (affects less than 1 in 1000 people)
- Jaundice (yellowing of the skin and eyes).
- Joint pain or Painful swelling in your groin, neck or armpits.
- Liver or kidney problems.
- Nausea and vomiting (in some cases, blood may bepresent).
- Bleeding in the lips, eyes, mouth, nose or genitals.
Fever and chills, headache, aching muscles
(flu-likesymptoms) and generally feeling unwell.
- Any changes to your skin, for example ulcers of themouth, 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
(thesemay be signs of a multi-organ sensitivity disorder).
- Formation of stones in the urinary tract, symptomsmay include blood in the urine and pain in theabdomen, flank, or groin.
Very rare (affects less than 1 in 10,000 people)
- Reduction in the number of white blood cells, which makes infections more likely
- Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
- High temperature
- Lethargy
- Bruising more easily than usual, or you may develop a sore throat or other signs of an infection. Tell 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
- blood in your urine (hematuria)
- high temperature
high levels of cholesterol in your blood
(hyperlipidemia)
- chest pain, high blood pressure or a slow pulse
weakness, numbness, unsteadiness on your feet, feeling
unable to move muscles (paralysis) or loss of consciousness
- a general feeling of being unwell
headache, dizziness, drowsiness or disturbance of your
vision male infertility or erectile dysfunction
Inability to get or maintain an erection, or ejaculation
during sleep ("wet dreams")
You may occasionally feel sick, but this can usually be
avoided by taking allopurinol after meals. Tell your doctor if this problem persists.
- enlargement of the breasts, in men as well as women
- a change in taste
- a change in your normal bowel habit
- cataracts
- hair loss or discoloration
- depression
- coma
- fits (convulsions)
buildup 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.
Occasionally Allopurinol tablets may affect your blood,
which can manifest as bruising more easily than usual, or you may develop a sore throat or other signs of an infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.
You may occasionally feel sick, but this can usually be avoided by taking allopurinol after meals. Tell your doctor if this problem persists.
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.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. "You can also report side effects directly via Yellow Card scheme at : www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side affects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ALLOPURINOL
Store in a cool, dry place below 25°C in the original package. Do not put the tablets into another container as they might get mixed up. Keep them in the pack in which they are supplied.
Do not use Allopurinol Tablets after the expiry date which is stated on the blister and the carton after EXP or EXP. DATE.
Keep this medicine out of the reach and sight of children. 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.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Allopurinol tablets contains
The active substance in these tablets is allopurinol.
They are available in 2 strengths of 100mg and 300 mg.
The other ingredients in your allopurinol tablets are
lactose, soluble starch, maize starch, polyvinyl pyrrolidone, croscarmellose sodium, colloidal silicone dioxide, magnesium stearate and purified water. What Allopurinol tablets Look Like and Contents of the Pack
Allopurinol Tablets 100mg are white to off white, round biconvex tablets debossed with an ankh on one side and on the reverse face R1 (100mg tablets).
Allopurinol Tablets 300mg are white to off white, round biconvex tablets debossed with an ankh on one side and on the reverse face R2 (300mg tablets).
The 100mg tablets are supplied in boxes of 28 or 100 tablets and the 300mg tablets are supplied in boxes of 28 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Rudipharm Limited
Unit 6, Salbrook Road Industrial Estate
Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom
Manufacturer:
Rudipharm Limited
Oak House, Reeds Crescent,
Watford, WD24 4QP, UK
This leaflet was last revised in September 2025.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only)
Please be ready to give the following information:
Product name Reference number Allopurinol 100mg Tablets PL 49565/0144 Allopurinol 300mg Tablets PL 49565/0145