Allopurinol tablets BP 100 mg – patient leaflet, side effects, dosage

1. WHAT ALLOPURINOL TABLETS IS AND WHAT IT IS USED FOR

• Allopurinol belongs to a group of medicines called enzyme inhibitors, which act to control the speed at which special chemical changes occur in the body.
• Allopurinol is used for the long term, preventative treatment of gout and may be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL

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).
• are currently having an attack of gout or have just had an attack of gout.

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if you:

• are of Han Chinese, African or Indian origin.
• have problems with your liver or kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely.
• have thyroid problems.
• have heart problems or high blood pressure and you take diuretics and/or a medicine called ACE-inhibitors.
• are currently having an acute attack of gout or have just had an attack of gout.

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. 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, have recently taken or might take any other medicines, including medicines obtained without a prescription, including herbal medicines. This is because allopurinol can affect the way some medicines work.

Date : 26-06-2024

Artist : Anjali Enterprises 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 It is especially important to tell your doctor if you are taking any of the medicines listed below. Your doctor may need to reduce the dose of your medicine and/or monitor you more carefully because of the increased risk of side effects when Allopurinol Tablets is taken at the same time as:

• other medication to treat gout e.g. probenecid

• any medicines used to thin the blood (anticoagulants)

  e.g. warfarin

• 6-mercaptopurine (used to treat blood cancer)

• ciclosporin or azathioprine (used to suppress the

  immune system)

• Chlorpropamide (used to treat diabetes)
• large doses of aspirin-type drugs (salicylates)
• Didanosine (used to treat HIV infections)

• cyclophosphamide, doxorubicin, bleomycin,

  procarbazine, mechloroethamine or any other anti-cancer medication.

• Vidarabine (adenine arabinoside), used in the treatment

  of herpes

• Theophylline (used for respiratory problems)
• Phenytoin (used to treat epilepsy)

• Medicines for heart problems or high blood pressure

  such as diuretics (“water tablets”) e.g. furosemide, or ACE inhibitors e.g. fosinopril, captopril

• Ampicillin or 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 or breast feeding, think you may be pregnant or are planning to have a baby, 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

Allopurinol can cause dizziness, drowsiness and can affect your coordination. If you are affected DO NOT drive, operate machinery or participate in dangerous activities. 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.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

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 of allopurinol may be adjusted depending on the severity of the condition. The maintenance dose is:

• mild conditions, 100-200 mg/day
• moderately severe conditions, 300-600 mg/day
• severe conditions, 700-900 mg/day.

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)

100 - 400 mg/day.

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.

If you take more Allopurinol Tablets than you should

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. DO NOT take a double dose to make up for a forgotten dose.

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. Stop taking Allopurinol and contact your doctor immediately or go to your nearest hospital casualty department if you experience:

The following common side effects (may affect up to 1 in 10 people):

• skin rashes (see section 2).

The following rare side effects (may affect up to 1 in 1,000 people):

• fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell
• bleeding in the lips, eyes, mouth, nose or genitals.
• 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).

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. 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
• sudden wheeziness.

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.

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting (very rarely, blood may be present)

  and diarrhoea.

Rare (affects less than 1 in 1000 people)

• Jaundice (yellowing of the skin and whites of the eyes).
• May affect your Liver or kidney fuction (diagnosed by blood and/or urine tests)
• Formation of stones in the urinary tract, symptoms may include blood in the urine and pain in the abdomen, 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
• blood in your urine (hematuria)
• high fat levels in your blood (diagnosed by blood tests )
• 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, pins and needles
• sleepiness
• difficulty in controlling movements (ataxia)
• A general feeling of being unwell
• headache, feeling of dizziness or spinning, drowsiness or disturbance of vision
• vomit blood (haematemesis)
• male infertility (inability to achieve a pregnancy after one year of regular contraceptive-free intercourse)
• Inability to get or maintain an erection, or ejaculation during sleep ("wet dreams")
• enlargement of the breasts, in men as well as women
• A change in taste perception, inflammation in the mouth

• A change in your normal bowel habit, or unusual

  foul-smelling bowel movements

• Cataracts (clouding of the lens of the eye)
• boils (small tender red lumps on the skin)
• hair loss or discoloration
• coma
• convulsions, fits or depression

• Retention 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.

• muscle pain

• 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.

Occasionally, allopurinol may affect your blood or lymphatic system. These effects have usually occurred in people with liver or kidney problems. Tell your doctor as soon as you can if you notice that you are bruising more easily than usual, or if you develop a sore throat or other signs of an infection.

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 March 2026. 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