ALLOPURINOL TABLETS BP 300 MG - patient leaflet, side effects, dosage

Package leaflet: Information for the user Allopurinol Tablets BP 300mg (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. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Allopurinol Tablets are and what they are 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. Contents of the pack and other information.

1. What Allopurinol Tablets are and what they are used for

Allopurinol Tablets contains the active substance allopurinol. It belongs to a group of medicines called enzyme inhibitors. It works by slowing down the speed of certain chemical reactions in your body to lower the level of uric acid in the blood and urine.

Allopurinol Tablets are used:

• to reduce or prevent the formation of urate/uric acid deposition in conditions where your body produces too much of a substance called uric acid. These may include gout or some types of kidney stones or certain other types of kidney problems or when you are having treatment for cancer or some other conditions. In gout the uric acid builds up in your joints and tendons as crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You can also find you get severe pain when the joint is moved.
• to treat certain enzyme disorders, in particular Lesch-Nyhan syndrome

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Do not take Allopurinol Tablets:

• if you are allergic (hypersensitive) to Allopurinol or any of the other ingredients of this ---- medicine (listed in section 6)

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 Allopurinol Tablets:

• if you are of Han Chinese, African or Indian origin
• if you 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.
• if you have heart problems or high blood pressure and you take diuretics and/or a medicine called ACE-inhibitors.
• if you are currently having an attack of gout.
• if you have thyroid problems

Take special care with Allopurinol Tablets:

• Serious skin rashes (Hypersensitivity syndrome, Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking 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, 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.

• 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 you drink sufficiently to dilute your urine.
• if in case you have kidney stones, the kidney stones will become smaller and may enter your urinary tract.

Children

Use in children is rarely indicated, except in some types of cancer (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.

Other medicines and Allopurinol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any any other medicines.

This includes medicines obtained without a prescription, including herbal medicines. This is because Allopurinol Tablets can affect the way some medicines work. Also some other medicines can affect the way Allopurinol tablets work. For example –

• 6-mercaptopurine used to treat cancer of the blood cells
• medicines used to reduce your immune response (immunosuppressant) e.g. azathiopine, ciclosporin
• vidarabine, used to treat herpes or chickenpox
• antibiotics e.g. amoxicillin or ampicillin
• aspirin
• theophylline, used for breathing problems
• medicines used for fits (epilepsy) e.g. phenytoin
• didanosine, used to treat HIV infection
• medicines used to treat diabetes e.g. chlorpropamide
• medicines used to thin your blood (anticoagulants) such as warfarin
• medicines for heart problems or high blood pressure such as ’ACE inihibitors’ or water tablets (diuretics)
• any other medicine to treat gout e.g. probenecid

If aluminium hydroxide is taken at the same time, this may weaken the effect of allopurinol. There should be an interval of at least 3 hours between taking both medicines.

When allopurinol is taken at the same time as some chemotherapy medicines (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood disorders occur more frequently.

Blood count monitoring should therefore be performed at regular intervals.

Pregnancy and breast-feeding

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 this medicine.

Allopurinol is excreted in the human breast milk. Allopurinol during breastfeeding is not recommended.

Driving and using machines

Allopurinol Tablets may cause drowsiness, affect your coordination, affect your vision or make you feel dizzy. If you experience these symptoms you should avoid driving or operating machinery. Allopurinol Tablet contains 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.

Information on sodium content

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

Always take Allopurinol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For oral use only. Allopurinol Tablets should be taken after food and swallow it with a glass of water.

Adults:(Over 18 years)

The recommended dose ranges from 100 to 900 mg each day. Initially 100 to 300mg per day is taken as a single dose which will be increased if necessary.

Use in children:(under 15 years)

The recommended dose is 10 to 20 milligrams per kilogram body weight/day up to a maximum of 400mg daily.

Use in the elderly: (over 65 years)

The lowest dosage possible will be given as recommended by your doctor.

Use in patients with kidney damage:

The level and frequency of dosage should be recommended by your doctor. The dose may need to be decreased depending on blood uric acid levels due to kidney damage which mean it takes longer to excrete Allopurinol.

Use in patients on kidney dialysis:

Allopurinol and its by-products are removed by dialysis. If dialysis is done frequently 300 to 400mg of Allopurinol may be given after each dialysis with none in the interim.

The dose should be adjusted by checking blood uric acid and/or urinary uric acid levels at appropriate intervals which will be done by your doctor. It might take one to three weeks for blood and/or urinary uric acid to return to the desired levels.

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