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Allopurinol Tablets Bp 300mg

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patient information leaflet

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allopurinol Tablets iOOmg & 300mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

2.    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 they are used for

This medicine contains allopurinol which works by reducing/ slowing the production of uric acid/urate in the body.

This medicine is used to prevent/manage the following conditions associated with too much uric acid in the body: gout (painful swelling and redness of the joints), cancer treatment and treatment with diuretics (water tablets), kidney stones, certain skin conditions and certain enzyme disorders eg. Lesch-Nyhan Syndrome.

2.    Before you take Allopurinol Tablets

Do not take these tablets if:

•    you are allergic to Allopurinol or to any of the ingredients in the tablets (see section 6).

Check with your doctor before taking these tablets if:

•    you have a kidney or liver disorder

•    you are being treated for cancer

•    you or your family have the condition called idiopathic haemochromatosis (iron storage disease).

Tell your doctor or pharmacist if you are taking other medicines including any that you can buy without a prescription. This is particularly important if you are taking:

•    anticoagulant medicines (to thin the blood) such as warfarin and acenocoumarol

•    theophylline, used to treat asthma/breathing problems

•    medicines used to treat cancer such as capecitabine, mercaptopurine and cyclophosphamide

•    phenytoin, for epilepsy

•    medicines for heart problems or high blood pressure such as “ACE inhibitors” eg. captopril, or diuretics (water tablets) eg. bendroflumethiazide, furosemide, etacrynic acid

•    chlorpropramide, used to treat diabetes

•    diazoxide, used to treat low blood sugar levels or high blood pressure

•    other medicines to treat gout called sulfinpyrazone and probenecid

•    pyrazinamide, used to treat tuberculosis

•    ampicillin and amoxicillin, antibiotics used to treat bacterial infections

•    vidarabine and didanisone, used to treat viral/HIV infections

•    ciclosporin or azathioprine, used to prevent organ rejection following a transplant or to treat severe rheumatoid arthritis or psoriasis

•    aspirin or other salicylates

•    medicines that may acidify the urine eg. Vitamin C.

Other special warnings:

•    Potentially life-threatening skin rashes (hypersensitivity syndrome, 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 of the body.

•    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 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.

•    The highest risk for occurence of serious skin reactions is within the first weeks of treatment.

•    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.

•    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.

Pregnancy and breastfeeding

Check with your doctor before taking this medicine if you are pregnant or breastfeeding.

Effects on driving or operating machinery Allopurinol may cause drowsiness or dizziness. Do not drive or operate machinery if it has this effect on you.

Alcohol: Avoid alcohol while taking this medicine.

Important information about an ingredient of 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.

3. How to take Allopurinol Tablets

The tablets should be swallowed with a drink of water after a meal or snack.

Your doctor will decide the dose that is best for you. The pharmacist’s label will tell you how many tablets to take and how often.

If you are not sure about anything, ask your doctor or pharmacist. Typical doses are given below.

Adults: The starting dose of Allopurinol is IOOmg daily.

Your doctor will then increase the dose by IOOmg at weekly intervals to a maintenance dose which is right for you, usually between 2OO-6OOmg daily. In severe conditions the dose may be 7OO-9OOmg daily. Doses of more than 3OOmg will be split into divided daily doses.

If you are taking Allopurinol along with treatment for cancer, you will start to take Allopurinol for 2-3 days before the cancer treatment at an initial dose of 2OOmg three times daily. This may be changed by your doctor to a maintenance dose, usually of 3OO-4OOmg daily.

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Measure bar should be 150mm at 100% scale


if you have an attack of gout while taking this medicine, continue to take the medicine and consult your doctor for treatment.

This medicine can trigger gouty arthritis when you start taking it, Your doctor may ask you to take colchicine or a non-steroidal anti-inflammatory medicine (but not aspirin or a salicylate) to prevent an attack, if you have liver or kidney problems, or if you are taking certain medicines such as mercaptopurine or azathioprine, your doctor may give you a lower dose, in renal dialysis, the dose is 300-400mg after each dialysis with none in between dialysis,

Elderly: Your doctor will set the minimum maintenance dose required.

Children under 15 years (for treatment of cancer or enzyme disorders): Your doctor will set the right dose based on body weight, The usual daily dose is 10-20mg/kg body weight/day, up to a maximum of 400mg per day.

If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department, Take with you any remaining tablets and the pack so that the medicine can be identified,

If you forget to take a dose:

Take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule, DO NOT DOUBLE THE DOSES,

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them,

The most common effects are skin reactions such as rashes, hives, itching, scaling, peeling, loosening or separation of skin tissue, burning or blistering, raw or red areas of the skin, tenderness, purple patches on the skin, Skin reactions may be followed by more serious allergic reactions, Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely (see section 2),

If you experience any of the following, stop taking your tablets and tell your doctor immediately:

Rare (affects less than 1 in 1,000 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, 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 (may affect less than 1 in 10,000 people):

•    sudden wheeziness, difficulty breathing, swelling of the mouth, throat, tongue or face, or sometimes collapse

•    swelling of the glands in the armpits, groin or neck.

You are more likely to get a skin rash or other allergic reaction if you have a liver or kidney disorder, or if you are taking certain other medicines such as ampicillin, amoxicillin, thiazide diuretics (water tablets) or vidarabine,

Tell your doctor or pharmacist if you suffer from any of the following other effects:

Uncommon (may affect less than 1 in 100 people):

•    feeling or being sick

•    change in liver function.

Rarely (may affect less than 1 in 1,000 people):

•    diarrhoea

•    aches and pains in muscles, back pain

•    sore throat, chills

•    liver problems (signs include yellowing of the skin and/or whites of the eyes, abdominal pain, loss of appetite)

•    difficulty in passing urine

•    disorder of the nerves (signs include tingling, numbness, muscle weakness),

Very rarely (may affect less than 1 in 10,000 people):

•    angina (chest pain), high blood pressure, slow pulse

•    blood in urine or vomiting blood

•    fever

•    depression

•    headache, dizziness, drowsiness

•    diabetes (signs may be feeling very thirsty or tired)

•    changes in vision or cataracts

•    taste disturbances

•    changes in normal bowel habit or oily stools

•    feeling of unsteadiness or numbness, unable to move muscles or loss of consciousness

•    blood disorders (signs include easier bruising, bleeding under the skin, tiredness, pale skin, frequent infections)

•    painful boils on the skin

•    high levels of cholesterol in the blood

•    build up of fluid leading to swelling, particularly of the ankles

•    hair loss or discolouration

•    mouth ulcers

•    a general feeling of being unwell or of weakness

•    male infertility, difficulty getting an erection and breast enlargement,

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,

5.    How to store Allopurinol Tablets

Keep the tablets in the pack provided and do not store above 250C,

KEEP ALL MEDiCiNES OUT OF THE SIGHT AND REACH

OF children

Do not take the tablets if the expiry date on the pack has passed, if you have any medicines that are out of date, return them to your pharmacist for safe disposal,

6.    Further information

Ingredients:

Allopurinol Tablets contain either 100mg or 300mg of Allopurinol as the active ingredient, The other ingredients are: lactose, sodium starch glycolate, povidone and magnesium stearate,

What the medicine looks like:

Allopurinol Tablets 100mg are white round tablets, engraved RL on one side and A329 on the other,

Allopurinol Tablets 300mg are white round tablets, engraved RL on one side and A330 on the other,

This medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets, Not all pack sizes are marketed,

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised: August 2014

If you would like this leaflet in a different format please contact the licence holder at the above address.

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