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Allopurinol 100mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Allopurinol 100mg Tablets Allopurinol 300mg Tablets

Allopurinol


Read all of this leaflet carefully before you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

The name of your medicine is Allopurinol Tablets. Allopurinol comes in two strengths and is a medicine used to reduce the levels of a chemical in the blood called uric acid. Uric acid is associated with a number of conditions and in high levels can cause gout, kidney disease and kidney stones.

2. Before you take Allopurinol Tablets

You should not take Allopurinol Tablets if you:

•    are allergic (hypersensitive) to allopurinol or to any of the other ingredients in Allopurinol Tablets (see section 6, Further information)

•    are suffering from an acute attack of gout and do not take this medicine already.

Talk to your doctor before taking Allopurinol Tablets if you:

•    suffer from kidney or liver disease

•    suffer from high blood pressure

•    suffer from heart failure

•    suffer from diabetes

•    suffer from rare inherited forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

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 people of Han Chinese or Thai origin.

If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Allopurinol Tablets may affect or be affected by the following medicines:

•    medicines used to treat high blood pressure (ACE inhibitors e.g. captopril)

•    medicines used to treat problems with stomach acid

(e.g. aluminium hydroxide)

•    medicines used to treat bacterial infections (antibiotics e.g. ampicillin and amoxicillin)

•    medicines used to thin the blood (anticoagulants e.g. dicoumarol, phenprocoumon, warfarin)

•    medicines used to treat diabetes ( e.g. chloropropamide and tolbutamide)

•    medicines used to treat epilepsy (e.g. phenytoin, carbamazepine)

•    medicines used for chemotherapy (e.g. azathioprine, mercaptopurine, pentostatin, cyclophosphamide, capecitabine)

•    didanosine - a medicine used to treat HIV

•    ciclosporin - a medicine used to suppress the immune system following organ transplant and in immune related disorders

•    theophylline - a medicine used in asthma and breathing disorders

•    thiazide diuretics - medicines used to get rid of excess fluid from the body and in high blood pressure

•    uricosurics - medicines that are used to reduce uric acid levels (e.g. probenecid)

•    aspirin - a medicine commonly used to treat pain and / or high temperature.

Pregnancy and breast-feeding

If you are pregnant you should discuss with your doctor before you use Allopurinol Tablets.

This medicine should not be used whilst breast feeding. Driving and using machinery

This medicine can cause drowsiness, dizziness, vertigo and visual disturbances. If you are affected then do not drive or operate machinery.

Important information about some of the ingredients in Allopurinol Tablets

This medicine 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

Always take Allopurinol Tablets as your doctor has told you. Your doctor will decide the right dose for you. This will be on the pharmacist’s label. This medicine is swallowed whole. In the first few months of treatment you may suffer an increase in the acute attacks of gout. It is therefore advised to take this medicine in combination with anti-inflammatory drugs for at least the first month.

Prevention of Gout:

•    the starting dose is usually 100mg daily, after food

•    this can be gradually increased over one to three weeks according to the levels of uric acid in your blood and/or urine

•    the average daily dose is 200 to 300mg for mild gout; 400 to 600mg for moderately severe gout

•    up to 300mg can be taken as a single dose; larger doses should be divided throughout the day.

Treatment of high Uric Acid levels in chemotherapy

•    commence one to two days before chemotherapy and take 600 to 800mg daily in divided doses for 2 to 3 days

•    the maintenance dose is then decided according to your response to treatment

•    while taking this medicine the dose of your chemotherapy may be reduced as this medicine can enhance its effects.

Patients with Kidney or Liver Disease:

•    your dose may need to be reduced; this is determined by monitoring your levels of uric acid

•    if you are receiving frequent dialysis for kidney disease then your dose may also need adjusting or else a single dose of 300 to 400mg following dialysis may be given.

Children (for use in enzyme disorders and with chemotherapy):

•    the usual daily dose is 10 to 20mg per kilogram of bodyweight.

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While you are taking this medicine your doctor may ask you to take regular blood tests to check your levels of uric acid and in some cases monitor the function of your liver and kidneys. If you take more Allopurinol Tablets than you should If you (or anybody else, including a child), take more Allopurinol Tablets than you should then you should contact your nearest hospital casualty department or doctor immediately. Always take the container and this leaflet with you.

If you forget to take Allopurinol Tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Allopurinol Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions

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

Common (affects less than 1 in 10 people)

•    skin rashes, itchiness

Rare (affects less than 1 in 1,000 people)

•    peeling of skin, blistering of the skin, mouth, eyes and genitals

•    fever, swollen lymph glands, joint pain, changes in blood composition, inflammation of small blood vessels under the skin (vasculitis), inflammation of the liver (hepatitis), or kidney problems

•    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 multi-organ sensitivity disorder)

Very rare (affects less than 1 in 10,000 people)

•    sudden difficulty breathing with tightness in the chest, swelling of tongue, drop in blood pressure and collapse

•    fits.

Do not take any more tablets unless your doctor tells you to do so.

Other side effects that have been reported with Allopurinol Tablets are:

Uncommon (affects less than 1 in 100 people)

•    feeling sick (nausea) or being sick (vomiting)

•    increases in levels of liver enzymes in the blood Rare (affects less than 1 in 1,000 people)

•    inflammation of liver with yellowing of the skin and eyes (jaundice)

Very rare (affects less than 1 in 10,000 people)

•    changes in your blood causing you to be anaemic, or to bruise more easily than usual, or to be more prone to infections such as a sore throat. These effects occur more frequently in people with liver or kidney problems. Tell your doctor as soon as possible

•    swelling of the face or throat

•    soreness of the lips or mouth

•    boils

•    solitary (sometimes multiple) small patch of rash on the skin often in the genital area

•    hair loss or discolouration

•    kidney problems

•    blood in your urine

•    high levels of cholesterol or other fats in your blood

•    high temperature

•    a general feeling of being unwell

•    weakness, numbness, altered sensation in skin, unsteadiness on your feet, unable to move muscles (paralysis), loss of consciousness, sleepiness

•    headache, dizziness (vertigo)

•    depression

•    build up of fluid leading to swelling (oedema) particularly of your ankles

•    a change in taste

•    cataracts or other visual disorders

•    chest pain, high blood pressure or a slow pulse

•    male infertility or erectile dysfunction

•    enlargement of the breasts, in men as well as women

•    vomiting blood

•    change in your normal bowel habit, greasy stools

•    diabetes - symptoms include feeling thirsty, tired and losing weight. Your doctor may wish to measure the level of sugar in your blood to check for diabetes

Frequency not known

•    diarrhoea

•    stomach pain

•    chills

•    bleeding into the stomach or intestines

•    increase in gout attacks in first few months of treatment.

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 national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting,

Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Allopurinol Tablets

Keep out of the reach and sight of children.

•    Allopurinol Tablets should be stored in a cool, dry place. Store in the original container to protect it from light and do not transfer to another container.

•    Allopurinol Tablets should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

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 protect the environment.

6. Further information

What Allopurinol Tablets contain

The active ingredient is: allopurinol 100mg or 300mg.

The other ingredients are: lactose, maize starch, povidone, sodium starch glycolate, magnesium stearate, water.

What Allopurinol Tablets looks like and the contents of the pack

Allopurinol Tablets are supplied in plastic containers containing 100 tablets or blister packs of 28 or 56 tablets. Marketing Authorisation Holder: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name

Reference number

Allopurinol 100mg Tablets

PL 29831/0004

Allopurinol 300mg Tablets

PL 29831/0005

This is a service provided by the Royal National Institute of Blind People.

Leaflet Prepared: 04/2015.

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