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310 x180mm - sidel

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALLOPURINOL 100mg TABLETS

(Allopurinol)

Read all of this leaflet carefully before you start taking this medicine.

•    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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT ALLOPURINOL TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Allopurinol 100mg Tablets. They contain the active ingredient called Allopurinol Tablets belong to a group of medicines called enzyme inhibitors, which act to control the speed at which chemical changes occur in the body.

Allopurinol Tablets reduce the formation and accumulation of uric acid in the body. They are used to prevent gout and gouty arthritis These tablets should not be used to treat sudden attack of gout.

Allopurinol Tablets are also used to relieve the symptoms of pain and inflammation due to the following conditions:

•    Gouty arthritis or gout.

•    certain types of kidney stones

•    increased uric acid level following some anti-cancer treatments

•    Lesch-Nyhansyndrome in children [inheritable disorder that affects how the body builds and breaks down purines, characterized by increased blood and uric acid levels and by the absence of the enzyme hypoxanthine guanine phosphoribosyltransferase (HGP)]

•    Psoriasis (skin disease that causes itchy or sore patches of thick, red skin with silvery scales)

To prevent an attack of gouty arthritis your doctor may prescribe a suitable anti-inflammatory medicine or colchicine for at least a month.

2. BEFORE YOU TAKE ALLOPURINOL TABLETS

Do not take Allopurinol Tablets if you:

•    are allergic to Allopurinol or any of other ingredients in this medicine (see section 6). Symptoms of allergic reaction to Allopurinol tablets may include:

•    shortness of breath, wheezing or difficulty in breathing

•    swelling of the face, lips, tongue or other parts of the body

•    rash, itching or hives on the skin

•    are currently suffering from an acute attack of gout. Treatments with Allopurinol tablets should not be started until an acute attack of gout is over. Your doctor may wish to prescribe another medicine to relieve the acute attack.

Take special care if you:

•    are suffering, or have suffered from any liver or kidney problems

•    are suffering from high blood pressure

•    have, or ever had heart disease

Check with your doctor or pharmacist before taking Allopurinol Tablets in such case.

Taking other medices

Check with your doctor or pharmacist if you are taking any of the following medicines:

•    medicines used to treat high blood pressure (like Captopril) or heart problems

•    Azathioprine (used to treat rheumatoid arthritis and after organ transplants)

•    6-mercaptopurine (used to treat some cancers and bowel diseases)

•    Vidarabine (used to treat herpes infections)

•    Capecitabine, Cyclophosphamide (used to treat certain types of cancer)

•    Thiazide diuretics (certain fluid tablets)

•    Aspirin or related medicines (Salicylates)

•    Probenecid (used in gout)

•    Chlorpropamide (used in diabetes)

•    Warfarin (used to help prevent blood clots)

•    Phenytoin (used in epilepsy)

•    Theophylline, used to treat asthma

•    certain antibiotics like Amoxicillin and Ampicillin

•    Ciclosporin (used to treat psoriasis, rheumatoid arthritis or after organ transplants)

•    Didanosine [used to treat human immunodeficiency virus (HIV) infection]

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.

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

Pegnancy and Breast-feeding

Allopurinol Tablets are not recommended for use during pregnancy or if you are intending to become pregnant, unless you and your doctor have discussed the risk and benefits involved. Allopurinol Tablets are not recommended if you are breast-feeding or plan to breast-feed. Allopurinol passes into breastmilk and therefore it is recommended to consult your doctor.

Ask your doctor or pharmacist for advice before taking any medicine. Effects on laboratory tests

Keep all appointment with your doctor and the laboratory. Your doctor will order certain lab test (like sugar tests, liver function tests, etc) to check your body's reponse to Allopurinol.

Taking Allopurinol with food and drink

Drink at least eight glasses of water or other fluids each day while taking Allopurinol Tablets unless directed to do otherwise by your doctor.

Driving and using machines

Allopurinol Tablets may cause drowsiness, dizziness, affect your co-ordination or make you sleepy. Make sure you are not affected befor you drive or operate machinery.

Important information about some of the ingredients of Allopurinol Tablets

This product contains Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicianal product.

3. HOW TO TAKE ALLOPURINOL TABLETS

The amount of AMopurinol Tablets that people can taken can vary. Always taken Allopurinol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Instructions for proper use

Take your Allopurinol Tablets after a meal, preferably at the same time each day. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.

Allopurinol Tablets are usually taken once daily. However, if your dose is more than 300mg, your doctor may advise you to take it morning and night after breakfast and dinner for a twice daily dosage.

Swallow Allopurinol Tablets with a full glass of water.

It is important to drink plenty of water while taking Allopurinol and it is recommended that you should drink at least 2 litres per day.

Dosage

Adults:- The usual starting dose is in the range of 100 - 300mg daily, which may be taken as a single dose after a meal. The dose may be increased upto 900mg daily, depending upon the severity of your condition.

Elderly:- Your doctor will prescribe the lowest dose of Allopurinol Tablets that best control your symptoms.

Children under 15 years:- The usual dose is in the range of 100 - 400mg daily.

If you have liver problems, your doctor will prescribe the lowest dose of Allopurinol Tablets that best controls your symptoms. Your doctor will arrange for you to have liver function tests during the early stages of your treatment.

If you have kidney problems, your doctor will prescribe the lowest dose of Allopurinol tablets that best controls your symptoms. If you have serious kidney problems, your doctor may prescribe less than 100mg per day, or tell you totake a single dose of 100mg at longer intervals than one day. If you have dialysis two or three times a week, your doctor may prescribe a dose of 300 - 400mg which is to be taken straight after dialysis.

There is a possibility that kidney stones may become impacted in the ureter (the tube that runs from the kidney to the bladder), during treatment with Allopurinol. Check with your doctor in such cases.

If you take more Allopurinol tablets than you should:-In the even of an accidental overdose, telephone your doctor immediately or go to the Accident and Emergency Department at your nearest hospitial. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too may Allopurinol Tablets, you may feel some or all of the following:

•    Nausea

•    Vomiting

•    Diarrhoea

•    Dizziness

If you forget to take Allopurinol Tablets

If it is almost time for your next dose, skip the dose you have missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for a forgotten dose. If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

4. POSSIBLE SIDE EFFECTS

•    Rare allergic (hypersensitive) reactions such as difficulty of breathing, tighntess of your chet, swelling of your face, throat or tongue, skin rash itching, hives or flaking skin.

Rare (occurring in less than 1 in 1,000 patients)

•    Joint pain or painful swelling in the groin, armpits or neck;

•    Jaundice (yellowing of the skin and eyes); and

•    Nausea and vomiting (in some cases, blood may be present)

If you experience any of the following, stop your tablets and tell your doctor immediately: Rare (affects less than 1 in 1000 patients)

•    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 (occurring in less than 1 in 10.000 patients)

Occasionally Allopurinol tablets may affect your blood or lymphatic system. These effects have usually occurred in people with liver or kidney problems. However, 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 sighs of an infections.

Rarely, Allopurinol tablets may affects your liver or kidney function. Very rare side effects of Allopurinol include male infertility, erectile dysfunction, enlargement of the breasts, in men as well as women, a change in your normal bowel habit, change in tast perception, cataracts, hair loss or discolouration, convulsions, fits or depresions.

If the side-effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ALLOPURINOL TABLETS

Do not store above 25°C. Store in the original container/blister pack. Keep the container tightly closed. Keep closed. Keep out of the reach and sight of children. Do not use Allopurinol Tablets after the expiry date which is stated on the pack.

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.

6. FURTHER INFORMATION

What Allopurinol Tablets contain

•    The active substance is Allopurinol 100mg

•    The other ingredients are Lactose, Maize Starch, Povidone, Crospovidone and Magnesium Stearate.

What Allopurinol Tablets look like and contents of the pack

White, circular, biconvex tablet with “100” on one face and plain on the

reverse.

Securitainer:28, 100, 500 & 1000 Tablets Blister Pack: 28 Tablets

Not all pack sizes may be marketed.

MA Holder: Special Concept Development (UK) Limited, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufacturer:

LPC Medical (UK) Ltd,

30 Chaul End Lane,

Luton, Bedfordshire LU4 8EZ, UK.

Date leaflet last revised: February 2014.

PL 36722/0034

Like all medicines, Allopurinol Tablets can cause side effects, although not everybody gets them.

If any of the following happens, stop taking Allopurinol Tablets and tell your doctor immediately or go to the nearest hospital emergency department: