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PACKAGE LEAFLET: INFORMATION FOR THE USER ALLOPURINOL 300mg 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.

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 • Thiazide (certain fluid tablets) THEY ARE USED FOR • or related medicines (Salicylates) • (used in ) The name of your medicine is Allopurinol 300mg Tablets. They • (used in diabetes) contain the active ingredient called Allopurinol, that belongs to a • (used to help prevent blood clots) group of medicines called inhibitors, which act to control the • (used in epilepsy) speed at which chemical changes occur in the body. • , used to treat asthma • Certain antibiotics like and Allopurinol reduces the formation and accumulation of in the • (used to treat psoriasis, rheumatoid arthritis or after body. They are used to prevent gout and gouty arthritis. These tablets organ transplants) should not be used to treat sudden attack of gout. • [used to treat human immunodeficiency virus (HIV) Allopurinol is also used to relieve the symptoms of pain and infection] inflammation due to the following conditions: Serious skin rashes (Hypersensitivity syndrome, Stevens- Johnson • Gouty arthritis or gout syndrome, toxic epidermal necrolysis) have been reported with the • certain types of stones use of allopurinol. Frequently, the rash can involve ulcers of mouth, • increased uric acid level following some anti-cancer treatments throat, nose, genitals and conjunctivitis ( red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms: • Lesch-Nyhan Syndrome in children [inheritable disorder that affects fever, headache, body ache. The rash may progress to widespread how the body builds and breaks down , characterized by blistering and peeling of the skin. increased blood and uric acid levels and by the absence of the enzyme phosphoribosyltransferase (HGP)] These serious skin reactions can be more common in people of Han • Psoriasis (skin disease that causes itchy or sore patches of thick, Chinese or Thai origin. red skin with silvery scales) If you develop a rash or any of the skin symptoms, stop taking To prevent an attack of gouty arthritis your doctor may prescribe a allopurinol and contact your doctor immediately. suitable anti-inflammatory medicine or for at least a month. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a 2. BEFORE YOU TAKE ALLOPURINOL TABLETS prescription. This is because Allopurinol can affect the way some medicines work. Also some other medicines can affect the way Do not take Allopurinol Tablets if you: Allopurinol works. • are allergic to Allopurinol or any of other ingredients in this medicine (see section 6). Symptoms of allergic reaction to Allopurinol may Pegnancy and Breast-feeding include: Allopurinol Tablets are not recommended for use during or • shortness of breath, wheezing or difficulty in breathing if you are intending to become pregnant, unless you and your doctor • swelling of the face, lips, tongue or other parts of the body have discussed the risk and benefits involved. Allopurinol Tablets are • rash, itching or hives on the skin not recommended if you are breast-feeding or plan to breast-feed. • are currently suffering from an acute attack of gout. Allopurinol passes into breastmilk and therefore it is recommended to Treatments with Allopurinol should not be started until an consult your doctor. acute attack of gout is over. Your doctor may wish to prescribe Ask your doctor or pharmacist for advice before taking any medicine. another medicine to relieve the acute attack. Laboratory tests Take special care if you: Keep all appointment with your doctor and clinic. Your doctor will • are suffering, or have suffered from any liver or kidney problems order certain lab test (like sugar tests, liver function tests, etc) to • are suffering from high blood pressure check your body’s reponse to Allopurinol. • have, or ever had heart disease Taking Allopurinol with food and drink Check with your doctor or pharmacist before taking Allopurinol Drink at least eight glasses of water or other fluids each day while Tablets in such case. taking Allopurinol Tablets unless directed to do otherwise by your doctor. Taking other medicines Check with your doctor or pharmacist if you are taking any of the Driving and using machines following medicines: Allopurinol may cause drowsiness, dizziness, affect your co-ordination • medicines used to treat high blood pressure (like Captopril) or heart or make you sleepy. Make sure you are not affected before you drive problems or operate machinery. • (used to treat rheumatoid arthritis and after organ transplants) Important information about some of the ingredients of • 6- (used to treat some cancers and bowel diseases) Allopurinol Tablets • (used to treat herpes infections) This product contains Lactose. If you have been told by your doctor • Capecitabine, (used to treat certain types of that you have an intolerance to some sugars, contact your doctor cancer) before taking this medicine. 310 x180mm - side2

If you experience any of the following, stop your tablets and tell your 3. HOW TO TAKE ALLOPURINOL TABLETS doctor immediately: The amount of Allopurinol Tablets that people can taken can vary. Rare (occurring in less than 1 in 1000 patients) Always take Allopurinol Tablets exactly as your doctor has told you. • Joint pain or painful swelling in the groin, armpits or neck; You should check with your doctor or pharmacist if you are not sure. • liver or kidney problems • Jaundice (yellowing of the skin and eyes); and Instructions for proper use • Feeling sick (nausea) or being sick () (in some cases, blood Take your Allopurinol Tablets after a meal, preferably at the same time may be present) each day. Taking your tablets at the same time each day will have the • Bleeding in the lips, eyes, mouth, nose or genitals. best effect. It will also help you remember when to take the tablets. • fever and chills, headache, aching muscles (flu-like symptoms) and Allopurinol Tablets are usually taken once daily. However, if your dose generally feeling unwell is more than 300mg, your doctor may advise you to take it morning • any changes to your skin, for example ulcers of the mouth, throat, and night after breakfast and dinner for a twice daily dosage. nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling Swallow Allopurinol Tablets with a full glass of water. • Serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be It is important to drink plenty of water while taking Allopurinol and it is signs of a multi-organ sensitivity disorder). recommended that you should drink at least 2 litres per day. • Rarely, Allopurinol tablets may affect your liver or kidney function. Dosage (blood in urine, abnormal liver function tests) The usual starting dose is in the range of 100 - 300mg daily, Adults:- Very rare (occurring in less than 1 in 10,000 patients) which may be taken as a single dose after a meal. The dose may be Tell your doctor as soon as you can if you notice you bruise more increased upto 900mg daily, depending upon the severity of your easily, or if you develop a sore throat and fever or other signs of an condition. infection as occasionally allopurinol may affect your blood and Elderly:- Your doctor will prescribe the lowest dose of Allopurinol lymphatic system or if you feel thirsty, tired, lose weight as may be Tablets that best control your symptoms. signs of developing diabetes.

Children under 15 years:- The usual dose is in the range of Very rare side effects of Allopurinol include male infertility, erectile 100 - 400mg daily. dysfunction, enlargement of the breasts in men as well as women, a change in taste perception, cataracts, hair loss or discolouration, If you have liver problems, your doctor will prescribe the lowest convulsions, fits or depression, high temperature, blood in your urine dose of Allopurinol Tablets that best controls your symptoms. Your (haematuria), high levels of cholesterol in your blood (hyperlipidaemia), doctor will arrange for you to have liver function tests during the early a general feeling of being unwell, weakness, numbness, unsteadiness stages of your treatment. on your feet, feeling unable to move muscles (paralysis) or loss of consciousness, headache, dizziness, drowsiness or disturbance of If you have kidney problems, your doctor will prescribe the lowest dose of Allopurinol tablets that best controls your symptoms. If you your vision, chest pain, high blood pressure or a slow pulse, build up have serious kidney problems, your doctor may prescribe less than of fluid leading to swelling (oedema) particularly of your ankles. 100mg per day, or tell you to take a single dose of 100mg at longer If the side-effect gets serious, or if you notice any side effect not listed intervals than one day. If you have dialysis two or three times a week, in this leaflet, please tell your doctor or pharmacist. your doctor may prescribe a dose of 300 - 400mg which is to be taken straight after dialysis. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. There is a possibility that kidney stones may become impacted in the This includes any possible side effects not listed in this leaflet. You ureter (the tube that runs from the kidney to the bladder), during can also report side effects directly via the Yellow Card Scheme at: treatment with Allopurinol. Check with your doctor in such cases. www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. If you take more Allopurinol tablets than you should:- In the event 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 5. HOW TO STORE ALLOPURINOL TABLETS or poisoning. You may need urgent medical attention. If you take too many Allopurinol Tablets, you may feel some or all of the following: Do not store above 25°C. Store in the original container/blister pack. Nausea, Vomiting, Diarrhoea, Dizziness. Keep the container tightly closed. Keep out of the sight and reach of children. Do not use Allopurinol Tablets after the expiry date which is stated on the pack. If you forget to take Allopurinol Tablets If it is almost time for your next dose, skip the dose you have missed Medicines should not be disposed of via wastewater or household and take your next dose when you are meant to. Otherwise, take it as waste. Ask your pharmacist how to dispose of medicines no longer soon as you remember, and then go back to taking your medicine as required. These measures will help to protect the environment. 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, 6. FURTHER INFORMATION ask your pharmacist for some hints. What Allopurinol Tablets contain If you stop taking Allopurinol: The active substance is Allopurinol 300mg. The other ingredients are Do not stop taking your Allopurinol without talking to your doctor. If Lactose, Maize Starch, Povidone, Crospovidone and you have any further questions on the use of this product, ask your Stearate. doctor or pharmacist. What Allopurinol Tablets look like and contents of the pack White, circular, biconvex tablet with “300” on one face and plain on 4. POSSIBLE SIDE EFFECTS the reverse. Like all medicines, Allopurinol Tablets can cause side effects, Securitainer:28, 100, 500 & 1000 Tablets & Blister Pack: 28 Tablets. Not all pack sizes may be marketed. although not everybody gets them. If any of the following happens, stop taking Allopurinol Tablets and tell MA Holder: Special Concept Development (UK) Limited, your doctor immediately or go to the nearest hospital emergency Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR department: Manufacturer: RX Farma Limited, Unit 3, Colonial Way, Watford, • Rare allergic (hypersensitive) reactions such as difficulty of breathing, Hertfordshire, WD24 4YR, United Kingdom. tightness of your chest, swelling of your face, throat or tongue, skin rash itching, hives or flaking skin, boils or sore lips and mouth. Very Date leaflet last revised: October 2015. PL 36722/0035 rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse, loss of consciousness, convulsions, fits and blood in your urine.