Package leaflet: Information for the user. Alopur 300 mg Tablets. Allopurinol

Transcription

1 Package leaflet: Information for the user Alopur 100 mg Tablets Alopur 300 mg 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 Alopur is and what it is used for 2. Before you take Alopur 3. How to take Alopur 4. Possible side effects 5. How to store Alopur 6. Further information 1. What Alopur is and what it is used for For Alopur 100 mg: Allopurinol is used to lower uric acid levels in the blood in: adults whose uric acid levels are too high and cannot be controlled by diet, or with symptoms, especially gout kidney damage caused by uric acid the dissolution and prevention of uric acid stones prevention of calcium oxalate stones when uric acid levels are also raised adults and children weighing 15 kg or more whose uric acid levels are too high and have increased excretion by urination of uric acid, for example caused by radiotherapy tumour treatment with medicines other severe cell disintegration children weighing 15 kg or more with kidney damage due to uric acid during treatment of blood cancer with too many or abnormal white blood cells certain hereditary enzyme deficiency disorders; known as Lesch-Nyhan syndrome and adenine phosophoribosyl transferase deficiency. For Alopur 300 mg: Allopurinol is used to lower uric acid levels in the blood in adults whose uric acid levels are too high and cannot be controlled by diet, or with symptoms, especially: gout kidney damage caused by uric acid the dissolution and prevention of uric acid stones prevention of calcium oxalate stones when uric acid levels are also raised

2 adults and children weighing 45 kg or more whose uric acid levels are too high and have increased excretion by urination of uric acid, for example caused by radiotherapy tumour treatment with medicines other severe cell disintegration children weighing 45 kg or more with kidney damage due to uric acid during treatment of blood cancer with too many or abnormal white blood cells certain hereditary enzyme deficiency disorders; known as Lesch-Nyhan syndrome and adenine phosophoribosyl transferase deficiency. 2. What you need to know before you take Alopur Do not take Alopur Alopur 100 mg if you are allergic (to allopurinol or any of the other ingredients of this medicine (listed in section 6) This medicinal product is not suitable for children weighing less than 15 kg. Alopur 300 mg: if you are allergic (to allopurinol or any of the other ingredients of this medicine (listed in section 6) if you have a severely reduced kidney function with a creatinine clearance below 20 ml/min This medicinal product is not suitable for children weighing less than 45 kg. Warnings and precautions Talk to your doctor before taking Alopur if you have: reduced kidney function Reduced kidney function is more likely in patients who take o medicines to treat high blood pressure with active substance names ending in pril or o water tablets for the treatment of high blodd pressure or heart disorder reduced liver function disorders of blood formation Your doctor will monitor your blood count carefully in these 3 cases. 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. It is important to consider that Treatment with medicines is not necessary if: your uric acid blood levels are below 9 mg/100 ml and you have normal kidney function and you follow dietary recommendations listed under Taking Alopur with food and drink. Drink plenty of liquids, enough to produce at least 2 litres of urine daily. This is especially important if you take Alopur to treat:

3 kidney gout uric acid stones Increasing your urine ph-levels may be considered in order to increase excretion of uric acid by urination, if taking Alopur: during radiotherapy, or treatment with medicines against cancer to treat the hereditary enzyme dificiency disorder Lesch-Nyhan syndrome. At the beginning of treatment gout attacks may occur. Therefore, your doctor may prescribe you painkillers or colchicine for the first 4 weeks of Alopur treatment. Other medicines and Alopur Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can influence or be influenced by Alopur: 6-mercaptopurine, a medicine to treat blood cancer with too many or abnormal white blood cells Medicines to treat aggressive tumours, such as o cyclophosphamide o doxorubicin o bleomycin o procarbazine o alkyl halides Your doctor will monitor your blood counts at short intervals. azathioprine, cyclosporine, medicines used to suppress the immune system or treat other diseases Please note, cyclosporine side effects may occur more frequently. vidarabine, a medicine to treat virus diseases Please note, vidarabine side effects can occur more frequently. Take special caution if these occur. didanosine, a medicine to treat HIV infection ampicillin, amoxicillin, medicines for bacterial infections Patients should receive other antibiotics where possible, as allergic reactions are more likely to occur. salicylates, medicines to reduce pain, fever or inflammation, such as acetylsalicylic acid probenecid, benzbromarone, medicines used to increase the excretion of uric acid by urination chlorpropamide, a medicine to treat diabetes Chlorpropamide dose reduction may be necessary, particularly in patients with reduced kidney function. warfarin, phenprocoumon, acenocoumarol, medicines used to prevent normal blood clotting Your doctor will monitor your blood clotting values more frequently and if necessary, reduce the dose of these medicines. phenytoin, a medicine to treat epilepsy or certain pain conditions theophylline, a medicine to treat asthma and other breathing diseases Your doctor will measure theophylline blood levels, particularly when treatment with Alopur begins, or following any dosage changes. captopril, a medicine to treat hypertension and heart disorder The risk of skin reactions can be raised, especially if your kidney function is chronically reduced. Alopur with food and drink and alcohol Avoid: alcohol, particularly beer foods with high purine content such as offal sweetbread, kidney, brain, heart and tongue and meat extract Pregnancy and breast-feeding and fertility Pregnancy:

4 Only take Alopur during pregnancy, if your doctor says it is absolutely necessary, as insufficient knowledge exists. Breast-feeding You should not take Alopur during breast-feeding, as the active substance passes into the breast milk. 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. Driving and using machines Only drive, use machines or engage in dangerous activities, if you are certain that Alopur does not impair your capabilities. Dizziness, drowsiness and difficulties in controlling movement can occur as side effects. 3. How to take Alopur Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For Alopur 100 mg Adults: Usual starting dose: 1 tablet daily. Your doctor may adjust your dose depending on the uric acid levels in your blood. Maximum dose: 9 tablets daily. Tablets containg 300 mg allopurinol are also available for individual dose adjustment. Children and adolescents under 18 years weighing 15 kg or more: Usual dose: 10 mg per kilogram bodyweight daily, divided into 3 doses. Maximum dose: 4 tablets daily. People over 65 years Your doctor will prescribe you the lowest dose necessary to treat your complaints. Reduced kidney function Take Alopur only under the careful supervision of a doctor, who will decide the dose. Maximum dose for patients with severely reduced kidney function: 1 tablet daily. However, following dialysis your doctor can prescribe you 3-4 tablets immediately after every treatment session. Reduced liver function Your doctor will decide your dose. Method of use Take Alopur unchewed with a glass of water after a meal and always at the same time of the day.

5 Divide the dose and take it over the course of the day, if you must take more than 3 tablets daily or stomach or bowel problems occur as a side effect. Tablet dividing instruction Divide the tablet as illustrated in this figure: Duration of use Treatment with Alopur is generally necessary for longer periods. Please take Alopur regularly and for as long as your doctor prescribes it. Contact your doctor regularly for check ups. For Alopur 300 mg Adults: Usual starting dose: 100 mg daily. Your doctor may adjust your dose depending on the uric acid levels in your blood. Maximum dose: 3 tablets daily. Children and adolescents under 18 years weighing 45 kg or more Usual dose: 10 mg per kilogram bodyweight daily, divided into 3 doses. Maximum dose: 400 mg allopurinol daily. Tablets containing 100 mg allopurinol are also available for individual dose adjustment. People over 65 years Your doctor will prescribe you the lowest dose necessary to treat your complaints. Children and adolescents under 18 years weighing less than 45 kg, people with reduced kidney or liver function Due to the high content of the active substance, Alopur is not suitable for these patient groups. Tablets containing 100 mg allopurinol are available for these patients. Following dialysis your doctor can prescribe you 300 to 400 mg allopurinol immediately after every treatment session. Method of use Take Alopur unchewed with plenty of liquid after a meal and always at the same time of the day. Divide the dose and take it over the course of the day, if you must take more than 1 tablet or stomach or bowel problems occur as a side effect.

6 Tablet dividing instruction Divide the tablet as illustrated in this figure: Duration of use Treatment with Alopur is generally necessary for longer periods. Please take Alopur regularly and for as long as your doctor prescribes it. Contact your doctor regularly for check ups. If you take more Alopur than you should Always consult a doctor. Nausea, vomiting, diarrhoea and dizziness can occur as signs of an overdose. If you forget to take Alopur Take the forgotten dose as soon as you remember it. If it is almost time for the next dose omit the forgotten dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Alopur Do not discontinue Alopur without your doctor s approval as this coud reduce the success of therapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people Skin reactions like o itching o blotchy skin with small knots o flaking of the skin o spots o skin bleeding o peeling of the skin (in rare cases) They can occur at any time during the treatment. Stop taking Alopur immediately and consult a doctor, if these skin reactions occur, as severe hypersensitivity reactions might follow. Uncommon, may affect up to 1 in 100 people nausea vomiting diarrhoea 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). a rise in liver function levels without symptoms reduction in blood platelets, which increases risk of bleeding or bruising severe reduction in number of white blood cells which makes infections more likely

7 reduced number of red blood cells due to decreased production, which can cause: o weakness o bruising or o make infections more likely See your doctor immediately, if you have infection symptoms such as fever and generally feeling unwell, or fever with local infections symptoms such as sore throat, pharynx, mouth or urinary problems. Rare, may affect up to 1 in 1,000 people If you experience any of the following, stop your tablets and tell your doctor immediately: 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 liver disorders, ranging from o liver inflammation including liver cell destruction to inflamed knotty liver tissue in extreme cases Very rare, may affect up to 1 in 10,000 people potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2) allergic reactions of different forms o fever o skin reactions o chills o joint pain o reversible increases in liver enzymes transaminases and alkaline phosphatase o bile duct inflammation o xanthine stone in the urinary tract life-threatening allergic shock reaction lymph node disorder (angioimmunoblastic lymphadenopathy), which disappeared after treatment with allopurinol ends vomiting blood increased excretion of fat in the stools stomach and bowel disorders altered white blood cell count o less than 4,000 white blood cells per microlitre blood o more than 10,000 white blood cells per microlitre blood o increased number of the white blood cells called granulocytes o increased number of the white blood cells known as eosinophylic granulocytes lack of red blood cells due to their abnormal or reduced production in the bone marrow feeling of weakness general feeling of being unwell painful, deep, knotty hair follicle inflammation caused by bacteria unconsciousness high blood pressure blood in the urine increase in the size of the breast on one or both sides in men (gynaecomastia) severe painful swelling of deep skin layers, mostly affecting the face sensory disturbances like tingling or numbness inflammation of the inner mouth lining raised levels of blood fats change in taste perception difficulty in controlling movements hair loss

8 sore throat impotence headache abnormal increase of substances in the blood, which usually occur in urine, due to reduced kidney function paralysis muscle pain nerve disorders, including nerve inflammation in arms or legs sleepiness dizziness depression ejaculation during sleep disturbed vision clouding of the eye lens certain eye disease with degeneration of the centre of the inner eye lining, which can result in loss of central vision infertility discoloured hair slower heart rate increased accumulation of water in the tissues diabetes mellitus 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE ALOPUR Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the plastic-aluminium blister/tablet container and the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require special storage conditions. For tablet containers: Shelf life after first opening of the tablet container: 6 months Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. FURTHER INFORMATION What Alopur contains For Alopur 100 mg - The active substance is allopurinol. One tablet contains 100 mg allopurinol. - The other ingredients are:

9 microcrystalline cellulose, cellulose powdered, crospovidone, macrogol 4000, magnesium stearate, povidone K25, talc For Alopur 300 mg - The active substance is allopurinol. One tablet contains 300 mg allopurinol. - The other ingredients are: microcrystalline cellulose, cellulose powdered, crospovidone, macrogol 4000, magnesium stearate, povidone K25, talc What Alopur looks like and contents of the pack For Alopur 100 mg A white round, tablet rounded on the upper and lower side, with a single sided score notch. The tablet can be divided into equal halves. The following pack sizes of the medicinal product are available: - blisters with 1, 7, 10, 25, 28, 30, 50, 90, and 100 tablets - tablet containers with 50, 100, 250, 500, and 1000 tablets Not all pack sizes and pack types may be marketed. For Alopur 300 mg A white to off-white, oblong tablet rounded on the upper and lower side, with a both sided score notch. The tablet can be divided into equal halves. The following pack sizes of the medicinal product are available: - blisters with 1, 7, 10, 20, 28, 30, 50, 90, 100, and 105 tablets - tablet containers with 20, 30, 50, 100, 105, 250, 500, 1000 tablets Not all pack sizes and pack types may be marketed. Marketing Authorisation Holder and Manufacturers Marketing Authoristation Holder Rowex Ltd., Bantry, Co. Cork, Ireland. Manufacturers Salutas Pharma GmbH, Otto-von-Guericke, Allee 1, Barleben, Germany. Salutas Pharma GmbH, Dieselstrasse 5, Gerlingen, Germany. LEK S.A., ul. Podlipie 16 C, Strykow, Poland. Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia. This medicinal product is authorised in the Member States of the EEA under the following names: Germany Zoprinol HEXAL 100 mg Tabletten Austria Allopurinol Hexal 100 mg Tabletten Italy Allopurinolo Hexal 100 mg compresse Ireland Alopur 100 mg Tablets Germany Italy Ireland Zoprinol HEXAL 300 mg Tabletten Allopurinolo Hexal 300 mg compresse Alopur 300 mg Tablets This leaflet was last approved in 01/2015..