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1. Name of the Medicinal Product 2. Qualitative And Sandoz Business use only Page 1 of 15 1.3.1 spc-label-pl - common-spc - EU - 66 20140220 (DE/H/1356/001-002/R/001- Response on FRAR ) ALLOPURINOL 100 MG; 300 MG TABLET 721-6139.00 721-6688.00 1. NAME OF THE MEDICINAL PRODUCT Allopurinol 100 mg tablets Allopurinol 300 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Allopurinol 100 mg tablets Each tablet contains 100 mg allopurinol. Allopurinol 300 mg tablets Each tablet contains 300 mg allopurinol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Allopurinol 100 mg tablets White, round, biconvex tablets with a single-sided score notch. The tablet can be divided into equal halves. Allopurinol 300 mg tablets White to off-white, biconvex oblong tablet with both-sided breaking notch. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Allopurinol 100 mg Adults All forms of hyperuricaemia not controllable by diet, with serum uric acid values in the range of 535 µmol/l (9 mg/100 ml) and above and in clinical complications of Sandoz Business use only Page 2 of 15 1.3.1 spc-label-pl - common-spc - EU - 66 20140220 (DE/H/1356/001-002/R/001- Response on FRAR ) ALLOPURINOL 100 MG; 300 MG TABLET 721-6139.00 721-6688.00 hyperuricaemic states, particularly manifest gout, urate nephropathy, for the dissolution and prevention of uric acid stones as well as for the prevention of the formation of calcium oxalate stones in concurrent hyperuricaemia Adults, children and adolescents ≥ 15 kg bodyweight Secondary hyperuricaemia of differing origin Children and adolescents ≥ 15 kg bodyweight Uric acid nephropathy during treatment of leukaemia Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial or total hypoxanthin-guanin phosphoribosyl transferase deficiency) and adenine phosophoribosyl transferase deficiency. Allopurinol 300 mg Adults All forms of hyperuricaemia not controllable by diet, with serum uric acid values in the range of 535 µmol/l (9 mg/100 ml) and above and in clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy, for the dissolution and prevention of uric acid stones as well as for the prevention of the formation of calcium oxalate stones in concurrent hyperuricaemia Adults, children and adolescents ≥ 45 kg bodyweight Secondary hyperuricaemia of differing origin Children and adolescents ≥ 45 kg bodyweight Uric acid nephropathy during treatment of leukaemia Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial or total hypoxanthin-guanin phosphoribosyl transferase deficiency) and adenine phosophoribosyl transferase deficiency. 4.2 Posology and method of administration Allopurinol 100 mg tablets Dosage in adults Allopurinol should be introduced at a low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor (see “Dosage in impaired renal function”). The following dosage schedules are suggested: 100 mg to 200 mg daily in mild conditions, 300 mg to 600 mg in moderately severe conditions, 700 mg to 900 mg daily in severe conditions. Dosage higher than 300 mg should be given in divided doses not exceeding 300 mg at any time. If dosage on a mg/kg bodyweight basis is required, 2-10 mg/kg bodyweight/day should be used. Sandoz Business use only Page 3 of 15 1.3.1 spc-label-pl - common-spc - EU - 66 20140220 (DE/H/1356/001-002/R/001- Response on FRAR ) ALLOPURINOL 100 MG; 300 MG TABLET 721-6139.00 721-6688.00 Dosage in children and adolescents ≥ 15 kg bodyweight The daily dose is 10 mg allopurinol per kilogram bodyweight (maximum 400 mg daily) given in 3 divided doses. Dosage in older people As there are no specific data available on the use of allopurinol in elderly patients, this patient group should be treated with the lowest therapeutically justifiable dosage. Furthermore, the possibility of impaired renal function should be considered, especially in older patients. Dosage in impaired renal function As allopurinol and its metabolites are excreted via the kidney, overdose can occur in cases of impaired renal function if the dosage is not adjusted appropriately. For this reason, an adjustment of the recommended dosage is indicated to minimise this risk. In cases of severe impairment of kidney function, a maximum of 100 mg allopurinol should be administered daily, or single doses of 100 mg should be administered at intervals of more than a day. The respective dose should be raised only if the effects are inadequate. The level of oxypurinol in the serum should not exceed a value of 15.2 g/ml. The following table provides guidance for the dosage in case of renal insufficiency: Creatinine Clearance Daily Dose > 20 ml/min standard dose 10 to 20 ml/min 100 to 200 mg < 10 ml/min 100 mg or 100 mg every 2 or 3 days In case of haemodialysis 300 mg to 400 mg allopurinol can be administered immediately after every treatment session (i.e. 2 or 3 times weekly). Dosage in impaired hepatic function Reduced doses should be used in patients with hepatic impairment. Periodic liver function tests are recommended during the early stages of therapy. Allopurinol 300 mg tablets Dosage in adults Allopurinol should be introduced at a low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor (see Dosage in patients with impaired renal or hepatic function). The following dosage schedules are suggested: 100 mg to 200 mg daily in mild conditions, 300 mg to 600 mg in moderately severe conditions, 700 mg to 900 mg daily in severe conditions. Sandoz Business use only Page 4 of 15 1.3.1 spc-label-pl - common-spc - EU - 66 20140220 (DE/H/1356/001-002/R/001- Response on FRAR ) ALLOPURINOL 100 MG; 300 MG TABLET 721-6139.00 721-6688.00 Dosage higher than 300 mg should be given in divided doses not exceeding 300 mg at any time. If dosage on a mg/kg bodyweight basis is required, 2-10 mg/kg bodyweight/day should be used. Dosage in children and adolescents ≥ 45 kg bodyweight The daily dose is 10 mg allopurinol per kilogram bodyweight (maximum 400 mg daily) given in 3 divided doses. Dosage in older people As there is no specific data available on the use of allopurinol in elderly patients, this patient group should be treated with the lowest therapeutically justifiable dosage. Furthermore, the possibility of impaired renal function should be considered, especially in older patients. Dosage in patients with impaired renal or hepatic function Due to the high content of active substance, Allopurinol 300 mg is not suitable for patients with impaired renal or hepatic function. In case of haemodialysis 300 mg to 400 mg allopurinol can be administered immediately after every treatment session (i.e. 2 or 3 times weekly). Allopurinol 100 mg and Allopurinol 300 mg Method and duration of treatment The tablets should be taken unchewed with plenty of liquid after a meal. If the daily dose of 300 mg allopurinol is exceeded or if symptoms of gastrointestinal intolerance occur, the dose should be divided and administered over the course of the day. The duration of treatment depends upon the underlying disorder. In order to prevent formation of calcium oxalate and uric acid stones and in cases of primary hyperuricaemia and gout, long-term therapy is necessary in most cases. In cases of secondary hyperuricaemia, transient treatment in accordance with the duration of raised uric acid values is recommended. 4.3 Contraindications Allopurinol 100 mg: Hypersensitivity to the active substance allopurinol or to any of the excipients listed in section 6.1. Children < 15 kg bodyweight Allopurinol 300 mg: Hypersensitivity to the active substance allopurinol or to any of the excipients. Severe renal dysfunction with a creatinine clearance of below 20 ml/min Sandoz Business use only Page 5 of 15 1.3.1 spc-label-pl - common-spc - EU - 66 20140220 (DE/H/1356/001-002/R/001- Response on FRAR ) ALLOPURINOL 100 MG; 300 MG TABLET 721-6139.00 721-6688.00 Children < 45 kg bodyweight 4.4 Special warnings and precautions for use Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of allopurinol. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Allopurinol treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of Allopurinol, Allopurinol must not be re-started in this patient at any time. Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN. These reactions are clinical diagnoses, and their clinical presentations remain the basis for decision making. If such reactions occur at any time during treatment, allopurinol should be withdrawn immediately. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. HLA-B*5801 allele The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN.
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