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50 Mg Film-Coated Tablets {Topiramate} 100 Mg Film-Coated Tablets {Topiramate} 200 Mg Film-Coated Tablets

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50 Mg Film-Coated Tablets {Topiramate} 100 Mg Film-Coated Tablets {Topiramate} 200 Mg Film-Coated Tablets 1. NAME OF THE MEDICINAL PRODUCT {Topiramate} 25 mg film-coated tablets {Topiramate} 50 mg film-coated tablets {Topiramate} 100 mg film-coated tablets {Topiramate} 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate. Excipients: 25 mg film-coated tablets: Each tablet contains 0.4 mg of lactose (as lactose monohydrate). 50 mg film-coated tablets: Each tablet contains 0.4 mg of lactose (as lactose monohydrate). 100 mg film-coated tablets: Each tablet contains 0.05 mg of Sunset yellow (E110). 200 mg film-coated tablets: Each tablet contains 3.2 mg of lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. {Topiramate} 25 mg are available as white, round, biconvex film-coated tablets. {Topiramate} 50 mg are available as yellow, round, biconvex film-coated tablets. {Topiramate} 100 mg are available as orange, oblong, biconvex film-coated tablets. {Topiramate} 200 mg are available as pink, oblong, biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Adults and adolescents aged 12 years and older: Monotherapy of epileptic patients with partial onset seizures and/or generalised tonic-clonic seizures. Adults and adolescents aged 12 years and older: Adjunctive therapy for epileptic patients with partial onset seizures and/or generalised tonic-clonic seizures. Adults: Second line treatment for migraine prophylaxis. 4.2 Posology and method of administration It is recommended that the dose should be titrated gradually to the therapeutic level in order to avoid dose dependent undesirable effects. Estimation of plasma levels is not necessary for optimisation of Topiramate therapy. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. Method of administration: Tablets should not be divided/broken. Topiramate can be taken with or without a meal with a sufficient quantity of liquid. Monotherapy for adults and adolescents aged 12 years and older: Titration should begin at 25 mg in the evening for one week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used. Dose and titration rate should be guided by clinical outcome. The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day and the maximum recommended daily dose is 400 mg. When concomitant antiepileptic medicinal products are withdrawn to achieve monotherapy with topiramate, the possible effects on seizure control should be taken into account. If the safety of the patient doesn’t require rapid interruption of the other concomitant epileptic therapy, a gradual discontinuation of the concomitant epileptic therapy by one third every other week is recommended. When enzyme inducing medicinal products are withdrawn, topiramate levels will increase. A decrease in topiramate dosage may be required if clinically indicated. The dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease. (See section 4.4) Adjunctive Therapy epilepsy for adults and adolescents aged 12 years and older: Titration should begin at 25 mg to 50 mg topiramate in the evening for one week. The total daily dose should then be increased by 25-50 mg increments at one to two weekly intervals and should be taken in two divided doses. Dose titration should be guided by clinical outcome. The minimum effective dose given in the clinical studies as adjunctive therapy was 200 mg per day. Therefore it was considered to be the minimum effective dose. The usual daily dose is 200 mg to 400 mg in two divided doses. For some patients good seizure control is achieved by one daily dose. Some patients may require the maximum daily dose 800 mg. Prophylaxis of migraine in adults: Titration should begin at 25 mg in the evening for one week. The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals. If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used. The recommended total daily dose of topiramate as treatment for the prophylaxis of migraine is 100 mg/day administered in two divided doses. Higher doses did not result in an increased benefit. Some patients may experience a benefit at a total daily dose of 50 mg/day. Dose and titration rate should be guided by clinical outcome. Use in children There is only limited information about the use of the medicinal product in children less than 12 years of age. Patients with hepatic and/or renal impairment: For patients with moderate (creatinine clearance 30-69 ml/min) and severe (creatinine clearance <30 ml/min) renal dysfunction, it is recommended to start with half of the daily dose than usual and to titrate with smaller steps and at slower pace as is usual. As with all patients, the titrations schedule should be guided by clinical outcome with the knowledge that it may require longer to reach steady-state after each dose change in renally impaired patients. In patients with moderate or severe renal impairment, it may take 10 to 15 days to reach steady concentrations as compared to 4 to 8 days in patients with normal renal function. In hepatically impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased. Patients undergoing haemodialysis: Since topiramate is removed from plasma by haemodialysis, a supplemental dose of topiramate equal to approximately one-half of the daily dose should be administered on haemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure. The supplemental dose may differ based on the characteristics of the form of dialysis and equipment being used. Like in other patients the dose titration occurs according to the clinical outcome (e.g. seizure control, avoidance of undesirable effects). Withdrawal: Antiepileptic drugs, including topiramate, should be withdrawn gradually to minimise the potential of increased seizure frequency. In clinical trials, dosages were decreased by 50-100 mg/day at weekly intervals. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients. Treatment for prophylaxis of migraine: In pregnancy, and in women of childbearing potential if not using an effective method of contraception. In pregnancy, the occurrence of seizures forms a considerable risk for mother and child. Preventing seizures by topiramate, provided given for the right indication, therefore outweighs the risk of malformations. Preventing migraine attacks however, does not outweigh this risk. Consequently, topiramate for the indication prophylaxis of migraine is contra-indicated in pregnancy and women with child bearing potential if not using an effective method of contraception (see section 4.6). 4.4 Special warnings and precautions for use Renal impairment The major route of elimination of topiramate and its metabolites is via the kidney. Caution should be followed in patients with moderate or severe renal impairment. Accumulation because of reduced elimination may occur and it may take longer than usual to achieve steady state. Dose titration should occur at lower pace than usually (see section 4.2). Hydration Adequate hydration while using topiramate is important. Hydration can reduce the risk of nephrolithiasis (see below). Treatment with topiramate may decrease sweating, primarily in paediatric patients. Activities such as exercise or exposure to warm temperatures while using topiramate may increase the risk of heat- related adverse events (see section 4.8). Nephrolithiasis There is an increased risk of renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain, especially in patients with a predisposition to nephrolithiasis. Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria. None of these risk factors can reliably predict stone formation during topiramate treatment. Topiramate, when used concomitantly with other agents predisposing to nephrolithiasis (Acetazolamide, Triamteren, Vitamin C >2g/day), may increase the risk of nephrolithiasis. While using topiramate, agents like these and ketogenic diets should be avoided since they may create a physiological environment that increases the risk of renal stone formation. Decreased hepatic function In hepatically impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased. Acute myopia and secondary angle closure syndrom Secondary angle-closure glaucoma with acute myopia has been reported in patients receiving topiramate(see also section 4.8). Treatment includes discontinuation of topiramate as rapidly as possible in the judgement of the treating physician, and appropriate measures to reduce intraocular pressure. Metabolic Acidosis Hyperchloraemic metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with topiramate treatment. This decrease in serum bicarbonate is due to the inhibitory effect of topiramate on renal carbonic anhydrase. Generally, the decrease in bicarbonate occurs in early treatment
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