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Fachinformation (Zusammenfassung Der Merkmale Des Arzneimittels)

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Fachinformation (Zusammenfassung Der Merkmale Des Arzneimittels) Summary of product characteristics 1. NAME OF THE MEDICINAL PRODUCT <INVENTED NAME> 50 mg film-coated tablets <INVENTED NAME> 100 mg film-coated tablets <INVENTED NAME> 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <INVENTED NAME> 50 mg film-coated tablets Each film-coated tablet contains 50 mg Sultiame. Excipient w ith know n effect: Each film-coated tablet contains 12.95 mg lactose (as monohydrate). <INVENTED NAME> 100 mg film-coated tablets Each film-coated tablet contains 100 mg Sultiame. Excipient w ith know n effect: Each film-coated tablet contains 25.89 mg lactose (as monohydrate). <INVENTED NAME> 200 mg film-coated tablets Each film-coated tablet contains 200 mg Sultiame. Excipient w ith know n effect: Each film-coated tablet contains 51.78 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet <INVENTED NAME> 50 mg film-coated tablets White, round, biconvex film-coated tablets w ith a diameter of approximately 6.0 mm. <INVENTED NAME> 100 mg film-coated tablets White, round, biconvex film-coated tablets scored on one side w ith a diameter of approximately 8.0 mm. The film-coated tablets can be divided into tw o equal doses. <INVENTED NAME> 200 mg film-coated tablets White, round, biconvex film-coated tablets cross-scored on one side w ith a diameter of approximately 11.0 mm. The film-coated tablets can be divided into four equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The medicinal product is used for the alternative treatment for Rolandic epilepsy w hen the treatment w ith other anti-epileptics has not produced the desired effect. Note: The treatment w ith Sultiame should only be performed by neuropaediatricians w ith experience in the treatment of epilepsy. The efficacy and safety of Sultiame for the above therapeutic indication have not been verified in controlled studies. Before starting a treatment w ith Sultiame careful differential diagnosis is required to distinguish the particular case from other forms of epilepsy in childhood. Rolandic epilepsy has a high spontaneous remission rate and in most cases a good outcome and a good prognosis - even w ithout medication. 4.2 Posology and method of administration Dosage The dose is determined and checked by the attending doctor on an individual basis. The daily maintenance dose is approx. 5 to 10 mg/kg body w eight. The treatment should be started at low initial doses and increased gradually to optimum amounts w ithin one w eek. Due to the short half-life of Sultiame the daily dose should be divided into three single doses, if possible. Provided the daily dose is distributed evenly over the day, constant plasma levels can be reached after five or six days. Therapeutic plasma concentrations for Sultiame have not been determined yet. Sw itching from another medicinal product or a combination treatment should be gradual. A neuropaediatrician w ith experience in the treatment of epilepsy should decide about the duration and discontinuation of the treatment on an individual basis. If the treatment does not produce the desired clinical response, Sultiame should be stopped after approx. one or tw o months of treatment. Sultiame should not be stopped suddenly. Route(s) and/or method of administration <INVENTED NAME> is for oral use. The film-coated tablets should be are sw allow ed w ith plenty of liquid (e.g. a glass of w ater). 4.3 Contraindications - hypersensitivity to the active substance, other sulphonamides or to any of the excipients listed in section 6.1. - know n acute porphyria, - hyperthyroidism or arterial hypertension. 4.4 Special warnings and precautions for use Sultiame should be used only w ith adequate monitoring in patients - w ith impaired renal function, - w ith a history of psychiatric disorders, - w ho are pregnant or breast-feeding (also see section 4.6). Note: Patients or their parents should be instructed to consult the attending doctor immediately if fever, sore throat, allergic skin reactions w ith lymph node sw elling and/or flu-like symptoms occur during the treatment w ith Sultiame. Progressive thrombocytopenia or leucopenia accompanied by clinical symptoms such as fever or sore throat requires interruption of treatment. In cases of severe allergic reactions Sultiame must be discontinued immediately. Treatment should also be interrupted if a lasting increase in creatinine occurs. The blood count, liver enzymes and urine should be checked regularly. Suicidal ideation and behaviour Suicidal thoughts and behaviour have been reported in patients treated w ith anti-epileptic medicinal products for various indications. A meta-analysis of randomised, placebo-controlled studies w ith anti-epileptics also show ed a slightly increased risk for suicidal thoughts and behaviour. The mechanism triggering this undesirable effect is unknow n, and the data available do not exclude a potentially increased risk w hen taking Sultiame. Therefore, patients should be monitored for the emergence of suicidal thoughts and behaviour, and an appropriate treatment should be considered. Patients (and their caregivers) should be advised to seek medical help if symptoms of suicidal thoughts or behaviour occur. Effect on laboratory tests Sultiame may interfere w ith the estimation of barbiturates in laboratory tests on blood. <INVENTED NAME> contains lactose Patients w ith rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on Sultiame Primidone The concomitant use of Sultiame and primidone may increase the intensity of undesirable effects of Sultiame; in particular in children dizziness, unstable gait and drow siness may occur. Carbamazepine There is evidence that Sultiame serum levels may decrease if carbamazepine is taken concomitantly. Effects of Sultiame on other medicinal products Phenytoin The combination of Sultiame and phenytoin may increase the plasma level of phenytoin significantly. This combination requires especially strict monitoring and frequent controls of phenytoin plasma levels, in particular in the case of impaired renal function. Lamotrigine In combination w ith lamotrigine, an elevation of lamotrigine levels in the blood has also been observed in individual cases. Therefore, lamotrigine levels should be checked more frequently at the beginning of such treatment. Carbonic anhydrase inhibitors Concomitant use of Sultiame and other carbonic anhydrase inhibitors (e.g. topiramate, acetazolamide) may increase the risk of undesirable effects due to carbonic anhydrase inhibition (also see section 4.8.). Alcohol Alcohol should not be consumed during the treatment w ith sultiame. As sulphonamides have an effect similar to that of disulfiram, Sultiame as a sulphonamide derivative can theoretically have a similar effect. These symptoms include a very unpleasant, although generally self- limiting systemic reaction caused by vasodilatation w ith pulsating headache, respiratory depression, nausea, vomiting, tachycardia, hypotension, amblyopia, confusion, shock reactions, arrhythmia, loss of consciousness and seizures. The degree and duration of these symptoms can vary to a great extent. 4.6 Fertility, pregnancy and lactation Pregnancy There is no systematic data available from the use of sultiame in pregnant w omen. Studies in animals have show n reproductive toxicity (see section 5.3). Sultiame is not recommended during pregnancy. Breast-feeding It is unknow n w hether sultiame is excreted in human milk. A risk to the suckling child cannot be excluded. Sultiame should not be used during breast-feeding. Fertility There are no clinical data available on the effects of sultiame on human fertility. Studies in animals have not been performed (see section 5.3). 4.7 Effects on ability to drive and use machines This medicinal product can change reactivity to an extent that patients are no longer able to participate safely in road traffic or operate machines, in particular at the beginning of treatment. This is even more so w hen drinking alcohol. 4.8 Undesirable effects The follow ing frequency categories form the basis for classification of undesirable effects: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1.000 to < 1/100) Not know n (frequency cannot be estimated from the available data): Metabolism and nutrition disorders Common Loss of w eight, loss of appetite Psychiatric disorders Uncommon Hallucination, anxiety, lack of drive Not know n Behavioural anomaly such as aggressiveness, irritability, mood sw ings, deterioration in cognitive function Nervous system disorders Common Paraesthesia in the extremities and in the face (dose dependent), dizziness, headache Uncommon Myastenic phenomena, grand-mal state, increased seizure activity Not know n Polyneuritis, somnolence Eye disorders Common Double vision Cardiac disorders Common Stenocardia, tachycardia Respiratory, thoracic and mediastinal disorders Common Tachypnoea, hyperpnoea, dyspnoea, singultus Gastrointestinal disorders Very common Gastric disorder Hepatobiliary disorders Not know n Hepatotoxic reactions, elevated liver enzymes Skin and subcutaneous tissue disorders Not know n Stevens-Johnson syndrome, Lyell's syndrome Musculoskeletal and connective tissue disorders Uncommon Joint pain Renal and urinary disorders Not know n Acute renal failure In one case, the administration
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