Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
stiripentol
Biocodex
N03AX17
stiripentol
Antiepileptics,
Myoclonic Epilepsy, Juvenile
Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Revision: 18
Authorised
2007-01-03
78 B. PACKAGE LEAFLET 79 PACKAGE LEAFLET: INFORMATION FOR THE USER DIACOMIT 100 MG HARD CAPSULES stiripentol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your child’s doctor or pharmacist. - This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s. - If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Diacomit is and what it is used for 2. What you need to know before your child takes Diacomit 3. How to take Diacomit 4. Possible side effects 5 How to store Diacomit 6. Contents of the pack and other information 1. WHAT DIACOMIT IS AND WHAT IT IS USED FOR Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics. It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES DIACOMIT YOUR CHILD MUST NOT TAKE DIACOMIT • if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6). • if your child has ever experienced attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations). WARNINGS AND PRECAUTIONS Talk to your child’s doctor or pharmacist before taking Diacomit • if your child has kidney or liver problems. • Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 months. • Your child’s blood count should be assessed prior to Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Diacomit 100 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg of stiripentol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Size 4, pink and white capsule, imprinted with “Diacomit 100 mg”, length of 14 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist experienced in the diagnosis and management of epilepsy in infants and children. Posology _Paediatric population_ The dose of stiripentol is calculated on a mg/kg body weight basis. The daily dosage may be administered in 2 or 3 divided doses. The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with clobazam and valproate. Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week. Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment. The recommended dose of 50 mg/kg/day is based on the available clinical study fin Прочетете целия документ