Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXCARBAZEPINE
Novartis Pharmaceuticals UK Ltd
N03AF02
OXCARBAZEPINE
60 Mg/Ml
Oral Suspension
Product subject to prescription which may be renewed (B)
Antiepileptics
Authorised
2001-12-03
Live Text: Yes / No / Both Production Site: Torre WO: 1315448 CTM: Monsurro’, Rosanna Comp. Description: LEAFLET_TRILEPTAL FCT ALL DOSAGES_IE Printing Colours: Black Comp. No. New: 1221613 IE TA Comp. No. Old: 1218220-1228221 IE TA Format/Dimension: 148 x 314.96 mm Tech. Drawing No.: 5666/O Technical Colours: Cutting Min. Font Size Text: 7.2 pt Font Type: News Gothic Version No.: 2 Date: 11 Nov 2014 J.N.: 239683 Braille: N/A ! PLEASE TURN OVERPRINTING ON ! 1221613 IE TA PACKAGE LEAFLET: INFORMATION FOR THE USER TRILEPTAL 150 MG FILM-COATED TABLETS TRILEPTAL 300 MG FILM-COATED TABLETS TRILEPTAL 600 MG FILM-COATED TABLETS Oxcarbazepine 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 or your child. 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 (see section 4), please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Trileptal is and what it is used for 2. What you need to know before you take Trileptal 3. How to take Trileptal 4. Possible side effects 5. How to store Trileptal 6. Further information 1. WHAT TRILEPTAL IS AND WHAT IT IS USED FOR WHAT TRILEPTAL IS The active ingredient of Trileptal is oxcarbazepine. Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics. WHAT TRILEPTAL IS USED FOR Medicines such as Trileptal are the standard treatment for epilepsy. Epilepsy is a brain disorder that causes people to have recurring seizuresand convulsions. Seizures happen because of a temporary fault in the brain’s electrical activity. Normally brain cells coordinate body movements by sending out signals through the nerves to the muscles in an organised, orderly way. In epilepsy, brain cells send out too many signals in a disord Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trileptal 60 mg/ml Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the oral suspension contains 60 mg oxcarbazepine. Excipients: Each ml also contains 0.30 mg propylparahydroxybenzoate (E216), 1.20 mg methylparahydroxybenzoate (E218), 250 mg sorbitol 70 % liquid (non crystallising) and 0.9 mg ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. Off-white to slightly reddish brown oral suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trileptal is indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures. Trileptal is indicated for use as monotherapy or adjunctive therapy in adults and in children of 6 years of age and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY In mono- and adjunctive therapy, treatment with Trileptal is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic medicinal products are replaced by Trileptal, the dose of the concomitant antiepileptic medicinal product(s) should be reduced gradually on initiation of Trileptal therapy. In adjunctive therapy, as the total antiepileptic medicinal product load of the patient is increased, the dose of concomitant antiepileptic medicinal product(s) may need to be reduced and/or the Trileptal dose increased more slowly (see section 4.5). The prescription for Trileptal oral suspension should be given in millilitres (see conversion table below which gives the milligram dose in millilitres). The prescribed dose in millilitres is rounded to the nearest 0.5 ml. The doses given in the table below are only applicable to patients aged 6 years and above. These doses are to be administered twice a day. Dose in milligrams (to be given b.i.d) Dose in millilitres (to be given b.i.d) 45 - 75 mg 1.0 ml 76 - 105 mg 1.5 ml 106 - 135 mg 2.0 ml 136 - 165 mg Read the complete document