Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
retigabine
Glaxo Group Limited
N03AX21
retigabine
Antiepileptics,
Epilepsy
Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.
Revision: 12
Withdrawn
2011-03-27
109 B. PACKAGE LEAFLET Medicinal product no longer authorised 110 PACKAGE LEAFLET: INFORMATION FOR THE USER TROBALT 50 MG FILM-COATED TABLETS TROBALT 100 MG FILM-COATED TABLETS TROBALT 200 MG FILM-COATED TABLETS TROBALT 300 MG FILM-COATED TABLETS TROBALT 400 MG FILM-COATED TABLETS Retigabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Trobalt is and what it is used for 2. What you need to know before you take Trobalt 3. How to take Trobalt 4. Possible side effects 5. How to store Trobalt 6. Contents of the pack and other information 1. WHAT TROBALT IS AND WHAT IT IS USED FOR Trobalt contains the active substance retigabine. Trobalt is one of a group of medicines called _antiepileptics_ . It works by preventing the brain overactivity that causes epileptic seizures (also called fits). Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation). It is used together with other anti-epileptic medicines to treat adults who continue to experience seizures and where other combinations of antiepileptic medicines have not worked well. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TROBALT DO NOT TAKE TROBALT • if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Trobalt: • if you are 65 years of age or above. • if you have kidney or liver problems. Tell your doctor i Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability. The maximum total daily starting dose is 300 mg (100 mg three times daily). Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability. An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day. The maximum total maintenance dose is 1,200 mg/day. The safety and efficacy of doses higher than 1,200 mg/day have not been established. If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember. After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed. When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4). _Elderly (65 years of age and above) _ There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above. A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients. Medicinal product no longer authorised 3 Th Прочетете целия документ