Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
dextromethorphan, quinidine
Jenson Pharmaceutical Services Limited
N07XX59
dextromethorphan hydrobromide, quinidine sulfate
Other nervous system drugs
Neurobehavioral Manifestations
Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.
Revision: 2
Withdrawn
2013-06-24
48 B. PACKAGE LEAFLET Medicinal product no longer authorised 49 PACKAGE LEAFLET: INFORMATION FOR THE USER NUEDEXTA 15 MG/9 MG HARD CAPSULES NUEDEXTA 23 MG/9 MG HARD CAPSULES dextromethorphan / quinidine 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 side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What NUEDEXTA is and what it is used for 2. What you need to know before you take NUEDEXTA 3. How to take NUEDEXTA 4. Possible side effects 5. How to store NUEDEXTA 6. Contents of the pack and other information 1. WHAT NUEDEXTA IS AND WHAT IT IS USED FOR NUEDEXTA IS a combination of two active substances: Dextromethorphan acts on the brain. Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver. NUEDEXTA IS USED FOR the treatment of pseudobulbar affect (PBA) in adults. PBA is a neurological condition characterized by involuntary and uncontrollable episodes of laughing and/or crying, which don’t match your emotional state or mood. NUEDEXTA can help reduce how often you have episodes of PBA. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUEDEXTA DO NOT TAKE NUEDEXTA if you are allergic to dextromethorphan, quinidine or any of the other ingredients of this medicine (listed in section 6)_._ if you have a history of low levels of blood cells caused by quinidine, quinine or mefloquine (this can cause a tendency to bleed or bruise more easily than normal) if you have a history of a liver disease (hepatitis) caused by quinidine if you have a history of a condition called lupus-like syndrome caused Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT NUEDEXTA 15 mg/9 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine. Excipient with known effect: Each hard capsule contains 119.1 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4). Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily. The recommended dose titration schedule is outlined below: Week 1 (day 1-7): The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days. Weeks 2-4 (day 8-28): The patient should take one NUEDEXTA 15 mg/9 mg capsule, two times per day, one in the morning and one in the evening, 12-hours apart, for 21 days. From Week 4 on: If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued. Medicinal product no longer authorised 3 If the clinical response with NUEDEXTA 15 mg/9 mg is inadequate, NUEDEXTA 23 mg/9 mg should be prescribed, taken two times per day, one in the morning and one in the evening, 12 hours apart. The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily. In case a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time. No more than 2 capsules should be taken in any 24-hour period, wit Прочетете целия документ