Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
SERTINDOLE
H. Lundbeck A/S
SERTINDOLE
16 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER SERDOLECT® 4 MG, 12 MG, 16 MG AND 20 MG FILM-COATED TABLETS sertindole 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. 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, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT SERDOLECT IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE SERDOLECT 3. HOW TO TAKE SERDOLECT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SERDOLECT 6. FURTHER INFORMATION 1. WHAT SERDOLECT IS AND WHAT IT IS USED FOR HOW DOES SERDOLECT WORK? Serdolect belongs to a group of medicines known as antipsychotics. These work by correcting imbalances in brain chemistry. Two of the naturally occurring chemical ‘messengers’ in the brain are called dopamine and serotonin. Too much dopamine and too little serotonin can produce symptoms of mental illness. The main ingredient of Serdolect is Sertindole, which corrects the imbalance. WHAT IS SERDOLECT USED FOR? Serdolect is used for treating schizophrenia. As Serdolect can affect your heart, your doctor will only prescribe Serdolect if you have not been able to continue taking another antipsychotic drug. Ask your doctor if you have any questions about why you have been prescribed Serdolect. DO NOT TAKE SERDOLECT IF: you are allergic (hypersensitive) to sertindole or any of the other ingredients of Serdolect (see section 6). Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serdolect 16 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 16 mg tablet contains: sertindole 16 mg Excipients: Each 16 mg film-coated tablet contains 90.32 mg lactose. See section 4.4. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval, rose, biconvex film-coated tablets marked with “S16” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertindole is indicated for the treatment of schizophrenia. Due to cardiovascular safety concerns, sertindole should only be used for patients intolerant to at least one other antipsychotic agent. Sertindole should not be used in emergency situations for urgent relief of symptoms in acutely disturbed patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sertindole is administered orally once daily with or without meals. In patients where sedation is required, a benzodiazepine may be co-administered. Titration All patients should be started on sertindole 4 mg/day. The dose should be increased by increments of 4 mg after 4– 5 days on each dose until the optimal daily maintenance dose, within the range of 12 -20 mg, is reached. Due to the 1 -blocking activity of sertindole, symptoms of postural hypotension may occur during the initial dose-titration period. A starting dose of 8 mg or a rapid increase in dose carries a significantly increased risk of postural hypotension. Maintenance Dependent on individual patient response, the dose may be increased to 20 mg/day. Only in exceptional cases should NOTE: ECG monitoring is required before and during treatment with sertindole; _see section 4.4_. Clinical studies have shown that sertindole prolongs the QT interval to a greater extent than some other Lesen Sie das vollständige Dokument