Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sertindole
Imported (Denmark)
N05AE03
Sertindole
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5702157188208
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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, 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 SERDOLECT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERDOLECT 3. HOW TO TAKE SERDOLECT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SERDOLECT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SERDOLECT IS AND WHAT IT IS USED FOR Serdolect contains the active substance sertindole and belongs to a group of medicines known as antipsychotics. It acts on nerve pathways in specific brain areas and helps there to correct chemical imbalances that cause your symptoms. Serdolect is used to treat SCHIZOPHRENIA in cases where another medicine was not effective. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERDOLECT DO NOT TAKE SERDOLECT if you are/have: • allergic to sertindole or any of the other ingredients of this medicine (listed in section 6). • untreated low potassium or magnesium in the blood • a significant heart and blood circulation disease • a severe heart disease such as - heart failure with tissue swelling caused by excess fluid - enlargement of the heart - irregular or slow heartbeat • born with or have had an episode of prolonged heart ventricle activity, measured in an ECG, or someone in your family has this abnormal heart rhythm • severely reduced liver function • taking medicines that prolong the time of the heart ventricle activity or affect the liver function. See the first two bull Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serdolect 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mg tablet contains: sertindole 20 mg Excipients: Each 20 mg film-coated tablet contains 112. 90 mg lactose. See section 4.4. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Description of tablets: Oval, pink, biconvex, film coated tablets marked with “S20” 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. 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 antipsychotics. Sertindole should therefore only be used for patients intolerant to at least one other antipsychotic agent. Prescribing physicians should comply fully with the required safety measures: see sections 4.3 and 4.4. 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 α 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 sh Lestu allt skjalið