国: マルタ
言語: 英語
ソース: Medicines Authority
FLUPENTIXOL
H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark
N05AF01
FLUPENTIXOL 0.5 mg
FILM-COATED TABLET
FLUPENTIXOL 0.5 mg
POM
PSYCHOLEPTICS
Authorised
2006-04-18
REG_00032958 v.9.0 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUANXOL® 0.5 MG FILM-COATED TABLETS FLUPENTIXOL WHAT IS IN THIS LEAFLET: 1. WHAT FLUANXOL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL 3. HOW TO TAKE FLUANXOL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FLUANXOL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FLUANXOL IS AND WHAT IT IS USED FOR Fluanxol contains the active substance flupentixol. Fluanxol belongs to a group of medicines known as antidepressants. These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances that are causing the symptoms of your illness. Fluanxol is used to treat depression in patients who may, or may not, also be showing signs of anxiety. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL DO NOT TAKE FLUANXOL • If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or to any of the other ingredients of this medicine (listed in section 6). • If you are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation • If you suffer with severe depression, which needs you to stay in hospital or if you need electroconvulsive therapy (ECT) • If you suffer from periods of excitement, overactivity or mania. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fluanxol if you: • have a heart condition (including an irregular heart beat) or severe breathing problems (such as asthma or bronchitis) • have liver, kidney or thyroid problems • suffer from epilepsy, or have been told that you are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal) • suffer from Parkinson’s disease, or myasthenia gravis (a condition causing severe muscular weakness) • have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney) • suffer from glaucoma (raised pressure withi 完全なドキュメントを読む
REG_00040835 v.7.0 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluanxol® 0.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg film-coated tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol dihydrochloride) Excipients with known effect: Lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM 0.5 mg Film-coated tablet Round, slightly biconvex, yellow, film-coated tablet marked FD. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of depression (with or without anxiety). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The standard initial dosage is 1 mg as a single morning dose. After one week the dose may be increased to 2 mg if there is inadequate clinical response. Daily dosage of more than 2 mg should be in divided doses up to a maximum of 3 mg daily. _Older patients _ Older patients should receive half the recommended dosages. The standard initial dosage is 0.5 mg as a single morning dose. After one week, if response is inadequate, dosage may be increased to 1 mg once a day. Caution should be exercised in further increasing the dosage but occasional patients may require up to a maximum of 1.5 mg a day which should be given in divided doses. _Children _ Flupentixol is not recommended for use in children due to lack of clinical experience. _Patients with reduced renal function _ Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4). _Patients with reduced hepatic function _ Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised (see section 4.4). Patients often respond within 2-3 days. If no effect has been observed within one week at maximum dosage the drug should be withdrawn. Method of administration The tablets are swallowed with water 完全なドキュメントを読む