Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
ZUCLOPENTHIXOL DIHYDROCHLORIDE
Lundbeck Limited
25 Milligram
Film Coated Tablet
1982-11-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopixol 25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg zuclopenthixol (as 29.55 mg zuclopenthixol dihydrochloride). Excipients: Each tablet contains 22 mg lactose monohydrate and 0.96 mg hydrogenated castor oil. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet (tablet). Round, biconvex red-brown, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of psychoses, especially schizophrenia, particularly in patients who are agitated or aggressive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration_ Oral. _Adults_ The usual dose is 20-30 mg/day, increasing as necessary to a maximum of 150 mg/day, in divided doses. The usual maintenance dose in chronic schizophrenia is 20-50 mg/day in divided doses. Lower doses may be appropriate depending on individual patient response. _Elderly patients_ Elderly patients should receive dosages in the lower end of the dosage range. _Children_ Not recommended. _Reduced renal function_ Clopixol can be given in usual doses to patients with reduced renal function. _Reduced hepatic function_ Dose reduction (relative to the degree of hepatic impairment) should be considered. If possible, where assay facilities exist dosage should be adjusted according to serum levels. _Method of administration_ The tablets are swallowed with water. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/03/2012_ _CRN 2110129_ _page number: 1_ 4.3 CONTRAINDICATIONS o Hypersensitivity to the active substance or to any of the excipients (see section 6.1) o Circulatory collapse o Depressed level of consiousness due t Olvassa el a teljes dokumentumot