Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM
PCO Manufacturing
20 Milligram
Tablets
2001-08-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cipramil 20 mg Film-Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains citalopram hydrobromide equivalent to 20 mg citalopram. Excipients: lactose monohydrate. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Spain, United Kingdom, France, Hungary, The Netherlands and Italy_: White, oval-shaped tablets plain on one side and with a breakline on the other side. ‘C’ is embossed to the left of the breakline and ‘N’ is embossed to the right of the breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Cipramil is also indicated in the treatment of panic disorder with or without agoraphobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Depression_ Adults: Cipramil should be administered as a single oral dose of 20mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 40 mg daily. The dose may be given in the morning or evening. A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse. _Panic Disorder_ Adults: In common with other pharmacotherapy used in this patient group, a low starting dose is advised to reduce the likelihood of a paradoxical initial anxiogenic effect. A single dose of 10 mg daily is recommended for the first week before increasing the dose to 20 mg daily. Dependent of individual patient response, the dose may be increased to a maximum of 40 mg daily. Maximum effectiveness of citalopram in treating panic disorder is reached after about 3 months and the response i Read the complete document