Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM
Pliva Pharma Limited
20 Milligram
Tablets
2005-09-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram 20mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains citalopram hydrobromide equivalent to 20mg of citalopram. _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet. Citalopram 20mg film-coated tablets are oval, biconvex, scored, white, film-coated tablets marked with ‘CI 20’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the different dosage regimens suitable strengths should be prescribed. Citalopram tablets are administered as a single daily dose. Citalopram tablets can be taken any time of the day without regard to food intake. Treating Major Depressive Episodes Citalopram should be administered as a single oral dose of 20mg daily. Dependent on individual patient response this may be increased to a maximum of 60mg daily. Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse. Treating Panic Disorder 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 oral dose of 10mg daily is recommended for the first week before increasing the dose to 20mg daily. The dose may be further increased, up to a maximum of 60mg daily dependent on individual patient response, however an optimum dose is 20-30mg daily. Maximum effectiveness of citalopram in treating panic disorder is reached after ab Read the complete document