Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROBROMIDE CITALOPRAM
Niche Generics Limited
10 Milligram
Film Coated Tablet
2005-02-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10mg tablet contains: 10mg Citalopram (as hydrobromide) Excipients: Each tablet contains 11.55mg of anhydrous lactose. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Citalopram 10mg tablets are round, white film coated, embossed 'B' on one side and '46' on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Citalopram tablets is also indicated in the treatment of panic disorder with or without agoraphobia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATING DEPRESSION Citalopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response this may be increased to a maximum of 60 mg daily. The dose may be taken in the morning or evening without regard for food. A treatment period of at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse. PANIC DISORDER Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose. The recommended dose is 20-30 mg daily. A low initial starting dose is recommended to minimise the potential worsening of panic symptoms, which is generally recognised to occur early in the treatment of this disorder. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg / day. (see secti Read the complete document