Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROBROMIDE’
Clonmel Healthcare Ltd
40 Milligram
Film Coated Tablet
2004-11-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprotan 40mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 49.98 mg citalopram hydrobromide, equivalent to 40 mg citalopram. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Round, white tablets with a break-line and diameter of 10 mm. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Citalopram should be administered as a single oral dose, either in the morning or in the evening. The tablets can be taken with or without food, but with fluid. Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. Treatment should continue until the patient has been free of symptoms for 4-6 months. Citalopram should be withdrawn slowly; it is advised that the dose is gradually reduced over 1-2 week periods. Adults: The recommended starting dose is 20 mg per day. If necessary, the dose can be increased up to 40 mg per day, depending on the individual response of the patient. The maximum dose is 60 mg per day. Elderly patients (>65 years of age): For elderly patients the dose should be decreased to half of the recommended dose, e.g. 10-20 mg per day. Depending on the individual response of the patient, the dose can be increased. The recommended maximum dose for the elderly is 40 mg/day. Children and adolescents under the age of 18: Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). Reduced renal function: Dosage adjustment is not required if the patient has mild to moderate renal Read the complete document