Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROBROMIDE
Pfizer Healthcare Ireland
20 Milligram
Film Coated Tablet
2011-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citalopram Pfizer 20mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg citalopram as citalopram hydrobromide. Excipient: Each film-coated tablet contains 45.72 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, biconvex, capsule shaped, film-coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘6’ on the other side. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Major depressive episodes. Panic disorder with or without agoraphobia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Major depressive episodes:_ Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. Patients with depression should be treated for a sufficient period of time and treatment should be continued 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 Citalopram should be withdrawn slowly: it is advised that the dose is gradually reduced over 1-2 week periods (see section 4.4) Adults: The recommended starting dose is 20 mg per day.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. _Panic disorder:_ Initial dose is 10 mg daily. A week later, the dose should be increased to 20 mg daily. The optimum dosage is 20 - 30 mg daily. If the individual patient’s response to treatment is insufficient, the dose may be increased gradually up to a maximum of 60 mg daily. Full therapeutic response may take up to 3 months to develop. It may be necessary to continue treatment for sev Read the complete document