Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROBROMIDE’
B & S Healthcare
10 Milligram
Tablets
2006-08-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cipramil 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Citalopram (as hydrobromide). Excipients: Lactose _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated Tablet. _Product imported from the UK:_ Round, white tablet marked ‘CL’ on one side. 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 Adults TREATING DEPRESSION Citalopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 60 mg daily. TREATING PANIC DISORDER A single oral dose of 10 mg is recommended for the first week before increasing the dose to 20 mg daily. The dose may be further increased, up to a maximum of 60 mg daily dependent on individual patient response. ELDERLY PATIENTS (> 65 YEARS OF AGE) In elderly patients the dose may be increased to a maximum of 40 mg daily. CHILDREN & ADOLESCENTS (<18 YEARS) Cipramil should not be used in the treatment of children and adolescents under the age of 18 years _(see section 4.4._ _Special warnings and precautions for use)._ REDUCED RENAL FUNCTION Dosage adjustment is not necessary in patients with mild or moderate renal impairment. No information is available on treatment of patients with severely reduced renal function (creatinine clearance <20 ml/min). REDUCED HEPATIC FUNCTION Patients with reduced hepatic function should receive dosages of no more than 30 mg Read the complete document