Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROCHLORIDE
IPS Healthcare Limited
40 Mg/Ml
Oral Drops Solution
2010-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cipramil 40 mg/ml Oral drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml contains 40mg citalopram (as 44.48mg citalopram hydrochloride) 1ml = 20 drops. 1 drop = 2mg citalopram Excipients Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ethanol less than 100mg in all doses For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution. _Product imported from United Kingdom:_ Clear, nearly colourless to yellowish solution with a bitter taste. 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 drops should be administered as a single oral dose of 16 mg (8 drops) daily. Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 48 mg (24 drops) daily. _Treating Panic Disorder_ A single oral dose of 8 mg (4 drops) daily is recommended for the first week before increasing the dose to 16 mg (8 drops) daily. The dose may be further increased, up to a maximum of 48 mg (24 drops) daily, dependent on individual patient response. _Elderly patients (> 65 years of age)_ In elderly patients the dose may be increased to a maximum of 32 mg (16 drops) 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 _Reduced renal function_ Dosage adjustment is not necessary in patients with mild or moderate renal impairment. No information Prečítajte si celý dokument