CIPRAMIL Oral Drops Solution 40 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
CITALOPRAM HYDROCHLORIDE
Available from:
IPS Healthcare Limited
Dosage:
40 Mg/Ml
Pharmaceutical form:
Oral Drops Solution
Authorization date:
2010-12-21
Summary of Product characteristics
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
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