ESCITALOPRAM Oral Drops Solution 20 Base mg/ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
08-05-2024
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Active ingredient:
ESCITALOPRAM OXALATE
Available from:
Chanelle Healthcare Limited
Dosage:
20 Base mg/ml
Pharmaceutical form:
Oral Drops Solution
Authorization date:
2012-03-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 20mg/ml Oral Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
20 mg escitalopram (as 25.56 mg escitalopram oxalate).
Each drop contains 1 mg of escitalopram.
Excipients: Each drop contains 4.7mg of ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
A clear solution with a bitter taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Safety of daily doses above 20 mg (20 drops) has not been demonstrated.
_Major depressive episodes_
Usual dosage is 10 mg (10 drops) once daily. Depending on individual patient response, the dose may be increased to a
maximum of 20 mg (20 drops) daily.
Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6
months is required for consolidation of the response.
_Panic disorder with or without agoraphobia_
An initial dose of 5 mg (5 drops) is recommended for the first week before increasing the dose to 10 mg (10 drops)
daily. The dose may be further increased, up to a maximum of 20 mg (20 drops) daily, dependent on individual patient
response.
Maximum effectiveness is reached after about 3 months. The treatment lasts several months.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/03/2012_
_CRN 2099216_
_page number: 1_
_Social anxiety disorder_
Usual d
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