ESCIPREX Film Coated Tablet 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ESCITALOPRAM
Available from:
Rowex Ltd
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-03-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0711/153/001
Case No: 2084305
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ESCIPREX 5MG FILM-COATED TABLETS
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 15/07/2010 until 05/03/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/08/2010_
_CRN 2084305_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esciprex 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg escitalopram (as oxalate)
Excipient: 65.07 mg lactose (as monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Safety of daily doses above 20mg has not been demonstrated.
Escitalopram is administered as a single daily dose and may be taken with or without food.
Usual dosage is 10 mg once daily. Depending on individual patient response, the does m
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