BELLCITAL Film Coated Tablet 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-04-2023
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Active ingredient:
CITALOPRAM HYDROBROMIDE
Available from:
Ranbaxy Ireland Limited
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2005-02-25
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Bellcital 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 12.5 mg of citalopram hydrobromide equivalent to 10 mg citalopram.
Each tablet also contains Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white circular biconvex film-coated tablet, debossed with “10” on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Major depressive episodes.
Panic disorder with or without agoraphobia.
4.2 Posology and method of administration
Bellcital Tablets are administered as a single daily dose. Bellcital Tablets can be taken any time of the day without
regard to food intake but with fluid.
Adults
Major depressive episodes: Citalopram should be administered as a single oral dose of 20 mg daily. If necessary, the
dose can be increased gradually by 10 mg. Dependent on individual patient response, this may be increased to a
maximum of 40 - 60 mg daily. Following treatment initiation, an antidepressant effect should not be expected for at
least two weeks. A treatment duration of at least 4&#
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