国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
CITALOPRAM HYDROBROMIDE
Ranbaxy Ireland Limited
CITALOPRAM HYDROBROMIDE
20 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-07-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellcital 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 25 mg of citalopram hydrobromide equivalent to 20 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 '20' on one side and a lip shaped scoreline on the other side. The scoreline is a design feature, not to facilitate breaking: tables do not divide into equal doses. 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 not breakable. For the different dosage regimens suitable strengths should be prescribed. 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 - 6 months is usually necessary to provide adequate maintenance against the potential for relapse. PANIC DISORDER: A single dose of 10mg per day for the first week is recommended; after this the dose may be increased to 20 mg per day. The dose may continue to be increased up to a maximum dose of 40 - 60 mg per day depending on individual pa 完全なドキュメントを読む