Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
B & S Healthcare
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
20 Milligram
Film Coated Tablet
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seroxat 20mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg paroxetine (as hydrochloride hemihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK:_ White, oval, film-coated tablets engraved ‘Seroxat 20’ on one side and a breakline on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of - Major Depressive Episode - Obsessive Compulsive Disorder - Panic Disorder with and without agoraphobia - Social Anxiety Disorders/Social phobia - Generalised Anxiety Disorder - Post-traumatic Stress Disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that paroxetine is administered once daily in the morning with food. The tablet should be swallowed rather than chewed. For oral administration. MAJOR DEPRESSIVE EPISODE The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. OBSESSIVE COMPULSIVE DISORDER The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on Læs hele dokumentet