QUETIAPINE ARROW
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
08-05-2024
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Składnik aktywny:
QUETIAPINE
Dostępny od:
Arrow Generics Limited
Dawkowanie:
25 Milligram
Forma farmaceutyczna:
Film Coated Tablet
Data autoryzacji:
2010-01-15
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine Arrow 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of quetiapine (as quetiapine fumarate).
Excipients: lactose (anhydrous) 4.91mg, Sunset Yellow (E110) 0.045mg and Allura Red (E129) 0.014mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Peach, round coated biconvex tablet with ‘QT’ on one side and ‘
’on the other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of schizophrenia.
•
Treatment of moderate to severe manic episodes.
•
Treatment of major depressive episodes in bipolar disorder.
Quetiapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Quetiapine Tablets can be administered with or without food.
_Adults_
FOR THE TREATMENT OF SCHIZOPHRENIA:
Quetiapine should be administered twice a day.
The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg
(Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg/day. Depending on
the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750
mg/day.
FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER:
Quetiapine should be administered twice a day.
The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg
(Day 4). Further dosage adjustments up to 800 mg per day by Day 6 should be in increments of no greater than 200 mg
per day.
The dose may be adjusted depending on clinical response and tolerability of
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