Geroquel 300 mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Quetiapine fumarate

Dostupné z:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC kód:

N05AH; N05AH04

INN (Medzinárodný Name):

Quetiapine fumarate

Dávkovanie:

300 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2007-10-19

Príbalový leták

Health Products Regulatory Authority
28 November 2018
CRN008RHR
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geroquel 300 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg of quetiapine as quetiapine fumarate
Excipient with known effect:
Each tablet contains 54.00 mg of lactose (as lactose monohydrate) and
approximately 2.61 mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’
breakline ‘300’ on
one side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Geroquel is indicated for:

Treatment of schizophrenia.

Treatment of bipolar disorder:
- For the treatment of moderate to severe manic episodes in bipolar
disorder.
- For the treatment of major depressive episodes in bipolar disorder
- For the prevention of recurrence of manic or depressed episodes in
patients with
bipolar disorder who previously responded to quetiapine treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Different dosing schedules exist for each indication. It must
therefore be ensured that
patients receive clear information on the appropriate dosage for their
condition.
Health Products Regulatory Authority
28 November 2018
CRN008RHR
Page 2 of 28
_ADULTS_
FOR THE TREATMENT OF SCHIZOPHRENIA
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 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 MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR
DISORDER
For the treatment of manic episodes associated with bipolar
disorder,quetiapine
should

Súhrn charakteristických

Health Products Regulatory Authority
08 January 2019
CRN008T3C
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geroquel 300 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg of quetiapine as quetiapine fumarate
Excipient with known effect:
Each tablet contains 54.00 mg of lactose (as lactose monohydrate) and
approximately 2.61 mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’
breakline ‘300’ on
one side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Geroquel is indicated for:

Treatment of schizophrenia.

Treatment of bipolar disorder:
- For the treatment of moderate to severe manic episodes in bipolar
disorder.
- For the treatment of major depressive episodes in bipolar disorder
- For the prevention of recurrence of manic or depressed episodes in
patients with
bipolar disorder who previously responded to quetiapine treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Different dosing schedules exist for each indication. It must
therefore be ensured that
patients receive clear information on the appropriate dosage for their
condition.
Health Products Regulatory Authority
08 January 2019
CRN008T3C
Page 2 of 28
_ADULTS_
FOR THE TREATMENT OF SCHIZOPHRENIA
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 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 MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR
DISORDER
For the treatment of manic episodes associated with bipolar
disorder,quetiapine
should be