Quetiapine Rowex 200 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine

Available from:

Rowex Ltd

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine

Dosage:

200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Authorization status:

Not marketed

Authorization date:

2012-10-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUETIAPINE ROWEX 200 MG PROLONGED-RELEASE TABLETS
QUETIAPINE ROWEX 300 MG PROLONGED-RELEASE TABLETS
QUETIAPINE ROWEX 400 MG PROLONGED-RELEASE TABLETS
Quetiapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Quetiapine Rowex is and what it is used for
2. What you need to know before you take Quetiapine Rowex
3. How to take
Quetiapine Rowex
4. Possible side effects
5. How to store Quetiapine Rowex
6. Contents of the pack and other information
1.
WHAT QUETIAPINE ROWEX IS AND WHAT IT IS USED FOR
Quetiapine Rowex contains the active substance quetiapine. This
belongs to a group of medicines
called anti-psychotics. Quetiapine Rowex can be used to treat several
illnesses, such as:
•
Schizophrenia: where you may hear or feel things that are not there,
believe things that are not
true or feel unusually suspicious, anxious, confused, guilty, tense or
depressed.
•
Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or have
poor judgment including being aggressive or disruptive.
•
Bipolar depression and major depressive episodes in major depressive
disorder: where you feel
sad. You may find that you feel depressed, feel guilty, lack energy,
lose your appetite or can’t
sleep.
When Quetiapine Rowex is being taken to treat major depressive
episodes in major depressive
disorder, it will be taken in addition to another drug being used to
treat this illness.
Your doctor may continue to prescribe
Quetiapine Rowex ev

Summary of Product characteristics

Health Products Regulatory Authority
31 May 2019
CRN008QGS
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine Rowex 200 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Prolonged Release Tablet contains 200 mg Quetiapine (as
Quetiapine fumarate)
Excipients with known effects: 40.70 mg Lactose monohydrate per tablet
For the full list of Excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-Release Tablet
Yellow coloured, round shaped, biconvex film coated tablets, debossed
with ‘I2’ on one side and plain on other.
Diameter of the tablet 9.60 ± 0.2mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetiapine prolonged release 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.
● add-on treatment of major depressive episodes in patients with
Major Depressive Disorder (MDD) who have had
sub-optimal response to antidepressant monotherapy (see section 5.1).
Prior to initiating treatment, clinicians should consider
the safety profile of quetiapine prolonged release (see section 4.4).
Health Products Regulatory Authority
31 May 2019
CRN008QGS
Page 2 of 20
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 dose for their condition.
ADULTS:
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN BIPOLAR DISORDER
Quetiapine prolonged release should be administrated at least one hour
before a meal. The daily dose at the start of therapy is
300 mg on Day 1 and 600 mg on Day 2. The recommended daily dose is 600
mg, however if clinically justified the dose may be