Quetex XR 50 mg prolonged-release tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Quetiapine

Prieinama:

Rowex Ltd

ATC kodas:

N05AH; N05AH04

INN (Tarptautinis Pavadinimas):

Quetiapine

Dozė:

50 milligram(s)

Vaisto forma:

Prolonged-release tablet

Recepto tipas:

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

Gydymo sritis:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Autorizacija statusas:

Marketed

Leidimo data:

2015-11-19

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUETEX XR 50 MG PROLONGED-RELEASE TABLETS
QUETEX XR 200 MG PROLONGED-RELEASE TABLETS
QUETEX XR 300 MG PROLONGED-RELEASE TABLETS
QUETEX XR 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 or pharmacist.
•
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, or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Quetex XR is and what it is used for
2.
What you need to know before you take Quetex XR
3.
How to take Quetex XR
4.
Possible side effects
5.
How to store Quetex XR
6.
Contents of the pack and other information
1.
WHAT QUETEX XR IS AND WHAT IT IS USED FOR
Quetex XR contains a substance called quetiapine. This belongs to a
group of medicines
called antipsychotics. Quetex XR can be used to treat several
illnesses, such as:
•
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.
•
Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or
have poor judgement including being aggressive or disruptive.
•
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.
When Quetex XR is being taken to treat major depressive episodes in
major depressive
disorder, it will be taken in addition to another medicine being used
to treat this illness.
Your doctor may continue to prescribe Quetex XR even when you feel
better.
2.
WHAT YOU NEED

Prekės savybės

Health Products Regulatory Authority
25 July 2023
CRN00D7LH
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetex XR 50 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 50 mg of quetiapine (as
quetiapine fumarate).
Excipient with known effect
Each prolonged-release tablet contains 14.2 mg of lactose (anhydrous).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off white, round biconvex tablet, 7.1 mm in diameter and 3.2
mm in thickness,engraved with "50" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetex XR is indicated for:

treatment of Schizophrenia.

treatment of bipolar disorder:
o
For the treatment of moderate to severe manic episodes in bipolar
disorder
o
For the treatment of major depressive episodes associated with bipolar
disorder
o
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 (see Section 4.4).
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
Quetex XR should be administered 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 increased to 800
mg daily. The dose should be adjusted within the effective dose range
of 400 mg to 800 mg per day, depending