Quentiax SR 400 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine hemifumarate

Available from:

KRKA, d.d., Novo mesto

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine hemifumarate

Dosage:

400 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:

Marketed

Authorization date:

2018-08-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUENTIAX SR 50 MG PROLONGED-RELEASE TABLETS
QUENTIAX SR 150 MG PROLONGED-RELEASE TABLETS
QUENTIAX SR 200 MG PROLONGED-RELEASE TABLETS
QUENTIAX SR 300 MG PROLONGED-RELEASE TABLETS
QUENTIAX SR 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 Quentiax SR is and what it is used for
2.
What you need to know before you take Quentiax SR
3.
How to take Quentiax SR
4.
Possible side effects
5.
How to store Quentiax SR
6.
Contents of the pack and other information
1.
WHAT QUENTIAX SR IS AND WHAT IT IS USED FOR
Quentiax SR contains a substance called quetiapine. This belongs to a
group of medicines called anti-
psychotics. Quentiax SR 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 Quentiax SR 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 Qu

Summary of Product characteristics

Health Products Regulatory Authority
24 March 2022
CRN00CMDQ
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quentiax SR 400 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 400 mg quetiapine (as
quetiapine hemifumarate).
Excipients with known effect
Each prolonged-release tablet contains 14.73 mg lactose and 23.46 mg
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White to almost white, capsule shaped, biconvex, film-coated tablets,
engraved with mark 400 on one side of the tablet. Tablet
dimensions: length is 18.7 - 19.5 mm and thickness is 5.5 – 7.1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quentiax SR 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 Quentiax SR (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 dosage for their condition.
ADULTS
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN BIPOLAR DISORDER
Quentiax SR 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 increased to 800
mg daily. The dose should be adjust