Noletil XL 200mg Prolonged-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine hemifumarate

Available from:

Bluefish Pharmaceuticals AB

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine hemifumarate

Dosage:

200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Administration route:

Oral use

Units in package:

10, 30, 50, 60 and 100 tablets

Prescription type:

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

Therapeutic group:

Antipsychotics; Diazepines, oxazepines and thiazepines

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Therapeutic indications:

It is indicated for Treatment of Schizophrenia and Treatment of bipolar disorder

Authorization status:

Not marketed

Authorization date:

2012-11-23

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOLETIL XL 200 MG PROLONGED-RELEASE TABLETS
NOLETIL XL 300 MG PROLONGED-RELEASE TABLETS
NOLETIL XL 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 the side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Noletil XL is and what it is used for
2.
What you need to know before you take Noletil XL
3.
How to take Noletil XL
4.
Possible side effects
5.
How to store Noletil XL
6.
Contents of the pack and other information
1. WHAT NOLETIL XL IS AND WHAT IT IS USED FOR
Noletil XL contains a substance called quetiapine. This belongs to a
group of medicines called anti-
psychotics. Noletil XL 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 may
feel sad all the time or you may find that you feel depressed, feel
guilty, lack energy, lose your
appetite or can’t sleep.
When Noletil XL 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 Noletil XL even when you are
feeling better.
2. WHAT YOU NEE

Summary of Product characteristics

Health Products Regulatory Authority
17 August 2021
CRN00CGG6
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noletil XL 200mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 200 mg prolonged release tablet contains 200 mg Quetiapine (as
Quetiapine Hemifumarate)
Excipients with known effect: 40.70 mg Lactose monohydrate and 3.5 mg
sodium per tablet.
For a 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
NOTE: Diameter of the tablet 9.60 ± 0.2 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noletil XL is indicated for
Treatment of Schizophrenia, including:
- Preventing relapse in stable schizophrenic patients who have been
maintained on Noletil XL (see section 5.1).
Treatment of bipolar disorder :
- For the treatment of moderate to severe manic episodes associated
with bipolar disorder
- For the treatment of major depressive episodes associated with
bipolar disorder
- For the preventing recurrence in bipolar disorder, in patients whose
manic, or depressive episode has 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 Noletil XL (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
Noletil XL should be administered once daily, without food.
Method of administration
The tablets should be swallowed whole and not split, chewed or
crushed.
ADULTS:
FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC
EPISODES IN BIPOLAR DISORDER
Noletil XL should be administrated at least o