Notiabolfen XL 300mg prolonged-release Tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

QUETIAPINE

Available from:

Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

ATC code:

N05AH04

INN (International Name):

QUETIAPINE 300 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

QUETIAPINE 300 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2011-08-18

Patient Information leaflet

Page 1 of 9 
PACKAGE LEAFLET: INFROMATION FOR THE USER 
NOTIABOLFEN XL 200 MG  
NOTIABOLFEN XL 300 MG  
NOTIABOLFEN XL 400 MG  
Prolonged-release Tablet  
Quetiapine  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
-  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. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
-  If any of the side effects gets serious, or if you notice any
side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 
-  The name of your medicine is ‘Notiabolfen XL
Prolonged-release Tablets’ but in the rest 
of the leaflet it will be called ‘Notiabolfen XL’. 

IN THIS LEAFLET: 
1. 
What Notiabolfen XL are and what they are used for  
2. 
Before you take Notiabolfen XL  
3. 
How to take Notiabolfen XL  
4. 
Possible side effects  
5. 
How to store Notiabolfen XL  
6. 
Further information 

1. 
WHAT NOTIABOLFEN XL ARE AND WHAT THEY ARE USED FOR           

Notiabolfen XL contains a substance called quetiapine. This belongs to
a group of medicines  
called  anti-psychotics.  Notiabolfen 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 ay feel sad all the time or you may find that you feel depressed,
feel guilty, lack 
energy, lose your appetite or can�

Summary of Product characteristics

Page 1 of 24 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Notiabolfen XL 200 mg prolonged-release Tablet  
Notiabolfen XL 300 mg prolonged-release Tablet  
Notiabolfen XL 400 mg prolonged-release Tablet  

2 QUALITATIVE 
QUANTITATIVE 
COMPOSITION: 

For 200mg: 
Each prolonged release tablet contains 200 mg Quetiapine (as
Quetiapine Hemifumarate) 
Excipients: 40.70 mg Lactose monohydrate and 3.5 mg sodium per
tablet 

For 300 mg: 
Each prolonged release tablet contains 300 mg Quetiapine (as
Quetiapine Hemifumarate) 
Excipients: 61.05 mg Lactose monohydrate and 5.3 mg sodium per
tablet 

For 400 mg: 
Each prolonged release tablet contains 400 mg Quetiapine (as
Quetiapine Hemifumarate) 
Excipients: 81.40 mg Lactose monohydrate and 7.1 mg sodium per
tablet 
For a full list of Excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM: 

Prolonged-release tablet 
FOR 200 MG: 
Yellow coloured, round shaped, biconvex film coated
tablets, debossed with ‘I2’ on one side 
and plain on other 
FOR 300MG: 
Light yellow coloured, round shaped, biconvex film coated tablets,
debossed with ‘Q300’ on 
one side and plain on other. 
FOR 400 MG: 
White coloured, round shaped, biconvex, film coated tablets debossed
with ‘I4’ on one side 
and plain on other. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Quetiapine prolonged release tablet is indicated for  
Treatment of Schizophrenia, including: 
-  Preventing relapse in stable schizophrenic patients who have
been maintained on 
Quetiapine prolonged-release tablet. 
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 
Page 2 of 24 
-  For the prevention of recurrence in patients with bipolar
disorder, in patients whose 
manic or depressive episode has responded to quetiapine treatment. 

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