Setinin SR 400mg prolonged-release Tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

QUETIAPINE

可用日期:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC代码:

N05AH04

INN（国际名称）:

QUETIAPINE 400 mg

药物剂型:

PROLONGED-RELEASE TABLET

组成:

QUETIAPINE 400 mg

处方类型:

POM

治疗领域:

PSYCHOLEPTICS

授权状态:

Withdrawn

授权日期:

2012-08-23

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

Setinin SR 50 mg prolonged-release tablets 
Setinin SR 200 mg prolonged-release tablets 
Setinin SR 300 mg prolonged-release tablets 
Setinin 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 Setinin SR is and what it is used for 
2. 
What you need to know before you take Setinin SR 
3. 
How to take Setinin SR 
4. 
Possible side effects 
5. 
How to store Setinin SR 
6. 
Contents of the pack and other information 

1. 
WHAT SETININ SR IS AND WHAT IT IS USED FOR 

Setinin SR contains a substance called quetiapine and belongs to a
group of medicines called 
antipsychotics. 
Setinin SR are prolonged-release tablets which means
that the active ingredients is released slowly 
from the tablet so that you only have to take them once a day. 

Setinin SR can be used to treat several illnesses, such as: 

•  schizophrenia.  
Schizophrenia is a mental illness associated with disturbances in
thinking, emotions and 
behaviour. The symptoms of schizophrenia include hallucinations
(hearing or seeing things that 
are not there), strange and frightening thoughts, changes in
your behaviour, feeling alone and 
confused. 

•  bipolar disorder, including the following: 
-  moderate to severe manic episodes

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Setinin SR 50 mg prolonged-release tablets 
Setinin SR 200 mg prolonged-release tablets 
Setinin SR 300 mg prolonged-release tablets 
Setinin SR 400 mg prolonged-release tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Setinin SR 50 mg prolonged-release tablet contains 50
mg quetiapine (as quetiapine fumarate).  
Excipient: 34.3 mg lactose monohydrate per tablet.  
Setinin SR 200 mg prolonged-release tablet contains 200
mg quetiapine (as quetiapine fumarate).  
Excipient: 29.9 mg lactose monohydrate per tablet.  
Setinin SR 300 mg prolonged-release tablet contains 300
mg quetiapine (as quetiapine fumarate).  
Excipient: 44.8 mg lactose monohydrate per tablet.  
Setinin SR 400 mg prolonged-release tablet contains 400
mg quetiapine (as quetiapine fumarate).  
Excipient: 59.7 mg lactose monohydrate per tablet.  

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Prolonged-release tablet 

Setinin SR 50 mg tablets are light pink to pink colored, capsule
shaped with dimensions of 12.4 mm x 
6.4 mm, biconvex, film-coated, printed with ‘305’ on one side
with black ink. 
Setinin SR 200 mg tablets are yellow colored, capsule
shaped with dimensions of 14.3 mm x 7.2 mm, 
biconvex, film coated, printed with ‘243’ on one side with
black ink. 
Setinin SR 300 mg tablets are pale yellow colored, capsule
shaped with dimensions of 17.9 mm x 7.0 mm, 
biconvex, film coated, printed with ‘244’ on one side with
black ink. 
Setinin SR 400 mg tablets are white to off-white, capsule
shaped with dimensions of 22.1 mm x 8.9 mm, 
biconvex, film coated, printed with ‘245’ on one side with
black ink. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

- 
Setinin SR is indicated for: 
 Trea