Serdolect

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Sertindole

Available from:

Lundbeck Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SERDOLECT
®

Serdolect
®
 Tablets 4, 12, 16 and 20 mg
_Sertindole_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet contains answers to some
common questions about Serdolect.
It does not contain all the information
that is known about Serdolect. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Serdolect
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SERDOLECT IS
USED FOR
Serdolect is used to treat
schizophrenia, a mental illness with
disturbances in thinking, emotional
reactions and behaviour.
Serdolect belongs to a group of
medicines called antipsychotics. It
helps to correct certain chemical
imbalances in the brain which cause
the symptoms of your illness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Serdolect is not addictive.
There is not enough information to
recommend the use of this medicine
for children and adolescents under
the age of 18 years.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SERDOLECT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SERDOLECT IF YOU HAVE
AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
SERTINDOLE.
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
•
ANY OTHER SIMILAR MEDICINES.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing, swelling of the face, lips,
tongue or other parts of the body, or
rash, itching or hives on the skin.
DO NOT TAKE SERDOLECT IF YOU HAVE,
OR EVER HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
Disturbed water or salt balance
(low potassium or low
magnesium levels in the blood)
which is currently not being
treated by your doctor
•
Severe blood v

Summary of Product characteristics

 
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PRODUCT INFORMATION 

SERDOLECT

 TABLETS 

ECG monitoring is
required before and during treatment with sertindole; see 
PRECAUTIONS.  
Clinical studies have shown that sertindole prolongs
the QT interval to a greater extent 
than some other antipsychotics. Sertindole should therefore
only be used for people who 
are not responsive to, or intolerant of at least one other
antipsychotic agent.  
Prescribing physicians
should comply fully with the required safety measures; see 
CONTRAINDICATIONS and PRECAUTIONS.  

NAME OF THE MEDICINE 
Sertindole 

Chemical name: 
1-[2-[4-[5-chloro-1-(4-fluorophenyl)-1H-indol-3-yl]-1-piperidinyl]ethyl]-2-
imidazolidinone 

CAS number: 
106516-24-9 

Molecular formula: 
C
24
H
26
ClFN
4
O 

Molecular weight: 
440.9 

Structural formula: 

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DESCRIPTION 

Sertindole  is  a  white  to  off-white  fine  powder,  practically  insoluble  in  water.  It  is 
soluble  in  0.1  N  acetic  acid,  sparingly  soluble  in  ethanol,  and  freely  soluble  in 
dichloromethane. 

Serdolect  4  mg  tablets  are  oval,  yellow,  biconvex  film-coated  tablets  marked  with 
“S4” on one side.   
Serdolect  12  mg  tablets  are  oval,  beige,  biconvex  film-coated  tablets  marked  with 
“S12” on one side.   
Serdolect  16  mg  tablets  are  oval,  rose,  biconvex  film-coated  tablets  marked  with 
“S16” on one side.   
Serdolect  20  mg  tablets  are  oval,  pink,  biconvex  film-coated  tablets  marked  with 
“S20” on one side.   

They 
contain 
the 
following 
excipients: 
starch 
- 
maize, 
lactose, 
hydroxypropylcellulose,  cellulose  -  microcrystalline,  croscarmellose  sodium  and 
magnesium�