Placil

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Cumpara asta acum

Descarcare Prospect (PIL)
03-06-2024

Ingredient activ:

Clomipramine hydrochloride

Disponibil de la:

Alphapharm Pty Ltd

Clasă:

Medicine Registered

Prospect

                                PLACIL
 
_contains the active ingredient clomipramine hydrochloride_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Placil.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Placil against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT WITH YOUR MEDICINE.
You may need to read it again.
WHAT PLACIL IS USED FOR
Placil is used to treat:
•
depression
•
obsessive-compulsive disorders
and phobias in adults
•
muscle weakness in people with a
sleep disorder called narcolepsy.
Depression is thought to be caused
by a chemical imbalance in parts of
the brain. This imbalance affects
your whole body and can cause
emotional and physical symptoms
such as feeling low, loss of interest in
activities, being unable to enjoy life,
poor appetite or overeating, disturbed
sleep, loss of sex drive, lack of
energy and feelings of guilt.
Placil belongs to a group of
medicines called tricyclic
antidepressants. These medicines are
thought to work by their action on
brain chemicals called amines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PLACIL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Placil for another reason.
PLACIL IS NOT APPROVED FOR USE IN
CHILDREN AND ADOLESCENTS BELOW 18
YEARS OF AGE FOR THE TREATMENT OF
DEPRESSION AND OTHER PSYCHIATRIC
DISORDERS.
The safe use and effectiveness of
Placil in treating the above
conditions, for this age group, has not
been established.
Placil is available only with a
doctor's prescription.
BEFORE YOU TAKE PLACIL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PLACIL IF YOU ARE
ALLERGIC TO:
•
medicines containing
clomipramine or any other
tricyclic antidepressant
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of a
                                
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Caracteristicilor produsului

                                ,HCl 
PLACIL 
_Clomipramine hydrochloride_ 
 
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
The  active  ingredient  is  clomipramine  hydrochloride.    The  chemical  name  is  3-chloro-5-[3-
(dimethylamino)-propyl]-10,11-dihydro-5H-dibenz[b,f]azepine hydrochloride. 
 
Molecular formula: C
19
H
23
ClN
2
,HCl      Molecular weight: 351.3 
   CAS Registry No.: 17321-77-6 
DESCRIPTION
 
Clomipramine is the 3-chloro derivative of imipramine.  It is a white crystalline powder, soluble in water, 
slightly  soluble  in  ethyl  alcohol  and  insoluble  in  diethyl  ether.    Each  tablet  contains  25  mg  of 
clomipramine  hydrochloride.    The  tablets  also  contain  the  following  excipients:  lactose,  
starch 
– maize, povidone, sodium starch glycollate, magnesium stearate, talc and Opadry Complete 
film coating system White Y-1-7000,
Proprietary Ingredient No. 1475. 
PHARMACOLOGY
 
PHARMACODYNAMICS 
Placil is a tricyclic antidepressant.  It inhibits the neuronal reuptake of noradrenaline (NA) and serotonin 
(5HT)  released  in  the  synaptic  cleft.    The  dominant  component  of  this  activity  is  inhibition  of  5HT 
uptake.    Placil  also  has  a  wide  spectrum  of  pharmacological  action,  including 

1
-adrenolytic, 
anticholinergic, antihistaminic and antiserotoninergic (5HT-receptor blocking) properties. 
PHARMACOKINETICS 
_Absorption._  Following oral administration, the active substance is completely absorbed but due to 
extensive hepatic first-pass
 
metabolism to the active metabolite, _N_-desmethylclomipramine, less than 
50% of a dose reaches the systemic circulation unchanged. 
During  oral  administration  of  constant  daily  doses  of  clomipramine,  the  steady  state  plasma 
concentrations of clomipramine
                                
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