Anafranil

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

Clomipramine hydrochloride

Patient Information leaflet

                                ANAFRANIL
®
 
_clomipramine hydrochloride_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Anafranil.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ANAFRANIL IS USED
FOR
Anafranil is used to treat:
1. depression that is longer lasting
and/or more severe than the "low
moods" that everyone has from
time to time due to the stress of
everyday life. 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 in spirit, 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.
2. obsessive-compulsive disorders
(OCD) and phobias in adults
3. muscle weakness in people with a
sleep disorder called narcolepsy.
The symptoms of these disorders
vary from person to person. Your
doctor can provide you with more
information.
Anafranil belongs to a group of
medicines called tricyclic
antidepressants.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for an
                                
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Summary of Product characteristics

                                1 
 
Page 1 of 16 
ANAFRANIL

 
(CLOMIPRAMINE) 
NAME OF THE MEDICINE 
Name: clomipramine hydrochloride. 
Chemical structure: 
 
Empirical formula:    C19 H23 N2Cl . HCl 
Molecular weight:   
351.3 
CAS No:  
 
17321-77-6  
DESCRIPTION 
3-Chloro-5-[3-(dimethylamino)-propy1]10, 
11-dihydro-5H-dibenz 
[b,f] 
azepine 
hydrochloride  (clomipramine  hydrochloride).    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. 
Anafranil  tablets  are  sugar  coated  and  contain  25  mg  of  clomipramine  with  the  excipients:  
silica-colloidal  anhydrous,  glycerol,  lactose,  magnesium  stearate,  maize  starch,  stearic  acid, 
talc, hypromellose, PVP-VA copolymer and titanium dioxide.  In addition the sugar coating 
contains microcrystalline cellulose, povidone, macrogol 8000, sucrose and the dye, iron oxide 
yellow (CI No. 77492). 
PHARMACOLOGY 
PHARMACODYNAMICS 
Clomipramine is a tricyclic antidepressant.  It inhibits the neuronal re-uptake of noradrenaline 
(NA) and serotonin (5-HT) released in the synaptic cleft, inhibition of 5-HT uptake being the 
dominant  component  of  this  activity.    Clomipramine  also  has  a  wide  spectrum  of 
pharmacological  action,  including  alpha1-adrenolytic,  anticholinergic,  antihistaminic  and 
antiserotoninergic (5-HT-receptor blocking) properties. 
 
N
Cl
CH
2
CH
2
CH
2
N(CH
3
)
2
.HCl
Clomipramine hydrochloride
 
 
 
 
 
 
 
 
 
 
 
 
 
PHARMACOKINETICS 
ABSORPTION: 
The  active  substance  is  completely  absorbed  following  oral  administration  but,  due  to 
extensive  hepatic  first-pass  metabolism  to  the  active  metabolite,  _N_-desmethylclomipramine, 
less than 50% of 
                                
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