Anafranil

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

clomipramine hydrochloride 10 mg

Available from:

Novartis Pharmaceuticals UK Limited

ATC code:

N06AA04

INN (International Name):

clomipramine hydrochloride

Pharmaceutical form:

coated tablet

Authorization status:

Authorised

Authorization date:

2005-11-22

Patient Information leaflet

ANAFRANIL
®

COATED TABLETS, SUSTAINED-RELEASE TABLETS 
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 further questions, please ask your doctor
or pharmacist. 
This medicine has been prescribed only for you. Do not give it to anybody else  or use it for 
any other illnesses. 
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. 
IN THIS LEAFLET 
1 
What Anafranil is and what it is used for 
2 
Before you take Anafranil 
3 
How to use Anafranil 
4 
Possible side effects 
5 
Storing Anafranil 
6 
Further information 
ANAFRANIL TABLETS 
1 
WHAT ANAFRANIL IS AND WHAT IT IS USED FOR 
WHAT ANAFRANIL IS 
Anafranil  is  available  as  tablets  and  sustained-release  tablets.  The  active  substance  in 
Anafranil is clomipramine hydrochloride, which belongs to group of medicines called
tricyclic 
antidepressants. 
WHAT ANAFRANIL IS USED FOR 
Anafranil is used to treat depression and mood disorders. Other psychological conditions that 
can  be  treated  with  Anafranil  are  obsessions,  panic  states  and  phobias  (irrational  fears), 
chronic painful  conditions  and  muscular weakness  (cataplexy) associated with  repeat  attacks 
of extreme sleepiness (narcolepsy) in adults. In children aged above 5 years, Anafranil is used 
to treat obsessions and bed-wetting. 

HOW ANAFRANIL WORKS 
Anafranil is believed to work either by increasing the amount of naturally occurring chemical 
messengers (noradrenaline and serotonin) in the brain or
by making their effects last longer. 
If  you  have  any  questions  about  how  Anafranil  works  or  why  this  me

Summary of Product characteristics

1 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
NAME OF THE MEDICINAL PRODUCT 
ANAFRANIL® 10mg, 25mg coated tablets; 75
mg sustained-release tablets 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

ACTIVE SUBSTANCE 
The  active  ingredient  is  3-Chloro-5-[3-(dimethylamino)-propyl]10,11-dihydro-5H-dibenz-[b,f]azepine 
hydrochloride (clomipramine hydrochloride).  
One coated tablet contains 10 mg or
25 mg clomipramine hydrochloride.  
One sustained-release tablet (divisible and non-divisible) contains
75 mg clomipramine hydrochloride.  

ACTIVE MOIETY 
Clomipramine 

EXCIPIENTS 
For the full list of excipients, please see section 6.1 

3. 
PHARMACEUTICAL FORM 
Coated tablets (Anafranil® 10, Anafranil 25)  
Sustained-release tablets, divisible (Anafranil SR 75 Divitabs) 

4.  
CLINICAL PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 
ADULTS 
Treatment of depressive states of varying aetiology and
symptomatology, e.g.  
• endogenous, reactive, neurotic, organic, masked, and involutional
forms of depression,  
• depression associated with schizophrenia and
personality disorders,  

2 
• depressive syndromes due to presenility or senility, to
chronic painful conditions, and to     
  chronic somatic diseases, depressive mood disorders
of a reactive, neurotic, or psychopathic      
  nature.  
Obsessive-compulsive syndromes.  
Phobias and panic attacks.  
Cataplexy accompanying narcolepsy.  
Chronic painful conditions.  
CHILDREN AND ADOLESCENTS 
Nocturnal enuresis (only in patients over the age of 5 years and
if organic causes have been excluded).  
No experience is available in children younger than 5 years
of age. 
4.2  
POSOLOGY AND METHOD OF ADMINISTRATION 
Before  initiating  treatment with
Anafranil,  hypokalaemia should  be treated
(see  section 4.4 Special 
warnings and precautions for use). The dosage should be a