ANAFRANIL SR 75 TABLET 75 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CLOMIPRAMINE HCl

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

N06AA04

Dosage:

75 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

CLOMIPRAMINE HCl 75 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

NOVARTIS FARMA S P A

Authorization status:

ACTIVE

Authorization date:

1993-10-27

Patient Information leaflet

ANAFRANIL


Tricyclic  antidepressant.  Noradrenaline  and  preferential  serotonin-reuptake  inhibitor  (non 
selective monoamine reuptake inhibitors). 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORMS 
Coated tablets (Anafranil
 ® 
10, Anafranil 25) 
Sustained-release tablets (Anafranil SR 75) 
Sustained-release tablets, divisible (Anafranil SR 75 Divitabs) 
Capsules 
Information might differ in some countries. 
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. 
One capsule contains 10 mg, 25 mg or 50
mg clomipramine hydrochloride. 
ACTIVE MOIETY 
Clomipramine 
Certain dosage strengths and dosage forms may not be available in
all countries. 
EXCIPIENTS 
10  mg  and  25  mg  Coated  tablets:  Lactose  monohydrate,  Maize  starch,  Hypromellose 
(hydroxypropyl  methylcellulose),  Magnesium  stearate,  Silica  colloidal  anhydrous,  Talc, 
Copovidone  (vinylpyrrolidone/vinylacetate  copolymer),  Titanium  dioxide  (E171),  Sucrose, 
Povidone  (polyvinylpyrrolidone),  Iron  oxide,  yellow  (E172),  Macrogol  8000  (polyethylene 
glycol 8000), Cellulose microcrystalline. 
The 25 mg Coated tablets also contain Stearic acid and Glycerol
(85%). 
Sustained-release,  divisible  tablets:  Calcium  hydrogen  phosphate  dihydrate,  Polyacrylate 
dispersion 30%,  Calcium stearate,  Silica  colloidal anhydrous, Hypromellose  (hydroxypropyl 
methylcellulose),  Talc,  Titanium  dioxide,  Macrogolglycerol  hydroxystearate  (polyoxyl  40 
hydrogenated castor oil), Iron oxide red. 
No

Summary of Product characteristics

ANAFRANIL

Tricyclic
antidepressant.
Noradrenaline
and
preferential
serotonin-reuptake
inhibitor
(nonselective monoamine reuptake inhibitors).
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Coated tablets (Anafranil
10mg, Anafranil 25mg)
Sustained-release tablets (Anafranil SR 75mg)
Sustained-release tablets, divisible (Anafranil SR 75mg Divitabs)
Capsules
Information might differ in some countries.
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 of clomipramine
hydrochloride.
One sustained-release tablet (divisible and non-divisible) contains 75
mg clomipramine
hydrochloride.
One capsule contains 10 mg, 25 mg or 50 mg clomipramine hydrochloride.
ACTIVE MOIETY
Clomipramine
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
10
mg
and
25
mg
Coated
tablets:
Lactose
monohydrate,
Maize
starch,
Hypromellose
(hydroxypropyl
methylcellulose),
Magnesium
stearate,
Silica
colloidal
anhydrous,
Talc,
Copovidone (vinylpyrrolidone/vinylacetate copolymer), Titanium dioxide
(E171), Sucrose,
Povidone (polyvinylpyrrolidone), Iron oxide, yellow (E172), macrogol
8000 (polyethylene
glycol 8000), Cellulose microcrystalline.
The 25 mg Coated tablets also contain Stearic acid and Glycerol (85%).
Sustained-release, divisible tablets: Calcium hydrogen phosphate
dihydrate, Polyacrylate
dispersion 30%, Calcium stearate, Silica colloidal anhydrous,
Hypromellose (hydroxypropyl
methylcellulose), Talc, Titanium dioxide, Macrogolglycerol
hydroxystearate (polyoxyl 40
hydrogenated castor oil), Iron oxide red.
Novartis
Page 2
Country Specific Package Leaflet
03 Jan 2015
Anafranil Tablets
Sustained-release tablets (non-divisible) and capsules: excipients
country-specific.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ADULTS
Treatment of depressive states of varying aetiology and
symptomatology, e.g.

endogenous, reactive, neuro