Imipramine 25 SC Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMIPRAMINE HYDROCHLORIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

N06AA02

INN (International Name):

IMIPRAMINE HYDROCHLORIDE 25 mg

Pharmaceutical form:

COATED TABLET

Composition:

IMIPRAMINE HYDROCHLORIDE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-11-15

Patient Information leaflet

PL08401901.doc                                     

- 1 - 

IMIPRAMINE

Ref: P18-0103-PILECY2-01

PATIENT INFORMATION LEAFLET 
IMIPRAMINE   10   
Film-coated Tablets        10mg 
IMI
IM
IMIPRAMINE 100   
Film-coated Tablets        100mg 
PRAMINE   25   
Sugar-coated Tablets      25mg 
IPRAMINE   25   
Film-coated Tablets         25mg 
PLE
d it again. 
sk your doctor or your pharmacist. 
This medicine was prescribed for you personally and you should not
pass it on to others. It 
, Sodium Starch 
um Stearate, Talc, Gelatin, Macrogol 6000, Sucrose, 
_ and 100_
: Lactose, Povidone, Microcrystalline Cellulose, Sodium 
ioxide, Magnesium Stearate, Talc, Hypromellose, Macrogol 400, 
, Ponceau 4R E124_ _
CTURER:  
gar-coated Tablets:    19951 
ASE READ CAREFULLY THIS LEAFLET BEFORE YOU START TAKING THE
MEDICINE. 
ep this leaflet in a safe place. You may need to rea
- 
Ke
- 
  If you have any questions a
- 
can be harmful, even when their symptoms are the same as yours. 
COMPOSITION: 
_Active substance: _
Imipramine Hydrochloride 
_Excipients:_

_Imipramine 25 sugar-coated Tablets_
: Lactose, Povidone, Microcrystalline Cellulose
Glycollate, Colloidal Silicon Dioxide, Magnesi
Calcium Carbonate, Ponceau 4R E124, Quinoline Yellow E104,
Hypromellose, Macrogol 400, 
Titanium Dioxide. 
_Imipramine film-coated Tablets 10, 25_
Starch Glycollate, Colloidal Silicon D
Titanium Dioxide, Sunset Yellow E110
MARKETING LICENCE HOLDER & MANUFA
R
ssol, Cyprus, EU. 
MARKETING LICENCE NUMBER:  
emedica Ltd, Limassol Industrial Estate, Lima
Imipramine   10   Film-coated Tablets:    18848 
Imipramine 100   Film-coated Tablets:  14389 
Imipramine   25 Su
Imipramine   25 Film-coated Tablets:       18849 
1. 
WHAT IS IMIPRAMINE AND WHAT ARE ITS USES

Imipramine, the active subs

Summary of Product characteristics

SPC08401901.doc 

Page 1 of 12 
Ref: IMIPRAMINE TABS-SPC-V3

SUMMARY OF PRODUCT CHARACTERISTICS
-00   

_EDICINAL PRODUCT _
 tablets 
ablets 
Imipramine 100: Each tablet contains Imipramine Hydrochloride BP
100 mg. 
let contains Imipramine Hydrochloride BP 25 mg. 
s Imipramine Hydrochloride BP 10 mg. 

_ _
: Film-coated tablets. 
_HERAPEUTIC INDICATIONS _

_1. NAME OF THE M_
Imipramine 100 FC
Imipramine 25 FC t
Imipramine 25 SC tablets 
Imipramine 10 FC tablets 

_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Imipramine 25: Each tab
Imipramine 10: Each tablet contain
_3. PHARMACEUTICAL FORM_
Imipramine 100, 25, 10
Imipramine 25: Sugar-coated tablets. 

_4. CLINICAL PARTICULARS _
_4.1. T_
1) Treatment of symptoms of depressive illeness. 
2) Relief of noctural enuresis in children. 

_4.2. POSOLOGY AND METHOD OF ADMINISTRATION   _
_ADULTS: _
25mg up to three times daily, increasing stepwise to 150-200mg. 
 should be reached by the end of the first week and
maintained until definite improvement has 
radually reducing 
vere cases, the dose may be increased to 100mg three times daily
until a 
distinct improvement is seen.  Against the subsequent maintenance
dose should be determined 
individually by reducing the dosage, usually to about 100mg. 
Elderly:
This
occurred.  The subsequent maintenance dose should be
individually determined by g
the dosage, usually to about 50-100mg daily. 
In patients in hospital, i.e. se

Patients over 60 years may respond to lower doses of imipramine
than dose recommended above.  
Treatment should be initiated with 10mg daily, gradually increasing
to 30-50mg daily.  The optimum 
dose should be reached after about 10 days and then continued
until the end of treatment. 
Children (for noctural enuresis only): 
SPC08401901.doc 

Page 2 of 12 
The tablets should be administered just before bedtime. 
-75mg daily. 
imum period of treatment should not exceed three 
l should b