ANAFRANIL SR 75 Milligram Tablets

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

CLOMIPRAMINE HYDROCHLORIDE

থেকে পাওয়া:

Novartis Pharmaceuticals UK Ltd

এটিসি কোড:

N06AA04

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE

ডোজ:

75 Milligram

ফার্মাসিউটিকাল ফর্ম:

Tablets

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Non-selective monoamine reuptake inhibitors

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

1993-09-19

তথ্য লিফলেট

PACKAGE LEAFLET: 
INFORMATION FOR THE USER 
ANAFRANIL
® 
SR 
75 MG PROLONGED RELEASE TABLETS 
CLOMIPRAMINE HYDROCHLORIDE 
This medicine will be referred to as Anafranil in
this leaflet. 
READ ALL OF THIS
INFORMATION CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 
• Keep this leaflet. You may need to read it again. 
• If you have further questions, ask your doctor
or pharmacist. 
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their 
symptoms are the same as yours. 
• If any of the side effects get 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 take Anafranil 
4. Possible side effects 
5. How to store Anafranil 
6. Further information 
1. WHAT ANAFRANIL IS AND WHAT IT IS USED FOR 
Anafranil contains a medicine called clomipramine hydrochloride.
This belongs to a group of medicines 
called “tricyclic antidepressants”. Anafranil is thought to
work either by increasing the amount of chemical 
“messengers” in the brain or by making their effects last
longer. 
Anafranil is used to treat depression,
obsessions and phobias (irrational fears). It is also used
to treat muscular 
weakness (cataplexy) associated with repeat attacks of extreme
sleepiness (narcolepsy) in adults. 
2. BEFORE YOU TAKE ANAFRANIL 
DO NOT TAKE ANAFRANIL IF: 
• you are allergic (hypersensitive) to clomipramine
or any of the other ingredients of Anafranil (listed in
Section 
6 below) 
• you have ever had a rash or other allergic reaction
to any other antidepressants 
• you have had a heart attack within the last 3 months 
• you have any serious heart disease 
• you have any serious liver disease 
• you have any other mental illnes

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anafranil SR 75 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg clomipramine hydrochloride
Also contains polyoxyl hydrogenated Castor Oil, 190 micrograms per
tablet
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged – release, film-coated tablet.
Pink,
capsule shaped,
biconvex,
film-coated tablet, scored on both sides.
One side debossed with ‘CG’ and the other
‘GD’.
The tablets should not be broken
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of endogenous depression including manic depression,
periodic and involutional depression,
reactive and neurotic depression, obsessional and phobic states and as
an adjunctive treatment of cataplexy associated
with narcolepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before initiating treatment with Anafranil, hypokalemia should be
treated (see 4.4 Special warnings and precautions for
use).
As a precaution against possible QTc prolongation and serotonergic
toxicity, adherence to the recommended doses of
Anafranil is advised and any increase in dose should be made with
caution if other serotonergic agents are co-
administered (see sections 4.4 Special Warnings and Precautions for
use and 4.5 Interaction with other Medicinal
Products and other forms of Interaction).
The dosage should be adapted to the individual patient’s condition.
The aim is to achieve an optimum effect while
keeping the doses as low as possible and increasing them cautiously.
After a response has been obtained, maintenance
therapy should be continued at the optimum dose to avoid relapse.
Patients with a history of recurrent depression
require maintenance treatment for a longer duration. Duration of
maintenance treatment and need for further treatment
should be reviewed periodically.
Abrupt discontinuation of Anafranil therapy should be avoided because
of possible withdrawal symptoms. Therefore,
dosage should be stopped gradually