ANAFRANIL 25MG TABLET

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

CLOMIPRAMINE HYDROCHLORIDE

Dostupné z:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

CLOMIPRAMINE HYDROCHLORIDE

Počet v balení:

30 Tablets

Výrobca:

NOVARTIS FARMA S.P.A.

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ANAFRANIL
® TABLETS
Clomipramine (25 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Anafranil is used for
2.
How Anafranil works
3.
Before you use Anafranil
4.
How to use Anafranil
5.
While you are using
Anafranil
6.
Side effects
7.
Storage and Disposal of
Anafranil
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ANAFRANIL IS USED FOR
Anafranil is used to treat

depression

obsessive-compulsive
disorder

panic states

phobias (irrational fears)

long-term painful conditions

muscular weakness
(cataplexy) associated with
repeat attacks of extreme
sleepiness (narcolepsy)
In children aged above 5 years,
Anafranil is used to treat
obsessive-compulsive disorder
and bed-wetting.
HOW ANAFRANIL WORKS
Anafranil belongs to group of
medicines called tricyclic
antidepressants.
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
medicine has been prescribed for
you, ask your doctor.
BEFORE YOU USE ANAFRANIL
It is important to tell your doctor
if you have other medical
problems.
-
_When you must not use it _
Make sure your doctor knows:

If you are allergic
(hypersensitive) to
clomipramine, to any other
tricyclic antidepressant, or to
any of the other ingredients
of Anafranil listed at the end
of this leaflet.

If you are
taking certain
medicines used to treat
depression such as
monoamine oxidase
inhibitors (MAO inhibitors),
selective serotonin reuptake
inhibitors (SSRI), or
serotonin and noradrenergic
reuptake inhibitors (SNaRI).

If you have recently had a
heart attack or if you suffer
from a serious heart disease.
If the answer to any of these is
YES, Anafranil is probably not
suitable for you.
_ _
_PREGNANCY _
Tell your doctor if you are
pregnant or breast-feeding.
Anafranil should not be used
during pregnancy

Súhrn charakteristických

Novartis
Page 2
Malaysian Package Leaflet
23 Jan 2015
Anafranil Tablets
ANAFRANIL

Tricyclic antidepressant. Noradrenaline and preferential
serotonin-reuptake inhibitor (non
selective monoamine reuptake inhibitors).
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Coated tablets (Anafranil
®
25).
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 25 mg clomipramine hydrochloride.
ACTIVE MOIETY
Clomipramine.
EXCIPIENTS
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, Stearic acid and Glycerol (85%).
DESCRIPTION
Light-yellow, round, biconvex sugar-coated tablets..
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,

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.
Novartis
Page 3
Malaysian Package Leaflet
23 Jan 2015
Anafranil Tablets
Chronic painful conditions.
CHILDREN AND ADOLESCENTS
Obsessive-compulsive syndromes.
Nocturnal enuresis (only in patients over the age of 5 years and if
organic causes have been
excluded). When initiating clomipramine for nocturnal enuresis to
children and adolescents,
careful consideration should be given to the benefits versus the risks
for the individual.
Potential alternative therap