ANAFRANIL 25mg coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLOMIPRAMINE HYDROCHLORIDE

Available from:

pharmaand GmbH Taborstrasse 1 1020 Vienna , Austria

ATC code:

N06AA04

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE 25 mg

Pharmaceutical form:

COATED TABLET

Composition:

CLOMIPRAMINE HYDROCHLORIDE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2005-11-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAFRANIL 10 MG AND 25 MG COATED TABLETS
ANAFRANIL 75 MG SUSTAINED-RELEASE TABLETS
Clomipramine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Anafranil is and what it is used for
2.
What you need to know before you take Anafranil
3.
How to take Anafranil
4.
Possible side effects
5.
How to store Anafranil
6.
Contents of the pack and other information
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
medicine has been prescribed for you,
ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANAFRANIL
It is important to t

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ANAFRANIL
®
10 mg, 25 mg coated tablets; 75 mg sustained-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains 10 mg or 25 mg clomipramine hydrochloride.
One sustained-release tablet contains 75 mg clomipramine
hydrochloride.
Excipient(s) with known effect
Each Anafranil 10 mg coated tablets contains 33.25 mg lactose (as
monohydrate) and 28.23 mg sucrose.
Each Anafranil 25 mg coated tablets contains 15 mg lactose (as
monohydrate) and 16.5 mg sucrose.
Each Anafranil 75 mg sustained release tablets contains 0.235 mg
macrogolglycerol hydroxystearate.
For the full list of excipients, please see section 6.1
3
PHARMACEUTICAL FORM
Anafranil 10 mg:
Coated tablets.
Lightly yellow, triangular, biconvex sugar-coated tablets.
Anafranil 25 mg:
Coated tablets.
Lightly yellow, round, biconvex sugar-coated tablets.
Anafranil 75 mg:
Prolonged-release tablets.
Pink, capsule shaped, biconvex, scored on both sides. One side bears
the imprint ‘CG’ and the other ‘GD’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Anafranil is indicated in adults for the 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.
−
Chronic painful conditions.
2
CHILDREN AND ADOLESCENTS
Anafranil is indicated in children and adolescents for the treatment
of 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 A