资料单张
ANAFRANIL
®
COATED TABLETS, SUSTAINED-RELEASE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor
or pharmacist.
This medicine has been prescribed only for you. Do not give it to anybody else or use it for
any other illnesses.
If any of the side effects gets 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 use Anafranil
4
Possible side effects
5
Storing Anafranil
6
Further information
ANAFRANIL TABLETS
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 me
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产品特点
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ANAFRANIL® 10mg, 25mg coated tablets; 75
mg sustained-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
ACTIVE MOIETY
Clomipramine
EXCIPIENTS
For the full list of excipients, please see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablets (Anafranil® 10, Anafranil 25)
Sustained-release tablets, divisible (Anafranil SR 75 Divitabs)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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,
2
• 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.
CHILDREN AND ADOLESCENTS
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 ADMINISTRATION
Before initiating treatment with
Anafranil, hypokalaemia should be treated
(see section 4.4 Special
warnings and precautions for use). The dosage should be a
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