ANAFRANIL SR 75 MG TABLETS

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

CLOMIPRAMINE HYDROCHLORIDE

זמין מ:

TZAMAL BIO-PHARMA LTD

קוד ATC:

N06AA04

טופס פרצבטיות:

TABLETS SLOW RELEASE

הרכב:

CLOMIPRAMINE HYDROCHLORIDE 75 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

NOVARTIS FARMA S.P.A., ITALY

קבוצה תרפויטית:

CLOMIPRAMINE

איזור תרפויטי:

CLOMIPRAMINE

סממני תרפויטית:

Depression of varying origin: In children and adolescents there is not sufficient evidence of safety and efficacy of Anafranil in the treatment of depressive states of varying aetiology and symptomatology. The use of Anafranil in children and odolescents ( 0 - 17 years of age ) in this indication is therefore not recommended. Obsessive compulcive syndromes: No experience is available in children younger than 5 years of age.

תאריך אישור:

2021-06-30

מאפייני מוצר

ANA API OCT21 V8
Page 1 of 17
Reference: Swiss PI, Sep.2015 (format updated Jan.2020)
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Anafranil 25 mg
Anafranil SR 75 mg tablets
2.
COMPOSITION
_Active substance:_
Clomipramine hydrochloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
Anafranil 25 mg: Coated tablets containing 25 mg clomipramine
hydrochloride
Anafranil SR 75 mg tablets: Slow-release divisible tablets
(“Divitabs”) containing 75 mg
clomipramine hydrochloride
4.
4.1. THERAPEUTIC INDICATIONS
DEPRESSION OF VARYING ORIGIN
In children and adolescents, there is not sufficient evidence of
safety and efficacy of Anafranil in
the treatment of depressive states of varying aetiology and
symptomatology. The use of
Anafranil in children and adolescents (0-17 years of age) in this
indication is therefore not
recommended.
OBSESSIVE-COMPULSIVE SYNDROMES
No experience is available in children younger than 5 years of age.
4.2. DOSAGE AND ADMINISTRATION
Before initiating treatment with Anafranil, hypokalemia should be
treated (see section 4.4
Warnings and precautions).
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.
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 drugs that prolong QT interval or other serotonergic agents
are co-administered (see
sections 4.4 Warnings and precautions and 4.5 Interactions).
ANA API OCT21 V8
Page 2 of 17
Reference: Swiss PI,