Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
CLOMIPRAMINE HYDROCHLORIDE
TZAMAL BIO-PHARMA LTD
N06AA04
COATED TABLETS
CLOMIPRAMINE HYDROCHLORIDE 25 MG
PER OS
Required
NOVARTIS FARMA S.P.A., ITALY
CLOMIPRAMINE
CLOMIPRAMINE
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.
2022-11-30
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, Lue koko asiakirja