Anafranil SR 75 mg Prolonged-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clomipramine hydrochloride

Available from:

Novartis Ireland Limited

ATC code:

N06AA; N06AA04

INN (International Name):

Clomipramine hydrochloride

Dosage:

75 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Non-selective monoamine reuptake inhibitors; clomipramine

Authorization status:

Marketed

Authorization date:

1988-09-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anafranil SR 75 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg clomipramine hydrochloride
Also contains polyoxyl hydrogenated Castor Oil, 190 micrograms per
tablet
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged – release, film-coated tablet.
Pink,
capsule shaped,
biconvex,
film-coated tablet, scored on both sides.
One side debossed with ‘CG’ and the other
‘GD’.
The tablets should not be broken
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of endogenous depression including manic depression,
periodic and involutional depression,
reactive and neurotic depression, obsessional and phobic states and as
an adjunctive treatment of cataplexy associated
with narcolepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before initiating treatment with Anafranil, hypokalemia should be
treated (see 4.4 Special warnings and precautions for
use).
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 other serotonergic agents are co-
administered (see sections 4.4 Special Warnings and Precautions for
use and 4.5 Interaction with other Medicinal
Products and other forms of Interaction).
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.
Abrupt discontinuation of Anafranil therapy should be avoided because
of possible withdrawal symptoms. Therefore,
dosage should be stopped gradually