ANAFRANIL Prolonged-release, film-coated tablet Ref.[2672] Active ingredients: Clomipramine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: zr pharma& GmbH, Hietzinger Hauptstrasse 37, 1130 Vienna, Austria

Product name and form

Anafranil SR 75 mg Prolonged-release Tablets.

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.

Qualitative and quantitative composition

Each tablet contains 75 mg clomipramine hydrochloride.

Excipient with known effect: Each tablet contains 235 micrograms polyoxyl hydrogenated castor oil.

For a full list of excipients see section 6.1.

Active Ingredient Description
Clomipramine

The therapeutic activity of clomipramine is believed to be based on its ability to inhibit the neuronal re-uptake of noradrenaline (NA) and serotonin (5-HT) released in the synaptic cleft, with inhibition of 5-HT reuptake being the more important of these activities.
List of Excipients

Eudragit E30D (polyacrylate dispersion 30%)
Calcium hydrogen phosphate
Silicon dioxide
Calcium stearate
Hypromellose
Red iron oxide (E172)
Castor oil, polyoxyl hydrogenated
Talc
Titanium dioxide (E171)

Pack sizes and marketing

PVC/Aluminium blister packs in cardboard cartons.

Pack sizes of 100, 30 and 28 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

zr pharma& GmbH, Hietzinger Hauptstrasse 37, 1130 Vienna, Austria

Marketing authorization dates and numbers

PA23086/001/001

Date of first authorisation: 19 September 1988
Date of last renewal: 01 April 2008

Drugs

Drug Countries
ANAFRANIL Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Poland, Romania, Singapore, Tunisia, Turkey, United States, South Africa
 
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