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Anafranil Capsules (2012)

Active ingredients: Chlorimipramine

Product Name and Form

Anafranil 10mg, 25mg and 50mg capsules.

Pharmaceutical form

Capsule.

Qualitative and Quantitative Composition

Chemical name: 3-chloro-5-[3-(dimethylamino)propyl] 10, 11 dihydro-5H-dibenz [b,f] azepine hydrochloride (= clomipramine hydrochloric).

Anafranil 10mg capsules: Each capsule contains 10mg clomipramine hydrochloride B.P.

Anafranil 25mg capsules: Each capsule contains 25mg clomipramine hydrochloride B.P.

Anafranil 50mg capsules: Each capsule contains 50mg clomipramine hydrochloride B.P.

For excipients see section 6.1 List of excipients

Chemical substance
Description
Chlorimipramine

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

Lactose
Gelatin (220 Bloom)
Magnesium stearate
Yellow iron oxide (E172)
Black iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide
Brown printing ink

Pack sizes and Marketing

10mg Capsules

The capsules are two tone brownish-caramel cap/greyish yellow body, hard gelatin size 4, imprinted ‘Geigy’ and come in PVC/PVDC/aluminium blister packs in pack sizes of 84 and 100.

25mg Capsules

The capsules are two tone brownish-orange/caramel-coloured, hard gelatin size 4, imprinted ‘Geigy’ and come in PVC/PVDC/aluminium blister packs in pack sizes of 84 and 100.

50mg Capsules

The capsules are two tone light grey/caramel-coloured, hard gelatin size 4, imprinted ‘Geigy’ and come in PVC/PVDC/aluminium blister packs in pack sizes of 56 and 100.

Marketing authorization holder
Authorization dates

Novartis Pharmaceuticals UK Limited

Trading as:

Geigy Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR

04 July 1997 / 26 February 2009

Marketing authorization number:

10mg: PL 00101/0438

25mg: PL 00101/0439

50mg: PL 00101/0440