GAMANIL Film-coated tablet Ref.[49943] Active ingredients: Lofepramine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic

Product name and form

Gamanil 70mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round, lacquered, brown-violet tablet, with occasional white dots, with a spindle shaped score line on one side, approximately 10 mm in diameter.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains lofepramine hydrochloride 76.10mg equivalent to 70.0mg lofepramine.

Excipient(s) with known effect: Each tablet contains 126.05mg lactose (as lactose monohydrate) and 1.15mg Ponceau 4R Red Aluminium Lake (E124).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lofepramine

Lofepramine is a tricyclic antidepressant. It exerts its therapeutic effect by blocking the uptake of noradrenaline by the nerve cell thus increasing the amine in the synaptic cleft and hence the effect on the receptors.

List of Excipients

Tablet core:

Lactose monohydrate
Maize starch
Ascorbic acid
Talc
Glycerol 85%
Glycerol monostearate 40-55
Disodium edetate (Titriplex III)
Dimeticone 1000
Silica, colloidal anhydrous (E551)
Hypromellose (HPMC 15)

Coating:

Macrogol 400
Hypromellose (HPMC 15)
Hypromellose (HPMC 5)
Cochineal Red (E124)
Talc
Titanium dioxide (E171)
Indigotine Lake (E132)

Pack sizes and marketing

Gamanil comes in 3 different types of containers:

  1. PVDC/AL foil blister packs containing 56 tablets
  2. Polypropylene containers of 250 tablets
  3. Amber glass bottles containing 56 tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic

Marketing authorization dates and numbers

PA1701/004/001

Date of first authorisation: 14 May 1984
Date of last renewal: 14 May 2009

Drugs

Drug Countries
GAMANIL Ireland

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