LUDIOMIL Film coated tablet Ref.[8259] Active ingredients: Maprotiline

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: AFT Pharmaceuticals Ltd., PO Box 33.203, Takapuna, Auckland Email:customer.service@aftpharm.com

Product name and form

Maprotiline hydrochloride 25 mg and 75 mg film coated tablets.

Pharmaceutical Form

Ludiomil 25 mg are round, grey-orange tablets with a white core, diameter 6.1 mm, with slightly convex faces and slightly bevelled edges. The tablets are imprinted DP and a score on one side. Each tablet contains 25 mg maprotiline hydrochloride.

Ludiomil 75 mg are round, brown-red tablets with a white core, diameter 8.1 mm, with slightly convex faces and slightly bevelled edges. The tablets are imprinted FS with score on one side. Each tablet contains 75 mg maprotiline hydrochloride.

Do not halve the 75 mg tablets. Dose equivalence when the 75 mg tablet is divided has not been established. Tablets should be swallowed whole with sufficient liquid.

Qualitative and quantitative composition

Tablets contain 25 mg or 75 mg of maprotiline hydrochloride.

Active Ingredient Description
Maprotiline

Maprotiline is a tetracyclic antidepressant, psychoanaleptics, non-selective mono-amine reuptake inhibitor, which shares a number of basic therapeutic properties with the tricyclic antidepressants. It displays a well-balanced spectrum of action, brightening mood and alleviating anxiety, agitation and psychomotor retardation. In masked depression, it can exert a favourable influence on somatic symptoms.

List of Excipients

Silica
Calcium phosphate
Lactose
Magnesium stearate
Stearic acid
Hydroxypropyl methylcellulose
Yellow iron oxide (E172)
Polysorbate 80
Titanium dioxide (E171)
Talc
Maize starch
Red iron oxide (E172)

Pack sizes and marketing

25 mg: Blister packs of 30, 50 and 100 tablets.

75 mg: Blister packs of 20 and 30 tablets.

Marketing authorization holder

AFT Pharmaceuticals Ltd., PO Box 33.203, Takapuna, Auckland Email:customer.service@aftpharm.com

Marketing authorization dates and numbers

20/05/1982

Drugs

Drug Countries
LUDIOMIL Austria, Spain, France, Japan, Poland, Turkey, South Africa

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