SYMPRAMOL Coated tablet Ref.[11015] Active ingredients: Opipramol

Revision Year: 2013  Publisher: SymPhar Sp. z o.o., ul.WÅ‚oska 1, 00-777 Warsaw, Poland

Product name and form

Sympramol 50 mg coated tablets.

Opipramol Dihydrochloride

Pharmaceutical Form

Coated tablet.

Reddish and round coated tablet.

Qualitative and quantitative composition

1 tablet contains 50 mg opipramol dihydrochloride.

Excipients:

lactose 45.6 mg
sucrose 81.3 mg

For a full list of excipients, see section 6.1.

Active Ingredient Description
Opipramol

Opipramol has high affinity for the sigma binding sites (type 1 and type 2) and has an antagonistic effect at the type 1 histamine receptors. The affinity for the type 2A serotonin receptors, type 2 dopamine receptors and the α-adrenergic receptors is lower. In contrast to the structurally related tricyclic antidepressants, opipramol has only slight anticholinergic activity and does not inhibit the reuptake of serotonin or noradrenaline. In humans, opipramol has sedating, anxiolytic and slight mood-elevating effects.

List of Excipients

Tablet core:

Maize starch
Lactose monohydrate
Povidone K 30
Microcrystalline cellulose
Talcum
Magnesium stearate

Tablet coating:

Shellac
Talcum
Calcium carbonate
Sucrose
Kaolin white (white clay)
Acacia (gum arabic)
Titanium dioxide (E171)
Iron-(III)-oxide (E172)
Opaglos 6000 NS made of yellow carnauba wax and white beeswax
Sodium benzoate

Pack sizes and marketing

Aluminium/PVC/PVDC blister.

Pack sizes: 20, 40, 50, 60, 90, 100, 120.

Hospital pack: 30 × 20.

Not all pack sizes may be marketed.

Marketing authorization holder

SymPhar Sp. z o.o., ul.WÅ‚oska 1, 00-777 Warsaw, Poland

Marketing authorization dates and numbers

12777

06.04.2007

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