SULPIREN Tablet Ref.[28259] Active ingredients: Sulpiride

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Sulpiren 50mg tablets.

Sulpiren 200mg tablets.

Pharmaceutical Form

Tablet.

Sulpiren 50 mg tablets: orange, round, flat, scored tablets embossed MC.

Sulpiren 200 mg tablets: white, round, flat, scored tablets embossed MC.

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

Qualitative and quantitative composition

Each tablet of Sulpiren 50 mg tablets contains 50mg sulpiride.

Each tablet of Sulpiren 200 mg contains 200 mg sulpiride.

Excipient with known effect: lactose.

Each Sulpiren 50 mg tablet contains 79.0 mg lactose.

Each Sulpiren 200 mg tablet contains 60.0 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sulpiride

Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, butyrophenones and thioxanthenes. One of the characteristics of sulpiride is its bimodal activity, as it has both antidepressant and neuroleptic properties. Schizophrenia characterised by a lack of social contact can benefit strikingly.

List of Excipients

Sulpiren 50 mg tablets: lactose, microcrystalline cellulose, crosscarmellose sodium, colloidal silicon dioxide, magnesium stearate, orange Lake E110, quinoline yellow lake E104.

Sulpiren 200 mg tablets: sodium starch glycolate, povidone, lactose, microcrystalline cellulose, powdered cellulose, colloidal silicon dioxide, magnesium stearate.

Pack sizes and marketing

PVC-Al blister of 10 in carton boxes of 20, 100 & 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Sulpiren 50mg tablets: 7231
Sulpiren 200mg tablets: 20909

Sulpiren 50mg tablets: 14.12.1979 / 10.02.2014
Sulpiren 200mg tablets: 01/03/2011

Drugs

Drug Countries
SULPIREN Cyprus, Hong Kong

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