DEVODIL Tablet Ref.[28186] Active ingredients: Sulpiride

Source: Υπουργείο Υγείας (CY)  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Devodil 50 mg tablets.

Devodil 200 mg tablets.

Pharmaceutical Form

Tablet.

Devodil 50 mg tablet: White, round, flat, scored tablets.

Devodil 200 mg tablet: White, round, flat, scored tablets.

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

Qualitative and quantitative composition

Devodil 50 mg tablets: Each tablet contains 50 mg sulpiride.

Devodil 200 mg tablet: Each tablet contains 200 mg sulpiride.

Excipient(s) with known effect:

Devodil 50 mg tablet contains 73.10 mg lactose.

Devodil 200 mg tablet contains 60.88 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

Cellulose, microcrystalline
Sodium starch glycolate (Type A)
Lactose monohydrate
Starch, pregelatinised
Povidone
Silica, colloidal anhydrous
Magnesium stearate
Talc

Pack sizes and marketing

Devodil 50 mg tablets:

PVC/Aluminium blisters. Pack sizes of 20 and 1000 tablets.

PP containers with PE closure. Pack size of 1000 tablets.

Devodil 200 mg tablets:

PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 tablets.

PP containers with PE closure. Pack size of 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Devodil 50 mg tablets: 20175
Devodil 200 mg tablets: 20176

Devodil 50 mg tablets:

Date of first authorization: 05 January 2007
Date of latest renewal: 12 July 2013

Devodil 200 mg tablets:

Date of first authorization: 05 January 2007
Date of latest renewal: 22 June 2012

Drugs

Drug Countries
DEVODIL Cyprus, Malta, Singapore

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