DUSPATALIN Modified release capsule, hard Ref.[51014] Active ingredients: Mebeverine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Product name and form

Duspatalin Retard 200mg Capsules.

Pharmaceutical Form

Modified release capsule, hard.

Opaque white, hard gelatine capsule size no. 1, with standard imprint 245.

Qualitative and quantitative composition

One modified release capsule, hard, contains 200 mg mebeverine hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mebeverine

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.
List of Excipients

Capsule content (granules):

Magnesium stearate
Polyacrylate dispersion 30%
Talc
Hypromellose
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
Glycerol triacetate

Capsule shell:

Gelatine
Titanium dioxide (E171)

Printing ink:

Shellac (E904)
Propylene glycol
Strong ammonia solution
Potassium hydroxide
Iron oxide black (E172)

Pack sizes and marketing

PVC-Al or PVC/PVDC-Al press through strips. Duspatalin Retard 200mg is available in pack size of 30 capsules.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Marketing authorization dates and numbers

16991

11th February 1997/22nd October 2012

Drugs

Drug Countries
DUSPATALIN Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Lithuania, Mexico, Poland, Romania, Singapore, Tunisia, Turkey
 
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