DULCOEASE Capsule, soft Ref.[8429] Active ingredients: Docusate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Product name and form

Dulcoease 100 mg Capsules.

Pharmaceutical Form

Capsule, soft.

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

Qualitative and quantitative composition

Docusate sodium 100 mg.

Excipients of known effect:

Sorbitol

Sunset yellow (E110)

Active Ingredient Description
Docusate

Docusate is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts. Docusate sodium also possesses stimulant activity.

List of Excipients

Macrogol 400
Propylene glycol
Gelatin 195 bloom
Purified water
Sorbitol special (E420)
Glycerol
Titanium dioxide E171
Quinoline yellow E104
Sunset yellow E110

Pack sizes and marketing

PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40, or 50 capsules.

Polyethylene/polypropylene containers, e.g.: securitainers/tampertainers containing 30, 100 and 250 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Marketing authorization dates and numbers

PL 53886/0022

06/10/2010

Drugs

Drug Countries
DULCOEASE United Kingdom

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