PLENADREN Modified-release tablet Ref.[27674] Active ingredients: Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Shire Services BVBA, Rue Montoyer 47, B 1000 Brussels, Belgium

Product name and form

Plenadren 5 mg modified-release tablets.

Plenadren 20 mg modified-release tablets.

Pharmaceutical Form
Modified-release tablet. Plenadren 5 mg modified-release tablets: The tablets are round (diameter 8 mm), convex and pink. Plenadren 20 mg modified-release tablets: The tablets are round (diameter 8 mm), convex and white.

Qualitative and quantitative composition

Plenadren 5 mg modified-release tablets:

Each modified-release tablet contains hydrocortisone 5 mg.

Plenadren 20 mg modified-release tablets:

Each modified-release tablet contains hydrocortisone 20 mg.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Hydrocortisone	Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates.

List of Excipients
Tablet core: Hypromellose Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate Plenadren 5 mg modified-release tablets Tablet coating: Macrogol (3350) Polyvinyl alcohol Talc Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172) Plenadren 20 mg modified-release tablets Tablet coating: Macrogol (3350) Polyvinyl alcohol Talc Titanium dioxide (E171)

Pack sizes and marketing

HDPE bottles with PP screw cap containing 50 modified-release tablets.

Carton containing 1 bottle of 50 modified-release tablets.

Carton containing 2 bottles of 50 modified release tablets (100 tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Shire Services BVBA, Rue Montoyer 47, B – 1000 Brussels, Belgium

Marketing authorization dates and numbers

Plenadren 5 mg modified-release tablets:

EU/1/11/715/001
EU/1/11/715/003

Plenadren 20 mg modified-release tablets:

EU/1/11/715/002
EU/1/11/715/006

Date of first authorisation: 3^rd November 2011
Date of latest renewal: 8^th August 2016

Drugs

Drug	Countries
PLENADREN	Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom

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