DILACORT Gastro-resistant tablet Ref.[49968] Active ingredients: Prednisolone

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Crescent Pharma International Limited, 260 Trip San Albert, Gzira GZR 1150, Malta

Product name and form

Dilacort 2.5 mg gastro-resistant tablets.

Pharmaceutical Form
Gastro-resistant tablet. [Tablet] Dark brown, circular, deep biconvex, enteric coated tablets.

Qualitative and quantitative composition

Each tablet contains 2.5 mg prednisolone.

Excipients with known effect: This medicine contains lactose.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Prednisolone	Prednisolone is a glucocorticoid which has anti-inflammatory activity. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

List of Excipients
Core Components: Lactose monohydrate Microcrystalline cellulose Pregelatinised maize starch Magnesium stearate Coating Components: Hypromellose Titanium dioxide (E171) Triethyl citrate Sorbic acid Acryl-eze white: Methacrylic acid – ethyl acrylate copolymer (1:1) Talc Titanium dioxide (E171) Triethyl citrate Colloidal anhydrous silica Sodium bicarbonate Sodium lauril sulfate Opadry II Brown: Polyvinyl alcohol Macrogol 3350 Talc Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172) Yellow iron oxide (E172)

Pack sizes and marketing

PVC/PVdC/Aluminium blisters.

Pack size of 28 tablets.

Marketing authorization holder

Crescent Pharma International Limited, 260 Trip San Albert, Gzira GZR 1150, Malta

Marketing authorization dates and numbers

PA22699/001/001

Date of first authorisation: 04^th January 2013
Date of last renewal: 30^th November 2017

Drugs

Drug	Countries
DILACORT	Ireland, Malta, United Kingdom

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