DELTACORTRIL ENTERIC Gastro-resistant tablet Ref.[50969] Active ingredients: Prednisolone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath., Ireland

Product name and form

DELTACORTRIL ENTERIC 5 mg gastro-resistant tablets.

Pharmaceutical Form

Gastro-Resistant Tablet.

Smooth, uniformly coloured maroon tablets.

Qualitative and quantitative composition

Each tablet contains 5 mg of prednisolone.

Also contains 31.6mg of 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:

Calcium carbonate
Lactose
Magnesium stearate
Maize starch

5mg Coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Purified talc
Lecithin
Xanthan gum (E415)
Polyvinyl acetate phthalate
Polyethylene glycol
Sodium hydrogen carbonate
Triethyl citrate
Purified stearic acid
Sodium alginate (E401)
Colloidal silicon dioxide
Lactose monohydrate
Methylcellulose (E461)
Sodium carboxymethyl cellulose
Carmine (E120)
Indigo carmine aluminium lake (E132)
Beeswax (E901)
Carnauba wax (E903)
Polysorbate 20 (E432)
Sorbic acid (E200)

Pack sizes and marketing

HDPE container with polypropylene child-resistant tamper evident screw cap containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath., Ireland

Marketing authorization dates and numbers

PA1113/003/001

Drugs

Drug Countries
DELTACORTRIL Ireland, Malta, Turkey

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