PREDNISOLONE Tablet Ref.[7045] Active ingredients: Prednisolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, N. Devon, EX32 8NS

Product name and form

Prednisolone 10mg Tablets.

Pharmaceutical Form

Tablets.

10mg tablet: Red, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A630” on one side and “10” on the other.

Qualitative and quantitative composition

Each tablet contains 10 mg prednisolone.

For the 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

Lactose monohydrate
Pregelatinised starch
Sodium starch glycolate, type A
Iron oxide yellow (E172)
Iron oxide red (E172)
Glycerol dibehenate
Magnesium stearate

Pack sizes and marketing

Blisters of AL/PVC containing packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Actavis UK Limited (Trading style: Actavis), Whiddon Valley, Barnstaple, N. Devon, EX32 8NS

Marketing authorization dates and numbers

PL 00142/0843

01/04/2016

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.