FLUDROCORTISONE ACETATE Tablet Ref.[6846] Active ingredients: Fludrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Fludrocortisone Acetate 0.1 mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white round tablet, marked with ‘FL 0.1’ on one side and a break-line on the other side.

The break-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 0.1 mg fludrocortisone acetate.

Excipient(s) with known effect: Each tablet also contains 93.4mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Fludrocortisone

Fludrocortisone, in very small doses, maintains life in adrenalectomised animals, enhances the deposition of liver glycogen and produces thymic involution, eosinopenia, retention of sodium and increased urinary excretion of potassium.

List of Excipients

Sodium starch glycolate
Lactose monohydrate
Talc
Magnesium stearate

Pack sizes and marketing

PVC/PVdC/Al blisters. Available in pack sizes of 30, 50 and 100 tablets.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0089

09/11/2015

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