DEXAMED Tablet Ref.[28236] Active ingredients: Dexamethasone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011, Limassol, Cyprus

Product name and form

Dexamed 0.5 mg tablets.

Dexamed 1.5mg tablets.

Pharmaceutical Form

Dexamed 0.5mg tablets: Pink, round flat, scored embossed “MC” tablets with diameter 7.0mm.

Dexamed 1.5mg tablets: White, round flat, scored tablets, 7mm diameter.

Qualitative and quantitative composition

Dexamed 0.5mg: Each tablet contains 0.5mg of dexamethasone

Dexamed 1.5mg: Each tablet contains 1.5mg of dexamethasone

Excipients with known effect: lactose monohydrate.

Each 0.5mg tablet contains 120.0mg lactose monohydrate.

Each 1.5mg tablet contains 105.0mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dexamethasone

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Dexamed tablets 1.5 mg: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate.

Dexamed tablets 0.5 mg: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal anhydrous silica, erythrosine lake (E127), quinoline yellow lake (E104).

Pack sizes and marketing

Dexamed 0.5mg: Packs of 100 tablets.

Dexamed 1.5mg: Packs of 50 and 100 tablets.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos street, 3011, Limassol, Cyprus

Marketing authorization dates and numbers

Dexamed 0.5mg: 19974
Dexamed 1.5mg: 19973

Dexamed 0.5mg:

Date of first authorisation: 20.12.2005
Date of latest renewal: 15.06.2011

Dexamed 1.5mg:

Date of first authorization: 20.12.2005
Date of latest renewal: 14.11.2013

Drugs

Drug Countries
DEXAMED Albania, Cyprus, Hong Kong, Malta, Romania, Singapore

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