EDAMOX Hard capsule Ref.[28244] Active ingredients: Amoxicillin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Edamox 500 mg hard capsules.

Pharmaceutical Form

Hard capsules.

Scarlet/Orange capsules.

Qualitative and quantitative composition

Each hard capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.

Excipient(s) with known effect: The capsule body of this product contains 0.2222% sunset yellow FCF E110. The capsule cap of this product contains 0.2032% sunset yellow FCF E110.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amoxicillin

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

List of Excipients

Capsule content:

Colloidal Silicon Dioxide
Magnesium Stearate

Capsule shell:

Body:

Brilliant blue FCF E133
D&C Red 22
Titanium Dioxide
Sunset Yellow FCF E110
Gelatin

Cap:

Brilliant blue FCF E133
D&C Red 22
D&C Red 33
Titanium dioxide
Sunset yellow FCF E110
Gelatin

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 20 and 1000 hard capsules.

PP/PE containers with PE closure. Pack size of 1000 hard capsules.

Not all sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

19693

Date of first authorization: 18 July 2005
Date of latest renewal: 07 September 2011

Drugs

Drug Countries
EDAMOX Cyprus, Hong Kong

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