AMOXIL Capsule Ref.[2505] Active ingredients: Amoxicillin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Product name and form

Amoxicillin 500 mg Capsules.

Pharmaceutical Form

Hard Capsules.

White to off-white granular powder filled in hard gelatine capsule shells size ‘0’. Scarlet colour cap, buff colour body printed with ‘AMOXY’ on cap and ‘500’ on body.

Qualitative and quantitative composition

Amoxicillin trihydrate equivalent to 500mg Amoxycillin per capsule.

For a full list of excipients, see section 6.1.

Active Ingredient

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

Magnesium Stearate (E572)
Silica Colloidal Anhydrous

Capsule shell components

Body:

Iron Oxide Red (E172)
Iron Oxide Yellow (E172)
Titanium Dioxide (El71)
To 100% Gelatin

Cap:

Indigo Carmine (E132)
Erythrosine (E127)
Titanium Dioxide (E171)
To 100% Gelatin

Composition of Ink

Shellac
Dehydrated Alcohol
Isopropyl Alcohol
Butyl Alcohol
Propylene Glycol
Strong Ammonia Solution
Potassium Hydroxide
Black Iron Oxide (E172)

Pack sizes and marketing

Polypropylene/polyethylene containers and tamper evident closures/1000, 500, 100, 21, 20 and 15 capsules.

Blister strips: 15 and 21 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0045

08/04/2002 / 04/02/2009

Drugs

Drug Countries
AMOXIL Australia, Brazil, Cyprus, Ecuador, Ireland, Lithuania, Malta, Mexico, Nigeria, New Zealand, Singapore, Tunisia, United States, South Africa
 
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