Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amoxapen 250 mg film-coated tablets.
Amoxapen 500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Amoxapen 250 mg film-coated tablets: Light-orange, round, scored film-coated tablets. Amoxapen 500 mg film-coated tablets: Light-orange, round, film-coated tablets, scored on one side. Amoxapen 250 mg film-coated tablets: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Amoxapen 500 mg film-coated tablets: The tablet can be divided into equal doses. |
Amoxapen 250 mg film-coated tablets: Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin.
Amoxapen 500 mg film-coated tablets: Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.
Excipient with known effect:
Amoxapen 250 mg film-coated tablets: This product contains 0.22 mg sunset yellow FCF E110.
Amoxapen 500 mg film-coated tablets: This product contains 0.5 mg 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 |
|---|
|
Core: Microcrystalline cellulose Coating: Hypromellose |
Amoxapen 250 mg film-coated tablets:
PVC/Aluminium blisters. Pack-sizes of 20 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100 and 1000 film-coated tablets.
Amoxapen 500 mg film-coated tablets:
PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amoxapen 250 mg film-coated tablets: 14284
Amoxapen 500 mg film-coated tablets: 20036
Amoxapen 250 mg film-coated tablets:
Date of first authorization: 03 August 1993
Date of latest renewal: 20 November 2009
Amoxapen 500 mg film-coated tablets:
Date of first authorization: 01 February 2006
Date of latest renewal: 28 August 2013
| Drug | Countries | |
|---|---|---|
| AMOXAPEN | Albania, Cyprus, Malta, Singapore |
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