PENOPEN Film-coated tablet Ref.[50308] Active ingredients: Phenoxymethylpenicillin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3506 Limassol, Cyprus

Product name and form

Penopen 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light orange, round, film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains phenoxymethylpenicillin potassium 250 mg.

Excipients with known effect: Each film-coated tablet contains 0.46 mg sunset yellow FCF aluminium lake E110.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Phenoxymethylpenicillin

Phenoxymethylpenicillin is a broad spectrum beta-lactam antibiotic. Phenoxymethylpenicillin binds to penicillin-binding proteins located on the inner membrane of the bacterial cell wall. Phenoxymethylpenicillin binds to and inactivates these proteins resulting in weakening of the bacterial cell wall and lysis.

List of Excipients

Core:

Povidone
Cellulose, microcrystalline
Sodium starch glycolate (Type A)
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate
Glycerol

Film-coating:

Hypromellose
Macrogol 400
Titanium dioxide
Talc
Sunset yellow FCF aluminium lake E110

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 100, 500 and 1000 film-coated tablets

PP containers with PE closure. Pack sizes of 500 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3506 Limassol, Cyprus

Marketing authorization dates and numbers

19922

Date of first authorization: 29 December 2005
Date of latest renewal: 16 September 2011

Drugs

Drug Countries
PENOPEN Cyprus, Malta, Singapore

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