ERMYCIN Film-coated tablet Ref.[28204] Active ingredients: Erythromycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Ermycin 250 mg film-coated tablets.

Ermycin 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Ermycin 250 mg film-coated tablets are pink, round, scored, film-coated tablets with Remedica’s logo on one side.

Ermycin 500 mg film-coated tablets are white, modified capsule shaped, scored, film-coated tablets.

The tablets can be divided into two equal doses.

Qualitative and quantitative composition

Ermycin 250 mg film-coated tablets: Each tablet contains erythromycin stearate equivalent to 250 mg erythromycin.

Ermycin 500 mg film-coated tablets: Each tablet contains erythromycin stearate equivalent to 500 mg erythromycin.

Excipients with known effect:

Each Ermycin 250 mg film-coated tablet contains 0.36 mg Ponceau 4R E124.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Erythromycin

Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin is bacteriostatic and bactericidal depending on its concentration and the type of organism.

List of Excipients

Ermycin 250 mg film-coated tablets

Core:

Povidone
Microcrystalline cellulose
Croscarmellose sodium
Sodium lauryl sulfate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium Dioxide E171
Ponceau 4R E124
Quinoline Yellow E104
Talc

Ermycin 500 mg film-coated tablets

Core:

Povidone
Microcrystalline cellulose
Croscarmellose sodium
Sodium lauryl sulfate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc

Pack sizes and marketing

Ermycin 250 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 film-coated tablets.

PP containers with PE closure. Pack size of 1000 film-coated tablets.

Ermycin 500 mg film-coated tablets:

PVC/Aluminium blisters. Pack sizes of 12, 20, 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Ermycin 250 mg film-coated tablets: 9340
Ermycin 500 mg film-coated tablets: 16033

Ermycin 250 mg film-coated tablets:

Date of first authorization: 26 May 1984
Date of latest renewal: 22 December 2011

Ermycin 500 mg film-coated tablets:

Date of first authorization: 03 February 1995
Date of latest renewal: 12 July 2012

Drugs

Drug Countries
ERMYCIN Cyprus, Malta, Singapore

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