When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Update sections 2, 4.1, 4.4, 4.5, 5.1, 6.4, 6.5, 9 and 10 as noted below in bold following renewal of licence. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250mg erythromycin For a full list of excipients, see 6.1. 4.1 Therapeutic Indications For the treatment of infections caused by erythromycin-sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 5.1 Pharmacodynamic properties ATC Code: J01FA Pharmacotherapeutic group: Macrolides Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. 6.4 Special precautions for storage Do not store above 25oC. Store in the original container to protect from light. 6.5 Nature and contents of container Type III amber glass bottles with a urea outer / aluminium liner cap, of 100 tablets. Polypropylene bottles with either an LDPE or an HDPE closure, of 50, 100, 500 and 1000 tablets. Aluminium foil/clear or opaque PVC/PVDC blisters in packs of 28, 40 and 56 tablets. Not all pack sizes may be marketed. 9. Date of First Authorisation/Renewal of Authorisation Date of first authorisation: 01 November 1982 Date of last renewal: 01 November 2007 10. Date of (partial) revision of text September 2010
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg erythromycin
For a full list of excipients, see 6.1.
4.1 Therapeutic Indications
For the treatment of infections caused by erythromycin-sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 5.1 Pharmacodynamic properties ATC Code: J01FA Pharmacotherapeutic group: Macrolides Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. 6.4 Special precautions for storage Do not store above 25oC. Store in the original container to protect from light. 6.5 Nature and contents of container Type III amber glass bottles with a urea outer / aluminium liner cap, of 100 tablets. Polypropylene bottles with either an LDPE or an HDPE closure, of 50, 100, 500 and 1000 tablets. Aluminium foil/clear or opaque PVC/PVDC blisters in packs of 28, 40 and 56 tablets. Not all pack sizes may be marketed. 9. Date of First Authorisation/Renewal of Authorisation Date of first authorisation: 01 November 1982 Date of last renewal: 01 November 2007 10. Date of (partial) revision of text September 2010
4.5 Interaction with other medicinal products and other forms of interaction
5.1 Pharmacodynamic properties
ATC Code: J01FA
Pharmacotherapeutic group: Macrolides
Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis.
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container to protect from light.
6.5 Nature and contents of container
Type III amber glass bottles with a urea outer / aluminium liner cap, of 100 tablets.
Polypropylene bottles with either an LDPE or an HDPE closure, of 50, 100, 500 and 1000 tablets.
Aluminium foil/clear or opaque PVC/PVDC blisters in packs of 28, 40 and 56 tablets.
Not all pack sizes may be marketed.
9. Date of First Authorisation/Renewal of Authorisation
Date of first authorisation: 01 November 1982
Date of last renewal: 01 November 2007
10. Date of (partial) revision of text
September 2010