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Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Telephone: +44 (0)208 8631 427
Fax: +44 (0)208 863 1426
WWW: http://www.accord-healthcare.eu
Medical Information Direct Line: +44 (0)208 901 3370
Medical Information e-mail: uk@accord-healthcare.com
Customer Care direct line: +44 (0)208 863 1427
Medical Information Fax: +44 (0)208 863 1426

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/02/2012
SPC Clarithromycin 500mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 20/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   15-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·       In section 1 (Name of Medicinal Product), product name has been modifed as

 


    Clarithromycin 500mg Film-coated Tablets

 

·       In section 2 (Qualitative and Quantitative composition), text has been updated in line with QRD template as

For a full list of excipients, see section 6.1.

·       In section 3, (Pharmceutical form), following has been updated


Clarithromycin tablets 500 mg are Light yellow coloured, oval shaped, biconvex, film -coated tablets, with 'C'‘C’ and '2' debossed‘2’debossed on either side of breakline on one side.

·       Sections 4.1 to 5.2 have been updated entirely as per the Reference SPC.

·       In Section 6.1 (list of excipients), following information has been added:

Printing ink components: shellac, black iron oxide (E172), Soya lecithin and polydimethylsiloxane.

·       In section 6.5 (Nature and contents of container), following text has been added

Not all pack sizes may be marketed.
Updated on 09/02/2012 and displayed until 20/02/2012
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  clarithromycin