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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 23/05/2011
SPC Zithromax Capsules, Suspension

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 23/05/2011 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC: changes to Sections: 4.3, 4.4, 4.5, 4.6 and 4.8
Updated on 15/02/2011 and displayed until 23/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: additional information regarding C. difficile has been added and excipients warnings have been added.
Section 4.8: additional side effect of ‘hypoesthesia
Updated on 18/11/2010 and displayed until 15/02/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update of section 5.3 (Preclinical safety data) of the SPC
Updated on 28/05/2008 and displayed until 18/11/2010
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2 – Modified to emphasise caution to be exercised in patients with severe renal impairment.

4.3 – Added contraindications: ketolide antibiotics, erythromycin, and any of the excipients listed in section 6.1.

4.4 – Super infection warning re-worded.

4.5 – Cyclosporine corrected back to ciclosporin, Nelfinavir warning added.

4.6 – Pregnancy and lactation warnings re-worded and expanded upon.

4.8 – format changes
Updated on 14/07/2006 and displayed until 28/05/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • 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 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   08/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to the clinical safety particulars - extensive amendments from Section 4.1 through to Section 6 (excluding Sections 4.3, 4.6)
Updated on 10/11/2004 and displayed until 14/07/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 01/11/2004 and displayed until 10/11/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/09/2004 and displayed until 01/11/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2004 and displayed until 24/09/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 25/09/2001 and displayed until 24/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2001 and displayed until 25/09/2001
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 04/02/2000 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  azithromycin dihydrate