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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
Telephone: +44 (0)1442 341 234
Fax: +44 (0)1442 341 200

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: 18/01/2012
SPC Ciloxan 3mg/g Eye Ointment

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 18/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   30-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update the storage conditions of the finished product from ‘Do not store above 30°C’ to ‘Do not store above 25°C’.

 
Updated on 20/01/2009 and displayed until 18/01/2012
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - 'Ciloxan eye ointment will be indicated for adults and children as follows:
Adults and children 1 year and above' added

Section 4.2 - 'Adults and children 1 year and above' added

Section 4.3 -  Amended to 'Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to quinolones'

Section 4.4 - Paragraph amended

Section 4.6 - Heading 'Lactation' added

Section 4.8 - New paragraph added after the heading 'Skin Effects'

Section 5.2 - 'There are no pharmacokinetic data available in respect of use in children' added

Section 5.3 - 'The degree of cartilage involvement was found to be dependent on age, specieis and dosage. With 30mg/kg ciprofloxacin in the effect on the joint was minimal.' added

Section 9 - '11/08/2008' added

Section 10 - '28/10/2008' added
Updated on 03/11/2005 and displayed until 20/01/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  ciprofloxacin hydrochloride