eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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: 03/06/2011
SPC Ketek 400mg 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 03/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   12-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 1 - full stop removed
Section 3 - commas inserted
Section 4.2 - Method of administration info reworded and moved to end of section. Rewording of titles and paediatric section.
Section 4.3 - Section reworded and restructured
section 4.4 - Includsion of titles for each subsection and
Section 4.5 - Cyclosporin, tacrolimus, sirolimus and metoprolol sections relocated in section
section 4.6 - titles added and info about fertility included
Section 4.7 - reworded
Section 4.8 - inclusion of statement about most commonly reported side effects in phase III clinical trials, table reordered and reworded in some places
Section 5.1 - insertion of "antibacterials for systemic use", and grammar corrections
Section 5.2 - "Metabolism" heading changed to "Biotransformation", and typo corrections
Section 5.3 - Inclusion of statement about reduction in fertility indices in rats
Section 6.4 - reworded
Updated on 27/04/2010 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   09-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 5.1 - Update of EUCAST break points
Updated on 20/07/2009 and displayed until 27/04/2010
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 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 Special Warnings: addition on following wording: Patients with concomitant treatment with pravastatin, rosuvastatin or fluvastatin should be carefully monitored for isgns and symptoms of mypoathy and rhabdomyolysis.

Section 4.5 Interactions: Addition of: The exposure of pravastatin, rosuvastatin and to a lesser extent fluvastain may be increased due to possible involvement of transporters proteins, but patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis when co-treated with pravastatin, rosuvastatin and fluvastatin.

Section 10 : 2 June 2009
Updated on 03/12/2008 and displayed until 20/07/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products 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 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5

addition of rhabsomyolysis in the statins section

Section 4.7

Addition of the words confusion or hallucination

Section 4.8

Addition of the following side effects

anosmia, agueusia, hypersensitivity, arthralgia, myalgia, confusion, hallucinations
Updated on 25/09/2007 and displayed until 03/12/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/06/2007 and displayed until 25/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
  • SPC Submitted in error
  • SPC Submitted in error

Active Ingredients/Generics

 
  telithromycin