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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: 26/08/2011
SPC Targocid 200mg & 400mg

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 26/08/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   04-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 01/07/2010 and displayed until 26/08/2011
Reasons for adding or updating:
  • 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 - 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
Date of revision of text on the SPC:   26-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 The SmPC has been updated in line with the Company's core safety data sheet and the following is a summary of the changes.

Section 4.2 : Addition of warning that:-
                   only the infusion method of administration should be used in neonates
                   the administration of teicoplanin by the intraventricular route is not indicated
                   Targocid must not be administered for more than 4 months
                    
                    Additional information given regarding:
                    the use of teicoplanin in endocarditis caused by Staph. A
                    treatment of antibiotic-associated diarrhoea caused by C.Difficile
                    the use of teicoplanin in peritoneal dialysis
                    combination therapy with other appropriate antibacterial agents
                    prophylaxis of endocarditis


Section 4.4 : addition of statement indicating that in some case of intraventricular use, seizures have been reported

Section 4.5 : addition of further examples of products and product classes which should be only be used with care in conjunction with teicoplanin

Section 4.6 : re-wording and strengthening of wording on pregnancy and lactation

Section 4.7 : addition of warning that as teicoplanin may cause dizziness and/or headache caution is advised regarding driving or operating machines or tools

Section 4.8 : Complete re-formatting of this section into a table grouping undesirable effects by body class system and frequency.

Section 4.9 : addition of information relating to overdose in children. Re-formatting of section

                  
                    
Updated on 06/01/2009 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   29-Nov-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - colour code of 400mg cap (green) added to this section
Updated on 16/09/2008 and displayed until 06/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   29-Nov-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 18/09/2007 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder): Change to sanofi-aventis.
Updated on 28/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • 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 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.4, 4.5 and 5.1 of the SPC have changed following the British Approved Names (BANs) cyclosporin, frusemide, etharynic, thiopentone and methicillin to their corresponding recommended International Non-Proprietary Name (r INNs) ciclosporin, furosemide, etacrynic, thiopental and meticillin.
Updated on 13/05/2002 and displayed until 28/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  teicoplanin