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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: 18/07/2011
SPC Sectral 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 18/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   06-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Name change to Sectral 400mg Tablets from SECTRAL tablets 400mg

 

All cases of SECTRAL changed to Sectral throughout

 

Typos and formatting changed throughout – some wording has changed but the meaning remains the same.

 

4.4 wording added;

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

4.6 – title changes from Pregnancy and lactation to Fertility, pregnancy and lactation

 

5.1 – following info added;

 

Pharmacotherapeutic group: Beta Blocker agents; Beta blocker agents, selective, ATC code: C07AB04.
Updated on 29/03/2011 and displayed until 18/07/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   22-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update sections 4.6 (Pregnancy and lactation), 4.7 (Effects on ability to drive and use machines) and 4.8 (Undesirable effects) of the SPC following the acebutolol EU PSUR.
Updated on 08/01/2009 and displayed until 29/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Feb-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Use of sanofi-aventis trading style
Updated on 19/09/2007 and displayed until 08/01/2009
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 (List of excipients): Excipients updated from BP to EP standards

Active Ingredients/Generics

 
  acebutolol hydrochloride