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UCB Pharma Limited
208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

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: 05/10/2010
SPC Ucerax Tablets 25 mg

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 05/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4 Correction - In jpatients with pre-existing prolonged QT intervals, use of alternative treatments is to be considered.
Updated on 26/08/2010 and displayed until 05/10/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   24-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 Pharmacokinetic properties
Addition of details for: absorption, distribution, biotransformation, elimination and special populations.
Updated on 15/07/2010 and displayed until 26/08/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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:   07-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Contraindications updated with lactose warning.
Section 4.4 Removal of lactose warning.
Section 4.8 Regrouping of AEs according to MedDRA system organ class and additional side-effect of fixed drug eruption.
Updated on 23/03/2010 and displayed until 15/07/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   15-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 - addition of pharmacodynamic properties in line with CCDS.
Updated on 04/02/2010 and displayed until 23/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of warning to section 4.4 Special warnings and precautions:

Caution is needed in patients who have a known predisposing factor to cardiac arrhythmia, or who are concomitantly treated with a potentially arrhythmogenic drug. In patients with pre-existing prolonged QT intervals use of alternative treatments is to be considered.
Updated on 24/02/2006 and displayed until 04/02/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/06/2002 and displayed until 24/02/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  hydroxyzine hydrochloride