A.Menarini Pharma U.K. S.R.L.

Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Telephone: +44 (0) 1628 856400
Fax: +44 (0) 1628 856402
Medical Information Direct Line: 0800 085 8678
Medical Information e-mail: menarini@medinformation.co.uk
Out of Hours contact: menarini@medinformation.co.uk

Summary of Product Characteristics last updated on the eMC: 13/08/2007
SPC Keral

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 13/08/2007 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 Posology and method of administration – statement added: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
4.3 Contra-indications - additional statement regarding gastro-intestinal contra-indications.
4.4 Special warnings and precautions - additional statement regarding lowest effective dose. Additional warnings regarding gastro-intestinal effects, the elderly, concomitant medication, serious skin reactions, cardiovascular and cerebrovascular effects.
4.5 Interactions - statement on corticosteroids, anti-platelet agents and SSRIs added.
4.6 Pregnancy and lactation - pregnancy statement updated.
4.8 Undesirable effects - statements added on gastrointestinal effects, bullous reactions, cardiovascular and cerebrovascular effects.
 
 
 
Updated on 23/11/2005 and displayed until 13/08/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   dexketoprofen