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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

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: 21/02/2012
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 21/02/2012 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5 Interactions - information regarding interaction with aminoglycosides has been included

 

Section 4.8 Undesirable effects - “hepatitis”, “laryngeal oedema” and “acute renal failure” have been included; “Hepatocellular damage” and “angioneurotic oedema” have been replaced by “Hepatocellular injury” and “angioedema”, respectively.

 

Other sections – clarification of existing wording.
Updated on 13/08/2007 and displayed until 21/02/2012
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 trometamol