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Meda Health Sales

Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co. Meath, Dublin, Ireland
Telephone: 00 353 18026624
Medical Information Direct Line: +44 (0) 1707 853000 press 1
Medical Information e-mail: info@mylan.co.uk
Summary of Product Characteristics last updated on medicines.ie: 2/14/2018
SPC Relifex 1g Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2/14/2018 and displayed until Current
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 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   31-May-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 4.2: Information added$0In section 4.3: Contraindications added$0$0In section 4.4: Specials warnings added/expanded$0$0In section 4.5: Medicines added/removed that interaction with Relifex$0$0In section 4.6: Information added$0$0In section 4.7:Information added wrt dizziness and confusion$0$0In section 4.8: Adverse events listed by system organ class and frequency. Undesirable effects added.$0$0In section 4.9: Information added regarding symptoms, signs and treatment$0$0In section 5.1: Pharmacodynamic information added$0$0In section 5.2: Pharmacokinetic information added$0
Updated on 2/4/2015 and displayed until 2/14/2018
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 2: A small text change as per QRD has been performed

In section 3: The description of the tablets has been expanded

In section 6.1: The excipients have been expanded

In section 10: date of revision has changed

Updated on 1/11/2011 and displayed until 2/4/2015
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Nabumetone