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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 Tablets 500 mg

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 4.2 - 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 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 andconfusion$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$0$0
Updated on 6/15/2015 and displayed until 2/14/2018
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Jun-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 6.5: the nature of the container has changed
In section 10: the date of revision has changed
Updated on 1/26/2011 and displayed until 6/15/2015
Reasons for adding or updating:
  • Change to product name
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to product name: name to be extended to full name which is Relifex 500mg Film-coated Tablets
In section 1: name to be extended to full marketing name
In section 2: Additional text is added and also a referral to section 6.1
In section 3: The text 'Film-coated tablet' is added
In section 4.2: Additional text added relating to how indesirable effects may be minimised by using the lowest dose for the shortest time
In section 4.3: Additional contradindications are added - in relation to severe heart failure and use in patients with a history of gastrointestinal bleeding & perforation related to previous NSAID use
In section 4.4: Additional text added in relation to using the lowest dose for the shortest time to minimise undesirable effects. Added warnings about gastrointestinal bleeding, ulceration and perforation, use in elderly, cardiovasular and cerebrovascular effects, female fertility, serious skin reactions, concomitant use of NSAIDs
In section 4.5: Additional warnings regarding anti-coagulants, anti-platelet agents, SSRIs,
In section 4.8: Additional warnings added
In section 5.1: The ATC code is added
In section 6.1: E numbers are added to the excipients
In section 6.4: The storage conditions are changed to instruct to keep the carton in the the outer carton to protect from light
In section 6.5: Description of nature and contents of container have changed
In section 9: Would like to use the new wording for date of first authorisation and date of last renewal
In section 10: Date of revision was chaned to July 2010
Updated on 11/12/2003 and displayed until 1/26/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 8/26/2003 and displayed until 11/12/2003
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 7/22/2003 and displayed until 8/26/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
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