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Oruvail 200mg Prolonged Release Capsules, Hard

  • Name:

    Oruvail 200mg Prolonged Release Capsules, Hard

  • Company:
    info
  • Active Ingredients:

    Ketoprofen

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/02/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 6/2/2017
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When a pharmaceutical company changes any document, 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 6 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 February 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II.C.1.4 Update SmPC & Product Labelling to align with ketoprofen CCDSv10

Updated on 2 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 February 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 23 January 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Alignment of SPC and PIL with CCDSv9 Ketoprofen and drug associated interaction s

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 19 December 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type II.C.1.4  Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data – Alignment with Ketoprofen CCDSv8

Updated on 24 November 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 2 June 2016 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New information added-


Hyperkalaemia may occur, especially in patients with underlying diabetes, renal failure, and/or concomitant treatment with hyperkalaemia promoting agents (see section 4.5). 

Potassium levels must be monitored under these circumstances.

Medicinal products and therapeutic categories that can promote hyperkalaemia (i.e. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular-weight or unfracioned), cyclosporine, tacrolimus and trimethoprim):  The risk of hyperkalaemia can be enhanced when the drugs mentioned above are administered concomitantly

 

Tenofovir:  Contomitant administration of tenofovir disoproxil fumarate and NSAID’s may increase the risk of renal failure.

Updated on 1 June 2015 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5: minor update to include 'diuretics' as highlighed below:

Drug associations to be taken into account

 

Anti-hypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilatator prostaglandins by NSAIDs).

Updated on 28 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 12 February 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 update with the following changes highlighted.  The new wording on adverse event reporting has also been included.

Blood and lymphatic system disorders

-    rare: haemorrhagic anaemia

-    not known: agranulocytosis, thrombocytopenia, bone marrow failure, haemolytic anaemia, leucopenia


Psychiatric disorders

- not known: depression, hallucinations, confusion, mood altered

Nervous system disorders

- uncommon: headache, dizziness, somnolence

- rare: paraesthesia

- not known: aseptic meningitis, convulsions, dysgeusia

Vascular disorders

-    not known: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis)

 

Gastrointestinal disorders

-    common: dyspepsia, nausea, abdominal pain, vomiting

-    uncommon: constipation, diarrhoea, flatulence, gastritis

-    rare: stomatitis, peptic ulcer

-    not known: exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage and perforation, pancreatitis

 

Skin and subcutaneous disorders

-    uncommon: rash, pruritis

-    not known: photosensitivity reaction, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalised exanthematous pustulosis

Metabolism and nutritional disorders

- unknown:      hyponatremia







 

Updated on 11 February 2015 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 16 April 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 15 February 2013 SmPC

Reasons for 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
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 & 4.9 updated in line with Core Safety Profile and with standard warning statements on NSAIDS

Section 4.2

Addition of a statement on the maximum daily dose of 200mg.


Section 4.3

Re-wording of the standard IMB pharmacovigilance statement with regard to Standard Warnings Statements on NSAIDS dated February 2007.

 

Section 4.4

Inclusion of standard glucose warning.


 

 

Updated on 13 September 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update
Section 1- Change product name
Section 2- Addition of excipients
Section 3 - Change pharmaceutical form

Updated on 1 September 2009 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to improve readability

Updated on 24 July 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 August 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 July 2007 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update sections
4.2 - treatment for shortest duration.
4.3 - use in patients who suffer from asthmatic attacks and peptic ulcer.
4.4 - risk of gastrointestinal toxicity, monitoring in patients with hypertension, warning on female fertility.
4.5 - addition of revised anticoagulant statement and use with SSRI's.  Also ACE inhibitors.
4.8 - revised gastrointestinal effects and statement on associated risk of arterial thrombotic events.
10 - date of revision.
 
 
 

Updated on 5 December 2006 SmPC

Reasons for 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 4.2 - Use in patients with impaired hepatic/renal function
Update section 4.3, 4.4, 4.5, 4.6, 4.8 - Additional safety information

Updated on 13 November 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change date of revision.

Updated on 29 August 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)