Arcoxia 30 60 90 120 film-coated tablets

  • Name:

    Arcoxia 30 60 90 120 film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Etoricoxib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/18

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Summary of Product Characteristics last updated on medicines.ie: 25/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
1 - 0 of 84 items.Total: Infinity pages

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 25 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

 

Updated on 9 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 16 April 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 15 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 August 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

        Section 4.2 – Posology: revised the recommended dosage for Rheumatoid Arthritis (RA) and Ankylosing spondylitis (AS) from 90mg to 60mg once daily

        Section 4.8 – Undesirable effects: updated number of patients in summary of safety profile.

        Section 5.1 – Pharmacodynamic properties: updated clinical efficacy details concerning RA and AS

        Section 6.5 – Nature and contents of container: Added the 98 tablets mono-pack size for Arcoxia 30mg and 60mg and corrected the spelling of ‘aluminium’

Updated on 15 August 2016 PIL

Reasons for updating

  • Change to dosage and administration
  • Introduction of new pack/pack size

Updated on 14 December 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 14 December 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 7 – Marketing authorisation holder:  The address of the Marketing authorisation holder has been changed to ‘Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031 BN, The Netherlands’

·         Section 8 – Marketing authorisation number: The MA numbers have  been updated to PA 1997/1/1 - 4

·         Section 10 – Date of revision: November 2015

Updated on 29 April 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

  • Section 2 – Qualitative and quantitative composition: Wording updated in the reference to excipients in line with the QRD template.
  • Section 3 – Pharmaceutical form: Section updated in line with the latest QRD template
  • Section 4.1 – Therapeutic indication: This section of the SmPC was updated to define the target population indicated for the use of this drug.
  • Section 4.2 – Posology and method of administration: Subheading and headings updated in line with the QRD template; also wording added to the paragraph under the subheading ‘Postoperative dental surgery pain’ regarding the treatment period for Arcoxia.
  • Section 4.3 – Contra-indications: The third bullet point has been updated as follows:

·         Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticarial, or allergic-type reactions. after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors

  • Section 4.8 – Undesirable effects: The heading ‘Adverse Experience Term’ in table 1 has been replaced with ‘Adverse Reactions’, in accordance with the QRD template. Addition of AE reporting statement for IE.
  • Section 5.1 – Pharmacodynamic properties: Section updated in line with the latest QRD template
  • Section 5.2 – Pharmacokinetic properties: Subheadings revised as per the QRD template.
  • Section 6.6 – Special precautions for disposal: Addition of statement on disposal of unused medicinal product in line with the QRD template.

Updated on 29 April 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 17 March 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 10 October 2014 PIL

Reasons for updating

  • Change of distributor details

Updated on 11 September 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 8 September 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 September 2014 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided