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Tramake 50mg Tablets

  • Name:

    Tramake 50mg Tablets

  • Company:
    info
  • Active Ingredients:

    Tramadol Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/05/21

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Summary of Product Characteristics last updated on medicines.ie: 11/5/2021

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Galen Pharma Ireland Limited

Galen Limited

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Medicine Name THORENS 10 000 I.U. /ml oral drops, solution Active Ingredients Colecalciferol (Vitamin D3)
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Medicine Name Thorens 25 000 IU capsules, hard Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Tramake 100mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Tramake 50mg Tablets Active Ingredients Tramadol Hydrochloride
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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 11 May 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 May 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.4, 4.8 and 10 of the SPC. The updates were made to add a warning on central sleep apnoea, a warning on adrenal insufficiency and to add hiccups as an adverse reaction. 

Updated on 13 March 2020 PIL

Reasons for updating

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

Updated on 13 March 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 not be renewed (A)

Updated on 1 July 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 July 2019 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)