Wakix 18 mg film-coated tablets

  • Name:

    Wakix 18 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Pitolisant hydrochloride

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 8/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Lincoln Medical Limited

Lincoln Medical Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe Active Ingredients Epinephrine
Medicine Name Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe Active Ingredients Epinephrine
Medicine Name Wakix 18 mg film-coated tablets Active Ingredients Pitolisant hydrochloride
Medicine Name Wakix 4.5 mg film-coated tablets Active Ingredients Pitolisant 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 8 October 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

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

Updated on 20 August 2019 SmPC

Reasons for updating

  • New SmPC for new product

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