Eldepryl 5 mg Tablets

  • Name:

    Eldepryl 5 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Selegiline Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/21

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Summary of Product Characteristics last updated on medicines.ie: 18/2/2021

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

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1 - 0 of 23 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 18 February 2021 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The following information has been added to the leaflet (warnings and precautions):

The use of Eldepryl together with buprenorphine can lead to serotonin syndrome, a potentially life-threatening condition.  

Updated on 18 February 2021 SPC

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

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

Free text change information supplied by the pharmaceutical company

Section 4.4:  Information on concomitant buprenorphine added:
Concomitant administration of selegiline and buprenorphine may result in serotonin syndrome, a potentially life-threatening condition. If concomitant treatment with buprenorphine is clinically warranted, careful observation of the
patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

 

Section 4.5:  Information on stopping Eldepry and starting a contra-indicated medication:

At least two weeks should elapse after stopping administration of Eldepryl before starting therapy with any contra-indicated medicinal product.

Updated on 26 November 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 November 2019 SPC

Reasons for updating

  • New SPC for new product

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