Spasmonal 60mg hard capsules

  • Name:

    Spasmonal 60mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Alverine Citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/05/19

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Summary of Product Characteristics last updated on medicines.ie: 28/9/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 97 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 24 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 September 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 28 September 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 13 March 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 2: Minor text change

Section 3: Description of capsule has been reworded

Section 4.2: Method of administration has been added

In section 4.3: Intestinal obstruction has been added as a contraindication

In section 4.4: Text has been removed

In section 4.5: Information regarding that no interaction studies have been performed

In section 4.6: Text has changed to refer to pregnancy and lactation being not recommended rather than contraindicated

In section 4.7: Information regarding Spasmonal causing dizziness has been added and not to drive and/or operate machinery if affected

In section 4.8: Side effects have been restructured into system organ classes and frequency. Additional side effects have been added. Adverse reaction statement has been added.

In section 4.9: Information regarding fatality with very high doses have been added

In section 5.1: The Pharmacotherapeutic group and ATC code has been added

In section 10: The date of revision has been changed

Updated on 13 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 March 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 23 March 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 February 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

In section 3; the description of the imprint on the capsule has been changed; Norgine logo removed
In section 10; the date of revision has changed

Updated on 24 January 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 1 June 2011 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