Mestinon 60mg Tablets

  • Name:

    Mestinon 60mg Tablets

  • Company:
    info
  • Active Ingredients:

    Pyridostigmine Bromide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/18

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Summary of Product Characteristics last updated on medicines.ie: 5/12/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 95 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 6 December 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 December 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 19 November 2015 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Information regarding the posology of patients with renal impairment has been added. Additional information regarding the administration has also been added.

In section 4.4: Renal impairment has been added to warnings and precautions. Text has been amended for better readability. Dosage information regarding kidney function has been added.

In section 4.5: Information regarding corticosteroids and thymectomy has been added.

In section 4.6: Sub-section regarding fertility has been added. Additional information in pregnancy and lactation has been added.

In section 4.7: small text changes

In section 4.8: Immune system and vascular  disorders have been added. Additional side effect added to cardiac disorders, gastrointestinal disorders, musculoskeletal disorders and  eye disorders.

In section 4.9: Additional information added

In section 5.1: Additional information added to pharmacodynamic properties

In section 5.2: information regarding absorption, distribution, metabolism and elimination has been added.

In section 10: The date of revision has been changed.

 

Updated on 19 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.2: Information regarding the posology of patients with renal impairment has been added. Additional information regarding the administration has also been added.

In section 4.4: Renal impairment has been added to warnings and precautions. Text has been amended for better readability. Dosage information regarding kidney function has been added.

In section 4.5: Information regarding corticosteroids and thymectomy has been added.

In section 4.6: Sub-section regarding fertility has been added. Additional information in pregnancy and lactation has been added.

In section 4.7: small text changes

In section 4.8: Immune system and vascular  disorders have been added. Additional side effect added to cardiac disorders, gastrointestinal disorders, musculoskeletal disorders and  eye disorders.

In section 4.9: Additional information added

In section 5.1: Additional information added to pharmacodynamic properties

In section 5.2: information regarding absorption, distribution, metabolism and elimination has been added.

In section 10: The date of revision has been changed.

 

Updated on 19 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 December 2014 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2: the API has been corrected to just bromide

In section 4.2: Text corrections have been made. Separate entries included for renal impairment, hepatic impairment and method of administration

In section 4.6: Information regarding isolated reports of stillbirth and miscarriage have been added

In section 4.8: Adverse reporting statement has been added

In section 4.9: Text regarding hypotension and bradyarrhythmia has been added

In section 5.3: Pre-clinical safety data has been added

In section 10: date of revision has changed

 

Updated on 17 December 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • 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 2: the API has been corrected to just bromide

In section 4.2: Text corrections have been made. Separate entries included for renal impairment, hepatic impairment and method of administration

In section 4.6: Information regarding isolated reports of stillbirth and miscarriage have been added

In section 4.8: Adverse reporting statement has been added

In section 4.9: Text regarding hypotension and bradyarrhythmia has been added

In section 5.3: Pre-clinical safety data has been added

In section 10: date of revision has changed

 

Updated on 27 June 2011 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 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