Mestinon 60mg Tablets
- Name:
Mestinon 60mg Tablets
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/02/20
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Mylan IRE Healthcare Limited
Company Products
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 10 February 2020 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 February 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 6 December 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 December 2018 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
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 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 SPC
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
Updated on 27 June 2011 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)