Mestinon 60mg Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 February 2020
File name
ie-spc-mestinon-pr1902954-rtq-clean.pdf
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
File name
ie-pl-mestinon-pr1902954-clean1.pdf
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 06 December 2018
File name
ie-pl-mestinon-clean-mahtransfer.pdf
Reasons for updating
- New PIL for new product
Updated on 05 December 2018
File name
ie-spc-mestinon-mahtransfer-clean.pdf
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
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
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
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
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 17 December 2014
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 27 June 2011
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
Updated on 27 June 2011
Reasons for updating
- New SPC for medicines.ie