Olmesartan Amlodipine Mylan - 20mg/5mg, 40mg/10mg, 40mg/5mg
*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 06 August 2024
File name
ie-combined-at0711_v024_maht-consol-clean_PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 06 August 2024
File name
ie-combined-at0711_v024_maht-consol-clean-SPC.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 April 2024
File name
ie-pl-at0711_v022g_clean_Olmesartan_Amlodipine.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 27 February 2024
File name
ie-combined-at0711_Ren_clean 27 Feb 2024.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 August 2022
File name
ie-pl-at0711-v018+v020-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 11 August 2022
File name
ie-spc-at0711-v018+v020-clean.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 August 2022
File name
ie-pl-at0711-v018-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 03 August 2022
File name
ie-spc-at0711-v018-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 April 2022
File name
ie-pl-at0711-v017-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 19 April 2022
File name
ie-spc-at0711-v017-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 March 2022
File name
ie-pl-at0711-v016-clean.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 27 October 2021
File name
ie-pl-at0711-v014-clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
Updated on 27 October 2021
File name
ie-spc-at0711-v014-clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2021
File name
Olmesartan Medox Amlod SPC.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2021
File name
Olmesartan Medox Amlod PIL v011.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 29 August 2019
File name
ie-pil-at0711-clean-v002-2.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 29 August 2019
File name
ie-spc-at0711-clean-v002.pdf
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
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 August 2018
File name
PACKAGE LEAFLET Olmesartan Amlodipine Mylan.pdf
Reasons for updating
- New PIL for new product
Updated on 02 August 2018
File name
SUMMARY OF PRODUCT CHARACTERISTICS Olmesartan Amlodipine Mylan.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)