Spasmonal 60mg hard capsules
*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 24 May 2019
File name
ie-pl-spasmonal-60-addbrsite clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 September 2018
File name
ie-pl-spasmonal-60-clean-mahtransfer.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 28 September 2018
File name
ie-spc-spasmonal-60mg-clean-mahtransfer.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 13 March 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 March 2015
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 23 March 2012
File name
PIL_15259_622.pdf
Reasons for updating
- New PIL for new product
Updated on 23 March 2012
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 24 February 2012
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 10; the date of revision has changed
Updated on 24 January 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 01 June 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)