Priligy 30 mg and 60 mg film-coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 October 2021
File name
ie-spc priligy clean Approved Oct 21.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Setcion 4.8 - HPRA reporting details updated
Section 6.5 - Blister type updated
Section 10 - Date of revision updated
Updated on 21 October 2021
File name
ie-pl priligy clean Approved Oct 21.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 6 - Blister type updated and date of revision updated
Updated on 05 March 2021
File name
ie-spc priligy Clean Approved March 2021.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Sodium content warning added
Section 4.5 - Under Medicinal products metabolized by CYP2C9 - glyburide replaced with glibenclamide
Section 10 - date of revision updated
Updated on 05 March 2021
File name
ie-pl priligy Clean Approved March 2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Slight change to text in "Priligy contains lactose" - Medicine replaced with medicinal product
Section 2 - Priligy contains sodium - new warning added
Date of revision updated
Updated on 18 November 2020
File name
ie-pl priligy clean 2-11-20.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 27 March 2019
File name
ie-pl priligy clean 15-3-19.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 27 March 2019
File name
ie-spc priligy clean 15-3-19.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 Interactions of the SmPC to add: ...Grapefruit juice is also a potent CYP3A4 inhibitor and should be avoided within 24 hours prior to taking Priligy.
Updated on 27 August 2015
File name
PIL_15829_301.pdf
Reasons for updating
- New PIL for new product
Updated on 27 August 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 17 February 2015
Reasons for updating
- PIL re-instated
Updated on 12 February 2015
Reasons for updating
- Change to improve clarity and readability
- PIL Submitted in error
Updated on 30 October 2014
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 01 April 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor amendments to correct minor typographical errors in section 4.5 and 6.1
4.8 Undesirable effects
Add information on the reporting of suspected adverse reactions.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Add date of renewal
10. DATE OF REVISION OF THE TEXT
Update this section.
Updated on 01 April 2014
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 29 August 2013
Reasons for updating
- Change to improve clarity and readability
Updated on 27 August 2013
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2013
Reasons for updating
- New PIL for new product