Violite 100/20 micrograms film-coated tablets *
Pharmacy Only: Prescription

Updated on 17 November 2020

File name

common-spc_1605631386.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of the product information to harmonise the safety information with the brand leader

Updated on 17 November 2020

File name

P1156 (appr 12.11.2020)_1605631294.pdf

Reasons for updating

  • 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 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update of the product information to harmonise the safety information with the brand leader

Updated on 22 May 2020

File name

common-spc-v005_1590152362.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 May 2020

File name

common-mockup-pl - v005_1590152179.pdf

Reasons for updating

  • 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 4 - possible side effects

Updated on 17 October 2019

File name

common-mockup - Mar 2019_1571330441.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update of the product information in line with the reference product

Updated on 17 October 2019

File name

common-spc-clean-08.03_1571330365.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of the product information in line with the reference product

Updated on 11 March 2019

File name

Violite common-mockup_1552307405.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 11 March 2019

File name

Violite-common-spc-clean-19.12.2018_1552307589.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 October 2016

File name

PIL_16939_837.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)