Elvina 0.03mg/3mg Film-coated Tablets *
Pharmacy Only: Prescription

EDM Updated on 04 May 2021

File name

CHC prescriber-checklist - IE Gedeon Richter FINAL_1620117330.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 04 May 2021

File name

Information sheet for women - IE Gedeon Richter FINAL_1620117330.pdf

Reasons for updating

  • Add New Doc

Updated on 15 July 2019

File name

01_P0906_345x635-approved 12.06.19_1563099524.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 14 July 2019

File name

ie-spc-approved 12.06.19_1563099449.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

PRAC update to inlcude warning of depression and depressed moods as a know side effect in the use of hormonal contraception. Warning in relation to withdrawal bleeding follwoing overdose. 

Updated on 18 December 2018

File name

P0799 345x635 (16-7-18) - approved 13.12.18_1545135038.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 16 November 2017

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 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

SmPC update

Updated on 15 November 2017

File name

PIL_16286_583.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 07 November 2016

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 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

$0$0In section 4.3 (Special warning and precautions for use), typo amendment and update to recommendation for patients on a lactose-free diet. $0$0In section 4.5 (Interaction with other medicinal products and other forms of interaction), update to substances decreasing the clearance of COCs and effects of Elvinette on other medicinal products sections.$0$0In section 4.8 (Undesirable effects), removal of migrane from serious adverse events discussed in section 4.4.$0$0In section 5.2 (Pharmacokinetic properties), updates under biotransformation section for both Drospirenone and Ethinylestradiol.$0$0

Updated on 04 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 22 March 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2 - Addition of paediatric population warning.$0$0$0$0Section 4.5 - Addition of new information$0$0$0$0$0Section 4.8 - Addition of new side effects$0$0$0$0

Updated on 21 March 2016

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 21 April 2015

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 April 2015

Reasons for updating

  • New PIL for new product