Elvinette 0.02mg/3mg film-coated tablets

  • Name:

    Elvinette 0.02mg/3mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Drospirenone, Ethinylestradiol

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/07/19

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Summary of Product Characteristics last updated on medicines.ie: 14/7/2019

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Consilient Health Ltd

Consilient Health Ltd

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Medicine Name altavitaD3 25,000 IU oral solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 25,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 7,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Azalia 75 microgram film-coated tablets Active Ingredients Desogestrel
Medicine Name Cadelius 600 mg / 1,000 IU orodispersible tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cilique 250/ 35 microgram tablets Active Ingredients Ethinylestradiol, Norgestimate
Medicine Name Elvina 0.03mg/3mg Film-coated Tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Elvinette 0.02mg/3mg film-coated tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Mysimba 8 mg/90 mg prolonged-release tablets Active Ingredients Bupropion Hydrochloride, Naltrexone Hydrochloride
Medicine Name Ovreena 30 micrograms/150 micrograms coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
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Medicine Name Violite 100/20 micrograms film-coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
1 - 0 of 13 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 July 2019 PIL

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 SmPC

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

Update to include warning of depression and depressed moods when using hormonal contraception. Also warning of withdrawal bleeding following overdose. 

Updated on 18 December 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 16 November 2017 SmPC

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 updated

Updated on 16 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017 PIL

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 6 - date of revision

Updated on 7 November 2016 SmPC

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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 (Contraindications), minor update to wording.$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 5.2 (Pharmacokinetic properties), updates under biotransformation section for both Drospirenone and Ethinylestradiol.$0$0In section 5.3 (Preclinical safety data), minor update to wording.$0$0

Updated on 3 November 2016 PIL

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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 11 May 2016 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

Date of renewal application was updated to 22nd December 2015.$0$0$0$0Date of revision of the text was updated to February 2016.$0$0$0$0$0Nature and contents of container we updated to remove "colourless, transparent"$0

Updated on 25 April 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 8 December 2015 PIL

Reasons for updating

  • New PIL for medicines.ie
  • PIL Submitted in error

Updated on 6 July 2015 SmPC

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