Prevenelle 1500 microgram Tablet

  • Name:

    Prevenelle 1500 microgram Tablet

  • Company:
    info
  • Active Ingredients:

    Levonorgestrel

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/09/19

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Summary of Product Characteristics last updated on medicines.ie: 12/9/2019

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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
Medicine Name Prevenelle 1500 microgram Tablet Active Ingredients Levonorgestrel
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 12 September 2019 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Re-upload of currently approved PIL

Updated on 12 September 2019 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update of the Product Information with regards to impact of Body Mass Index on efficacy.

Updated on 14 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 14 March 2018 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to few sections of SmPC

Updated on 14 March 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 20 January 2017 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Removal of text in section 5.1 regarding the paediatric population. 

Updated on 19 December 2016 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 15 December 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration), update to paediatric population section. $0In section 5.1 (Pharmacodynamic properties), data on paediatric population added. $0$0In section 6.1 (List of excipients), Corn starch changed to maize starch. $0

Updated on 8 December 2016 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 7 December 2016 SmPC

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration), addition of information for women who have used enzyme-inducing drugs. $0In section 4.5 (Interaction with other medicinal products and other forms of interaction), addition on information regarding CYP3A4 enzyme inducers and efavirenz, addition of information for women who have used enzyme-inducing drugs. $0$0In section 4.8 (Undesirable effects), update to reporting information.$0In section 5.1 (Pharmacodynamic properties), removal on information relating to taking 2 tablets 12 hours apart. $0$0In section 5.2 (Pharmacokinetic properties), update to elimination wording. $0$0In section 7 (Marketing authorisation holder), change of MAH to Gedeon Richter. $0$0In section 8 (Marketing authorisation number), change in MA number.$0

Updated on 4 February 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 3 February 2015 PIL

Reasons for updating

  • New PIL for new product