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Kyleena 19.5 mg intrauterine delivery system

  • Name:

    Kyleena 19.5 mg intrauterine delivery system

  • Company:
    info
  • Active Ingredients:

    Levonorgestrel

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/10/20

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Summary of Product Characteristics last updated on medicines.ie: 7/7/2020

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Bayer Limited

Bayer Limited

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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 6 October 2020 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 5 October 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

The start of the PIL

Deletion of Patient's name, Doctor's name, Doctor's phone number, Date of insertion, Latest date of removal, First check up visit and Next visits: 1, 2, 3, 4, 5.

 

Section 6

Deletion of Croatia from the list of member states of the EEA.

 

Section 6 - date of revision

This leaflet was last revised in July 2020September 2020.

 

Change to information for healthcare professionals

Summary of Product Characteristics for Kyleena online at www.pi.bayer.com/kyleena/ie

(Addition of website address).

 

Updated on 21 August 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

HCP brochure containing information re differentiation between Bayer's LNG-IUDs and ectopic pregnancy

Updated on 7 July 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

 

PIL Section 2 Warnings and Precautions

 

[.....]

 

Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Kyleena.

 

PIL Section 4 Possible side effects

 

[.....]

 

Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

 

 

[.....]

 

<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

 

[.....]

 

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

 

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

 

[.....]

 

PIL Section 6:

This leaflet was last revised in April 2019 July 2020

Updated on 7 July 2020 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

 

SmPC Section 4.8

Tabulated summary of adverse events

 [.....]

'Deceased libido' added as a common side effect under System Organ Class: Psychiatric disorders.

'Dizziness' added as a common side effect under System organ Class: Vascular disorders

'Increased weight' added as a common side effect under System Organ Class: Investigations

[.....]

 

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W  website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

 

SmPC section 10, Date of revision of the text:

April 2019 June 2020

 

Updated on 7 July 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

 

PIL Section 2 Warnings and Precautions

[.....]

Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Kyleena.

[.....]

 

PIL Section 4 Possible side effects

[....]

Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

[.....]

 

[.....]

<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

[.....]

 

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

 

PIL Section 6:

[.....]

This leaflet was last revised in April 2019 July 2020

[.....]

 

Updated on 20 June 2019 PIL

Reasons for updating

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

Updated on 19 June 2019 SPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to warnings and prcautions due to PRAC reccommendation

Updated on 10 December 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 December 2018 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 May 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SmPC has updated as a result of the final study report for the subgroup of EURAS-IUD. The perforation text under subsection ‘Insertion and removal/ replacement’ was adapted to current medical practice, the average estimated in vivo release rate over the 1st year was added to section 5.2 and text under 4.8 regarding sepsis was adjusted to reflect the class effect. Editorial spelling changes also made.

Updated on 26 April 2018 PIL

Reasons for updating

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

Updated on 4 April 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 April 2018 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

In section 6.3, the shelf-life has been changed from 2 to 3 years.

In section 10, the revision date has been updated to March 2018.

Updated on 4 April 2017 SPC

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

None provided

Updated on 4 April 2017 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 April 2017 PIL

Reasons for updating

  • New PIL for new product