Moventig 12.5 mg and 25 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 07 October 2019

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland CLEAN_1570452932.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 07 October 2019

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland_track CLEAN_1570452714.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

  • Removal of black triangle
  • Section 2: Removal of excipients with known effect
  • Section 4.2 Addition of wording “ No data are available” under paediatric population
  • Section 4.2: Revised wording around crushing of the tablet, some wording moved to section 6.6. Content unchanged.
  • Section 4.4: Changes to wording only (medicinal product instead of medicine).
  • Section 5.1: revised text for the paediatric population (previously stated: “children from 6 months to 18 years”; now states one of the subsets of the paediatric population)
  • Section 6.6: Inclusion of wording from section 4.2 on how to crush the tablet
  • Section 9: Date of renewal updated
  • Section 10: Date of revision of the text updated

Updated on 28 June 2019

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland clean_1561730299.pdf

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 6 - date of revision

Updated on 28 June 2019

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland clean_1561730230.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC section 4.4 has been revised to the following wording:

​​

Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) perforation. Naloxegol must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, or in patients with underlying cancer who are at heightened risk of GI perforation (see section 4.3).

 

 

Section 4.8 the additional safety term has been added under the frequency "Unknown": Gastrointestinal perforation (see section 4.4)

​​

Section 10: Date of revision of the text has been updated to June 2019.

 

Updated on 25 February 2019

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland clean_1551089411.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland-clean_1547461084.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland-clean_1547461042.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5 - Addition of wording:

Interaction with other opioid antagonists

Use of naloxegol with another opioid antagonist (e.g. naltrexone, naloxone) should be avoided due to the potential for an additive effect of opioid receptor antagonism and an increased risk of opioid withdrawal.

Section 10 - Date of revision of the text updated

 

Updated on 30 October 2018

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland - clean_1540828179.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 29 October 2018

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland - clean_1540828047.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

In section 2 addition of text:

 

Excipients with known effect

Each 12.5 mg tablet contains 0.9 mg sodium.

Each 25 mg tablet contains 1.9 mg sodium.

 In section 4.4 addition of text:

 

Moventig contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free’.

 

In section 10: Date of revision of the text.

Updated on 03 September 2018

File name

Naloxegol oxalate tablets (Moventig) PIL Ireland - clean_1535973313.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 September 2018

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland - clean_1535973294.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Updated on 03 September 2018

File name

Naloxegol oxalate tablets (Moventig) SPC Ireland - clean_1535973223.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Section 10 - Chnage od MAH to Kyowa Kirin Holdings B. V. 

Updated on 02 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 February 2018

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life. The Shelf Life  was increased from 2 years to 4 years.

Updated on 02 February 2018

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life. The Shelf Life  was increased from 2 years to 4 years.

Updated on 22 January 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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 4.8  Addition of hypersensitivity
In section 6.5 addition of perforated pack presentations
In section 8 addition of perforated pack presentations (Marketing authorisation numbers)
In section 10, date of revision of the text updated

Updated on 22 January 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.8  Addition of hypersensitivity
In section 6.5 addition of perforated pack presentations
In section 8 addition of perforated pack presentations (Marketing authorisation numbers)
In section 10, date of revision of the text updated

Updated on 11 October 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Section 7 - Change of Marketing Authorisation Holder to Kyowa Kirin$0Section 10 - date of revision of the text $0

Updated on 11 October 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 7 - Change of Marketing Authorisation Holder to Kyowa Kirin$0Section 10 - date of revision of the text $0

Updated on 11 May 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company



Update to section 2 – inclusion of product name headings above each composition declaration

Update to section 3 – inclusion of full product name

Update to section 4.2 – editorial changes in line with QRD and inclusion of paragraph on crushed tablet administration

Update to section 4.4 – editorial changes in line with QRD

Update to section 4.8 – update to Malta ADR reporting details in line with QRD

Update to section 5.2 - inclusion of paragraph on crushed tablet administration

Update to section 10 – update to date of revision of text

Updated on 11 May 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company



Update to section 2 – inclusion of product name headings above each composition declaration

Update to section 3 – inclusion of full product name

Update to section 4.2 – editorial changes in line with QRD and inclusion of paragraph on crushed tablet administration

Update to section 4.4 – editorial changes in line with QRD

Update to section 4.8 – update to Malta ADR reporting details in line with QRD

Update to section 5.2 - inclusion of paragraph on crushed tablet administration

Update to section 10 – update to date of revision of text

Updated on 01 September 2015

Reasons for updating

  • New SPC for medicines.ie

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 01 September 2015

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided