Molaxole powder for oral solution

Product Information *

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 10 September 2020

File name

ie-spc-dk1199-v040-clean_1599739898.pdf

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 10 - Date of revision of the text

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

Updated on 10 September 2020

File name

ie-pl-dk1199-v040-clean_1599739841.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 23 January 2020

File name

ie-pl-dk1199-v038-clean_1579773924.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to product name

Free text change information supplied by the pharmaceutical company

Change of invented name of medicinal product in Poland

Updated on 30 August 2019

File name

ie-pl-dk1199-v036rtq-clean_1567169602.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 30 August 2019

File name

ie-spc-dk1199-v036-clean_1567169686.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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)

Updated on 14 June 2019

File name

ie-spc-molaxole-mahtransfer-clean_1560509695.pdf

Reasons for updating

  • Change to improve clarity and readability

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

Updated on 13 November 2018

File name

ie-pl-dk1199-ia035g-clean_1542110541.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 August 2018

File name

Update Molaxole PIL_1535028948.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 02 July 2018

File name

Molaxole PIL - MAH Transfer - May 2018 - clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 July 2018

File name

ie-spc-molaxole-mahtransfer-clean.docx

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited

Updated on 10 April 2015

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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic 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

Section 2: Minor text change

Section 3: Description of capsule has been reworded

Section 4.2: Method of administration has been added

In section 4.3: Intestinal obstruction has been added as a contraindication

In section 4.4: Text has been removed

In section 4.5: Information regarding that no interaction studies have been performed

In section 4.6: Text has changed to refer to pregnancy and lactation being not recommended rather than contraindicated

In section 4.7: Information regarding Spasmonal causing dizziness has been added and not to drive and/or operate machinery if affected

In section 4.8: Side effects have been restructured into system organ classes and frequency. Additional side effects have been added. Adverse reaction statement has been added.

In section 4.9: Information regarding fatality with very high doses have been added

In section 5.1: The Pharmacotherapeutic group and ATC code has been added

In section 10: The date of revision has been changed

 

Updated on 10 April 2015

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 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 2: Minor text change

Section 3: Description of capsule has been reworded

Section 4.2: Method of administration has been added

In section 4.3: Intestinal obstruction has been added as a contraindication

In section 4.4: Text has been removed

In section 4.5: Information regarding that no interaction studies have been performed

In section 4.6: Text has changed to refer to pregnancy and lactation being not recommended rather than contraindicated

In section 4.7: Information regarding Spasmonal causing dizziness has been added and not to drive and/or operate machinery if affected

In section 4.8: Side effects have been restructured into system organ classes and frequency. Additional side effects have been added. Adverse reaction statement has been added.

In section 4.9: Information regarding fatality with very high doses have been added

In section 5.1: The Pharmacotherapeutic group and ATC code has been added

In section 10: The date of revision has been changed

 

Updated on 10 April 2015

Reasons for updating

  • New SPC for new product

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

Updated on 25 June 2013

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.6: There has been changes to this section including an additional sub-section added for lactation and changes are also made to the sub-section regarding fertility.

In section 4.8: There has been a large change to this section with additional information added to side effects.
In section 9: the date of last renewal has been added.

In section 10: the date of revision has been changed.

Updated on 25 June 2013

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.6: There has been changes to this section including an additional sub-section added for lactation and changes are also made to the sub-section regarding fertility.

In section 4.8: There has been a large change to this section with additional information added to side effects.
In section 9: the date of last renewal has been added.

In section 10: the date of revision has been changed.

Updated on 19 June 2012

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 4.6 - Pregnancy and lactation
  • 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

In section 4.4: additional information is added regarding the diagnosis of impaction/faecal
In section 4.5: Additional infromation has been added re abosrption of other medicinal products and Molaxole
In section 4.6; Fertility information and heading has been added
In section 4.8; small errors have been corrected in the table
In section 10; the date of revision has changes

Updated on 19 June 2012

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: additional information is added regarding the diagnosis of impaction/faecal
In section 4.5: Additional infromation has been added re abosrption of other medicinal products and Molaxole
In section 4.6; Fertility information and heading has been added
In section 4.8; small errors have been corrected in the table
In section 10; the date of revision has changes

Updated on 30 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

In section 4.2; typo errors corrected
In section 7: the address of the MAH has changed

Updated on 30 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

In section 4.2; typo errors corrected
In section 7: the address of the MAH has changed

Updated on 11 January 2011

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 11 January 2011

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided