Laxido Orange, powder for oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/04/19

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Summary of Product Characteristics last updated on medicines.ie: 25/4/2019

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Galen Pharma Ireland Limited

Galen Limited

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Medicine Name Laxido Orange, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution. Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
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Medicine Name Tramake 100mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Tramake 50mg Tablets Active Ingredients Tramadol Hydrochloride
1 - 0 of 10 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 25 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 April 2019 SmPC

Reasons for updating

  • 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)

Updated on 14 February 2019 PIL

Reasons for updating

  • Addition of manufacturer
  • Change to date of revision

Updated on 7 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings

Updated on 7 December 2018 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Information regarding the sodium content of the product was added to Section 2 of the SPC, in line with the newly updated Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.Updates in line with the current EU product information requirements (QRD template). 

Updated on 17 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 17 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 2 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 March 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 4 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 January 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Update to Sections 2, 4.1, 4.2, 4.3 and 4.8.

Updated on 24 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 10 June 2015 SmPC

Reasons for updating

  • SPC retired pending re-submission
  • 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

The renewal for Laxido Orange has been approved.  The date of revision of the SPC has been updated, as a result of this renewal. 

Updated on 7 May 2014 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been updated:

4.6 Fertility, pregnancy and lactation

4.8 Undesirable effects

5.3 Preclinical safety data

Updated on 6 May 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 9 July 2012 SmPC

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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Sections 4.4, 4.5, 4.6, 4.8 and 5.3 updated.

Updated on 4 July 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 8 September 2009 PIL

Reasons for updating

  • Change to date of revision
  • PIL retired pending re-submission

Updated on 4 August 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission

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

Free text change information supplied by the pharmaceutical company


Section 10:
  Date of revision updated

Updated on 12 February 2009 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5  an additional pack size (100 sachet) has been added

Updated on 28 October 2008 SmPC

Reasons for updating

  • New SPC for new product

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