Lactulose 10 g / 15 ml Oral Solution Sachets *

  • Company:

    Intrapharm Laboratories Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through pharmacy only
  • Active Ingredient(s):

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

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 01 May 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Finished product shelf-life extended from 2 to 3 years. Type IB MRP variation approved 12Jan2017 (adopted nationally 19Jan2017).

Updated on 01 May 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 07 August 2015

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 4.4 - 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 9 - Date of renewal of authorisation
  • 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

SmPC changes reflect national approval for the MRP renewal as issued by HPRA 24Jul2015.

Updated on 04 August 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to product name
  • Addition of information on reporting a side effect.

Updated on 04 August 2015

File name

PIL_15872_559.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 November 2013

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 07 November 2013

Reasons for updating

  • New PIL for new product