Dioralyte Natural

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/03/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 8/7/2019

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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 8 July 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 26 March 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 26 June 2018 SmPC

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 4.6 - Pregnancy and lactation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Section 4.2          Posology and Method of Administration

Amended as follows:-

The contents of each sachet should be dissolved in 200ml (approximately 7 fluid ounces) of drinking water. 

Daily intake may be based on a volume of 150ml/kg body weight for infants up to the age of 24 months and 20-40 mgml/kg body weight for adults and children

Infants under 24 months              Use only under medical advice.

One to one and a half times the usual 24 hour feed volume.

Children over 24 months              One sachet after every loose motion

Adults including elderly One or two sachets after every loose motion.   .

More may be required initially to ensure early and full volume repletion.

Special population

No specific dose adjustment for the use of Dioralyte in elderly patients is recommended.

For patients with renal or hepatic impairment see section 4.4.

4.3 Contraindications

Amended as follows:-

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings and Special Precautions for Use

Amended as follows:

Dioralyte should not be used for treatment in infants below the age of 24 months without medical supervision.

Dioralyte should not be used for self-treatment by patients with:

-              Chronic or persistent diarrhoea

-              Liver or kidney disease

-              Diabetes

-              On low potassium or sodium diets

-              Intestinal obstruction

The use of Dioralyte in patients with these conditions should be supervised by a doctor.

A weaker solution than recommended will not contain the optimal glucose and electrolyte concentration and a stronger solution than recommended may give rise to electrolyte imbalance.

4.6 Pregnancy and Lactation

Amended as follows:-

Medical supervision is recommended for use during pregnancy and lactation.

Updated on 26 June 2018 PIL

Reasons for updating

  • 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 3 - how to take/use

Updated on 22 December 2016 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SmPC – Update to section 4.8 to include HPRA adverse event reporting details.

Updated on 22 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 19 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 December 2016 PIL

Reasons for updating

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

Updated on 18 June 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life has been changed from 24 months to 36 months.
Section 6.4: Storage conditions have changed from 'Store in a cool dry place.' to 'Store below 25°C.  Store in the original package in order to protect from moisture.'
Section 7: Addition of 'Sanofi' as a trading style.

Updated on 14 June 2012 PIL

Reasons for updating

  • Change to storage instructions

Updated on 2 June 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 November 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 October 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 July 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 29 March 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Update
Section 2 - Addion of sulphur dioxide for Dioralyte Citrus
Section 10 - Date of revision of text.

Updated on 13 December 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update Section
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision

Updated on 8 November 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 6 October 2003 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only