Dioralyte Citrus *
Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive 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 17 May 2021
File name
1.3.1 Dioralyte Rebalance patient leaflet_1621241668.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 14 May 2021
File name
1.3.1 SmPC Dioralyte Rebalance Citrus_1620981722.pdf
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Updated on 28 April 2021
File name
SPC Dioralyte Citrus_1619602743.pdf
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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 28 April 2021
File name
IE1080 cropped PL 421022_1619602704.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- 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 06 July 2020
File name
PIL Dioralyte IE777_1553611691.pdf
Reasons for updating
- XPIL Updated
Updated on 08 July 2019
File name
Dioralyte Citrus Powder for Oral Solution SPC (4)_1562590278.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 26 March 2019
File name
PIL Dioralyte IE777_1553611691.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 26 June 2018
File name
Dioralyte Citrus Powder for Oral Solution SPC.docx
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
File name
Dioralyte Natural Citrus & Blackcurrant Powder for Oral Solution PIL.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 22 December 2016
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 19 December 2016
File name
PIL_13774_783.pdf
Reasons for updating
- New PIL for new product
Updated on 19 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 18 June 2012
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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
Reasons for updating
- Change to storage instructions
Updated on 02 June 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 10 November 2009
Reasons for updating
- Improved electronic presentation
Updated on 13 October 2008
Reasons for updating
- New PIL for medicines.ie