Suero oral Casen powder for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sueroral Casen powder for oral solution
Glucose, sodium chloride, trisodium citrate dihydrate, potassium chloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine contained in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 5 days.
Leaflet contents:
- What Sueroral is and what it is used for
- What you need to know before taking Sueroral
- How to take Sueroral
- Possible side effects
- How to store Sueroral
- Contents of the pack and other information
1. What Sueroral is and what it is used for
Sueroral belongs to a group of medicines called oral rehydration salt formulations.
Sueroral is indicated for the oral replacement of electrolytes and fluids in patients with dehydration, particularly associated with acute diarrhoea of various origins.
The aim of treatment is to rehydrate the patient and maintain hydration by replacing ongoing losses due to diarrhoea, vomiting, and normal water loss until adequate nutrition can be resumed.
You should consult a doctor if symptoms worsen or do not improve after 5 days.
2. What you need to know before starting Sueroral
Do not take Sueroral:
- If you are allergic to the active substances (glucose, sodium chloride, sodium citrate dihydrate, potassium chloride) or to any of the other components of this medicine (listed in section 6).
- If you have little or no urine output
- If you have severe and persistent vomiting
- If you have a known glucose malabsorption disorder
- If you are diabetic
- If you are unable to drink
- If you have intestinal obstruction
- If you have paralytic ileus
- If you have renal failure
- If you have intestinal perforation
- In premature infants and children under 1 month of age
- In pre-shock collapse, where oral administration should be performed via gastric tube or intravenous infusion of Ringer's solution and others
Warnings and precautions
Consult your doctor or pharmacist before starting to take Sueroral.
Take special care with Sueroral:
- When parenteral rehydration is indicated, such as in cases of severe dehydration and persistent or frequent vomiting, since Sueroral administration is not appropriate in such cases.
- If you regularly consume cow's milk, you should not drink more than 150 ml every four hours; if diarrhea worsens, you should stop consuming it and replace it with another protein-containing food.
- You may resume normal eating once diarrhea has resolved.
- Breastfeeding should continue between administrations of oral rehydration solution.
Use of Sueroral with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Taking Sueroral with food and drinks
Laxatives should not be administered.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Sueroral does not affect your ability to drive or operate machinery.
Sueroral contains glucose, sodium, potassium, and Orange Yellow S dye (E-110)
This medicine contains glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 20 g of glucose per sachet.
Patients on low-sodium diets should be aware that this medicine contains 2,000 mg (90 mmol) of sodium per sachet.
Patients with renal failure or on low-potassium diets should be aware that this medicine contains 780 mg (20 mmol) of potassium per sachet.
This medicine may cause allergic reactions because it contains Orange Yellow S dye (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Sueroral
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Sueroral should be taken by dissolving the contents of each sachet always in one liter of drinking water. The solution must be prepared and administered at room temperature.
The water, if necessary, may have been previously boiled but not after preparation.
Do not add other ingredients, such as sugar.
The usual dose should be individually calculated based on the patient's weight and the severity of their illness, although the following doses are generally recommended:
Use in children and adolescents
Infants over one month of age:
The recommended dose is approximately 1–1.5 times their usual volume of food. It is recommended to administer the solution frequently, in small amounts and slowly.
Infants receiving 150 ml of solution per kilogram of body weight within less than 24 hours should frequently drink plain water to quench thirst.
Children from 1 year of age:
The recommended dose is approximately 200 ml of solution for each diarrheal stool. It is recommended to administer the solution frequently, in small amounts and slowly.
In children, especially if weak or suffering from vomiting, it is advisable to administer the solution at a rate of 25 to 30 ml at intervals of 10 to 15 minutes.
In cases of severe weakness, the solution may be administered via nasogastric tube.
If dehydration is mild and in children under 2 years of age, during the first day of treatment, one dose of plain water should be given for every two doses of Sueroral solution, all of the same volume.
In the following days, drink water frequently.
Adults:
The recommended dose is 200 to 400 ml of solution for each diarrheal stool.
There is no recommended maximum daily dose; therefore, the solution can be administered freely, as the patient's thirst regulates the amount of Sueroral taken.
Elderly:
The recommended dose is the same as for adults.
Impaired liver function:
In this case, dose adjustment is not necessary.
Impaired renal function:
Sueroral must not be taken under any circumstances by patients with impaired renal function.
Patients with very frequent diarrhea should be encouraged to drink, and those who are very weak should be assisted.
In cases of severe dehydration treated intravenously with Ringer's solution or physiological saline, once shock has resolved and the patient is able to drink, treatment may continue with oral solution.
Duration of treatment: Treatment should be continued while diarrhea persists, and even after diarrhea has stopped, until the physician considers it necessary, which is normally achieved within 4 to 5 days.
If you take more Sueroral than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).
The symptom you may experience is swelling of the eyelids; if this occurs, you should stop taking Sueroral.
If you forget to take Sueroral
Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. The most common are vomiting, which may occur when the solution is administered too quickly. In such cases, administration of Sueroral should be interrupted for 10 minutes and then resumed by giving smaller amounts more frequently.
In patients with impaired renal function, overdose may lead to hypernatremia and hyperkalemia.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (Website: www.notificaram.es).
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sueroral
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
When not using Sueroral, the solution may be stored in the refrigerator (between 2°C and 8°C) and must be discarded 24 hours after preparation.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sueroral
- The active substances are:
Sodium chloride………………………….3.5 g
Potassium chloride………………………..1.5 g
Trisodium citrate dihydrate…………...2.9 g
Glucose…………...……………………..20.0 g
- The other components are:
Flavouring system, composed of: maltodextrin, dextrose, gum arabic (E-414), citric acid (E-330), ascorbic acid (E-300), sodium benzoate (E-211), natural origin extract rich in tocopherols (E-306), Neohesperidin dihydrochalcone (E-959), glycerol ester gum (E-445).
Sodium saccharin (E-954)
Orange-yellow S colourant (E-110)
Anhydrous colloidal silica
Nature of the product and contents of the pack
Sueroral is presented in the form of sachets containing 30.261 g of powder for oral solution each. Each pack contains 5 sachets.
Marketing Authorization Holder and Manufacturer
Casen Recordati, S.L
Autovía de Logroño, km 13,300
50180 Utebo - Zaragoza
Date of the most recent revision of this leaflet: June 1999
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/