SUERORAL CASEN Powder for Oral Solution

Introduction

Leaflet: information for the user

Sueroral Casen powder for oral solution

Glucose, sodium chloride, trisodium citrate dihydrate, potassium chloride

Read the entire leaflet carefullybefore starting to take thismedication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the leaflet:

1. What Sueroral is and what it is used for
2. What you need to know before taking Sueroral
3. How to take Sueroral
4. Possible side effects

5 Conservation of Sueroral

1. Package contents and additional information

1. What Sueroral is and what it is used for

Sueroral belongs to a group of medications called oral rehydration salt formulations.

Sueroral is indicated for oral replacement of electrolytes and fluids in patients with dehydration, particularly associated with acute diarrhea of various origins.

The goal of treatment is to rehydrate the patient and maintain hydration by replacing subsequent losses caused by diarrhea, vomiting, and normal water loss until adequate nutrition can be resumed.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Sueroral

Do not take Sueroral:

• If you are allergic to the active ingredients (glucose, sodium chloride, trisodium citrate dihydrate, potassium chloride) or to any of the other components of this medication (listed in section 6).
• If you have low or no urine secretion
• If you have significant and continuous vomiting
• If you have a known glucose malabsorption
• 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
• In pre-shock depression, in which oral administration by gastric tube or intravenous Ringer's solution and others should be performed

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sueroral.

Be especially careful with Sueroral:

• When parenteral rehydration is indicated, such as in cases of severe dehydration and continuous or frequent vomiting, as in this case, Sueroral administration is not appropriate.
• If you normally consume cow's milk, you should not take more than 150 ml every four hours, and if diarrhea worsens, you should stop consuming it, replacing it with another protein food.
• You can eat food normally when diarrhea is corrected.
• Breastfeeding should continue between oral rehydration solution administrations.

Using Sueroral with other medications

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Taking Sueroral with food and drinks

Purgatives should not be administered.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Sueroral does not affect your ability to drive or use machines.

Sueroral contains glucose, sodium, potassium, and yellow-orange colorant S (E-110)

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 20 g of glucose per sachet.

Patients with low-sodium diets should note that this medication contains 2,000 mg (90 mmol) of sodium per sachet.

Patients with renal failure or low-potassium diets should note that this medication contains 780 mg (20 mmol) of potassium per sachet.

This medication may cause allergic reactions because it contains yellow-orange colorant S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Sueroral

Follow the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Sueroral will be taken by dissolving the contents of each sachet in 1 liter of drinking water. The solution should be prepared and administered at room temperature.

The water, if necessary, can be boiled beforehand but not after preparation.

No other ingredients, such as sugar, should be added.

The normal dose should be calculated individually based on the patient's weight and the severity of their illness, although in general, the following doses are recommended:

Use in children and adolescents

Infants over 1 month:

The recommended dose is approximately 1-1.5 times their usual food volume. It is recommended to administer the solution frequently, in small amounts, and slowly.

Infants who are administered 150 ml of solution per kilogram of body weight in less than 24 hours should drink water frequently to quench their thirst.

Children from 1 year onwards:

The recommended dose is approximately 200 ml of solution per diarrheal stool. It is recommended to administer the solution frequently, in small amounts, and slowly.

In children, especially if they are weak or have vomiting, it is convenient to administer the solution at a rate of 25-30 ml at intervals of 10-15 minutes.

In cases of great weakness, the solution can be administered through a nasogastric tube.

If dehydration is mild and, in children under 2 years, the first day of treatment will be administered with a single water intake for every two intakes of Sueroral solution, all of the same volume.

In the following days, drink water frequently.

Adults:

The recommended dose is 200-400 ml of solution per diarrheal stool.

There is no recommended maximum daily dose, so the solution can be administered freely, as the patient's thirst regulates the amount of Sueroral.

Elderly:

The recommended dose is the same as for adults.

Altered liver function:

In this case, no dose adjustment is necessary.

Altered renal function:

In patients with altered renal function, Sueroral should not be taken in any case.

In patients with very frequent diarrhea, they should be encouraged to drink, and in the very weak, they should be helped.

In cases of severe dehydration treated intravenously with Ringer's solution or physiological solution, once the shock has passed and the patient can drink, treatment can be continued with the oral solution.

Duration of treatment: It is recommended to continue treatment while diarrhea lasts and, once it has ended, until the doctor considers it necessary, which is usually achieved in 4 or 5 days.

If you take more Sueroral than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested)

The symptom you will notice 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. The most common are vomiting, which can occur when administered too quickly. In these cases, you should interrupt the administration of Sueroral for 10 minutes and resume it, giving smaller amounts more frequently.

In patients with renal impairment, overdose can lead to hypernatremia and hyperkalemia.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication and Healthcare Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sueroral

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

When not using Sueroral, you can store the solution in the refrigerator (between 2°C and 8°C) and discard it 24 hours after preparation.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Sueroral composition

• The active ingredients 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:

Aromatizing system, composed of: maltodextrin, dextrose, gum arabic (E-414), citric acid (E-330), ascorbic acid (E-300), sodium benzoate (E-211), natural extract rich in tocopherols (E-306), Neohesperidina dihydrochalcone (E-959), ester gum (E-445).

Sodium saccharin (E-954)

Yellow-orange colorant S (E-110)

Anhydrous colloidal silica

Product appearance and package contents

Sueroral is presented in the form of sachets containing 30.261 g of powder for oral solution each. Each package contains 5 sachets.

Marketing authorization holder and manufacturer

Casen Recordati, S.L. Autovía de Logroño, km 13, 300

50180 Utebo - Zaragoza

Date of the last revision of this leaflet:June 1999

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)http://www.aemps.gob.es/