Prospecto: information for the user

Sueroral Powder for Oral Solution

Glucose, sodium chloride, trisodium citrate dihydrate, potassium chloride

Read this prospect carefullybefore starting to take thismedicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

1.What Sueroral is and for what it is used

2.What you need to knowbeforestarting totake Sueroral

3. How to take Sueroral

4.Possible adverse effects

5Storage of Sueroral

6.Contents of the package andadditional information

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

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

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

You should consult a doctor if you worsen or do not improve after 5 days.

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 reduced or no urine production.
• If you have persistent and continuous vomiting.
• If you have 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 kidney insufficiency.
• If you have intestinal perforation.
• In premature infants and children under 1 month.
• In pre-shock conditions, where oral administration through a gastric tube or intravenous administration of Ringer's solution and other fluids is required.

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 frequent or continuous vomiting, as in this case, Sueroral administration is not appropriate.
• If you normally consume cow's milk, do not take more than 150 ml every four hours, and if diarrhea worsens, you should discontinue its consumption, replacing it with another protein-rich food.
• You can eat normally when diarrhea is corrected.
• Continue breastfeeding between administrations of oral rehydration solution.

Use of Sueroral with other medications

Inform 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 operating machinery

Sueroral does not affect your ability to drive or operate machinery.

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 dose.

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

Patients with kidney insufficiency or low-potassium diets should note that this medication contains 780 mg (20 mmol) of potassium per dose.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Sueroral should be taken by dissolving the content of each sachet always in one liter of potable water. The solution must be prepared and administered at room temperature.

The water, if considered necessary, may have been previously boiled but not after its 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 disease, although in general, the following doses are recommended:

Use in children and adolescents

Infants over one month:

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 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 old:

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 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 through a nasogastric tube.

If dehydration is mild and in children under 2 years old, on the first day of treatment, one water intake will be administered 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 to 400 ml of solution per diarrheal stool.

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

Seniors:

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 very weak patients, 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, the treatment can be continued with 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested)

The symptom you will notice will be swelling of the eyelids, if this occurs, you should stop taking Sueroral.

If you forgot to take Sueroral

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. The most common ones are vomiting, which may appear when it is administered too quickly. In these cases, you should interrupt the administration of Sueroral for 10 minutes and resume giving smaller amounts more frequently.

In patients with renal deterioration, an overdose may lead to hypernatremia and hyperkalemia.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (Website:www.notificaram.es).

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears 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 in the trash. Dispose of the containers and medications you no longer need at your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Sueroral Composition

• The active principles 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:

Syrup flavoring 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), ester gum (E-445).

Sodium saccharin (E-954)

Yellow-orange S colorant (E-110)

Colloidal anhydrous silica

Product appearance and packaging contents

Sueroral is presented in the form of sachets containing30.261 gof powder for oral solution each. Each package contains 5 sachets.

Marketing authorization holder and manufacturer responsible

Casen Recordati, S.LAutovía de Logroño, km 13, 300

50180 Utebo - Zaragoza

Last review date of this leaflet:June 1999

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