PROSPECTO : INFORMATION FOR THE USER

Sueroral Hypotonic Powder for Oral Solution

(Sodium Chloride, Potassium Chloride, Sodium Citrate, Glucose)

Read this prospectus carefully as it contains important information for you.

This medication can be purchased without a prescription. However, for the best results, it must be used properly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 5 days, you must consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1.What Sueroral Hypotonic is and for what it is used

2.Before taking Sueroral Hypotonic

3.How to take Sueroral Hypotonic

4.Possible adverse effects

5Storage of Sueroral Hypotonic

6.Additional information

Hypertonic Saline belongs to a group of medications called oral rehydration formulas.

Hypertonic Saline is indicated for the prevention and treatment of dehydrations caused by vomiting or diarrhea, whether of infectious or non-infectious origin, infantile diarrhea and summer diarrhea, acidosis and ketoacidosis

Do not take Sueroral Hiposódico

• if you are allergic (hypersensitive) to the active ingredients or any of the other components of Sueroral Hiposódico.

- In premature infants and children under 1 month.

- if you cannot swallow.

- if you have significant and continuous vomiting.

- if you have an intestinal obstruction.

- if you have an intestinal perforation.

- if you have a known poor glucose absorption.

- if you are diabetic.

• if you have any kidney impairment.

Be especially careful with Sueroral Hiposódico

- If you normally consume cow's milk, you should not take more than 150 ml every four hours, and if diarrhea worsens, you should discontinue its consumption.

- You can eat food normally when diarrhea is corrected.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Pregnancy and breastfeeding

• Consult your doctor or pharmacist before using any medication.

- Sueroral Hiposódico can be taken during pregnancy and lactation.

• If you are breastfeeding, you will continue with the same dosage even if you are taking this medication.

Driving and operating machinery

Sueroral Hiposódico will not affect your ability to drive or operate machinery.

Important information about some of the components of Sueroral Hiposódico

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

Patients with diabetes mellitus should note that this medication contains20 gof glucose per dose.

Patients with low-sodium diets should note that this medication contains1.15 g(50.11 mmol) of sodium per dose.

This medication may cause allergic reactions because it contains Yellow Orange S (E-110) as an excipient.

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Patients with renal insufficiency or low-potassium diets should note that this medication contains0.84 g(21.51 mmol) of potassium per dose,of which0.054 g(1.39 mmol) of potassium forms part of the excipient and0.784 g(20.12 mmol) of potassium forms part of the active ingredient.

Follow exactly the administration instructions for SueroralHiposódico as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Sueroral Hiposódico should be taken by dissolving the contents of each sachet in one liter of potable water.

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 dose of Sueroral Hiposódico will depend on the patient's weight and the severity of their illness, although in general, the following doses are recommended:

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, without needing to suspend breastfeeding.

Children from 1 year old:The recommended dose is approximately 200 ml of solution for each diarrheal stool. It is recommended to administer between 25-30 ml of solution every 10–15 minutes.

Adults:The recommended dose is 200 to 400 ml of solution per each 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 Hiposódico needed.

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 Hiposódico should not be taken in any case.

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

If you take more Sueroral Hiposódico than you should

Consult your doctor or pharmacist immediately or the toxicology information service. Phone 91 562 04 20

The symptom you will notice is eyelid swelling, if this occurs, you should stop taking Sueroral Hiposódico.

If you forgot to take Sueroral Hiposódico

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

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

Like all medications, Sueroral Hiposódico may produce adverse effects, although not everyone will experience them, when administered too quickly.when administered too quickly.

The most common are vomiting. In these cases, you should interrupt the intake of Sueroral Hiposódico for 10 minutes and resume afterwards giving smaller but more frequent amounts.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not use Hypoosmolar Solution after the expiration date that appears on the packaging, after the CAD initials. The expiration date is the last day of the month indicated..

When not in use, Hypoosmolar Solution can be stored between2°Cand8°C(in the refrigerator) and must be discarded 24 hours after preparation.

Medicines should not be thrown away through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Sueroral Hypertonic Solution Composition:

• The active principles are:

Sodium chloride………………………….1.2 g

Potassium chloride………………………..1.5 g

Sodium citrate…………....2.9 g

Glucose………………………………..20.0 g

• The other components are…

Sweetening system:orange flavor (maltodextrin, gum arabic E-414, ascorbic acid E-300 and BHA E-320)

Acesulfame potassium (E-950)

Yellow-orange S (E-110)

Product appearance and packaging content

Sueroral Hypertonic Solution is presented in the form of sachets that contain27.365 gof powder each. Each package contains 5 sachets.

Marketing authorization holder and manufacturer responsible

Casen Recordati, S.L.

Autovía de Logroño, km 13,300

50180 Utebo - Zaragoza

This prospectus was approved in March 2010.

The 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/