Label: information for the user

Citorsal

Oral solution powder in sachet

Calcium lactate anhydrous, anhydrous magnesium sulfate, anhydrous citric acid, anhydrous sodium citrate, anhydrous sodium chloride, anhydrous potassium chloride, anhydrous sodium phosphate, and monohydrate glucose

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

Citorsal belongs to the pharmacotherapeutic group of oral rehydration salts, and is used in the prevention and treatment of mild and moderate states of dehydration produced by different causes such as: acute gastro-intestinal disorders of the infant, acidosis, ketonemic vomiting, extrarenal uremia, vomiting of pregnant women and, in general, all cases of abundant loss of liquids by persistent vomiting or diarrhea.

Citorsal is indicated in adults, infants and children.

Do not take Citorsal:

• If you are allergic to the active ingredients or any of the components of this medication (listed in section 6).
• If you have malabsorption of glucose or galactose.
• If you have diabetes.
• If you are unable to drink.
• If you need oral administration through a gastric tube or intravenously.
• If you have severe, persistent diarrhea, and other critical fluid losses that require parenteral therapy.
• If you have intense and sustained vomiting.
• If you have intestinal obstruction, paralytic ileus, or intestinal perforation.
• If you have anuria (cessation of urine production), or oliguria (decreased urine production).
• If you have renal insufficiency.
• Infants born prematurely or less than one month old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Citorsal.

Be especially careful with Citorsal:

• When parenteral rehydration is indicated, such as in cases of severe dehydration and frequent vomiting, as in this case, it is not appropriate to administer Citorsal.
• You may eat normal foods once the diarrhea is corrected.

Taking Citorsal with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Due to its calcium content, it interferes with the absorption of tetracyclines.

Taking Citorsal with food and drinks

• Avoid taking foods or other liquids with high sugar content, such as fruit juices or other liquids containing electrolytes; if additional liquid is desired, use water.
• Avoid salty foods.
• Stop drinking cow's milk only if the diarrhea worsens significantly after consuming it, replacing it with another protein-rich food.

Pregnancy and breastfeeding

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

Driving and operating machinery

This medication does not affect your ability to drive and operate machinery.

Citorsal 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 5 g of glucose per 100 ml of reconstituted solution.

This medication contains 115 mg of sodium (main component of table salt/for cooking) per 100 ml of prepared solution. This is equivalent to 6% of the maximum daily sodium intake recommended for an adult.

Patients with renal insufficiency or low-potassium diets should note that this medication contains 78 mg (2 mmol) of potassium per 100 ml of prepared solution.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Citorsal should be taken by dissolving the contents of one sachet in half a liter of water or two sachets in one liter.

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.

Citorsal is administered orally.

The normal dose should be calculated individually based on the patient's weight and the severity of their disease, although the recommended dose is generally:

Infants fromone month: it is recommended between 1 – 1.5 times their usual volume of food.

Children from one year: 200 ml of solution per each diarrheal stool.

Adults: between 200 and 400 ml of solution per each diarrheal stool.

It is recommended to continue treatment while diarrhea persists and, once it has ended, your doctor will assess whether rehydration has been achieved and there is no risk of dehydration, which is usually achieved in 4 or 5 days.

Administration is usually done "ad libitum" allowing the patient to drink as much as they want. In the case of patients with very frequent diarrhea, they should be encouraged to drink, and in the case of very weak patients, they should be helped.

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.

If dehydration is mild and, in children under 2 years, on the first day of treatment, one dose of water alone will be administered for every two doses of Citorsal powder for oral solution, all of the same volume. In the following days, water should be drunk frequently.

Start with small amounts and increase as needed by the patient. In all cases, it is recommended to administer the solution frequently, in small amounts, and slowly to facilitate its absorption. In infants and children, it is essential to maintain continuous feeding, including breast milk, to maintain hydration and nutrition.

In adults, the diet should be resumed as soon as they regain their appetite.

Geriatric patients

The recommended dosage regimen is the same as for adults.

Patients with hepatic insufficiency

In this case, no dose adjustment is necessary.

Patients with renal insufficiency

In patients with altered renal function, Citorsal should not be administered in any case, as these patients may develop very high levels of sodium (hypernatremia) and potassium (hyperkalemia) in the blood.

Instructions for correct administration of the preparation:

Pour the contents of one sachet into half a liter of water (500 ml) or two sachets into one liter. To facilitate the dissolution of the product, it is recommended to add the powder slowly to the water, stirring vigorously with a spoon until complete dissolution.

Under certain circumstances, which do not affect its therapeutic qualities, Citorsal may become hardened in the package. Simply press the sachet with your hand to convert it into a fine powder and equally soluble.

If you take more Citorsal 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 used.

An excess of Citorsal may cause overhydration. Discontinue treatment if you notice that your eyelids are swollen.

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

If you forgot to take Citorsal

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctoror,pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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.

Unused solution must be discarded within 24 hours of preparation and does not require special storage precautions.

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

Medications should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Citorsal

• The active principles are anhydrous calcium lactate, anhydrous magnesium sulfate, anhydrous citric acid, anhydrous sodium citrate, anhydrous sodium chloride, anhydrous potassium chloride, anhydrous sodium phosphate, and monohydrate glucose.
• The other components are: neohesperidin, orange aroma, and yellow-orange S (E-110) dye.

Each sachet must be dissolved in half a liter (500 ml) of water. Each 100 ml of the resulting solution contains as active principles: 0.0436 g of anhydrous calcium lactate, 0.024 g of anhydrous magnesium sulfate, 0.032 g of anhydrous citric acid, 0.258 g of anhydrous sodium citrate, 0.0585 g of anhydrous sodium chloride, 0.149 g of anhydrous potassium chloride, 0.071 g of anhydrous sodium phosphate, and 5 g of glucose (monohydrate).

Appearance of the product and contents of the packaging

Citorsal is presented in the form of sachets with a light orange powder and an orange aroma. It may be presented in two formats: boxes containing 2 or 5 sachets of aluminum paper.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain

Date of the last review of this prospectus:June 2020

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/.