SALCEDOL effervescent powder

Introduction

Prospectus: Information for the User

Salcedol Effervescent Powder

sodium hydrogen carbonate, tartaric acid, sodium sulfate, and potassium sulfate

Contents of the Prospectus:

1. What Salcedol is and what it is used for
2. What you need to know before taking Salcedol
3. How to take Salcedol
4. Possible side effects
5. Storage of Salcedol
6. Package contents and additional information

1. What Salcedol is and what it is used for

Salcedol is indicated in adults and adolescents over 12 years old for the treatment of symptoms related to digestive disorders:

• Acidity and heartburn.
• Constipation, when a diet high in water and daily physical exercise has not yielded satisfactory results.

2. What you need to know before taking Salcedol

Do not takeSalcedol:

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have severe kidney or heart failure.
• If you have alkalosis (decreased acidity of the blood and tissues).
• If you are on a low-sodium diet due to high blood pressure or heart failure.
• If you have appendicitis or any of its symptoms (abdominal pain associated with cramps, nausea, and vomiting).
• If you have a bloated abdomen.
• If you have intestinal obstruction or inflammation, Crohn's disease, ulcerative colitis, or toxic megacolon.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medication if you are in any of the situations described below:

If you have bloody stools, a tendency to water retention (edema), or if you are being treated with diuretics (medications that facilitate and increase urine elimination).

If you have kidney failure.

If you have heart failure.

If you have a colostomy.

If you have an electrolyte imbalance.

Prolonged or excessive treatment may lead to metabolic alkalosis (decreased acidity of the blood and tissues), so do not exceed the recommended dose.

Do not use for more than 7 consecutive days, or if symptoms persist or worsen, without consulting a doctor.

Children

Do not administer this medication to children under 12 years old.

Other medications and Salcedol

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

Before taking Salcedol, inform your doctor if you are taking any of these medications:

• Oral anticoagulants (medications used to prevent blood clotting).
• Phenytoin (medication used for epilepsy).
• Diazepam (medication used for anxiety and insomnia).
• Digitalis glycosides (medications for the heart).
• Iron salts (used to treat some anemias).
  • Antibiotics (tetracyclines, quinolones) (used to treat some infections).
• Cimetidine and ranitidine (medications for stomach ulcers).
• Amphetamines (central nervous system stimulants).
• Quinine (used for malaria).
• Ephedrine (used in medications for asthma or as a nasal decongestant in some cold medications).

Take Salcedol 2 hours apart from these medications.

Interference with diagnostic tests:

This medication interferes with tests for detecting gastric acid secretion, so do not take it on the day the tests are performed.

Taking Salcedol with food, drinks, and alcohol

Do not take this medication with milk or dairy products or with calcium. Consumption of milk and dairy products should be done at different times from taking the medication.

Do not take this medication with a full stomach.

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.

Pregnancy

Caution should be exercised when administering this medication during pregnancy.

Breastfeeding

Women who are breastfeeding should consult their doctor before taking this medication.

Driving and using machines

This medication does not affect the ability to drive or use machinery.

This medication contains sodium, potassium, and tartrazine

Salcedol contains 754.1 mg of sodium(main component of table salt/cooking salt) per unit dose (5 g). This is equivalent to 38% of the maximum daily recommended sodium intake for an adult.

Salcedol contains 44.9 mg of potassiumper unit dose (5 g), which should be taken into account in patients with renal failure or in patients with low-potassium diets.

Salcedol contains tartrazine, which may cause allergic reactions.

3. How to take Salcedol

Follow the administration instructions for this medication contained in this prospectus or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is as follows:

Adults:

Heartburn: the recommended dose is half to one dessert spoon (2.5 – 5 g) dissolved in a glass of water.

Administer 20 minutes to 1 hour after main meals or when symptoms occur.

Do not take more than twice a day.

Laxative: the recommended dose is one to two dessert spoons (5 – 10 g) dissolved in a glass of water, at bedtime, and the same dose the next day on an empty stomach, resting for a few minutes if possible.

In case of stubborn constipation, administer two dessert spoons, dissolved in half a glass of water, on an empty stomach, and repeat the same dose after one hour.

Adolescents and children over 12 years old:

Heartburn: the recommended dose is half a dessert spoon (2.5 g), dissolved in a glass of water.

Administer 20 minutes to 1 hour after main meals or when symptoms occur.

Do not take more than twice a day.

Laxative: the recommended dose is half to one dessert spoon (2.5 – 5 g), dissolved in a glass of water, at bedtime, and the same dose the next day on an empty stomach, resting for a few minutes if possible.

In case of stubborn constipation, administer one dessert spoon, dissolved in a glass of water, on an empty stomach, and repeat the same dose after one hour.

Use in children

This medication is not recommended for children under 12 years old.

Method of administration

Oral route.

Dissolve the dose to be administered in a glass of water, stir until the effervescence stops. Once dissolved in water, it should be taken immediately.

If you take moreSalcedol than you should

The main symptoms of overdose are metabolic alkalosis (headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting, occasional diarrhea, hyperirritability, and tetany) and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeSalcedol

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, Salcedol can cause side effects, although not everyone experiences them.

Used in the recommended doses, no side effects have been described.

During the period of use of this medication, the following side effects may appear with their associated frequency:

Frequency not known (frequency cannot be estimated from available data):

• Flatulence (gas in the stomach or intestine), belching, vomiting, cramps, distension (swelling) of the stomach, and rebound effect (increase in acidity produced by the medication itself).
• Hypernatremia (increased sodium levels in the blood).
• Gastric perforation, due to the gas production caused by sodium hydrogen carbonate.

Veryrare (may affect up to 1 in 10,000 patients):

• If used continuously or at high doses, it may produce systemic alkalosis, whose symptoms include difficulty breathing, muscle weakness, increased muscle tone, spasms, tetany (involuntary muscle contraction).

If used continuously or at high doses, it may produce hypertension (high blood pressure) and edema (fluid retention).

If you consider that any of the side effects you are experiencing is serious or if you notice any other side effect not mentioned in this prospectus, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Salcedol

Keep the bottle tightly closed to protect it from moisture.

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

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.

Do not use this medication if you notice that it has changed color or is clumped.

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

6. Package contents and additional information

Composition of Salcedol

A 5 g dose of effervescent powder contains:

• As active ingredients 0.4 g of sodium sulfate, 0.1 g of potassium sulfate, 2.25 g of sodium hydrogen carbonate, and 2.0 g of tartaric acid.
• The other components (excipients) are sodium carboxymethylcellulose, sodium saccharin, and lemon flavor (corn maltodextrin, modified corn starch, tartrazine (E102)).

Appearance of the product and package contents

Salcedol is an effervescent powder, white-yellow in color and with a lemon odor.

It is presented in a bottle with 125 g of effervescent powder.

Marketing authorization holder and manufacturer

Laboratory of Pharmacodynamic Applications, S.A.

Grassot, 16 – 08025 Barcelona

Spain.

Date of the last revision of this prospectus:July 2025

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