SALMAGNE POWDER FOR EFFEVESCENT SOLUTION

Introduction

Leaflet: information for the user

Salmagne effervescent powder

magnesium citrate, magnesium sulfate, mannitol, sodium hydrogen carbonate, and tartaric acid

Read the entire leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• 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 7 days of treatment.

Contents of the leaflet:

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

1. What Salmagne is and what it is used for

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

? Digestive alterations due to excess food or stomach acid secretion.

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

2. What you need to know before taking Salmagne Effervescent Powder

Do not take Salmagne

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have severe kidney or heart failure.
• If you are following 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 intestinal obstruction or intestinal inflammation, Crohn's disease, ulcerative colitis, or toxic megacolon.
• If you have a tendency to fluid retention or edema formation.
• If you have chronic diarrhea.

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 a colostomy.

If you have an alteration in the electrolyte balance.

Prolonged or excessive treatment may lead to metabolic alkalosis (decrease in blood and tissue acidity), so you should 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 Salmagne

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

Before taking Salmagne, 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 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 Salmagne 2 hours apart from these medications.

Interference with diagnostic tests:

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

Taking Salmagne 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 very full stomach or after drinking.

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

Breastfeeding women should consult their doctor before taking this medication.

Driving and using machines

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

This medication contains sodium and tartrazine

Salmagne contains 538.5 mg of sodium(main component of table salt/cooking salt) in each dose unit (5 g). This is equivalent to 27% of the maximum recommended daily sodium intake for an adult.

Salmagne contains tartrazine, which may cause allergic reactions.

3. How to take Salmagne

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

The recommended dose is:

Heartburn:

Take one or two dessert spoons per day, dissolved in half a glass of water. It should be administered after meals, 20 minutes to 1 hour after eating, or when symptoms occur.

Constipation:

Take two dessert spoons per day, dissolved in half to one glass of water, at bedtime, and the same dose the next day on an empty stomach, resting for a few minutes if possible.

If symptoms persist after 7 days of continuous treatment, consult your doctor to rule out more serious illnesses.

Use in children

Administration of this medication is not recommended for children under 12 years old.

Method of administration

Oral route.

Dissolve the dose to be administered in half to one glass of water, as indicated, and stir until the effervescence stops. Once dissolved in water, it should be taken immediately.

If you take more Salmagne 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 (muscle weakness)) and difficulty breathing.

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

If you forget to take Salmagne

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, Salmagne 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, along with their associated frequency:

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

• Flatulence (gas in the stomach or intestine), belching, vomiting, cramps, stomach distension, and rebound effect (increase in acidity produced by the medication itself).
• Hypernatremia (increased sodium levels in the blood).
• Hypertension (increased blood pressure) and edema (fluid retention) if used continuously or at high doses.
• Oral ingestion of sodium hydrogen carbonate has caused spontaneous gastric perforation due to gas production.
• After taking high doses for long periods or in patients with decreased kidney function, increased magnesium levels in the blood may occur.

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

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

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, 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 leaflet. 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 Salmagne

Keep the bottle tightly closed to protect it from moisture.

Keep this medication out of 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 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 SIGRE point in the pharmacy. 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.

Composition of Salmagne

A 5 g dose of effervescent powder contains:

• The active ingredients: 0.55 g of magnesium citrate, 0.20 g of magnesium sulfate, 0.25 g of mannitol, 2.03 g of sodium hydrogen carbonate, and 1.88 g of tartaric acid.
• The other components are sodium carboxymethylcellulose, sodium saccharin, and lemon flavor (corn maltodextrin, modified corn starch, tartrazine (E102)).

Appearance of the product and package contents

Salmagne is an effervescent powder, granular, fine, irregular, and homogeneous, white in color, and with a slight lemon odor.

It comes in a bottle with 125 g of effervescent powder.

Marketing authorization holder and manufacturer

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16 – 08025 Barcelona

Spain

Date of the last revision of this leaflet: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