Salmagne effervescent powder
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package 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 you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
Contents of the leaflet:
- What Salmagne is and what it is used for
- What you need to know before taking Salmagne
- How to take Salmagne
- Possible adverse effects
- How to store Salmagne
- Contents of the pack and other information
1. What Salmagne is and what it is used for
Salmagne is indicated in adults and adolescents over 12 years of age for the treatment of symptoms related to the following digestive disorders:
? Digestive disturbances due to excessive food intake or excessive gastric acid secretion.
? Constipation, when a diet high in water and daily physical exercise have 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 substances or to any of the other components of this medicine (listed in section 6).
- If you have severe kidney or heart failure.
- 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 intestinal obstruction or intestinal inflammation, Crohn's disease, ulcerative colitis, or toxic megacolon.
- If you are prone to fluid retention or development of edema.
- If you suffer from chronic diarrhea.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if you are in any of the following situations:
If you have bloody stools, a tendency to water retention (edema), or if you are being treated with diuretics (medications that promote and increase urine elimination).
If you have kidney failure.
If you have a colostomy.
If you have an electrolyte imbalance.
Prolonged or excessive treatment may lead to metabolic alkalosis (reduced acidity in blood and tissues); therefore, do not exceed the recommended dose.
Do not use for more than 7 consecutive days, or if symptoms persist or worsen, without consulting your doctor.
Children
Do not administer this medicine to children under 12 years of age.
Other medicines and Salmagne
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.
Before taking Salmagne, inform your doctor if you are taking any of the following medicines:
- Oral anticoagulants (medications used to prevent blood clotting).
- Phenytoin (a medication used for epilepsy).
- Diazepam (a medication used for anxiety and insomnia).
- Digitalis glycosides (medications for heart conditions).
- Iron salts (used to treat certain anemias).
- Antibiotics (tetracyclines, quinolones) (used to treat certain infections).
- Cimetidine and ranitidine (medications for ulcers).
- Amphetamines (central nervous system stimulants).
- Quinine (used for malaria).
- Ephedrine (used in asthma medications or as a nasal decongestant in some cold remedies).
The administration of Salmagne should be spaced at least 2 hours apart from these medications.
Interference with diagnostic tests:
This medicine interferes with tests for detecting gastric acid secretion; therefore, you should not take it on the day these tests are performed.
Taking Salmagne with food, drinks, and alcohol
Do not take this medicine with milk or dairy products or with calcium supplements. Consumption of milk and dairy products should occur at different times from when you take the medicine.
Do not take this medicine when your stomach is overly full of food or drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Caution should be exercised when administering this medicine during pregnancy.
Breastfeeding
Women who are breastfeeding should consult their doctor before taking this medicine.
Driving and use of machines
This medicine does not affect the ability to drive or operate machinery.
This medicine contains sodium and tartrazine
Salmagne contains 538.5 mg of sodium (a main component of table/cooking salt) per dose unit (5 g). This corresponds to 27% of the maximum recommended daily sodium intake for an adult.
Salmagne contains tartrazine, which may cause allergic-type reactions.
3. How to take Salmagne
Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Stomach acidity:
Take one or two dessertspoons per day, dissolved in half a glass of water. It should be taken after meals, from 20 minutes to 1 hour after eating, or at the time symptoms occur.
Constipation:
Take two dessertspoons per day, dissolved in half to one full glass of water, at bedtime, and the same dose the following 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 diseases.
Use in children
Administration of this medicine is not recommended for children under 12 years of age.
Method of administration
Oral use.
Dissolve the dose to be administered in half to one glass of water, as indicated, and stir until 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, tinnitus, blurred vision, drowsiness, sweating, nausea, vomiting, occasionally 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 immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Salmagne
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Salmagne may cause adverse effects, although not everyone experiences them.
When used at the recommended doses, no adverse effects have been described.
During the period of use of this medicine, the adverse effects described below may occur, together with their associated frequency:
Frequency not known (cannot be estimated from the available data):
- Flatulence (gas in the stomach or intestine), belching, vomiting, stomach cramps, stomach distension, and rebound effect (increased acidity caused by the medicine itself).
- Hypernatraemia (increased sodium levels in the blood).
- Hypertension (increased blood pressure) and oedema (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 over long periods or in patients with reduced kidney function, an increase in 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, systemic alkalosis may occur, whose symptoms include difficulty breathing, muscle weakness, increased muscle tone, spasms, and tetany (involuntary muscle contractions).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Salmagne
Keep the bottle tightly closed to protect it from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any change in colour or if it is clumped.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6.
Composition of Salmagne
One 5 g effervescent powder dose contains:
- Active substances: 0.55 g magnesium citrate, 0.20 g magnesium sulfate, 0.25 g mannitol, 2.03 g sodium hydrogen carbonate, and 1.88 g tartaric acid.
- Other components: sodium carboxymethylcellulose, sodium saccharin, and lemon flavour (corn maltodextrin, modified corn starch, tartrazine (E102)).
Appearance of the product and contents of the container
Salmagne is an effervescent powder, granular, fine, irregular and homogeneous, white in colour with a slight lemon odour.
It is supplied in a bottle containing 125 g of effervescent powder.
Marketing Authorization Holder and Manufacturer
Laboratorio de Aplicaciones Farmacodinámicas, S.A.
Grassot, 16 – 08025 Barcelona
Spain
Date of the most recent revision of this package leaflet: July 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es