Leaflet: information for the user

Lebersal effervescent granule orange flavor

Sodium hydrogen carbonate (Bicarbonatesodium) / Anhydrous disodium phosphate

Anhydrous sodium sulfate/Anhydrous magnesium sulfate

Read this leaflet carefully before you start taking the medicine because it contains important information for you.

• Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Lebersal is indicated for the relief and treatment of symptoms related to digestive disorders such as:

• Chronic or accidental constipation
• Stomach acid reflux
• Heavy digestion
• Digestive disorders due to excessive alcohol consumption or food.

Do not takeLebersal:

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lebersal:

Lebersalwith other medications:

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

Do not administer concurrently with other oral medications as it may affect their absorption, such as tetracyclines, ketoconazole, cimetidine, ranitidine, famotidine, mecamylamine, methenamine, bisphosphonates, digoxin, indomethacin, iron salts, lithium, salicylates, and naproxen.

Due to its content of sodium bicarbonate and magnesium sulfate, it may decrease the elimination of anorexics and quinidine in urine.

Aluminum, calcium, or magnesium salts may decrease the absorption of Lebersal due to its phosphate content. On the other hand, vitamin D increases phosphate absorption, which may cause hyperphosphatemia (excess phosphate in blood).

The administration with medications affecting serum electrolytes (minerals in blood) such as diuretics, calcium channel blockers, lithium treatment, may lead to elevated levels in blood of phosphate (hyperphosphatemia), sodium (hypernatremia), magnesium (hypermagnesemia), and low levels of calcium (hypocalcemia).

Additionally, taking it with calcium supplements may increase the risk of ectopic calcification (deposits of calcium salts in extra-skeletal tissues).

In any case, if these medications need to be taken, they should be separated by at least two hours.

Lebersalwith food and beverages

Do not take with a full stomach of food or drink, as it may cause an increase in carbon dioxide production, leading to gastric distension and, in rare cases, may perforate the stomach walls.

Pregnancy, lactation, and fertility

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

This medication is not recommended during pregnancy. The presence of sodium bicarbonate in Lebersal may induce metabolic alkalosis (disorder of water and mineral balance in blood), water retention, and weight gain, both in the mother and the fetus.

This medication is not recommended during lactation, as it is unknown whether Lebersal is excreted in breast milk.

Driving and operating machinery

No effects of Lebersal on the ability to drive vehicles or operate machinery have been described.

Lebersalcontains sodium

This medication contains 470 mg of sodium (main component of table salt/for cooking) in 2.5 grams. This is equivalent to 24% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need a spoonful or more daily for a prolonged period, especially if you have been recommended a low-sodium diet.

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

Lebersal is administered orally.

The recommended dose is 1 or 2 teaspoons (2.5 or 5 g) in the morning or before main meals. The granule is poured into a half glass of water.

It can be taken before or after the effervescence.

It is recommended not to take more than 4 teaspoons per day.

If you take moreLebersalthan you should

Consult your doctor or pharmacist immediately. Doses above the recommended levels ofLebersalmay cause diarrhea, headaches, nausea, vomiting, abdominal cramps, weakness, loss of appetite. At very high doses, in prolonged treatments, it may lead to metabolic alkalosis.

The treatment you will receive will be aimed at alleviating symptoms and restoring balance in the content ofwaterandelectrolytesin the blood.

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/ingested.

If you forgot to takeLebersal

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Used at the recommended dosage, no adverse effects have been described.

In cases of renal insufficiency (kidney failure), high levels of phosphate (hyperphosphatemia), sodium (hypernatremia), magnesium(hypermagnesemia) in the blood may occur, as well as low levels of calcium (hypocalcemia). The frequency of these adverse effects is unknown.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

KeepLebersalout of sight and reach of children.

Keep the bottle perfectly closed to protect it from humidity.

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

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofLebersal

• The active principles are: Sodium hydrogen carbonate (Sodium bicarbonate) (39.30 g), anhydrous disodium phosphate (8.28 g), anhydrous sodium sulfate (3.15 g) and anhydrous magnesium sulfate (0.99 g).
• The other components are: Tartaric acid, sodium carbonate, orange essence and saccharin.

Appearance of the product and content of the packaging

Lebersalis an effervescent granule for oral use. It is presented in a bottle containing 100 g of white effervescent granule, with an orange flavor.

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 thisleaflet:June 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/