LEBERSAL GRANULATED EFFEVESCENT ORANGE FLAVORED

Introduction

Leaflet: information for the user

Lebersal orange-flavored effervescent granules

Sodium hydrogen carbonate (Sodium bicarbonate) / Anhydrous disodium phosphate

Anhydrous sodium sulfate / Anhydrous magnesium sulfate

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

• Follow the administration instructions for the medicine contained in this leaflet or as 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 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.

Contents of the leaflet

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

1. What Lebersal is and what it is used for

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

• Chronic or accidental constipation
• Heartburn
• Heavy digestion
• Digestive disorders due to excess alcohol or food consumption.

2. What you need to know before taking Lebersal

Do not takeLebersal:

• If you are allergic to sodium bicarbonate, anhydrous disodium phosphate, anhydrous sodium sulfate, anhydrous magnesium sulfate, or any of the other components of this medicine (listed in section 6).
• If you have an electrolyte imbalance (alteration of water or electrolyte content), hypernatremia (elevated sodium levels in the blood), or diarrheal processes.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lebersal:

• If you have heart failure.
• If you have kidney failure (kidney disease).
• If you are prone to water retention (edema).
• If you are on a low-sodium diet.
• If you have high blood pressure.
• During treatment with diuretics (medicines that increase urine elimination).
• If you are pregnant or breastfeeding.

Taking Lebersal with other medicines:

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

It should not be administered concurrently with other oral medicines, as it may affect their absorption, such as tetracyclines, ketoconazole, cimetidine, ranitidine, famotidine, mecamylamine, methenamine, bisphosphonates, digoxin, indomethacin, iron salts, lithium, salicylates, and naproxen.

As it contains sodium bicarbonate and magnesium sulfate, it may decrease the urinary elimination of amphetamines and quinidine.

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

Administration with medicines that affect serum electrolytes (minerals found in blood), such as diuretics, calcium channel blockers, lithium treatment, may lead to elevated blood levels of phosphate (hyperphosphatemia), sodium (hypernatremia), magnesium (hypermagnesemia), and low calcium levels (hypocalcemia).

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

In any case, if it is necessary to take these medicines, the doses should be separated by at least two hours.

Taking Lebersal with food and drinks

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

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 medicine.

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

Its use is not recommended during breastfeeding, as it is unknown whether Lebersal is excreted in breast milk.

Driving and using machines

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

Lebersal contains sodium

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

Consult your doctor or pharmacist if you need a spoonful or more per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take Lebersal

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Lebersal is administered orally.

The recommended dose is 1 or 2 spoonfuls (2.5 or 5 g) on an empty stomach or before main meals. The granules are poured into a half-glass of water.

It can be taken before or after effervescence.

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

If you take moreLebersalthan you should

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

The treatment will be aimed at alleviating the symptoms and recovering the balance of water and electrolytes in the blood.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used/ingested.

If you forget to takeLebersal

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

When used at the recommended dosage, no side effects have been described.

In case of kidney failure, high blood levels of phosphate (hyperphosphatemia), sodium (hypernatremia), magnesium (hypermagnesemia), and low calcium levels (hypocalcemia) may occur. The frequency of these side effects is unknown.

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 Medicines and Health Products Agency (AEMPS) website: http://www.aemps.gob.es/

5. Storage of Lebersal

Keep Lebersal out of the sight and reach of children.

Keep the bottle perfectly closed to protect it from moisture.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofLebersal

• The active ingredients 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 ingredients are: Tartaric acid, sodium carbonate, orange flavor, and saccharin.

Appearance of the product and package contents

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

Marketing authorization holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Manufacturer

LABORATORIOS ERN, S.A.

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

Date of the last revision of thisleaflet:June 2021

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