Label: information for the user

ALKA-SELTZER2,1 geffervescent tablets

Sodium hydrogen carbonate

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 not listed in this label. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

It belongs to the group of medications called antacids that act by reducing excess stomach acidity.

This medicationis indicated for symptomatic relief of stomach acid and heartburn in adults and adolescents 12 years of age and older.

Do not take ALKA-SELTZER:

• If you are allergic to sodium bicarbonate or any of the other components of this medication (listed in section 6).
• If you have metabolic or respiratory alkalosis.
• If you have hypocalcemia.
• If you have hypochlorhydria.
• If you have a tendency to form edemas (fluid retention).
• If you have appendicitis or its symptoms (nausea, vomiting, cramps, abdominal pain).
• If you have intestinal obstruction (partial or total blockage of the intestine that interrupts the passage of intestinal content).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Alka-Seltzer.

Like other antacids, this medication may mask the symptoms of a more serious stomach disease, so if symptoms persist or worsen after 14 days of treatment, you should consult your doctor.

Use this medication with caution in patients with hypertension (elevated blood pressure), patients with liver, kidney, and heart diseases, edema, hypopotasemia, hypocalcemia, and aldosteronism (a syndrome associated with increased secretion of aldosterone hormone by the adrenal gland), and in patients taking diuretics, as it may cause hypochloremic alkalosis.

The use of Alka-Seltzer at high doses or for prolonged periods may cause metabolic alkalosis.

Due to its citric acid content, use this medication with caution in patients with uric acid stones, as it may promote the formation of calcium stones.

Children and adolescents:

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

Taking Alka-Seltzer with other medications:

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

This is especially important in the case of:

• ketoconazole (used to treat fungal infections)
• quinolones, tetracyclines (especially doxycycline), acidic forms of sulfonamide, erythromycin, methenamine (different classes of antibiotics)
• iron salts (medications used to prevent or treat anemia)
• naproxen, salicylates (used to treat pain and fever)
• valproic acid (used to treat epilepsy)
• levodopa (used to treat Parkinson's disease)
• amphetamine, dextroamphetamine, ephedrine (central nervous system stimulants)
• antiarrhythmic cardiac medications
• methadone (used to relieve intense pain)
• mecamilamine (medication for hypertension)
• lithium salts (used in some psychiatric diseases)
• barbiturates
• methotrexate (used to treat cancer and rheumatoid arthritis)

• preparations containing calcium, as it may cause milk-alkali syndrome, whose symptoms are: hypercalcemia, kidney problems, heart problems, metabolic alkalosis, dizziness, vomiting, muscle cramps, apathy, headache, confusion, and anorexia.

Like other antacids, this medication, when taken with enteric-coated medications, may cause the coating to dissolve too quickly, leading to gastric or duodenal irritation.

Antacids modify the absorption of numerous medications, so, in general, their administration should be separated from any other medication.In general, this medication should be taken at least 2 hours before or after the administration of any other medication.

Inform your doctor or pharmacist if you are taking, or have taken recently, any other medication, including those acquired without a prescription.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, gastric acid secretion tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking ALKA-SELTZER with food and beverages:

Do not take this medication with milk or dairy products.

Due to its sodium bicarbonate content, do not take this medication immediately after excessive food and drink, as it may cause an increase in carbon dioxide production, leading to gastric distension and, in rare cases, perforation of the stomach walls.

Pregnancy, lactation, and fertility:

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

Driving and operating machines:

No effects of Alka-Seltzer on the ability to drive and operate machines have been described.

Alka-Seltzer contains Sodium and Aspartame (E-951).

This medication contains 570 mg of sodium (main component of table salt/for cooking) in each effervescent tablet. This is equivalent to 28.5% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need 6 or more effervescent tablets daily for a prolonged period, especially if you have been recommended a low-sodium diet.

This medication contains 10 mg of aspartame in each effervescent tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

This medication is administered orally.

The recommended dose is:

Adults and adolescents 12 years and older: The usual dose is 1 effervescent tablet, if necessary increase to 2, after meals or when experiencing gastrointestinal discomfort.

Do not exceed 6 tablets per day.

Individuals 65 years and older: Do not exceed 3 tablets per day.

Patients with renal insufficiency

They must consult their doctor before taking this medication.

Use in children and adolescents

Do not use in children under 12 years

Always use the smallest effective dose.

If you estimate that the action of ALKA-SELTZER is too strong or too weak, inform your doctor or pharmacist.

This medication should not be taken with an excessively full stomach.Wait between 20 minutes and 1 hour after meals before taking the medication.It is necessary to wait always until the effervescent tablet has completely dissolved in water and the bubbling has stopped, before taking it. Consult your doctor if you observe strong stomach pain immediately after taking the medication.

The administration of this preparation is subject to the appearance of gastrointestinal discomfort. As these symptoms disappear, this medication should be discontinued.

If symptoms persist for more than 14 days or worsen, or if other symptoms appear, treatment should be interrupted and the doctor consulted.

If you take more ALKA-SELTZER than you should

The main symptoms of overdose are metabolic alkalosis (headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting, occasionally diarrhea, hyperirritability, and tetany (muscle weakness)) and fluid retention.

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

If you forgot to take ALKA-SELTZER:

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

Like all medications, Alka-Seltzer may produce adverse effects, although not everyone will experience them.

Adverse reactions are listed in decreasing order of severity within each frequency range.

The convention used for defining frequencies is as follows: very common (≥1/10); common (≥1/100 to <1

Unknown frequency (frequency cannot be estimated from available data):Flatulence (gas in the stomach or intestines), belching, vomiting, nausea, stomach distension, and rebound effect (increase in acidity produced by the medication itself).

Hypokalemia (decrease in potassium level in blood) and hypernatremia (increase in sodium level in blood).

Continuous use or high doses may produce systemic alkalosis, whose symptoms include difficulty breathing, muscle weakness, increased muscle tone, spasms, tetany (involuntary muscle contractions), especially with hypercalcemia, anxiety, and other effects on the central nervous system.

Hypertension (increase in blood pressure) and edema (fluid retention) with continuous use or high doses.

Unknown frequency, oral ingestion of sodium hydrogen carbonate has caused spontaneous gastric perforation due to gas production.

Excessive oral administration of medications containing citrate salts may have a laxative effect.

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: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

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

Keep the container perfectly closed.

Do not use Alka-Seltzer after the expiration date that appears on the container, after the abbreviation 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 containers 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 containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Alka-Seltzer

• The active ingredient is Sodium Hydrogen Carbonate. Each effervescent tablet contains2.1 g(2081.8 mg) of sodium hydrogen carbonate (sodium bicarbonate).
• The other components (excipients) are citric acid, aspartame (E-951), mannitol (E-421), potassium acesulfame, lemon-lime flavor, vanilla flavor, and amiflex (a compound of amino acids, glutamic acid, and sodium chloride).

Appearance of the product and contents of the packaging:

This medication iseffervescent tablets, round, and white in color. They are presented in packaging of 10 or 20 effervescent tablets.

Some packaging sizes may not be marketed.

The holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

BAYER BITTERFELD GmbH

OT Greppin

Salegaster Chaussee, 1

06803 Bitterfeld-Wolfen

Germany

Date of the last review of this leaflet: September 2019

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