SODIUM BICARBONATE TORRES MUÑOZ 500 mg TABLETS

Introduction

Leaflet: information for the user

SOSA TORRES MUÑOZ SODIUM BICARBONATE 500 mg tablets

Sodium bicarbonate (sodium hydrogen carbonate)

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of 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 Sosa Torres Muñoz Sodium Bicarbonate is and what it is used for
2. What you need to know before taking Sosa Torres Muñoz Sodium Bicarbonate
3. How to take Sosa Torres Muñoz Sodium Bicarbonate
4. Possible side effects
5. Storage of Sosa Torres Muñoz Sodium Bicarbonate
6. Package contents and additional information

1. What Sosa Torres Muñoz Sodium Bicarbonate is and what it is used for

Sodium bicarbonate is an antacid with activity that neutralizes excess acid in the stomach.

It is indicated for the symptomatic relief of heartburn and stomach acid in adults and adolescents from 12 years old.

You should consult a doctor if it worsens or symptoms persist for more than 7 days of treatment.

2. What you need to know before taking Sosa Torres Muñoz Sodium Bicarbonate

Do not take Sosa Torres Muñoz Sodium Bicarbonate:

• If you are allergic to sodium bicarbonate or any of the other components of this medicine (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 edema (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 produces an interruption of the passage of intestinal contents through it).

Warnings and precautions

If it worsens, symptoms persist for more than 7 days, or other symptoms appear, you should consult a doctor, as this medicine, like other antacids, may mask the symptoms of a more serious stomach disease.

Consult your doctor or pharmacist before starting to take Sosa Torres Muñoz Sodium Bicarbonate tablets if you have: hypertension (high blood pressure), liver, kidney, or heart disease, and in patients with diuretic treatment or low-sodium diets.

Interaction with analytical tests

If you are going to have any diagnostic tests (including blood tests, urine tests, detection of gastric acid secretion, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Children and adolescents

Children under 12 years old should not take this medicine.

Taking Sosa Torres Muñoz Sodium Bicarbonate with other medicines

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

Especially if you are being treated with:

• ketoconazole (used to treat fungal infections)
• quinolones, tetracyclines, acid forms of sulfonamide, erythromycin, methenamine (different classes of antibiotics)
• iron salts (medicines 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)
• amphetamines, dezanfetamine, ephedrine (central nervous system stimulants)
• cardiac antiarrhythmics
• methadone (used to relieve intense pain)
• mecamylamine (medicine for hypertension)
• lithium salts (used in some psychiatric illness)
• methotrexate (used to treat cancer and rheumatoid arthritis)
• preparations containing calcium, as it may develop the milk-alkali syndrome, whose symptoms include: excess calcium in the blood, kidney problems, heart problems, metabolic alkalosis, dizziness, vomiting, muscle cramps, apathy, headache, confusion, and anorexia.
• medicines with enteric coating (special coating to avoid stomach or duodenal discomfort), because when taken with any antacid, this coating dissolves too quickly, which could cause stomach or duodenal irritation.

In general, antacids modify the absorption of numerous medicines, so the intake of this medicine should be done at least 2 hours before or after taking any other medicine.

Taking Sosa Torres Muñoz Sodium Bicarbonate tablets with food and drinks

Do not take this medicine with milk or dairy products.

Due to its sodium bicarbonate content, this medicine should not be taken immediately after excessive food and drink, as it may cause an increase in carbon dioxide production, which could lead to gastric distension and, in rare cases, perforation of the stomach walls.

Pregnancy and breastfeeding

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 or breastfeeding.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is null or insignificant.

Sosa Torres Muñoz Sodium Bicarbonate contains sodium

Patients with low-sodium diets should note that this medicine contains 137 mg (6 mmol) of sodium per tablet.

3. How to take Sosa Torres Muñoz Sodium Bicarbonate

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

The recommended dose is:

Adults and adolescents over 12 years old:2 to 4 tablets.

Do not take more than 2 times a day.

Use in children under 12 years old:Children under 12 years old should not take this medicine.

Patients with renal insufficiency:Should consult a doctor before taking this medicine.

Always use the lowest effective dose.

How to take

This medicine should not be taken with the stomach excessively full of food or drink. You should wait between 20 minutes and 1 hour after meals before taking the medicine.

The tablets should be swallowed whole with a little water.

The intake of this medicine is subject to the appearance of gastric discomfort. As these disappear, this medication should be suspended.

If it worsens or symptoms persist for more than 7 days or other symptoms appear, you should interrupt treatment and consult a doctor. Your doctor may indicate that you take it for up to a maximum of 14 days.

If you take more Sosa Torres Muñoz Sodium Bicarbonate 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) and fluid retention.

In case of overdose or accidental ingestion, go immediately to the doctor or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible side effects

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

During the marketing period of this medicine, the following side effects have occurred, whose frequency has not been established with precision:

• Flatulence (gas in the stomach or intestine), vomiting, and rebound effect (increase in acidity produced by the medicine itself).
• If used continuously or at high doses, it may produce systemic alkalosis, whose symptoms include difficulty breathing, muscle weakness, increased muscle tone, anxiety, and other effects on the central nervous system.

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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Sosa Torres Muñoz Sodium Bicarbonate

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

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

Store in the original package to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sosa Torres Muñoz Sodium Bicarbonate:

• The active ingredient is sodium bicarbonate (sodium hydrogen carbonate). Each tablet contains 500 mg of sodium bicarbonate.
• The other components (excipients) are microcrystalline cellulose and talc.

Appearance of the product and package contents

Sosa Torres Muñoz Sodium Bicarbonate 500 mg tablets are white, biconvex, round tablets.

They are presented in aluminum blisters of 15 tablets, boxed in cardboard boxes of 30 tablets.

Marketing authorization holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 – Madrid – Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Crtra. De Irán, Km 26, 200

28700 San Sebastián de los Reyes (Madrid)

Date of the last revision of this leaflet:September 2015

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/