SODIUM BICARBONATE TORRES MUÑOZ ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

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SODA BICARBONATE TORRES MUÑOZ powder for oral solutionSodium bicarbonate (sodium hydrogen carbonate)

Read the entire package leaflet carefully before starting to take this medication, because

it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Package Leaflet Contents

1. What Soda Bicarbonate Torres Muñoz is and what it is used for
2. What you need to know before taking Soda Bicarbonate Torres Muñoz
3. How to take Soda Bicarbonate Torres Muñoz
4. Possible side effects
5. Storage of Soda Bicarbonate Torres Muñoz
6. Package Contents and Additional Information

1. What Soda Bicarbonate Torres Muñoz 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 Soda Bicarbonate Torres Muñoz

Do not take Soda Bicarbonate Torres Muñoz:

• If you are allergic to sodium bicarbonate.
• 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 because, as with other antacids, this medication may mask the symptoms of a more serious stomach disease.

Consult your doctor or pharmacist before starting to take Soda Bicarbonate Torres Muñoz if you have: high blood pressure, liver, kidney, or heart disease, or if you are being treated with diuretics or on a low-sodium diet.

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 medication, as it may alter the results.

Children and Adolescents

Children under 12 years old should not take this medication.

Taking Soda Bicarbonate Torres Muñoz with Other Medications

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

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 (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)
• amphetamines, dezanfetamine, ephedrine (central nervous system stimulants)
• cardiac antiarrhythmics
• methadone (used to relieve intense pain)
• mecamylamine (medication for hypertension)
• lithium salts (used in some psychiatric diseases)
• 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.
• medications 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 medications, so the intake of this medication should be done at least 2 hours before or after taking any other medication.

Taking Soda Bicarbonate Torres Muñoz with Food and Drinks

Do not take this medication with milk or dairy products.

Due to its sodium bicarbonate content, this medication 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, may perforate 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 medication.

Its use is not recommended during pregnancy or breastfeeding.

Driving and Using Machines

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

Soda Bicarbonate Torres Muñoz contains Sodium

Patients on low-sodium diets should note that this medication contains 822 mg (35.9 mmol) of sodium per 3-gram dose.

3. How to take Soda Bicarbonate Torres Muñoz

Follow the administration instructions of the medication contained in this package 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:1 or 2 small coffee spoons (1 to 2 grams) dissolved in half a glass of water.

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 medication.

Patients with renal insufficiency:They should consult their doctor before taking this medication.

Always use the smallest effective dose.

How to take

Do not take this medication with a stomach that is excessively full of food or drink. Wait between 20 minutes and 1 hour after meals before taking the medication.

Dissolve the powder in half a glass of water.

Wait until the effervescence has completely stopped before taking.

The intake of this medication is subject to the appearance of gastric discomfort. As these disappear, you should suspend this medication.

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

If you take more Soda Bicarbonate Torres Muñoz 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, go immediately to the doctor or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the marketing period of this medication, 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 medication 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use.

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

5. Storage of Soda Bicarbonate Torres Muñoz

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

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

Keep in the original package.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications 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 medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Soda Bicarbonate Torres Muñoz:

• The active substance is sodium bicarbonate (sodium hydrogen carbonate). Each gram of powder contains 1 gram of sodium bicarbonate.
• The other components (excipients) are: this medication does not contain excipients.

Appearance of the Product and Package Contents

Soda Bicarbonate Torres Muñoz oral solution powder is a crystalline powder of white color.

It is presented in paper envelopes of 60 g, plastic bottles of 200 g, and plastic bags of 750 g.

Marketing Authorization Holder

Haleon Spain, S.A.

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

Manufacturer

Haupt Pharma Amareg GmbH

Donaustaufer Strasse 378

D-93055 - Regensburg, Germany

Date of the Last Revision of this Package Leaflet:September 2015

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