GAVISCON FORTE CHEWABLE TABLETS WILD BERRY FLAVOR

Introduction

Leaflet:information for the user

Gaviscon Forte chewable tablets forest fruit flavor

Sodium alginate, sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate

Read the entire leaflet carefullybefore starting to take thismedication,as it contains important informationfor you

Follow the administration instructions for the medication 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 Gaviscon Forte is and what it is used for
2. What you need to know before taking Gaviscon Forte
3. How to take Gaviscon Forte
4. Possible side effects

5 Conservation of Gaviscon Forte

1. Package contents and additional information

1. What Gaviscon Forte is and what it is used for

It belongs to the group of medications called other agents for peptic ulcer and gastroesophageal reflux.

It acts in two distinct ways:

1. The sodium alginate along with sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate form a protective barrier in the stomach to prevent gastric reflux, calming the burning in the stomach.
2. The sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate neutralize excess acid in the stomach.

Gaviscon Forte is indicated for the symptomatic treatment of stomach hyperacidity and heartburn caused by acid reflux from the stomach in adults and children over 12 years old.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Gaviscon Forte

Do not take Gaviscon Forte

• If you are allergic to calcium carbonate, sodium hydrogen carbonate (sodium bicarbonate), sodium alginate, or any of the other components of this medication (listed in section 6).
• If you have severe kidney disease or suffer from kidney stones.
• If you have high blood calcium levels or low blood phosphate levels.
• If you have high calcium levels in the urine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication if you have mild or moderate kidney problems, have been diagnosed with sarcoidosis (inflammation that can affect multiple organs in the body), suffer from constipation or hemorrhoids, or suffer from symptoms of stomach or intestinal diseases, appendicitis, or edema.

If you are taking or are going to take other medications, you should separate their intake by 1 to 2 hours (see "Other medications and Gaviscon Forte").

Avoid prolonged use as it can cause kidney stones, as well as high doses over a long period, which can also cause high blood calcium levels or urine, kidney failure, or worsen it if you already have it.

The medication should not be administered with milk or dairy products.

If symptoms persist after 7 days of treatment, consult your doctor.

Children and adolescents

Gaviscon Forte is not recommended for children under 12 years old.

Interference with analytical tests

If you are going to undergo any analytical test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Gaviscon Forte

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

Before taking this medication, inform your doctor if you are taking antibiotics (tetracyclines, quinolones), heart medications such as cardiac glycosides (digoxin, digitoxin), or other medications such as fluorides, phosphates, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, glucocorticoids, chloroquine, bisphosphonates, beta-blocker medications (atenolol, metoprolol, propranolol), or estramustine, as it may affect the efficacy of these medications.

As Gaviscon Forte may interfere with some medications, after taking it, you should wait 2 hours before taking another medication orally. If you have taken another medication, before taking Gaviscon Forte, you should wait 1 to 2 hours to obtain the maximum benefit from the treatment with that other medication.

Taking Gaviscon Forte with food and drinks

Like all antacids that contain calcium, this medication should not be taken with large amounts of milk or dairy products, as it may cause increased blood calcium levels and milk-alkali syndrome (Burnett syndrome).

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 medication.

This medication may be used during pregnancy and breastfeeding if taken according to these recommendations and not taken for a long time.

As this medication provides a significant amount of calcium in addition to what the pregnant or breastfeeding woman takes each day, pregnant or breastfeeding women should not exceed the indicated amounts in section 3. How to take Gaviscon Forteand should not take large amounts of dairy products and milk at the same time (1 liter of milk contains 1.2 grams of elemental calcium).

Driving and using machines

This medication does not affect the ability to drive or use machines.

Gaviscon Forte contains sodium, aspartame, azorubine, and sucrose

This medication contains 223.7 mg of sodium (main component of table salt/cooking salt) per 4 tablets. This is equivalent to 11.2% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need 7 or more tablets per day for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

This medication contains 23.44 mg of aspartame (E-951) per 4 tablets.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication may cause allergic reactions because it contains azorubine (E-122).

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Gaviscon Forte

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

The recommended dose in adults, including elderly people and children over 12 years old, is 2 to 4 tablets, as needed, 1 hour after meals and before bedtime. You can take a maximum of 16 tablets per day.

Renal insufficiency: Caution is required in patients with low-salt diets (see section 2).

How to take

This medication is taken orally.

Remove the tablets from the packaging and chew them.

If symptoms persist after 7 days of continuous treatment, consult your doctor to rule out more serious diseases.

If you take more Gaviscon Forte than you should

Overdose symptoms include nausea and vomiting, constipation, fatigue, increased urine production, thirst, dehydration, and abnormal muscle weakness.

Drink plenty of water and consult your doctor or pharmacist.

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

If you forget to take Gaviscon Forte

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

When you need it, take it again as indicated in section 3. How to take Gaviscon. If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

During the use of the combination of sodium alginate, sodium hydrogen carbonate (sodium bicarbonate), and calcium carbonate, the following side effects have been observed with the following frequencies:

Frequency not known (frequency cannot be estimated from available data):

• Allergic reactions, such as skin rashes and itching, difficulty breathing, and swelling of the face, mouth, or throat, and anaphylactic shock.

• Increased blood calcium levels, especially in people with kidney function disorders (with prolonged use and high doses).
• Constipation, nausea, vomiting, fatigue, confusion, increased urine production, thirst, and dehydration (alkalosis) (with prolonged use and high doses).
• Milk-alkali syndrome (Burnett syndrome) that can cause high blood calcium levels (with prolonged use and high doses).

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 Medication Surveillance System for Human Use www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Gaviscon Forte

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD.

The expiration date is the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Gaviscon Forte

• The active ingredients are 250 mg of sodium alginate, 106.5 mg of sodium hydrogen carbonate (sodium bicarbonate), and 187.5 mg of calcium carbonate.
• The other components (excipients) are xylitol, sodium carmellose, magnesium stearate, macrogol, mannitol (E-421), copovidone, acesulfame potassium, aspartame (E-951), blueberry flavor, raspberry flavor, fruit flavor, and azorubine (E-122). The flavors contain sucrose.

Appearance of the product and package contents

Gaviscon Forte are chewable tablets, flat, circular, with flavor and forest fruit flavor. One layer of the tablet is pink and slightly speckled, and the other is white.

It is presented in a transparent, unprinted PVC/PE/PVdC blister pack with an aluminum foil sheet, in a cardboard box with its leaflet.

Each package may contain 4, 24, 32, 48, and 64 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reckitt Benckiser Healthcare, S.A.

C/Mataró, 28 08403

Granollers Barcelona-Spain

Manufacturer

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol,

Netherlands

Date of the last revision of this leaflet: November 2024

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