GAVISCON FORTE ORAL SUSPENSION IN SACHETS, FOREST FRUITS FLAVOR

Introduction

Leaflet:information for the user

Gaviscon Forte oral suspension in sachets with 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 this medication exactly as stated 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do 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 Storage 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 known as other agents for peptic ulcer and gastroesophageal reflux.

It acts in two different ways:

1. Sodium alginate, along with sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate, forms a protective barrier in the stomach to prevent gastric reflux, soothing the burning sensation in the stomach.
2. 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 of age.

You should consult a doctor if your symptoms worsen or do 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 your 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 experience symptoms of stomach or intestinal diseases, appendicitis, or edema.

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

Avoid prolonged use, as it can cause kidney stones, and high doses over a long period can also cause high blood calcium levels, kidney failure, or worsen existing kidney failure.

The medication should not be taken 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 of age.

Interference with laboratory tests

If you are going to have any laboratory tests (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, antifungals like 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 oral medication. If you have taken another medication, before taking Gaviscon Forte, you should wait 1 to 2 hours to get 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 can be used during pregnancy and breastfeeding if taken according to these recommendations and not for an extended period.

As this medication provides a significant amount of calcium in addition to the daily intake of pregnant or breastfeeding women, these women should not exceed the recommended amounts stated in section 3, "How to take Gaviscon Forte," and should not consume large amounts of dairy products and milk (1 liter of milk contains 1.2 grams of elemental calcium) at the same time.

Driving and using machines

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

Gaviscon Forte contains methylparaben, propylparaben, propylene glycol, and sodium

This medication may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

This medication contains 64.54 mg of propylene glycol (E-1520) in each 2 sachets (20 ml).

This medication contains 255.76 mg of sodium (the main component of table salt/cooking salt) in each 2 sachets (20 ml). This is equivalent to 12.8% of the maximum recommended daily sodium intake for an adult.

Consult your doctor if you need 3 sachets or more per day for an extended period, especially if you have been advised to follow a low-salt diet.

3. How to take Gaviscon Forte

Follow the administration instructions for this medication exactly as stated 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 the elderly and children over 12 years of age, is 1 to 2 sachets, as needed, 1 hour after meals and before bedtime. You can take a maximum of 8 sachets per day.

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

How to take

This medication is taken orally.

Open the sachet and take it directly from the sachet.

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 further questions 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 may 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 elevated blood calcium levels (with prolonged use and high doses).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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. Storage of Gaviscon Forte

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

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

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

Do not store above 30°C. Do not refrigerate or freeze.

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

6. Package contents and additional information

Gaviscon Forte composition

• Each 10 ml sachet contains 500 mg of sodium alginate, 213 mg of sodium hydrogen carbonate (sodium bicarbonate), and 325 mg of calcium carbonate.

• The other components (excipients) are carbomer, methylparaben (E-218), propylparaben (E-216), sodium saccharin, blueberry flavor, raspberry flavor, fruit flavor, sodium hydroxide, and purified water. The flavors contain propylene glycol (E-1520).

Appearance of the product and package contents

Gaviscon is a white, suspensoid liquid with a forest fruit flavor and aroma.

It is available in cardboard packages with 4, 12, 24, or 48 sachets of 10 ml each.

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/)