GAVISCON CHEWABLE TABLETS MINT FLAVOR

Introduction

Leaflet: information for the user

Gaviscon chewable tablets mint flavor

Sodium alginate, sodium hydrogen carbonate (sodium bicarbonate)

and calcium carbonate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for 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 is and what it is used for
2. What you need to know before taking Gaviscon
3. How to take Gaviscon
4. Possible side effects
5. Storage of Gaviscon
6. Package contents and additional information

1. What Gaviscon is and what it is used for

It belongs to the group of medications called other agents against 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 mouth.
2. The sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate additionally neutralize the excess acid in the stomach.

Gaviscon is indicated for the symptomatic treatment of stomach hyperacidity and burning caused by acid reflux from the stomach in adults and adolescents 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

Do not takeGaviscon

• 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 failure or suffer from kidney stones.
• If you have high blood calcium levels or low blood phosphate levels.
• If you have high calcium levels in urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if: you have mild or moderate kidney problems, you have been diagnosed with sarcoidosis (inflammation that can affect multiple organs in the body), if you suffer from constipation or hemorrhoids, or if you suffer from symptoms of stomach or intestine 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").

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 taken with milk or dairy products.

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

Children and adolescents

Gaviscon is not recommended for children under 12 years old.

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

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

Before taking Gaviscon, 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, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine, and bisphosphonates; as it may affect the efficacy of these medications.

As Gaviscon 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, you should wait 1 to 2 hours to get the maximum benefit from the treatment with that other medication.

Taking Gaviscon 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 taken for a long time.

As this medication provides a significant amount of calcium in addition to what the pregnant or breastfeeding woman takes every day, pregnant or breastfeeding women should not exceed the amounts indicated in the section "3. How to take Gaviscon" and 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 contains sodium and aspartame.

This medication contains 254.64 mg of sodium (main component of table salt/cooking salt) in each 4 tablets. This is equivalent to 12.6% 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 15 mg of aspartame in each 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.

3. How to take Gaviscon

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

The recommended dose in adults, including elderly people and adolescents 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.

Kidney failure: 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 possible more serious diseases.

If you take moreGavisconthan you should

The symptoms of overdose 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 call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeGaviscon

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

When you need it, take it again as indicated in the section "3. How to take Gaviscon".

If you have any other questions about the use of this medication, 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 association 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. Storage of Gaviscon

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

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

Do not store above 30°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 ofGaviscon

• The active ingredients are 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate (sodium bicarbonate), and 80 mg of calcium carbonate.

• The other components (excipients) are macrogol, mannitol (E421), copovidone, peppermint flavor, aspartame (E-951), acesulfame potassium (E-950), and magnesium stearate.

Appearance of the product and package contents

Gaviscon is a chewable tablet with a light cream color and slight speckling.

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

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

It is also presented in a polypropylene container in a cardboard box with its leaflet. Each container contains 12 or 20 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

Spain

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the last revision of this leaflet: August 2020.

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/