Leaflet: information for the user

Gaviscon Forte oral suspension in sachets

Sodium alginate,sodium hydrogenocarbonate (bicarbonate) and calcium carbonate

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

2. What you need to know before you start taking Gaviscon Forte

3. How to take Gaviscon Forte

4. Possible side effects

5. Storage of Gaviscon Forte

6. Contents of the pack and additional information

It belongs to the group of medicines known as other agents for peptic ulcers and gastroesophageal reflux.

It acts in two different ways:

1. Sodium alginate together with sodium hydrogenocarbonate (bicarbonate) and calcium carbonate form a protective barrier in the stomach to prevent gastric reflux and calm heartburn in the stomach.

2. Sodium hydrogenocarbonate (bicarbonate) and calcium carbonate additionally neutralize excess acid in the stomach.

Gaviscon Forte is indicated for the symptomatic treatment of hyperacidity of the stomach andtheheartburn caused by the acidic reflux of the stomachinadultsandadolescentsolderthan12years.

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

Do not take Gaviscon Forte:

• If you are allergic to calcium carbonate, sodium hydrogenocarbonate (bicarbonate), sodium alginate, or any of the other components of this medication (listed in section 6).
• If you havesevere kidney insufficiency or suffer from kidney stones.
• If you have elevated blood calcium levels or low blood phosphate levels.
• Ifyou havehigh levels of calcium 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 need to take other medications, separate your intake by 1 to 2 hours (see"Other Medications and Gaviscon Forte").

Avoid prolonged use as it may cause kidney stones, as well as high blood calcium levels or urine, kidney insufficiency, or worsening it if you already have it.

This 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.

Interference with Analytical Tests

If you are to undergo any analytical test (including blood, urine, skin tests that use 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 taken recently, 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 medicationssuch asfluorides, phosphates,sodium iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, glucocorticoids, chloroquine, diphosphonates, beta-blockers (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, wait 2 hours before taking another oral medication. If you have taken another medication, wait 1 to 2 hours before taking Gaviscon Forte to obtain the maximum benefit of treatment with that other medication.

Taking Gaviscon Forte with Food and Drinks

Like all calcium-containing antacids, 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).

Fertility, Pregnancy, and Breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 woman or breastfeeding mother takes daily, pregnant women or breastfeeding mothers cannot exceed the amounts indicated in the section3. How to Take Gaviscon Forteand cannot take, at the same time, large amounts of dairy products and milk (1 liter of milk contains 1.2 grams of elemental calcium).

Driving and Operating Machines

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

Gaviscon Forte contains sodium, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

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

Consult your doctor if you need 3 sachets or more per day for a prolonged period, especially if you have been recommended a low-sodium diet.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults, including older adults and adolescents over 12 years, 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 on low-sodium diets (see section 2).

How to Take:

This medication is taken orally.

Open the sachet and take directly from the sachet.

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

If You Take More Gaviscon Forte Than 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 visit 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 compensate for the missed dose.

When needed, take it again as indicated in the section3. How to Take Gaviscon.If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of the association of sodium alginate, sodium hydrogenocarbonate (bicarbonate) and calcium carbonate, the following adverse effects have been observed with the following frequencies:

Unknown frequency (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 levels of calcium in the blood, 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 levels of calcium in the blood (with prolonged use and high doses).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 30°C.Norefrigerateorfreeze.

Medicines should not be disposed of through drains or in the trash.

Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Gaviscon

The active principles are 500 mg of sodium alginate, 213 mg of sodium hydrogenocarbonate (bicarbonate) and 325 mg of calcium carbonate.

The other components (excipients) are carboxymethyl cellulose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium saccharin, peppermint flavor no. 2, sodium hydroxide and purified water.

Appearance of the product and contents of the packaging

Gaviscon is a white suspension with a minty odor and taste.

It is presented in cardboard containers with 2, 12, 24, or 30 sachets, each containing 10 ml.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Last review date of this leaflet: August 2020.

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