Leaflet: information for the user

Gaviscon oral suspension in mint-flavored sachets

Sodium alginate, sodium hydrogenocarbonate (bicarbonate) and calcium carbonate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this leaflet. See section 4.
• You must see a doctor if your symptoms worsen or do not improve after 7 days.

1. What Gaviscon is and what it is used for

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

3. How to take Gaviscon

4. Possible side effects

5. Storage of Gaviscon

6. Contents of the pack and additional information

It belongs to the group of medications known as other agents against 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 is indicated for the symptomatic treatment of hyperacidity of the stomach and heartburn 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.

Do not takeGaviscon

• If you are allergic to calcium carbonate, sodium hydrogen carbonate (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 levels of calcium in your blood or low levels of phosphates in your blood.

• If you have high levels of calcium in your urine.

Warnings and precautions

Consult your doctor or pharmacist before starting 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 have to take other medications, separate your intake by 1 to 2 hours (see “Other medications and Gaviscon”).

Avoid prolonged use as it may cause kidney stones, as well as high levels of calcium in the blood or urine, kidney failure, or worsening of existing kidney failure.

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 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 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 taken recently, or may have 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 like 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, wait 2 hours before taking another oral medication. If you have taken another medication, wait 1 to 2 hours before taking Gaviscon to obtain the maximum benefit from the treatment with that other medication.

Taking Gaviscon 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 an increase in calcium levels in the blood 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 woman or breastfeeding mother takes each day, pregnant women or breastfeeding mothers cannot exceed the amounts indicated in the section “3. How to take Gaviscon” and 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 machinery

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

Gaviscon contains sodium, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

This medication contains 285.2 mg of sodium (main component of table salt/for cooking) in each 2 sachets. This is equivalent to 14.3% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 3 or more sachets daily 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 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 inadults, including the elderly and adolescents over 12 yearsis 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-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 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeGaviscon

Do not take a double dose to compensate for the missed dose.

When you need it, take it again according to the instructions 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.

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

During the period of use of the association of sodium alginate, hydrogenocarbonate (bicarbonate) of sodium 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, facial, oral or pharyngeal swelling, and anaphylactic shock.
• Increased levels of calcium in the blood, especially in people with kidney function disorders (with long-term 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 long-term 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGaviscon

• The active principles are 500 mg of sodium alginate, 267 mg of sodium hydrogenocarbonate (bicarbonate) and 160 mg of calcium carbonate.

-The other components (excipients) are carboxymethyl cellulose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium saccharin, natural peppermint flavor, sodium hydroxide and purified water..

Appearance of the product and contents of the packaging

Gavisconis a white suspension with a minty odor and taste.

It is presentedin cardboard containers with 2, 12, 24, or 30, sachets of 10 ml each.

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.

The 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/