GAVISCON FORTE ORAL SUSPENSION IN SACHETS

Introduction

Package Leaflet: Information for the User

Gaviscon Forte Oral Suspension in Sachets

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

Contents of the Package Leaflet:

1. What is Gaviscon Forte and what is it 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
6. Package Contents and Additional Information

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

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

It acts in two different ways:

1. The sodium alginate along with the sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate form a protective barrier in the stomach to prevent gastric reflux, calming the burning sensation in the stomach.
2. The sodium hydrogen carbonate (sodium bicarbonate) and calcium carbonate also 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 adolescents over 12 years of age.

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 medicine (listed in section 6).
• If you have severe kidney failure or suffer from kidney stones.
• If you have high levels of calcium in the blood or low levels of phosphates in the blood.
• If you have high levels of calcium in the urine.

Warnings and Precautions

Consult your doctor or pharmacist before taking this medicine 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 intestinal diseases, appendicitis, or edema.

If you are taking or are going to take other medicines, you should separate their intake by 1 to 2 hours (see "Other medicines 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 levels of calcium in the blood or urine, kidney failure, or worsen it if you already have it.

The medicine 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 medicine, as it may alter the results.

Other Medicines and Gaviscon Forte

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

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

As Gaviscon Forte may interfere with some medicines, after taking it, you should wait 2 hours before taking another oral medicine. If you have taken another medicine, before taking Gaviscon Forte, you should wait 1 to 2 hours to get the maximum benefit from the treatment with that other medicine.

Taking Gaviscon Forte with Food and Drinks

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

Fertility, Pregnancy, and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

As this medicine 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 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 medicine does not affect the ability to drive or use machines.

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

This medicine contains 255.76 mg of sodium (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 a prolonged period, especially if you have been recommended a low-salt diet (sodium).

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

3. How to take Gaviscon Forte

Follow exactly the administration instructions of the medicine 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 of age, is 1 to 2 sachets, as needed, 1 hour after meals and before bedtime. A maximum of 8 sachets can be taken per day.

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

How to take:

This medicine 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 possible more serious diseases.

If you take more Gaviscon Forte than you should

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 go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 the section 3. How to take Gaviscon Forte. If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the 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 high levels of calcium in the blood (with prolonged use and high doses).

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gaviscon Forte

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

Do not use this medicine 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 above 30°C. Do not refrigerate or freeze.

Medicines should not be disposed of through wastewater or household waste.

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

6. Package Contents and Additional Information

Composition of Gaviscon Forte

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

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

Appearance of the Product and Package Contents

Gaviscon Forte is a white suspension with a peppermint odor and flavor

It comes in cardboard boxes with 2, 12, 24, or 30 sachets, each containing 10 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

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 medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/