Gaviscon Forte chewable tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Gaviscon Forte Chewable Tablets
Sodium alginate, sodium hydrogen carbonate (bicarbonate) and calcium carbonate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
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Contents of the leaflet:
- What Gaviscon Forte is and what it is used for
- What you need to know before taking Gaviscon Forte
- How to take Gaviscon Forte
- Possible side effects
- Storage of Gaviscon Forte
- Contents of the pack and further information
1. What Gaviscon Forte is and what it is used for
It belongs to the group of medicines known as other agents for peptic ulcer and gastroesophageal reflux.
It works in two different ways:
- Sodium alginate together with sodium hydrogen carbonate (bicarbonate) and calcium carbonate form a protective barrier in the stomach to prevent gastric reflux, relieving heartburn.
- Sodium hydrogen carbonate (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 adolescents over 12 years of age.
You should consult a doctor if 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 (bicarbonate), sodium alginate, or any of the other components of this medicine (listed in section 6).
- If you have severe kidney impairment or suffer from kidney stones.
- If you have high levels of calcium in your blood or low levels of phosphate in your blood.
- If you have elevated levels of calcium in your 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 (an inflammatory condition that can affect multiple organs in the body), if you suffer from constipation or haemorrhoids, or if you experience symptoms of stomach or intestinal diseases, appendicitis, or oedema.
If you are taking or need to take other medicines, you should separate their administration by 1 to 2 hours (see "Other medicines and Gaviscon Forte").
Avoid prolonged use, as it may lead to kidney stones. Likewise, high doses over a long period may cause kidney stones, elevated calcium levels in blood or urine, kidney failure, or worsen pre-existing kidney impairment.
This 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 scheduled to undergo any laboratory tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Other medicines and Gaviscon Forte
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.
Before taking this medicine, inform your doctor if you are taking antibiotics (tetracyclines, quinolones), heart medications 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 this medicine may affect the efficacy of these drugs.
Since Gaviscon Forte may interfere with certain medicines, you should wait 2 hours after taking it before taking any other oral medicine. If you have taken another medicine, wait 1 to 2 hours before taking Gaviscon Forte to ensure maximum benefit from the other medicine.
Taking Gaviscon Forte with food and drinks
Like all calcium-containing antacids, this medicine should not be taken with large amounts of milk or dairy products, as this may lead to increased calcium levels in the blood and the development of milk-alkali syndrome (Burnett's syndrome).
Fertility, pregnancy, and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy and breastfeeding if taken according to these recommendations and not taken for prolonged periods.
Since this medicine provides a significant amount of calcium in addition to the daily intake of pregnant or breastfeeding women, such women must not exceed the doses indicated in section 3. How to take Gaviscon Forte, and must not simultaneously consume large amounts of dairy products and milk (1 litre of milk contains 1.2 grams of elemental calcium).
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Gaviscon Forte contains sodium, aspartame, azorubine, and mannitol.
This medicine contains 223.56 mg of sodium (a main component of table/cooking salt) in each 4 tablets. This corresponds to 11.2% of the maximum daily sodium intake recommended for an adult.
Consult your doctor or pharmacist if you need to take 7 or more tablets daily over a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.
This medicine contains 23.44 mg of aspartame in each 4 tablets.
Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine may cause allergic reactions because it contains azorubine (E-122). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.
It may produce a mild laxative effect due to the presence of mannitol.
3. How to take Gaviscon Forte
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose for adults, including elderly people and adolescents over 12 years of age, is 2 to 4 tablets as needed, 1 hour after meals and before going to bed. The maximum dose is 16 tablets per day.
Renal insufficiency: caution is required in patients on low-salt diets (see section 2).
How to take
This medicine 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 more serious conditions.
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, go to a medical center, or call the Toxicology Information Service at telephone number: 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 missed doses.
When needed, resume taking it 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed during the use of the combination of sodium alginate, sodium hydrogen carbonate (bicarbonate), and calcium carbonate, 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, swelling of the face, mouth or throat, and anaphylactic shock.
- Increased levels of calcium in the blood, especially in people with impaired kidney function (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's syndrome), which may cause elevated calcium levels in the blood (with prolonged use and high doses).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse 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 expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Gaviscon Forte
The active substances are 250 mg of sodium alginate, 106.5 mg of sodium hydrogen carbonate (bicarbonate), and 87.5 mg of calcium carbonate.
The other components (excipients) are macrogol (20000), mannitol (E-421), copovidone, acesulfame potassium (E-950), aspartame (E-951), peppermint flavour, azorubine (E-122), magnesium stearate, xylitol DC (containing sodium carmellose).
Appearance of the product and contents of the pack
Gaviscon are flat, circular chewable tablets. One side of the tablet is pink and slightly speckled, and the other side is white.
It is presented in PVC/PE/PVdC blisters, transparent unprinted, with aluminium foil, contained in a cardboard box with the package leaflet.
Each pack may contain 4, 24, 32, 48, and 64 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Reckitt Benckiser Healthcare, S.A.
Paseo de Gracia, 9, 08007, Barcelona, Spain
RB NL Brands B.V. Schiphol Blvd 207, 1118 BH Schiphol, The Netherlands
Date of the most recent revision of this leaflet: August 2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/