Gaviscon Chewable Tablets Strawberry Flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gaviscon Chewable Tablets, strawberry flavour
Sodium alginate, sodium hydrogen carbonate (bicarbonate) and calcium carbonate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you. Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Package leaflet contents:
- What Gaviscon is and what it is used for
- What you need to know before taking Gaviscon
- How to take Gaviscon
- Possible side effects
- How to store Gaviscon
- Contents of the pack and other information
1. What Gaviscon 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, thereby relieving heartburn.
- Sodium hydrogen carbonate (bicarbonate) and calcium carbonate neutralize excess acid in the stomach.
Gaviscon is indicated for the symptomatic treatment of stomach hyperacidity and heartburn caused by acid reflux from the stomach, in adults and children 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
Do not take Gaviscon:
- If you are allergic to calcium carbonate, sodium hydrogen carbonate (bicarbonate), sodium alginate, or any of the other ingredients of this medicine (listed in section 6).
- If you have severe kidney insufficiency 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 starting to take 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 have symptoms of stomach or intestinal diseases, appendicitis, or oedema.
If you are taking or need to take other medicines, separate their administration by 1 to 2 hours (see "Other medicines and Gaviscon").
Avoid prolonged use as it may lead to kidney stones. Likewise, high doses over a long period may not only cause kidney stones, but also lead to high levels of calcium in blood or urine, kidney failure, or worsening of pre-existing kidney problems.
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 is not recommended for children under 12 years of age.
Interference with laboratory tests
If you are due to have 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
Inform your doctor or pharmacist if you are 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 or digitoxin), or other medicines such as fluorides, phosphates, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, glucocorticoids, chloroquine, bisphosphonates, beta-blockers (such as atenolol, metoprolol, propranolol), or estramustine, as this medicine may affect the efficacy of these drugs.
Since Gaviscon may interfere with certain medicines, you should wait 2 hours after taking Gaviscon before taking any other oral medicine. If you have taken another medicine, wait 1 to 2 hours before taking Gaviscon to ensure maximum benefit from the other medicine.
Taking Gaviscon with food and drinks
Like all antacids containing calcium, this medicine should not be taken with large amounts of milk or dairy products, as this may lead to increased calcium levels in blood and the milk-alkali syndrome (Burnett's syndrome).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 breast-feeding 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 the pregnant or breast-feeding woman, pregnant or breast-feeding women must not exceed the doses indicated in section "3. How to take Gaviscon" 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 contains sodium and aspartame.
This medicine contains 254.84 mg of sodium (main component of table/cooking salt) in each 4 tablets. This corresponds to 12.74% of the maximum recommended daily sodium intake 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 35.2 mg of aspartame in each 4 tablets.
Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
3. How to take Gaviscon
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients and adolescents over 12 years of age, is 2 to 4 tablets as needed, taken 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 thoroughly.
If symptoms persist after 7 days of continuous treatment, consult your doctor to rule out more serious conditions.
If you take more Gaviscon 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, contact 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
Do not take a double dose to make up for missed doses.
Resume taking the medicine as indicated in section "3. How to take Gaviscon". If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
During the period of use of the combination of sodium alginate, sodium hydrogen carbonate (bicarbonate) and calcium carbonate, the following adverse 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, 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 high levels of calcium 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to 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
The active substances are 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate (bicarbonate), and 80 mg of calcium carbonate.
The other components (excipients) are: macrogol, mannitol (E-421), aspartame (E-951), magnesium stearate, xylitol DC (containing sodium carmellose), strawberry flavour (containing maize starch, vegetable oil, propylene glycol (E-1520)), iron oxide red.
Appearance of the product and contents of the pack
Gaviscon is pale pink, flat, bevelled-edge chewable tablets with a strawberry odour and flavour.
It is presented in transparent, unprinted PVC/PE/PVdC blisters with aluminium foil, packed 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/