Gaviscon chewable tablets, peppermint flavour
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Gaviscon Chewable Tablets, peppermint flavour
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.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
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, forms a protective barrier in the stomach to prevent gastric reflux, thereby relieving heartburn.
- Sodium hydrogen carbonate (bicarbonate) and calcium carbonate additionally 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 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
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 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 high 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 (inflammation that can affect multiple organs in the body), if you suffer from constipation or haemorrhoids, or if you experience symptoms of stomach or intestinal disorders, 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. Similarly, high doses over a long period may cause elevated calcium levels in blood or urine, kidney impairment, 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 diagnostic tests:
If you are scheduled to undergo any diagnostic 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 Gaviscon, 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, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine, or bisphosphonates; as Gaviscon may affect the efficacy of these medicines.
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 that other medicine.
Taking Gaviscon with food and drink
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 blood and the milk-alkali syndrome (Burnett's syndrome).
Pregnancy, breastfeeding, and fertility
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 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" and should not simultaneously consume large amounts of dairy products or 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 254.64 mg of sodium (the main component of table/cooking salt) in each 4 tablets. This corresponds to 12.6% 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 15 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 properly eliminate it.
3. How to take Gaviscon
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose in adults, including elderly people and adolescents over 12 years of age, is 2 to 4 chewable 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-sodium 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 underlying conditions.
If you take more Gaviscon than you should
Symptoms of overdose may 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, 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 can 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 Medicinal Products (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 which is stated on the packaging 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 empty containers and unused medicines at the SIGRE Point in 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
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The active substances are 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate (bicarbonate), and 80 mg of calcium carbonate.
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The other components (excipients) are macrogol, mannitol (E421), copovidone, peppermint flavour, aspartame (E-951), acesulfame potassium (E-950), and magnesium stearate.
Appearance of the medicine and contents of the pack
Gaviscon is cream-coloured, slightly mottled, chewable tablets.
It is presented in PVC/PE/PVdC strips, transparent and unprinted, with an aluminium foil lid, packed in a cardboard box with the leaflet.
Each pack may contain 4, 24, 32, 48 or 64 tablets.
It is also available in a polypropylene container packed in a cardboard box with the leaflet. Each container contains 12 or 20 tablets.
Only certain 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 review of this leaflet: August 2020.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/