Gaviscon oral suspension in sachets, peppermint flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gaviscon oral suspension sachets, peppermint 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.
Follow exactly the instructions for administration of this medicine contained in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet:
- What Gaviscon is and what it is used for
- What you need to know before taking Gaviscon
- How to take Gaviscon
- Possible adverse 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:
-
The sodium alginate together with sodium hydrogen carbonate (bicarbonate) and calcium carbonate form a protective barrier in the stomach to prevent gastric reflux, relieving heartburn.
-
The 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
Talk to 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 disorders, 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").
Avoid prolonged use, as it may lead to kidney stones. Similarly, high doses over a long period may not only cause kidney stones but also lead to elevated calcium levels in blood or urine, kidney failure, or worsening of pre-existing kidney disease.
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 due to have 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, digitoxine), or other medicines such as fluorides, phosphates, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine, and bisphosphonates; as Gaviscon may affect the effectiveness 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 already taken another medicine, wait 1 to 2 hours before taking Gaviscon to ensure maximum benefit from the other treatment.
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 the 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 the pregnant or breastfeeding woman, pregnant or breastfeeding women must not exceed the doses indicated in section "3. How to take Gaviscon" and must 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, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.
This medicine contains 285.2 mg of sodium (the main component of table/cooking salt) in each 2 sachets. This corresponds to 14.3% of the maximum daily sodium intake recommended for an adult.
Consult your doctor or pharmacist if you need to take 3 or more sachets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
3. How to take Gaviscon
Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose in adults, including elderly patients and adolescents over 12 years of age, is 1 to 2 sachets as needed, taken 1 hour after meals and before going to bed. The maximum dose is 8 sachets per day.
Renal insufficiency: caution is required in patients on low-salt diets (see section 2).
How to take:
This medicine is taken orally.
Open the sachet and take the contents directly from it.
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.
Take the next dose as indicated under 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.
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 available data):
- Allergic reactions, such as skin rash 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 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's syndrome), which may cause elevated blood calcium levels (with long-term 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 can 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 30°C.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any 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
-
The active substances are 500 mg of sodium alginate, 267 mg of sodium hydrogen carbonate (bicarbonate), and 160 mg of calcium carbonate.
-
The other components (excipients) are carbomer, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium saccharin, natural peppermint flavour, sodium hydroxide, and purified water.
Appearance of the product and contents of the container
Gaviscon is a white, opaque suspension with a minty odour and taste.
It is available in cardboard packs containing 2, 12, 24, or 30 sachets, each sachet containing 10 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Reckitt Benckiser Healthcare, S.A.
RB NL Brands B.V.
Schiphol Blvd 207, 1118 BH Schiphol, Netherlands
Date of the most recent revision of this leaflet: August 2020.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/