Gaviscon for heartburn and indigestion: detailed information

Package leaflet: Information for the user

Gaviscon Heartburn and Indigestion

500mg/213mg/325mg
oral suspension, peppermint flavour
Sodium alginate / Sodium bicarbonate / Calcium carbonate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 7 days.

Contents of this leaflet:

What Gaviscon Heartburn and Indigestion is and what it is used for
What you need to know before taking Gaviscon Heartburn and Indigestion
How to take Gaviscon Heartburn and Indigestion
Possible side effects
How to store Gaviscon Heartburn and Indigestion
Contents of the pack and other information

1. WHAT GAVISCON HEARTBURN AND INDIGESTION IS AND WHAT IT IS USED FOR

Gaviscon Heartburn and Indigestion oral suspension, peppermint flavour in sachets, is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate that works in two ways.

By neutralizing excess acid in the stomach to relieve pain and discomfort.
By forming a protective barrier on top of the stomach contents to soothe heartburn in the chest for up to 4 hours.

This medicine is indicated for the treatment of symptoms of gastro-oesophageal reflux related to acidity, such as acid regurgitation, heartburn and indigestion, for example after meals or during pregnancy.

2. WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON HEARTBURN AND INDIGESTION

Do not take Gaviscon Heartburn and Indigestion

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before using Gaviscon Heartburn and Indigestion if:

you have severe kidney problems
you have electrolyte imbalances causing low levels of phosphate in the blood (hypophosphatemia)
you suffer or have suffered from significant kidney or heart diseases, as some salts may interfere with these conditions (consult your doctor regarding the salt content)
if you know you have reduced gastric acid in the stomach, as this medicine may be less effective.

As with other antacid products, taking Gaviscon Heartburn and Indigestion oral suspension
mint flavour in sachets may mask symptoms of other, more serious underlying conditions.
If symptoms persist after 7 days, consult your doctor.
Children
Do not give this medicine to children under 12 years of age without medical advice.
There is a risk that sodium levels in the blood (hypernatraemia) may increase in children who have
kidney problems or inflammation of the stomach or intestine (gastroenteritis).
Other medicines and Gaviscon Heartburn and Indigestion
Do not take this medicine within two hours of taking any other oral medicines, as it may
interfere with the action of certain other medicines. Inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those without a prescription.
Pregnancy, breastfeeding and fertility
You may take this medicine if you are pregnant, breastfeeding, or planning a pregnancy.
As with all medicines, treatment duration should be kept as short as possible.
Important information about some components of Gaviscon Heartburn and Indigestion
This medicine contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216), which
may cause allergic reactions (including delayed reactions).
It also contains 127.88 mg (5.56 mmol) of sodium per 10 ml/1 sachet. The maximum recommended daily dose
of this medicine contains 1023 mg of sodium (the main component of table salt).
This corresponds to 51.15% of the maximum recommended daily dietary intake of sodium for an adult.
Ask your doctor or pharmacist if you need to take Gaviscon Heartburn and Indigestion daily for a
prolonged period, especially if you are on a low-sodium diet.
In addition, this medicine contains 130 mg (3.25 mmol) of calcium per dose. Consult your doctor before
using this medicine if you have kidney stones or high levels of calcium in the blood.

3. HOW TO TAKE GAVISCON HEARTBURN AND INDIGESTION

Take this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults, including elderly and children aged 12 years and over: 10–20 ml (1 to 2 sachets) after meals and at bedtime, up to four times a day.
Children under 12 years: should only be administered on medical advice.
If you take more Gaviscon Heartburn and Indigestion than you should
Taking more Gaviscon Heartburn and Indigestion than recommended is unlikely to cause harm.
However, you may feel bloated. Consult your doctor if this symptom persists.
If you forget to take Gaviscon Heartburn and Indigestion
If you miss a dose, do not double the next dose; continue taking it as before.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you experience any of these adverse reactions, stop taking this medicine and consult a doctor immediately.
Very rarely (less than 1 patient in 10,000), an allergic reaction to the components of the medicine may occur. Symptoms may include abdominal pain, diarrhoea, nausea, vomiting, skin itching, rash, pruritus, dizziness, swelling of the face, lips, tongue or throat, and difficulty breathing.
Ingestion of large amounts of calcium carbonate, a component of this medicine, may lead to an increase in blood pH (alkalosis), too much calcium in the blood (hypercalcemia), increased acid secretion in the stomach, and constipation. These symptoms usually occur following intake of doses higher than the recommended dose.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

5. HOW TO STORE GAVISCON HEARTBURN AND INDIGESTION

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and sachet after Exp. (month/year). The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Gaviscon Heartburn and Indigestion contains
The active substances are sodium alginate, sodium bicarbonate and calcium carbonate. Each 10 ml sachet contains 500 mg of sodium alginate, 213 mg of sodium bicarbonate and 325 mg of calcium carbonate. The other components are carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, peppermint flavour, sodium hydroxide, purified water.

Description of the appearance of Gaviscon Heartburn and Indigestion and pack contents
Gaviscon Heartburn and Indigestion contains a white suspension with a mint odour and flavour.
Gaviscon Heartburn and Indigestion is available in packs containing 4, 12 and 24 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A.
Via G. Spadolini, 7
20141 Milan, Italy

Manufacturer
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, UK, HU8 7DS
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Gaviscon Antizuur-Antireflux Unidose suspensie voor oraal gebruik/Gaviscon Antiacide-Antireflux Unidose suspension buvable/Gaviscon Antisäure-Antireflux Unidose Suspension zum Einnehmen
Cyprus: Gaviscon Double Action Liquid Sachets
Czech Republic: Gaviscon Duo Efekt Sáčky
Denmark: Galieve Forte, oral suspension i brev
Finland: Galieve 500 mg/213 mg/325 mg oraalisuspensio, annospussi
Germany: Gaviscon Dual 500 mg / 213 mg / 325 mg Suspension zum Einnehmen im Beutel
Greece: Gaviscon Double Action Liquid Sachets Peppermint Flavour
Hungary: Gaviscon Forte borsmenta ízű belsőleges szuszpenzió tasakban
Iceland: Galieve Forte 500 mg/213 mg/325 mg mixtúra, dreifa í skammtapokum
Ireland: Gaviscon Extra Liquid Sachets Peppermint Flavour Oral Suspension sodium alginate 500mg/10ml, sodium bicarbonate 213mg/10ml, calcium carbonate 325mg/10ml
Italy: Gaviscon Bruciore e Indigestione 500 mg + 213 mg + 325 mg sospensione orale gusto menta
Luxembourg: Gaviscon Antiacide-Antireflux Unidose suspension buvable
Netherlands: Gaviscon Duo sachets, suspensie voor oraal gebruik
Norway: Galieve Forte 500 mg/213 mg/325 mg mikstur, suspensjon i dosepose med peppermyntesmak
Poland: Gaviscon Duo
Portugal: Gaviscon Duefet 500 mg + 213 mg + 325 mg Suspensão oral em saquetas
Slovenia: Gaviscon Duo Efekt vrecká
Sweden: Galieve 500 mg/213 mg/325 mg

Package leaflet: Information for the user

Gaviscon Heartburn and Indigestion oral suspension, peppermint flavour

Sodium alginate/Sodium bicarbonate/Calcium carbonate
500 mg/213 mg/325 mg
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if symptoms worsen after 7 days.

Contents of this leaflet:

What Gaviscon Heartburn and Indigestion is and what it is used for
What you need to know before taking Gaviscon Heartburn and Indigestion
How to take Gaviscon Heartburn and Indigestion
Possible side effects
How to store Gaviscon Heartburn and Indigestion
Contents of the pack and other information

1. WHAT GAVISCON HEARTBURN AND INDIGESTION IS AND WHAT IT IS USED FOR

Gaviscon Heartburn and Indigestion is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate that works in two ways.

By neutralizing excess stomach acid to relieve pain and discomfort.
By forming a protective barrier on top of the stomach contents to soothe heartburn in the chest for up to 4 hours.

2. WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON HEARTBURN AND INDIGESTION

Do not take Gaviscon Heartburn and Indigestion

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Talk to your doctor or pharmacist before taking Gaviscon Heartburn and Indigestion if:

you suffer or have suffered from significant kidney or heart disease, as certain salts may interfere with these conditions (consult your doctor regarding the salt content)
you have severe kidney problems
you have electrolyte disturbances causing low levels of phosphate in the blood (hypophosphatemia)
if you know you have reduced gastric acid in your stomach, as this medicine may be less effective.

As with other antacid products, taking this medicine may mask symptoms of other, more serious pre-existing conditions.

contains sulfites: these may rarely cause severe allergic reactions (hypersensitivity) and wheezing or breathing difficulties (bronchospasm).

If symptoms persist after 7 days, consult your doctor.
Children
Do not give this medicine to children under 12 years of age without medical advice.
There is a risk of increased sodium levels in the blood (hypernatraemia) in children who have
kidney problems or inflammation of the stomach or intestine (gastroenteritis).
Other medicines and Gaviscon Heartburn and Indigestion
Do not take this medicine within two hours of taking any other oral medicines, as it may interfere with the action of certain other medicines.
This is particularly important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron salts, thyroid hormones, antifungals such as ketoconazole, digoxin and beta-blockers (medicines used for heart conditions), neuroleptics (medicines used for mental disorders), thyroxine, chloroquine (a medicine used to treat malaria), bisphosphonates (medicines used to treat certain bone diseases), and estramustine (a medicine used to treat prostate cancer).
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding and fertility
You may take this medicine if you are pregnant, breastfeeding, or planning to become pregnant.
As with all medicines, treatment duration should be kept as short as possible.

Important information about some ingredients of Gaviscon Heartburn and Indigestion
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
It contains sulfites, which may cause allergic reactions including bronchospasm.
A 20 ml dose contains 9.12 mg of propylene glycol (E1520).
A 20 ml dose also contains 255.76 mg (11.12 mmol) of sodium. The maximum recommended daily dose of this medicine contains 1021 mg of sodium (the main component of table salt).
This corresponds to 51% of the maximum recommended daily dietary intake of sodium for an adult. Ask your doctor or pharmacist if you need to take Gaviscon Heartburn and Indigestion daily for a prolonged period, especially if you are on a low-sodium diet.
In addition, a 20 ml dose of this medicine contains 260 mg (6.5 mmol) of calcium. Consult your doctor before using this medicine if you have kidney stones or high levels of calcium in the blood.

3. HOW TO TAKE GAVISCON HEARTBURN AND INDIGESTION

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Shake the suspension before use.
Adults and children aged 12 years and over: when symptoms occur, take 10–20 ml after meals and at bedtime, up to four times daily.
If you take more Gaviscon Heartburn and Indigestion than you should
Taking more Gaviscon Heartburn and Indigestion than recommended is unlikely to cause harm. However, you may feel bloated. Consult your doctor if this symptom persists.
If you forget to take Gaviscon Heartburn and Indigestion
If you miss a dose, do not double the next dose; continue taking it as before.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of these adverse reactions, stop taking this medicine and consult a doctor immediately.
Very rarely (less than 1 patient in 10,000), there is a possibility of an allergic reaction to the components of the medicine, which may manifest as swelling of the face, lips, tongue or throat, and breathing difficulties (anaphylactic reaction, anaphylactoid reaction), or itchy skin rash (urticaria). Other symptoms may include abdominal pain, diarrhoea, nausea, vomiting, skin itching, skin rash, and shortness of breath (bronchospasm).
Ingestion of large amounts of calcium carbonate, one of the components of this medicine, may cause an increase in blood pH (alkalosis), excessive calcium in the blood (hypercalcaemia), which may lead to milk-alkali syndrome, increased acid secretion in the stomach (very rare effect), and constipation. These symptoms usually occur following intake of doses higher than the recommended dose.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

5. HOW TO STORE GAVISCON HEARTBURN AND INDIGESTION

Keep this medicine out of the sight and reach of children. Do not use this medicine after the
expiry date stated on the label after Exp. (month/year). The expiry date refers to the last
day of that month.
Do not refrigerate or freeze. Use within 6 months after opening. Check that the seal on the
cap is intact before first use of this product.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Gaviscon Heartburn and Indigestion contains

The active substances are sodium alginate, sodium bicarbonate and calcium carbonate. 10 ml of suspension contain 500 mg of sodium alginate, 213 mg of sodium bicarbonate and 325 mg of calcium carbonate.
The other components are carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, peppermint flavour (contains propylene glycol (E1520)), sodium hydroxide, purified water. This medicine does not contain sugar or gluten.

Description of the appearance of Gaviscon Heartburn and Indigestion and pack contents
Gaviscon Heartburn and Indigestion contains a white suspension with a peppermint odour and flavour.
Gaviscon Heartburn and Indigestion is available in packaging containing: 1 amber glass bottle of
300 ml or 500 ml of oral suspension. It may be supplied with a dosing dispenser (in natural polypropylene)
marked at 5 ml, 10 ml, 15 ml and 20 ml.
It is possible that not all pack sizes are marketed. The secondary packaging (cardboard box) and dosing dispenser may not be provided in all countries/authorised pack sizes.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A.
Via G. Spadolini, 7
20141 Milano
Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
The Netherlands: Gaviscon Duo suspensie, muntsmaak

Package leaflet: Information for the user

Gaviscon Heartburn and Indigestion Chewable Tablets, peppermint flavour

Sodium alginate/Sodium bicarbonate/Calcium carbonate
250 mg/106.5 mg/187.5 mg
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What Gaviscon Heartburn and Indigestion is and what it is used for
What you need to know before taking Gaviscon Heartburn and Indigestion
How to take Gaviscon Heartburn and Indigestion
Possible side effects
How to store Gaviscon Heartburn and Indigestion
Contents of the pack and other information

1. WHAT GAVISCON HEARTBURN AND INDIGESTION IS AND WHAT IT IS USED FOR

Gaviscon Heartburn and Indigestion is a combination of two antacids (calcium carbonate and sodium bicarbonate)
and an alginate that works in two ways.

Forming a protective barrier on top of the stomach contents to soothe heartburn in the chest for up to 4 hours.
Neutralizing excess acid in the stomach to relieve pain and discomfort.

This medicine is indicated for the treatment of symptoms of gastro-oesophageal reflux related to acidity,
such as acid regurgitation, heartburn, and indigestion, for example after meals or during pregnancy.

2. WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON HEARTBURN AND INDIGESTION

Do not take Gaviscon Heartburn and Indigestion

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Talk to your doctor or pharmacist before using Gaviscon Heartburn and Indigestion if:

you suffer or have suffered from significant kidney or heart diseases, as some salts may interfere with these conditions (consult your doctor regarding salt content)
if your doctor has told you that you have an intolerance to certain sugars
you have severe kidney problems
you have electrolyte disturbances causing low levels of phosphate in the blood (hypophosphatemia)
if you know you have reduced gastric acid in the stomach, as this medicine may be less effective.

As with other antacid products, taking Gaviscon Heartburn and Indigestion oral suspension
mint flavour in sachets may mask symptoms of other, more serious underlying diseases.

contains sulphites: these may rarely cause severe allergic reactions (hypersensitivity) and wheezing or breathing difficulties (bronchospasm)

If symptoms persist after 7 days, consult your doctor.
Children
Do not give this medicine to children under 12 years of age without medical advice.
There is a risk that sodium levels in the blood (hypernatraemia) may increase in children who have
kidney problems or who have inflammation of the stomach or intestine (gastroenteritis).
Other medicines and Gaviscon Heartburn and Indigestion
Do not take this medicine within two hours of taking any other oral medicines, as it may
interfere with the action of certain other medicines.
This is particularly important if you are taking antihistamines, antibiotics (tetracyclines and quinolones such as norfloxacin), iron salts, thyroid hormones, antifungals such as ketoconazole, digoxin and beta-blockers (medicines used for heart conditions), neuroleptics (medicines used for mental disorders), thyroxine, chloroquine
(medicine used to treat malaria), bisphosphonates (medicines used to treat certain bone diseases), and estramustine (medicine used to treat prostate cancer).
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including those not requiring a prescription.

Important information about some ingredients of Gaviscon Heartburn and Indigestion
Each chewable tablet contains 5.86 mg of aspartame (E951).
Aspartame is a source of phenylalanine and may be harmful for patients with phenylketonuria,
a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
The tablets contain carmoisine (E122), which may cause an allergic reaction.
This medicine contains 223.7 mg (9.728 mmol) of sodium per 4 tablets. The maximum recommended daily dose
of this medicine contains 895 mg of sodium (the main component of table salt).
This corresponds to 44.75% of the maximum recommended daily dietary intake for an adult.
Ask your doctor or pharmacist if you need to take Gaviscon Heartburn and Indigestion daily for a
long period, especially if you are on a low-sodium diet.
In addition, this medicine contains 300 mg (7.5 mmol) of calcium per 4 tablets. Consult your doctor before
using this medicine if you have kidney stones or high levels of calcium in the blood.
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. HOW TO TAKE GAVISCON HEARTBURN AND INDIGESTION

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and over: when symptoms occur, take 2 to 4 tablets after meals and at bedtime, up to four times daily.
For oral administration, the tablets should be chewed before swallowing.
If you take more Gaviscon Heartburn and Indigestion than you should
Taking more Gaviscon Heartburn and Indigestion than recommended is unlikely to cause harm. However, you may feel bloated. Consult your doctor if this symptom persists.
If you forget to take Gaviscon Heartburn and Indigestion
If you miss a dose, do not double the next dose; continue taking it as before.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of these adverse reactions, stop taking this medicine and consult a doctor immediately.
Very rarely (less than 1 patient in 10,000), there is a possibility of an allergic reaction to the components of the medicine, which may manifest as swelling of the face, lips, tongue or throat, and breathing difficulties (anaphylactic reaction, anaphylactoid reaction) or itchy skin rash (urticaria). Other symptoms may include abdominal pain, diarrhoea, nausea, vomiting, skin itching, skin rash, and shortness of breath (bronchospasm).
The ingestion of large amounts of calcium carbonate, one of the components of this medicine, may cause an increase in blood pH (alkalosis), too much calcium in the blood (hypercalcaemia), which may lead to milk-alkali syndrome, increased gastric acid secretion (a very rare effect), and constipation. These symptoms usually occur following intake of doses higher than the recommended dose.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. HOW TO STORE GAVISCON HEARTBURN AND INDIGESTION

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after Exp. (month/year). The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Gaviscon Heartburn and Indigestion contains

The active substances in each tablet are 250 mg of sodium alginate, 106.5 mg of sodium bicarbonate, and 187.5 mg of calcium carbonate.
The other components are xylitol (contains sodium carmellose), magnesium stearate, macrogol, mannitol (E421), copovidone, acesulfame-K, aspartame (E951), peppermint flavour (contains maltodextrin and gum arabic), and carmoisine (E122). The product does not contain gluten.

Description of the appearance of Gaviscon Heartburn and Indigestion and pack contents
Flat, round, two-layered tablets with bevelled edges, having a peppermint odour and taste. One layer of the tablet is light pink with slight mottling, the other layer is white.
Gaviscon Heartburn and Indigestion is available in packs containing 16, 24, 48 and 60 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A.
Via G. Spadolini, 7
20141 Milano
Italy

Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Gaviscon Duo muntsmaak, kauwtabletten

Package leaflet: Information for the user

Gaviscon Heartburn and Indigestion oral suspension sachet, red fruit flavour

sodium alginate/sodium bicarbonate/calcium carbonate
500 mg / 213 mg / 325 mg
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What Gaviscon Heartburn and Indigestion is and what it is used for
What you need to know before taking Gaviscon Heartburn and Indigestion
How to take Gaviscon Heartburn and Indigestion
Possible side effects
How to store Gaviscon Heartburn and Indigestion
Contents of the pack and other information
What Gaviscon Heartburn and Indigestion is and what it is used for

Gaviscon Heartburn and Indigestion is a combination of an alginate and two antacids (calcium carbonate and sodium bicarbonate) that works in two ways:

forming a protective barrier over the stomach contents to soothe heartburn in your chest for up to 4 hours;
neutralizing excess acid in the stomach to relieve pain and discomfort.

This medicine is used to treat symptoms of gastro-oesophageal reflux related to acidity, such as heartburn, acid regurgitation, and indigestion, for example after meals, in adults and children aged 12 years and older, or during pregnancy.

What you need to know before taking Gaviscon Heartburn and Indigestion

Do not take Gaviscon Heartburn and Indigestion:

if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gaviscon Heartburn and Indigestion if:

you suffer or have suffered from significant kidney or heart disease, as some salts may interfere with these conditions (consult your doctor regarding salt content); you have severe kidney problems.
you have electrolyte disturbances causing low phosphate levels in the blood (hypophosphataemia);
you are aware of having reduced gastric acid in your stomach, as this medicine may be less effective.

Contains sulfites: may rarely cause severe allergic reactions (hypersensitivity), wheezing or difficulty breathing (bronchospasm).
Prolonged use should be avoided. As with other antacid medicines, taking this medicine may mask symptoms of more serious underlying conditions.
If symptoms persist beyond 7 days, consult your doctor.
Children
Administration to children under 12 years of age is not recommended.
There is a risk of increased sodium levels in the blood (hypernatraemia) in children with kidney problems or with stomach or intestinal inflammation (gastroenteritis).
Other medicines and Gaviscon Heartburn and Indigestion
Do not take this medicine within two hours of taking any other oral medicines, as it may interfere with the action of certain other medicines. This is particularly important if you are taking antihistamines (for allergic symptoms), antibiotics (tetracyclines and quinolones such as norfloxacin for bacterial infections), iron preparations (for iron deficiency disorders), thyroid hormones (for thyroid hormone deficiency), antifungals such as ketoconazole (for fungal infections), digoxin and beta-blockers (for heart conditions), neuroleptics (to treat certain mental disorders), thyroxine (for thyroid hormone deficiency), chloroquine (for malaria), bisphosphonates (for osteoporosis), or estramustine (for prostate cancer).
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility:
You may take this medicine if you are pregnant, planning a pregnancy, or breastfeeding.
As with all medicines, treatment duration should be kept as short as possible.
Important information about some ingredients of Gaviscon Heartburn and Indigestion oral suspension sachet.
This medicine contains 40 mg of methyl hydroxybenzoate (E218) and 6 mg of propyl hydroxybenzoate (E216) per sachet, which may cause allergic reactions (including delayed reactions).
This medicine contains 32 mg of propylene glycol (E1520) in each sachet.
This medicine contains 128 mg (5.6 mmol) of sodium per 10 ml/1 sachet. The maximum recommended daily dose of this product contains 1023 mg of sodium (present in table salt). This corresponds to 51% of the maximum recommended daily dietary sodium intake for an adult. Consult your pharmacist or doctor if you need to take Gaviscon Heartburn and Indigestion daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.
In addition, this medicine contains 130 mg (3.25 mmol) of calcium per sachet. Consult your doctor before using this medicine if you have kidney stones or high calcium levels in the blood.

How to take Gaviscon Heartburn and Indigestion

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For oral use.
Adults and children aged 12 years and older: at onset of symptoms, take 10–20 ml (one or two sachets) after meals and before bedtime, up to four times daily.
Children under 12 years: administration to children under 12 years of age is not recommended.
If you take more Gaviscon Heartburn and Indigestion than you should:
Taking more than the recommended amount is unlikely to cause harm. However, you may feel bloated and experience abdominal discomfort. Consult your doctor if these symptoms persist.
If you forget to take Gaviscon Heartburn and Indigestion: If you miss a dose, do not double the next dose, but continue as before.

Possible side effects

Like all medicines, Gaviscon Heartburn and Indigestion can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

Very rarely (in fewer than 1 in 10,000 patients), an allergic reaction to the ingredients of the medicine may occur. Symptoms may include swelling of the face, lips, tongue or throat, breathing difficulties (anaphylactic or anaphylactoid reaction), or itchy rash (urticaria).
Other symptoms may include abdominal pain, diarrhoea, nausea, vomiting, itching or skin rash, and wheezing (bronchospasm).

Ingestion of large amounts of calcium carbonate, a component of this medicine, may cause an increase in blood pH (alkalosis), high calcium levels in the blood (hypercalcaemia), increased acid secretion in the stomach, and constipation. These symptoms usually occur following intake of doses higher than recommended.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

How to store Gaviscon Heartburn and Indigestion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after “Exp.” (month/year). The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Contents of the pack and other information

What Gaviscon Heartburn and Indigestion contains:
The active substances in each 10 ml sachet are 500 mg sodium alginate, 213 mg sodium bicarbonate and 325 mg calcium carbonate.
The other components are: carbomers, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), sodium saccharin, raspberry flavour, cranberry flavour, fruit flavour, sodium hydroxide and purified water. The flavours contain propylene glycol (E1520).
Description of the appearance of Gaviscon Heartburn and Indigestion and contents of the pack:
Gaviscon Heartburn and Indigestion contains a suspension of variable colour, from whitish to creamy, with a red fruit odour and taste.
Gaviscon Heartburn and Indigestion is available in packs containing 4, 12, 24 and 48 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A. - Via G. Spadolini, 7 - 20141 Milano
Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands
This medicine is authorised in the EEA Member States under the following names:
The Netherlands: Gaviscon Duo bosvruchtensmaak 500 mg/213 mg/325 mg, suspensie voor oraal gebruik in sachets
This leaflet was last updated on

Patient Information Leaflet: Information for the user

Gaviscon Heartburn and Indigestion Chewable Tablets, Red Fruit Flavour

sodium alginate / sodium bicarbonate / calcium carbonate
250 mg / 106.5 mg / 187.5 mg
Please read this entire leaflet carefully before using this medicine, as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet

What Gaviscon Heartburn and Indigestion is and what it is used for
What you need to know before taking Gaviscon Heartburn and Indigestion
How to take Gaviscon Heartburn and Indigestion
Possible side effects
How to store Gaviscon Heartburn and Indigestion
Package contents and other information

1. What Gaviscon Heartburn and Indigestion is and what it is used for

Consult your doctor if you do not feel better or if you feel worse after 7 days.
Gaviscon Heartburn and Indigestion is a combination of an alginate and two antacids (calcium carbonate and sodium bicarbonate) that works in two ways:

forming a protective barrier on top of the stomach contents to soothe heartburn in your chest for up to 4 hours.
neutralizing excess acid in the stomach to relieve pain and discomfort.

This medicine is used to treat symptoms of gastro-oesophageal reflux related to acidity, such as heartburn, acid regurgitation, and indigestion, for example after meals or during pregnancy.

2. What you need to know before taking Gaviscon Heartburn and Indigestion

Do not take Gaviscon Heartburn and Indigestion

if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Gaviscon Heartburn and Indigestion if:

you suffer or have suffered from significant kidney or heart disease, as certain salts may interfere with these conditions (consult your doctor regarding the salt content).
your doctor has informed you that you have an intolerance to certain sugars.
you suffer from severe kidney problems.
you have electrolyte imbalances causing low phosphate levels in the blood (hypophosphatemia).
you know you have reduced gastric acid in your stomach, as this medicine may be less effective.

Prolonged use should be avoided.
As with other antacids, taking this medicine may mask symptoms of other, more serious underlying conditions.

Contains sulphites: rarely may cause severe allergic reactions (hypersensitivity), wheezing or breathing difficulties (bronchospasm).

If symptoms persist after 7 days, consult your doctor.
Children
Administration to children under 12 years of age is not recommended.
There is a risk of increased sodium levels in the blood (hypernatraemia) in children who have kidney problems or
gastroenteritis (inflammation of the stomach or intestines).
Other medicines and Gaviscon Heartburn and Indigestion:
Do not take this medicine within two hours of taking other oral medicines, as it may interfere with the action of certain other medicines.
This is especially important if you are taking antihistamines (for allergic symptoms), antibiotics (tetracyclines and quinolones such as norfloxacin (for treating bacterial infections)), iron preparations (for conditions associated with iron deficiency), thyroid hormones (for thyroid hormone deficiency), antifungals such as ketoconazole (for fungal infections), digoxin and beta-blockers (for heart conditions), neuroleptics (to treat certain mental disorders), thyroxine (for thyroid hormone deficiency), chloroquine (for malaria), bisphosphonates (for osteoporosis), or estramustine (for prostate cancer).
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility:
You may take this medicine if you are pregnant, planning a pregnancy, or breastfeeding. As with all medicines, treatment duration should be kept as short as possible.
Important information about certain ingredients of this medicine:
This medicine contains 5.86 mg of aspartame (E951) per chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly remove it.
These chewable tablets contain carmoisine (E122), which may cause an allergic reaction.
This medicine contains 223.7 mg (9.728 mmol) of sodium per four chewable tablets. The maximum recommended daily dose of this product contains 895 mg of sodium (found in table salt). This corresponds to 44.75% of the maximum recommended daily dietary intake for an adult. Consult your pharmacist or doctor if you need to take Gaviscon Heartburn and Indigestion daily over a prolonged period, especially if you have been advised to follow a low-sodium diet.
Additionally, this medicine contains 300 mg (7.5 mmol) of calcium per 4 tablets. Consult your doctor before using this medicine if you have kidney stones or high levels of calcium in the blood.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Gaviscon Heartburn and Indigestion

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For oral use: chew the tablets before swallowing.
Adults and children aged 12 years and older:
At the onset of symptoms, take two to four chewable tablets after meals and before bedtime, up to four times a day.
Children under 12 years of age:
Administration to children under 12 years of age is not recommended.
If you take more Gaviscon Heartburn and Indigestion than you should:
Taking more than the recommended dose is unlikely to cause harm. However, you may feel bloated and experience abdominal discomfort. Consult your doctor if these symptoms persist.
If you forget to take Gaviscon Heartburn and Indigestion:
If you miss a dose, do not double the next dose; continue taking it as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, stop taking the medicine and contact your doctor immediately: very rare occurrence (may affect up to 1 in 10,000 people) of an allergic reaction to the ingredients. Symptoms may include abdominal pain, diarrhoea, nausea, vomiting, rash, itching, dizziness, swelling of the face, lips, tongue or throat, and breathing difficulties.
Ingestion of large amounts of calcium carbonate, a component of this medicine, may lead to an increased blood pH (alkalosis), too much calcium in the blood (hypercalcaemia), increased acid secretion in the stomach, and constipation. These symptoms usually occur following intake of doses higher than those recommended.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gaviscon Heartburn and Indigestion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gaviscon Heartburn and Indigestion contains
The active substances in each chewable tablet are 250 mg of sodium alginate, 106.5 mg of sodium bicarbonate,
and 187.5 mg of calcium carbonate.
The other ingredients are xylitol, sodium carmellose, magnesium stearate, macrogols, mannitol (E421),
copovidone, potassium acesulfame, aspartame (E951), cranberry flavour, raspberry flavour, fruit flavour, and carmoisine (E122).
The flavours contain propylene glycol (E1520) and sucrose.

Description of the appearance of Gaviscon Heartburn and Indigestion and the pack contents
Chewable tablet, 15 mm in diameter, flat, circular, two-layered, with bevelled edges, and with a red fruit odour and taste. One layer of the chewable tablet is pink with slight streaks and bears the surface markings GDB, while the other layer is white with sword- and circle-shaped markings.
This medicine is available in packs containing 16, 24, 48 and 60 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., Via G. Spadolini 7, 20141 Milano, Italy

Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

This medicine is authorized in the EEA Member States under the following names:
Netherlands: Gaviscon Duo bosvruchtensmaak 250 mg/106.5 mg /187.5 mg, kauwtabletten
Italy: Gaviscon Bruciore e Indigestione
Greece: GAVISCON DOUBLE ACTION Mixed Berries μασώμενο δισκίο
Cyprus: GAVISCON DOUBLE ACTION Mixed Berries μασώμενο δισκίο
250mg/106.5mg/187.5mg