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Gaviscon® (Tablets, Suspension) Instructions for Use

ATC Code

A02BX (Other drugs for the treatment of gastric and duodenal ulcers and GERD)

Active Substances

Calcium carbonate (Ph.Eur.)

Sodium bicarbonate (BP)

Sodium alginate (Ph.Eur.)

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Reflux esophagitis treatment agent

Pharmacological Action

After oral administration, the active substances of the drug quickly interact with the acidic gastric contents.

This results in the formation of an alginate gel with a pH value close to neutral.

The gel forms a protective layer on the surface of the gastric contents, preventing the occurrence of gastroesophageal reflux for up to 4 hours.

In severe cases (with regurgitation), the gel enters the esophagus faster than the rest of the gastric contents, where it reduces irritation of the mucous membrane.

Reduction of irritation is felt within 3-4 minutes after taking the drug.

Indications

Treatment of symptoms such as acid belching, heartburn, dyspepsia (indigestion, feeling of heaviness in the stomach) that occur after eating in patients with gastroesophageal reflux or during pregnancy.

ICD codes

ICD-10 code Indication
K21 Gastro-esophageal reflux
K30 Functional dyspepsia (digestive disorder)
O99.6 Diseases of the digestive system complicating pregnancy, childbirth and the puerperium
R12 Heartburn
R14 Flatulence and related conditions (including abdominal bloating, belching)
ICD-11 code Indication
DA22.Z Gastro-esophageal reflux disease, unspecified
DD90.0 Globus sensation
DD90.1 Functional dysphagia
DD90.3 Functional dyspepsia
DD90.Z Functional disorders of esophagus or gastroduodenal system, unspecified
JB64.6 Diseases of the digestive system complicating pregnancy, childbirth, or the puerperium
MD95 Heartburn
ME08 Flatulence and related conditions

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, according to an individual regimen.

2-4 tablets up to 4 times/day are prescribed.

If symptoms persist after 7 days of using the drug, the patient should consult a doctor.

Suspension

Orally, according to an individual regimen, depending on the dosage form.

The drug should not be used for a long time. If symptoms persist after 7 days of taking the drug, the patient must consult a doctor.

Adverse Reactions

Immune system disorders: anaphylactic and anaphylactoid reactions, hypersensitivity reactions (urticaria) are possible.

Respiratory system disorders: respiratory effects (bronchospasm) are possible.

Contraindications

Hypersensitivity to the components of the drug, phenylketonuria, children under 12 years of age.

Use with caution in hypercalcemia, nephrocalcinosis and urolithiasis with the formation of oxalate stones, congestive heart failure, impaired renal function. In the presence of these diseases or conditions, the patient should consult a doctor before using the drug.

Use in Pregnancy and Lactation

If clinically necessary, after consultation with a doctor, the drug can be used during pregnancy and breastfeeding.

Use in Hepatic Impairment

No dose adjustment is required for patients with impaired liver function.

Use in Renal Impairment

The drug should be used with caution in nephrocalcinosis and urolithiasis with the formation of oxalate stones, and in impaired renal function.

Pediatric Use

The use of the drug is contraindicated in children under 12 years of age.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

The drug contains sodium, which should be taken into account when it is necessary to follow a salt-restricted diet (for example, in congestive heart failure, impaired renal function).

The drug contains Calcium Carbonate. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis and urolithiasis with the formation of calcium oxalate stones.

Drug Interactions

The drug contains Calcium Carbonate, which exhibits antacid activity, therefore an interval of at least 2 hours should be maintained between taking this drug and other drugs, especially when used concomitantly with histamine H2-receptor blockers, antibiotics of the tetracycline group, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, levothyroxine sodium, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticosteroids, chloroquine, bisphosphonates and estramustine.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® Double Action Chewable tablets (mint) 250 mg+106.5 mg+187.5 mg: 12 or 24 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets (mint) round, flat, two-layer, with beveled edges and a minty odor; one layer is pink in color with small inclusions of a darker color, the other layer is white; on one side of the tablet: an image of a circle and a sword, on the other side: “GDA250”.

1 tab.
Sodium alginate 250 mg
Sodium bicarbonate 106.5 mg
Calcium Carbonate 187.5 mg

Excipients: mannitol – 598.799 mg, macrogol 20000 – 30 mg, copovidone – 33.75 mg, acesulfame potassium – 5.863 mg, aspartame – 5.863 mg, dye azorubine (11012) – 0.375 mg, mint flavor – 18.75 mg, xylitol (DC) – 100 mg, magnesium stearate – 6.75-12.6 mg.

2 pcs. – blisters (6) – cardboard packs.
4 pcs. – blisters (3) – cardboard packs.
4 pcs. – blisters (6) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.
6 pcs. – blisters (4) – cardboard packs.
8 pcs. – blisters (3) – cardboard packs.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® Double Action Oral suspension (mint) 500 mg+213 mg+325 mg/10 ml: sachet 12 pcs.

Dosage Form, Packaging, and Composition

Oral suspension (mint) viscous, opaque, from almost white to light brown in color, with a minty odor.

10 ml
Sodium alginate 500 mg
Sodium bicarbonate 213 mg
Calcium Carbonate 325 mg

Excipients: carbomer (974P) – 65 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium hydroxide – 26.67 mg, sodium saccharinate – 10 mg, mint flavor – 6 mg, purified water – up to 10 ml.

10 ml – multilayer sachets (12) – cardboard packs.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® Double Action Oral suspension (mint) 500 mg+213 mg+325 mg/10 ml: fl. 150 ml or 300 ml

Dosage Form, Packaging, and Composition

Oral suspension (mint) viscous, opaque, from almost white to light brown in color, with a minty odor.

10 ml
Sodium alginate 500 mg
Sodium bicarbonate 213 mg
Calcium Carbonate 325 mg

Excipients: carbomer (974P) – 65 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium hydroxide – 26.67 mg, sodium saccharinate – 10 mg, mint flavor – 6 mg, purified water – up to 10 ml.

150 ml – dark glass bottles with first-opening control.
300 ml – dark glass bottles with first-opening control.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® Oral suspension (mint) 500 mg+267 mg+160 mg/10 ml: fl. 150 ml or 300 ml

Dosage Form, Packaging, and Composition

Oral suspension (mint) viscous, opaque, from almost white to cream in color, with a minty odor.

10 ml
Sodium alginate 500 mg
Sodium bicarbonate 267 mg
Calcium Carbonate 160 mg

Excipients: carbomer – 65 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium saccharinate – 10 mg, peppermint oil – 1 mg, sodium hydroxide – 26.667 mg, purified water – up to 10 ml.

150 ml – dark glass bottles with first-opening control.
300 ml – dark glass bottles with first-opening control.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® Chewable tablets (mint) 250 mg+133.5 mg+80 mg: 12, 24 or 48 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets (mint) from almost white to cream in color with small inclusions, round, flat, with beveled edges; on one side of the tablet – an image of a circle and a sword, on the other – “G 250”; with a minty odor.

1 tab.
Sodium alginate 250 mg
Sodium bicarbonate 133.5 mg
Calcium Carbonate 80 mg

Excipients: mannitol – 255 mg, macrogol 20000 – 30 mg, magnesium stearate – 4 mg, aspartame – 3.75 mg, copovidone – 28 mg, potassium acesulfame – 3.75 mg, mint flavor – 12 mg.

4 pcs. – blisters (3) – cardboard packs.
4 pcs. – blisters (6) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.
6 pcs. – blisters (4) – cardboard packs.
8 pcs. – blisters (3) – cardboard packs.
8 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® forte Oral suspension (mint) 1000 mg+200 mg/10 ml: sachets 12 pcs.

Dosage Form, Packaging, and Composition

Oral suspension (mint) viscous, from almost white to light brown in color, with a minty odor.

10 ml
Sodium alginate 1000 mg
Potassium bicarbonate 200 mg

Excipients: calcium carbonate – 200 mg, carbomer – 40 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium hydroxide – 14.44 mg, sodium saccharinate – 10 mg, mint flavor – 6 mg, purified water – up to 10 ml.

10 ml – multilayer sachets (12) – cardboard packs.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Contact Information

RECKITT BENCKISER HEALTHCARE LLC (Russia)

Dosage Form

Bottle OTC Icon Gaviscon® forte Oral suspension (mint) 1000 mg+200 mg/10 ml: bottle 150 ml

Dosage Form, Packaging, and Composition

Oral suspension (mint) viscous, from almost white to light brown in color, with a minty odor.

10 ml
Sodium alginate 1000 mg
Potassium bicarbonate 200 mg

Excipients: calcium carbonate – 200 mg, carbomer – 40 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium hydroxide – 14.44 mg, sodium saccharinate – 10 mg, mint flavor – 6 mg, purified water – up to 10 ml.

150 ml – dark glass bottles with first-opening control.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Dosage Form

Bottle OTC Icon Gaviscon® forte Oral suspension (anise) 1000 mg+200 mg/10 ml: bottle 80 ml, 150 ml, 200 ml, 250 ml or 300 ml

Dosage Form, Packaging, and Composition

Oral suspension (anise) viscous, from almost white to light brown in color, with an anise odor.

10 ml
Sodium alginate 1000 mg
Potassium bicarbonate 200 mg

Excipients: calcium carbonate – 200 mg, carbomer – 40 mg, methylparahydroxybenzoate – 40 mg, propylparahydroxybenzoate – 6 mg, sodium hydroxide – 14.44 mg, sodium saccharinate – 10 mg, fennel flavor – 7 mg, purified water – up to 10 ml.

80 ml – dark glass bottles with first-opening control.
150 ml – dark glass bottles with first-opening control.
200 ml – dark glass bottles with first-opening control.
250 ml – dark glass bottles with first-opening control.
300 ml – dark glass bottles with first-opening control.

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