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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Chewable tablets (mint) 250 mg+106.5 mg+187.5 mg: 12 or 24 pcs.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (mint) 500 mg+213 mg+325 mg/10 ml: sachet 12 pcs.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (mint) 500 mg+213 mg+325 mg/10 ml: fl. 150 ml or 300 ml
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (mint) 500 mg+267 mg+160 mg/10 ml: fl. 150 ml or 300 ml
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Chewable tablets (mint) 250 mg+133.5 mg+80 mg: 12, 24 or 48 pcs.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (mint) 1000 mg+200 mg/10 ml: sachets 12 pcs.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (mint) 1000 mg+200 mg/10 ml: bottle 150 ml
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Contact Information
RECKITT BENCKISER HEALTHCARE LLC (Russia)
Dosage Form
| 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.
Oral suspension (anise) 1000 mg+200 mg/10 ml: bottle 80 ml, 150 ml, 200 ml, 250 ml or 300 ml
Marketing Authorization Holder
Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)
Dosage Form
| 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.
