GAVISCON Susp buv en flacon Fl/250ml

Oral suspension.
Bottle of 250 ml.

For 100 ml :

Sodium alginate : 5,000 g
Sodium bicarbonate : 2,670 g

1 ml contains 50 mg of sodium alginate and 26,7 mg of sodium bicarbonate

Excipients with known effect:

One dose of 10 ml contains : 142,5 mg of sodium, 1,1 mg of benzyl alcohol, 40 mg of methyl parahydroxybenzoate (E218) and 6 mg of propyl parahydroxybenzoate (E216).

Symptomatic treatment of gastro-oesophageal reflux.

Dosage

Adults and children over 12 years:

2 teaspoons (10 ml) 3 times a day after the 3 main meals and possibly in the evening at bedtime.

This dosage may be doubled in cases of severe reflux or oesophageal inflammation.

Duration of treatment

If symptoms do not improve after 7 days of treatment, the clinical situation should be reconsidered.

Method of administration

Oral use. Shake the bottle well before use.

Hypersensitivity to the active substances or to any of the excipients listed in the section Composition.

This medicine contains 142,5 mg of sodium per 10 mL, which is equivalent to 7 % of the WHO-recommended maximum daily dietary intake of sodium.

The maximum daily dose of this medicine is equivalent to 57 % of the WHO-recommended maximum daily dietary intake of sodium.

GAVISCON oral suspension in bottle is considered a medicine with a high sodium content. This must be particularly taken into account for patients on a low-sodium diet, for example in cases of congestive heart failure or renal failure.

This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

This medicine contains calcium: 160 mg of calcium carbonate per 2 teaspoons. Precautions must be taken in patients with hypercalcaemia, nephrocalcinosis and renal calculi.

This medicine contains 1,1 mg of benzyl alcohol per 10 ml.

Benzyl alcohol may cause allergic reactions.

Large quantities of benzyl alcohol may accumulate in the body and cause metabolic acidosis, which must be taken into consideration in patients with liver or kidney disease, and in pregnant or breast-feeding women.

For children under 12 years, see section Dosage and administration.

As a precaution, a period of 2 hours (if possible) should be considered between taking GAVISCON and other medicines, such as acetylsalicylic acid, H2 antihistamines, lansoprazole, bisphosphonates, cationic resins, certain antibiotics (fluoroquinolones, cyclines, lincosamides), digitalis glycosides, glucocorticoids, thyroid hormones, thiazide and related diuretics, phenothiazine neuroleptics, sulpiride, certain beta-blockers, penicillamine, ions (iron, phosphorus, fluoride), zinc, strontium, chloroquine, dolutegravir, elvitegravir, fexofenadine, ledipasvir, rosuvastatin, teriflunomide, ulipristal, estramustine.

Pregnancy

Clinical studies conducted in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, have not revealed any malformative or toxic effect of the active substances on the foetus and newborn.

GAVISCON may be used during pregnancy if necessary.

See also section Warnings and precautions.

Breast-feeding

No effect of the active substances has been demonstrated in newborns/infants breast-fed by a treated woman. GAVISCON may be used during breast-feeding.

See also section Warnings and precautions.

Fertility

Clinical data do not suggest that GAVISCON has an effect on human fertility at therapeutic doses.

GAVISCON has no or negligible influence on the ability to drive and use machines.

Undesirable effects are listed below by frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

Symptoms

The possible symptoms of an overdose are minor; gastrointestinal discomfort may be felt.

Treatment

In case of overdose, treatment is symptomatic.

Pharmacotherapeutic class: OTHER MEDICINES FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD), ATC code: A02BX.

The physicochemical characteristics of the GAVISCON gel, formed on contact with acidic gastric fluid, give it the 3 following properties:

• its lightness allows it to float above the gastric contents at the level of the gastro-oesophageal junction,
• its viscosity and cohesiveness form a physical barrier that opposes reflux (reduction in the number of reflux episodes). In cases of severe reflux, the gel regurgitates first into the oesophagus and interposes itself between the oesophageal wall and the irritating gastric fluid,
• its alkaline pH replaces the acidic pH of the refluxed fluid. Gastric pH-metry shows that administration of GAVISCON increases the pH by 2 units at the level of the cardia but does not modify the pH in the rest of the stomach.

Its pharmacological efficacy is confirmed by oesophageal pH-metry studies which show that GAVISCON significantly reduces the overall percentage of time spent at acidic pH in the oesophagus (pH < 4), as well as the number and average duration of reflux episodes.

The efficacy of GAVISCON on reflux symptoms has notably been established in patients who had previously healed grade I or II oesophagitis.

GAVISCON immediately transforms in the stomach on contact with acidic fluid into a light foaming gel (release of carbon dioxide bubbles), viscous (alginate precipitate), with a pH close to neutral.

This gel persists durably (2 to 4 hours) in the upper part of the stomach and is evacuated progressively as gastric emptying occurs; it does not modify transit.

Alginates (non-absorbable polysaccharides) are completely eliminated via the digestive tract.

No significant pre-clinical data have been reported.

Before opening: 3 years.

After first opening: 3 months.

Store at a temperature not exceeding 25 °C.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.