GAVISCON Susp buv en sachet 24Sach/10ml

Oral suspension.
Sachets of 10 ml, box of 24.

For one sachet :

Sodium alginate : 500,00 mg
Sodium bicarbonate : 267,00 mg

Excipients with known effect : each sachet contains 142,5 mg (i.e. 6,3 mmol) of sodium, 40,00 mg of methyl parahydroxybenzoate (E218) and 6,00 mg of propyl parahydroxybenzoate (E216).

Symptomatic treatment of gastro-oesophageal reflux.

Adults and children over 12 years :

1 sachet 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.

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

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

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 sachet 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. Each sachet contains 160 mg of calcium carbonate. Precautions must be taken in patients with hypercalcaemia, nephrocalcinosis and those with renal calculi.

Associations requiring precautions for use

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 or newborn.

GAVISCON may be used during pregnancy if necessary.

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.

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 been established notably in patients who had previously healed grade I or II oesophagitis.

Gaviscon immediately transforms in the stomach upon contact with acidic fluid into a light, foamy, viscous gel (release of carbon dioxide bubbles, precipitate of alginates), 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.

2 years.

Store at a temperature not exceeding 25 °C.

No special requirements.