GAVIX

Treatment of symptoms of gastroesophageal reflux such as acid regurgitation, pyrosis and difficult digestion (reflux-related), such as after meals or during pregnancy, or during an oesophageal process.

If there is no improvement in symptoms after 7 days, the c-linic situation should be reconsidered.

For children under 12 years of age This medicinal product contains calcium.

Each sachet contains 160 mg calcium carbonate.

Caution should be exercised in patients with hypercalcaemia, nephrocalcinosis and renal stones.

Excipients with known effect

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

This medicinal product contains 139 mg sodium per sachet, equivalent to 7% of the WHO recommended maximum daily dietary intake of 2 g sodium per adult.

The maximum daily dose of this medicinal product is equivalent to 56% of the maximum daily dietary intake of sodium recommended by WHO.

ALGINATE/BICARBONATE SODIUM ARROW COUNCIL is considered a medicine with a high sodium dose.

This should be particularly taken into account for patients following a hyposedic diet, e.g., renal failure in heart failure.

Pharmacotherapeutic group: other medicinal products for peptic ulcer and gastroesophageal reflux (G.R.O)., ATC code: A02BX.

• its lightness allows it to float above gastric content at the gastric junction;

• its viscosity and consistency form a physical barrier that opposes reflux (decrease in reflux number).

In case of severe reflux, the regurgite gel first in the oesophageal and interposes between the oesophageal wall and the irritant gastric fluid;

• its alkaline pH is substitutable to the acid pH of the reflux liquid.

The sodium alginate/sodium bicarbonate administration thus increases the sodium-likeness of the pH II-refected process of the pH-2-fold of the acidic acidity of the acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acidic acid.

Adverse reactions are classified 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), not known (cannot be estimated from the available data).

Class of Organ Systems Frequency Adverse reactions Immune system disorders Very rare Anaphylactic and anaphylactoid reactions Hypersensitivity reactions such as l'urticaria Respiratory, thoracic and mediastinal disorders Very rare Respiratory effects such as bronchospasm Reporting suspected adverse reactions following authorisation of the drug is important, allowing for continuous monitoring of the benefit/risk ratio of the drug.

Health care professionals report any suspected adverse reactions via the national reporting system: National Drug and Health Products Safety Agency (NSHA) and Network of Regional Pharmacovigilance Centres.

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening.

2 to 3 sprays orally, three times daily.

Children under twelve one half adult dosage.

Do not take within 15 minutes of consuming food, beverage or brushing teeth.

Consult a physician for use in children under 12 years of age.