Gaviscon 500mg/10ml + 267mg/10ml oral suspension mint flavour 24 sachets 10ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic treatment of occasional heartburn

CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, such as methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (parabens).

WARNINGS AND PRECAUTIONS FOR USE

In adolescents (12-18 years) use only if clearly necessary and under strict medical supervision. Kidney failure: In case of renal insufficiency, the medicine should be used with caution since the exogenous salt supplement provided by antacids can cause potentially serious electrolyte imbalances. This medicine contains: Sodium: • 126.5mg (5.5 mmol) of sodium for each 500 mg + 267 mg chewable tablet, equivalent to approximately 6% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. • 63.25 mg (2.75 mmol) of sodium for each 250 mg +133.5 mg chewable tablet, equivalent to approximately 3% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. • 142.6 mg (6.2 mmol) of sodium for each 10 ml dose of oral suspension and mint flavor oral suspension, equivalent to approximately 7% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. 391 mg sodium (17 mmol) corresponds to approximately 20% of the WHO recommended maximum daily dietary intake of 2 g for an adult; this medicine is therefore considered to be high in sodium. This should be taken into account in cases where a particularly low-salt diet is recommended, for example in some cases of congestive heart failure and renal impairment. Football: Each 500 mg + 267 mg chewable tablet contains 160 mg (1.6 mmol) calcium carbonate. Each 250 mg +133.5 mg chewable tablet contains 80 mg (0.8 mmol) of calcium carbonate. Each 10 ml dose of oral suspension and mint flavor oral suspension contains 160 mg (1.6 mmol) of calcium carbonate. Each maximum recommended dose (2 tablets of 500 mg + 267 mg, 4 tablets of 250 mg +133.5 mg, 20 ml of oral suspension and mint flavor oral suspension) contains 320 mg of calcium carbonate. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis, and recurrent calcium-containing renal stones. Aspartame: Each 500 mg + 267 mg chewable tablet contains 7.5 mg of aspartame. Each 250 mg +133.5 mg mint flavor chewable tablet contains 3.75 mg of aspartame. Each 250 mg +133.5 mg strawberry flavor chewable tablet contains 8.8 mg of aspartame. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria. Parahydroxybenzoates: The oral suspension and the mint flavor oral suspension contain methyl parahydroxybenzoate (40 mg/10 ml of suspension) and propyl parahydroxybenzoate (6 mg/10 ml of suspension) which may cause allergic reactions (even delayed) Benzyl alcohol: GAVISCON 500 mg/10 ml + 267 mg/10 ml oral suspension contains fennel flavour, which in turn contains benzyl alcohol. Each 10 ml dose of oral suspension contains 1.1 mg of benzyl alcohol. Benzyl alcohol can cause allergic reactions. Large volumes should be used with caution and only if necessary, especially in patients who are pregnant, breastfeeding, with hepatic or renal insufficiency due to the risk of accumulation and toxicity (metabolic acidosis). Duration of treatment: If symptoms do not improve after seven days, the clinical picture should be re-evaluated.

INTERACTIONS

It is advisable to place an interval of at least two hours between taking Gaviscon and other medicines, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates and estramustine (See also section 4.4).

SIDE EFFECTS

Below are the side effects of Gaviscon, organized according to the MedDRA system organic classification. They are divided by frequency (very common (≥ 1/10), common (≥ 1/100 to ≤ 1/10), uncommon (≥ 1/1,000 to ≤ 1/100), rare (≥ 1/10,000 to 1/1,000), very rare (≤ 1/10,000), not known (the frequency cannot be estimated on the basis of available data)).

Classification by systems and organs | Frequency | Adverse Reaction

Immune system disorders | Very rare | anaphylactic or anaphylactoid reactions. Hypersensitivity reactions (such as urticaria).

Respiratory, thoracic and mediastinal disorders | Very rare | respiratory symptoms such as bronchospasm

Gastrointestinal disorders | Very rare | flatulence, nausea

Systemic pathologies and conditions relating to the administration site | Very rare | edema

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.