Gaviscon Heartburn and Indigestion 24 Sachets

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

INDICATIONS

Treatment of acid-related symptoms of gastro-oesophageal reflux, such as acid regurgitation, heartburn and indigestion, for example after meals or during pregnancy.

CONTRAINDICATIONS

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

WARNINGS AND PRECAUTIONS FOR USE

This medicinal product contains 127.88 mg sodium per 10ml/ 1 sachet, equivalent to 6.39% of the WHO recommended maximum daily sodium intake. The maximum daily dose of this medicine is equivalent to 51.15% of the maximum daily sodium intake recommended by the WHO. This medicine is therefore considered to be high in sodium. This must 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. Each 10 ml dose (1 sachet) contains 130 mg (3.25 mmol) of calcium. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal stones. If symptoms do not improve after seven days, the clinical picture should be re-evaluated. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed). Prolonged use should be avoided. As with other antacid medicinal products, taking Gaviscon Burning and Indigestion mint flavor oral suspension in sachets can mask the symptoms of other more serious pre-existing pathologies. Gaviscon Heartburn and Indigestion mint flavor oral suspension in sachets must not be used in the following cases: - patients with severe impairment of renal function/renal failure; - patients with hypophosphatemia. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. There is an increased risk of hypernatremia in children with gastroenteritis or suspected renal failure. Treatment of children under 12 years of age is generally not recommended unless prescribed by a doctor.

INTERACTIONS

Due to the presence of calcium and carbonates which act as antacids, it is necessary to consider a time interval of two hours between the intake of Gaviscon and the administration of other medicinal products, especially antihistamines-antiH2, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, tyrosine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine and bisphosphonates. See also paragraph 4.4.

SIDE EFFECTS

Adverse reactions associated with the use of sodium alginate, sodium bicarbonate and calcium carbonate are reported below, according to system organ class and frequency. Frequencies are defined as: 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 (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are reported in order of decreasing seriousness.

System and Organ Classification | Frequency | Adverse reactions

Immune system disorders | Very rare | Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria

Metabolism and nutrition disorders | Not known | Alkalosis¹, Hypercalcemia¹, Lactealkali syndrome¹

Respiratory, thoracic and mediastinal disorders | Not known | Respiratory effects such as bronchospasm.

Gastrointestinal pathologies |i | Very rare | Abdominal pain, acid return, diarrhea, nausea, vomiting

Not known | Constipation¹

Skin and subcutaneous tissue disorders | Very rare | Itchy skin rash

Description of selected adverse reactions: ¹ They generally occur following the intake of doses higher than the recommended dose. 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.