Gaviscon Heartburn and Indigestion 24 Sachets

INDICATIONS

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

ACTIVE INGREDIENTS

Each 10 ml dose (1 sachet) contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg. Excipients with known effects: Methyl parahydroxybenzoate (E218) 4O mg; Propyl parahydroxybenzoate (E216) 6 mg; Sodium 127.88 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Carbomer 974P, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium saccharin, Mint flavouring, Sodium hydroxide, Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

For oral administration. Adults and children aged 12 years and over: 10-20 ml (1 to 2 sachets) after meals and in the evening before going to bed, up to four times a day. Children under 12 years: should only be administered on medical advice. Elderly: it is not necessary to change the doses for this age group.

CONSERVATION

Do not store above 30°C. Do not refrigerate or freeze.

WARNINGS

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.

Immune system disorders - Frequency: Very rare. Adverse reactions: Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.

Metabolism and nutrition disorders - Frequency: Not known. Adverse reactions: Alkalosis¹, Hypercalcemia¹, Lactealkali syndrome¹

Respiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reactions: Respiratory effects such as bronchospasm.

Gastrointestinal disorders - Frequency: Very rare. Adverse reactions: Abdominal pain, acid return, diarrhea, nausea, vomiting.

Gastrointestinal disorders - Frequency: Not known. Adverse reactions: Constipation¹

Skin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reactions: 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.

OVERDOSE

Symptoms Abdominal distention may be evident. Management In case of overdose, symptomatic treatment should be used.

PREGNANCY AND BREASTFEEDING

Pregnancy A moderate amount of data in pregnant women (between 300 and 1,000 exposed pregnancies) indicates that the active ingredients do not cause malformations or fetal/neonatal toxicity. Based on this and previous experience, the medicine can be used during pregnancy if clinically necessary. However, given the presence of calcium carbonate, it is recommended to limit the duration of treatment as much as possible. Breastfeeding No effect of the active ingredients has been shown on newborns/infants breast-fed by treated women. This product can be used during breastfeeding. Fertility Pre-clinical animal investigations have found that alginate does not have an adverse effect on the fertility of the parental generation and offspring or on reproduction. Clinical data do not suggest that Gaviscon may have an effect on fertility in humans.

EFFECTS ON DRIVING ABILITY

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