GAVISCON BURNER AND INDIG * 24BS

GAVISCON BURNER AND INDIG * 24BS

Therapeutic indications

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

Dosage and method of use

For oral administration. Adults and children 12 years and older: 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 given on medical advice. Elderly: it is not necessary to change the doses for this age group.

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.

Side effects

Adverse reactions associated with the use of sodium alginate, sodium bicarbonate and calcium carbonate are listed below according to system organ class and frequency. Frequencies are defined: Very common (≥1 / 10); Common (≥1 / 100,

They typically occur as a result of taking higher doses than the recommended dose. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special 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 WHO recommended maximum daily sodium intake. This medicine is therefore considered to be high in sodium. This should be taken into consideration 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 (1 sachet) dose contains 130 mg (3.25 mmol) of calcium. Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones. If symptoms do not improve after seven days, the clinical picture should be reassessed. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which can cause allergic reactions (including delayed). Prolonged use should be avoided. As with other antacid medicinal products, taking Gaviscon Burn and Indigestion oral suspension mint flavor in sachets can mask the symptoms of other more serious pre-existing diseases. Gaviscon Burn and Indigestion Mint-flavored oral suspension in sachets should not be used in the following cases: - patients with severe renal impairment / renal insufficiency - patients with hypophosphataemia There is potential for reduced efficacy in patients with very low gastric acid levels. There is an increased risk of hypernatremia in children with gastroenteritis or suspected renal insufficiency. Treatment of children under the age of 12 is generally not recommended, unless prescribed.

Pregnancy and breastfeeding

PregnancyA moderate amount of data in pregnant women (between 300 and 1,000 exposed pregnancies) indicates that the active substances do not cause malformations or fetal / neonatal toxicity. Based on this and previous experience, the medicine can be used during pregnancy if clinically needed. However, in consideration of the presence of calcium carbonate, it is recommended to limit the duration of treatment as much as possible.Feeding timeNo effect of the active substances has been shown on breastfed newborns / infants from treated women. This product can be used during breastfeeding.FertilityPre-clinical investigations in animals have found that alginate does not have an adverse effect on the fertility of parental and offspring or on reproduction. Clinical data do not suggest that Gaviscon may have an effect on human fertility.

Expiration and retention

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

Interactions with other drugs

Due to the presence of calcium and carbonates which act as antacids, it is necessary to consider a time interval of two hours from taking 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 section 4.4.

Overdose

SymptomsAbdominal distension may be noted.ManagementIn the event of an overdose, symptomatic treatment should be used.

Active principles

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

Excipients

Carbomer 974P Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Saccharin sodium Mint flavor Sodium hydroxide Purified water.