Gaviscon oral suspension mint taste 500 mg + 267 mg 200 ml

Product Description

Gaviscon oral suspension is indicated for occasional heartburn.

Indications

Symptomatic treatment of occasional heartburn.

Composition

Active ingredients

10 ml contain sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipients with known effect: methyl parahydroxybenzoate 40 mg propyl parahydroxybenzoate 6 mg sodium 142.6 mg For the full list of excipients, see section 6.1.

Excipients

Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavouring, sodium hydroxide, purified water.

Directions for use and Dosage

Adults and adolescents (12-18 years): 10-20 ml (second-fourth mark of the measuring cup or 2-4 measuring spoons or 1-2 single-dose sachets) after meals and at bedtime. Method of administration: For oral administration. Shake the suspension before use. Take the medicine orally without water.
Special populations. Elderly: It is not necessary to modify the doses for this age group. Patients with renal insufficiency: The reduced ability to eliminate the exogenous saline supplement provided by antacids in the urine can cause potentially serious electrolyte imbalances (see section 4.4).

Warnings

In adolescents (12-18 years), use only if clearly needed and under strict medical supervision.
Renal insufficiency: In case of renal insufficiency, the medicine must be used with caution since the exogenous saline supplement provided by antacids can cause potentially serious electrolyte imbalances. This medicine contains:
Sodium: • 126.5 mg (5.5 mmol) sodium per 500 mg + 267 mg chewable tablet, equivalent to approximately 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. • 63.25 mg (2.75 mmol) sodium per 250 mg + 133.5 mg chewable tablet, equivalent to approximately 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. • 142.6 mg (6.2 mmol) sodium per 10 ml dose of oral suspension and mint flavour oral suspension, equivalent to approximately 7% of the WHO recommended maximum daily intake of 2 g 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 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.
Calcium: 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) calcium carbonate. Each 10 ml dose of oral suspension and mint-flavored oral suspension contains 160 mg (1.6 mmol) 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-flavored oral suspension) contains 320 mg calcium carbonate. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis, and recurrent calcium-containing kidney stones. Aspartame: Each 500 mg + 267 mg chewable tablet contains 7.5 mg of aspartame. Each 250 mg + 133.5 mg mint-flavored chewable tablet contains 3.75 mg of aspartame. Each 250 mg + 133.5 mg strawberry-flavored 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-flavored 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 (possibly delayed).
Benzyl alcohol: GAVISCON 500 mg/10 ml + 267 mg/10 ml oral suspension contains fennel flavor, which in turn contains benzyl alcohol. Each 10 ml dose of oral suspension contains 1.1 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Large volumes should be used with caution and only if necessary, especially in patients who are pregnant, breastfeeding, or 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.

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).

Undesirable effects

The following are the undesirable effects of Gaviscon, organised according to the MedDRA system organ class. 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 (frequency cannot be estimated from the available data)).

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Experience with overdose is very limited. The only possible consequence of overdose is abdominal distension: in this case, symptomatic treatment should be resorted to, adopting general supportive measures.

Pregnancy and breastfeeding

Pregnancy: Clinical studies on more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate that the active substances do not cause malformations or fetal/neonatal toxicity. Gaviscon can be used during pregnancy, if clinically necessary.
Breastfeeding: No effects of the active substances on newborns/infants breastfed by treated mothers have been shown. Gaviscon can be used during breastfeeding.
Fertility: Preclinical studies have shown that alginate has no adverse effect on fertility and reproduction. Clinical data do not suggest that Gaviscon affects human fertility.

Format

200 ml