Gaviscon 500 + 267mg / 10ml Oral Suspension Mint Aroma 24 Sachets

Gaviscon 500 + 267mg / 10ml Oral Suspension Mint Aroma

Symptomatic treatment of occasional heartburn

Active principles

Gaviscon 500mg / 10ml + 267mg / 10ml oral suspension 10ml contain: Active ingredients: sodium alginate 500 mg sodium bicarbonate 267 mg Excipients: methyl parahydroxybenzoate 40 mg propyl parahydroxybenzoate 6 mg For a full list of excipients, see section 6.1.

Excipients

Oral suspension Calcium carbonate; carbomers; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium saccharin; fennel flavoring; sodium hydroxide; erythrosine; purified water.

Therapeutic indications

Symptomatic treatment of occasional heartburn

Contraindications

Hypersensitivity to the active substances or to any of the excipients, including esters of hydroxybenzoates (parabens). Severe renal insufficiency.

Dosage

Oral suspension Adults and adolescents (12–18 years): 10–20 ml (second – fourth notch of the measuring cup or 2–4 measuring spoons or 1– 2 single-dose sachets) after meals and at bedtime. For oral administration. Shake the suspension before use. Special populations Elderly: there is no need to adjust the doses for this age group. Patients with renal insufficiency: The reduced ability to urinate the exogenous salt supplement provided by antacids can affect potentially severe electrolyte imbalances (see section 4.4).

Warnings and Precautions

Do not use for prolonged treatments. In patients with very low gastric acid levels there is a possibility of lower efficacy. In adolescents (12–18 years) use only when clearly needed and under close medical supervision. In case of renal insufficiency, the medicinal product should be used with caution as the exogenous salt supplement provided by antacids can affect potentially severe electrolyte imbalances. Each 10 ml dose of suspension contains 141 mg (6.2 mmol) of 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 dose of suspension contains 160 mg (1.6 mmol) of calcium carbonate. Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones. The tablets contain aspartame, a source of phenylalanine and should therefore not be taken by patients with phenylketonuria. The suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions. Delayed-type reactions (contact dermatitis) usually occur, rarely immediate reactions with urticaria and bronchospasm.

Interactions

It is advisable to interpose an interval of at least two hours between taking Gaviscon and that of other drugs.

Side effects

Below are the side effects of Gaviscon, organized 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)). Gastrointestinal disorders Very rare: flatulence, nausea Skin and subcutaneous tissue disorders Very rare: fluid retention (edema). Immune system disorders Very rare: allergic manifestations such as urticaria and bronchospasm, anaphylactic or anaphylactoid reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Use in case of real need and under strict medical supervision.

Format

Pack of 24 sachets of 10 ml mint flavor (500mg + 267mg)

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