Gaviscon Mint Flavor Chewable Tablets 250mg 48 Tablets

Therapeutic indications

Symptomatic treatment of occasional heartburn

Dosage

Chewable tablets (strawberry flavor and mint flavor) Posology Adults and adolescents (12–18 years) : 1–2 tablets of 500 mg + 267 mg after meals and at bedtime. 2–4 tablets of 250 mg + 133.5 mg after meals and at bedtime. Method of administration For oral administration. The tablets should be chewed well (they can be broken up and chewed a little at a time). Afterwards you can drink some water. Oral suspension Posology 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. Method of administration For oral administration. Shake the suspension before use. Oral powder Posology Adults and adolescents (12–18 years) : 1–2 single-dose sachets after meals and at bedtime. Method of administration Take the drug orally without water. 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).

Overdose

Experience with overdose is very limited. The only possible consequence of overdose is abdominal distension: in this case, resort to symptomatic treatment by adopting generic support measures.

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).

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)).

Pregnancy and breastfeeding

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

Special warnings

Do not use for prolonged treatments. In adolescents (12–18 years) use only when clearly needed and under close medical supervision. Renal insufficiency In case of renal insufficiency, the medicinal product should be used with caution as the exogenous salt supplement provided by antacids can cause potentially serious electrolyte imbalances. Each 500 mg + 267 mg tablet contains 123 mg (5.3 mmol) of sodium. Each 250 mg +133.5 mg tablet contains 61.5 mg (2.65 mmol) of sodium. Each 10 ml dose of suspension contains 141 mg (6.2 mmol) of sodium. Each 500 mg + 267 mg single-dose sachet of oral powder contains 123 mg (5.3 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 500 mg + 267 mg tablet contains 160 mg (1.6 mmol) of calcium carbonate. Each 250 mg +133.5 mg tablet contains 80 mg (0.8 mmol) of calcium carbonate. Each 10 ml dose of suspension contains 160 mg (1.6 mmol) of calcium carbonate. Each 500 mg + 267 mg single-dose sachet of oral powder 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 and oral powder 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. Duration of treatment If symptoms do not improve after seven days, the clinical picture should be re-evaluated.

Expiry and Retention

Oral suspension and mint flavored oral suspension: do not store above 30 ° C. Store in the original package. Do not refrigerate. Mint flavored oral suspension in sachets: do not store above 25 ° C. Store in the original package. Do not refrigerate. Mint-flavored chewable tablets: do not store above 30 ° C. Store in the original package. Strawberry flavored chewable tablets: Do not store above 25 ° C. Store in the original package. Oral powder: Do not store above 25 ° C. Store in the original package.

Active principles

Gaviscon 500 mg + 267 mg chewable tablets mint flavor One tablet contains: Active ingredients: sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipient with known effect: aspartame 7.5 mg. Gaviscon 250 mg + 133.5 mg chewable tablets mint flavor One tablet contains: Active ingredients: sodium alginate 250 mg; sodium bicarbonate 133.5 mg. Excipient with known effect: aspartame 3.75 mg. Gaviscon 250 mg + 133.5 mg chewable tablets strawberry flavor One tablet contains: Active ingredients: sodium alginate 250 mg; sodium bicarbonate 133.5 mg. Excipient with known effect: aspartame 8.80 mg. Gaviscon 500mg / 10ml + 267mg / 10ml oral suspension 10ml contain: Active ingredients: sodium alginate 500mg; sodium bicarbonate 267 mg. Excipients with known effects: methyl parahydroxybenzoate 40 mg; propyl parahydroxybenzoate 6 mg. Gaviscon 500mg / 10ml + 267mg / 10ml oral suspension mint flavor 10ml contain: Active ingredients: sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipients with known effects: methyl parahydroxybenzoate 40 mg; propyl parahydroxybenzoate 6 mg. Gaviscon 500mg + 267mg oral powder Each sachet contains: Active ingredients: sodium alginate 500mg; sodium bicarbonate 267 mg. Excipients with known effects: aspartame 10 mg. For the full list of excipients, see section 6.1.

Excipients

Mint flavor chewable tablets Mannitol (E421), calcium carbonate, magnesium stearate, copovidone, aspartame (E951), acesulfame potassium, macrogol 20,000, mint flavor. Strawberry flavored chewable tablets Xylitol, mannitol (E421), calcium carbonate, macrogol 20,000, strawberry flavor, aspartame (E951), magnesium stearate, red iron oxide. Oral suspension Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, fennel flavor, sodium hydroxide, erythrosine, purified water. Mint aroma oral suspension Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavor, sodium hydroxide, purified water. Oral powder Calcium carbonate, silicon dioxide, granular anhydrous citric acid, mint flavor, aspartame (E951), macrogol 20000, macrogol 400, passion fruit flavor, acesulfame potassium (E950), xylitol.