GAVISCON * 24BUST 500 + 267MG / 10ML

GAVISCON * 24BUST 500 + 267MG / 10ML

Therapeutic indications

Symptomatic treatment of occasional heartburn

Dosage and method of use

Chewable tablets (strawberry flavor and mint flavor). Dosage.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 . Dosage.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. Take the drug by mouth without water. Special populations. Elderly people:it is not necessary to change the doses for this age group.Patients with renal insufficiency: the reduced ability to eliminate exogenous saline supplementation provided by antacids in the urine can affect potentially severe electrolyte imbalances (see section 4.4).

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), not known (cannot be estimated from the available data)).

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

In adolescents (12-18 years) use only if clearly needed and under close medical supervision.Kidney failure:In case of renal insufficiency, the medicine should be used with caution as the exogenous salt supplement provided by antacids can cause potentially serious electrolyte imbalances. This medicine contains:Sodium: • 126.5mg (5.5mmol) sodium per 500mg + 267mg chewable tablet, equivalent to approximately 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. • 63.25 mg (2.75 mmol) of sodium for each 250 mg +133.5 mg chewable tablet, equivalent to approximately 3% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for one adult. • 142.6 mg (6.2 mmol) sodium per 10 ml dose of oral suspension and mint flavored oral suspension, equivalent to approximately 7% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. 391 mg of sodium (17 mmol) corresponds to approximately 20% of the maximum daily intake recommended by the WHO with the diet of an adult which is 2 g; 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.Soccer: Each 500 mg + 267 mg chewable tablet contains 160 mg (1.6 mmol) of calcium carbonate. Each 250 mg +133.5 mg chewable tablet contains 80 mg (0.8 mmol) of calcium carbonate. Each 10 ml dose of mint flavoring oral suspension and oral suspension contains 160 mg (1.6 mmol) of 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 flavoring oral suspension) contains 320 mg of calcium carbonate. Care should be taken when treating patients with hypercalcaemia, 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 aspartame. Aspartame is a source of phenylalanine and can be harmful to patients with phenylketonuria.Parahydroxybenzoates:The mint flavored oral suspension and oral suspension contain methyl parahydroxybenzoate (40 mg / 10 ml suspension) and propyl parahydroxybenzoate (6 mg / 10 ml suspension) which may cause allergic reactions (including 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 can cause allergic reactions. Large volumes should be used with caution and only as necessary, especially in pregnant, lactating, hepatic or renal patients 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 reassessed.

Pregnancy and breastfeeding

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

Expiration and retention

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

Interactions with other drugs

It is advisable to interpose an interval of at least two hours between taking Gaviscon and taking other drugs, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates and estramustine (See also 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.

Active principles

Gaviscon 500 mg + 267 mg chewable mint flavor tablets.One tablet contains:Active principles: sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipient with known effect: aspartame 7.5 mg sodium 126.5 mg Gaviscon 250 mg + 133.5 mg chewable mint flavor tablets. One tablet contains:Active principles: sodium alginate 250 mg; sodium bicarbonate 133.5 mg. Excipient with known effect: aspartame 3.75 mg sodium 63.25 mg Gaviscon 250 mg + 133.5 mg strawberry flavored chewable tablets.One tablet contains:Active principles: sodium alginate 250 mg, sodium bicarbonate 133.5 mg. Excipient with known effect: aspartame 8.80 mg sodium 63.25 mg Gaviscon 500 mg / 10 ml + 267 mg / 10 ml oral suspension . 10 ml contain:Active principles: sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipients with known effects: methyl parahydroxybenzoate 40 mg propyl parahydroxybenzoate 6 mg benzyl alcohol 1.1 mg sodium 142.6 mg Gaviscon 500 mg / 10 ml + 267 mg / 10 ml mint flavored oral suspension.10 ml contain:Active principles: 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 a full list of excipients, see section 6.1.

Excipients

Mint-flavored 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-flavored oral suspension: Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavor, sodium hydroxide, purified water.