GAVISCON OS 500+267MG/10ML MEN

GAVISCON

active ingredients

Gaviscon 500 mg + 267 mg tablets chewable taste mint. . One tablet contains: Active ingredients: sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipient with known effects: aspartame 7.5 mg sodium 126,5 mg Gaviscon 250 mg + 133,5 mg chewable tablets mint taste. One tablet contains: Active ingredients: sodium alginate 250 mg; sodium bicarbonate 133,5 mg. Excipient with known effects: aspartame 3,75 mg sodium 63,25 mg Gaviscon 250 mg + 133,5 mg chewing tablets strawberry taste. . One tablet contains: Active ingredients: sodium alginate 250 mg, sodium bicarbonate 133,5 mg. Excipient with known effects: aspartame 8,80 mg sodium 63,25 mg Gaviscon 500 mg/10 ml + 267 mg/10 ml oral suspension . 10 ml contain: Active ingredients: sodium alginate 500 mg; sodium bicarbonate 267 mg methyl parahydroxybenzoate 40 mg propile parahydroxybenzoate 6 mg alcohol benzyl 1,1 mg sodium 142,6 mg Gaviscon 500 mg/10 ml + 267 mg/10 ml oral suspension aroma minta. . 10 ml contain: Active ingredients: sodium alginate 500 mg; sodium bicarbonate 267 mg methyl parahydroxybenzoate 40 mg propile parahydroxybenzoate 6 mg sodium 142,6 mg For the complete list of excipients, see paragraph 6.1.

Excellent

Chewable tablets mint taste: Mannitol (E421), calcium carbonate, magnesium stearate, copovidone, aspartame (E951), potax acesulfame, macrogol 20,000, mint aroma. Tablets chewable strawberry taste: Xylitol, mannitol (E421), calcium carbonate, macrogol 20,000, strawberry aroma, aspartame (E951), magnesium stearate, red iron oxide. Oral suspension: Calcium carbonate, carbomer, methyl parahydroxybenzoate (E218), propile parahydroxybenzoate (E216), sodium saccharin, fennel aroma, sodium hydroxide, erythrosine, purified water. Oral suspension aroma mint: Calcium carbonate, carbomer, methyl parahydroxybenzoate (E218), propile parahydroxybenzoate (E216), sodium saccharin, mint aroma, sodium hydroxide, purified water.

Therapeutic indications

Syntomatic treatment of occasional heartburn

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1, such as methyl parahydroxybenzoate (E218) and propile parahydroxybenzoate (E216) (parabens).

Population

Chewable tablets (corner and mint taste). Posology. Adults and teenagers (12-18 years): 1-2 tablets of 500 mg + 267 mg after meals and at the time of bedtime; 2-4 tablets of 250 mg + 133.5 mg after meals and at bedtime. Method of administration: For oral administration. Tablets must be well chewed (they can be broken and chewed a little at a time). Then you can drink some water. Oral suspension . Posology. Adults and teenagers (12-18 years): 10-20 ml (second-quarter cup of the scoop or 2-4 tablespoons dispenser or 1- 2 single-dose sachets) after meals and at the time of bedtime. Method of administration: For oral administration. Shake the suspension before use. Take the medication by mouth without water. Special popularity. Seniors: it is not necessary to change the doses for this age group. Patients with kidney failure: the reduced ability to eliminate with urine the exogenous saline supplement provided by antacids can affect potentially severe electrolytic imbalances (see paragraph 4.4).

Conservation

Oral suspension and oral suspension aroma mint: do not store at temperature above 30°C. Store in the original packaging. Don't refrigerate. Oral suspension aroma mint in sachets: do not store at a temperature greater than 25°C. Don't refrigerate. Chewable tablets: do not store at temperature above 30 ° C. Store in the original packaging. Chewable strawberry flavour tablets: do not store at temperature above 25°C. Store in the original packaging.

Warnings

In teenagers (12-18 years) use only in case of actual need and under strict control of the doctor. Renal insufficiency: In case of kidney failure, the drug must be used with caution since the exogenous salt supplement provided by antacids can cause potentially serious electrolytic imbalances. This medicine contains: Sodium: • 126,5mg (5.5 mmol) of sodium for each chewable tablet of 500 mg + 267 mg, equivalent to about 6% of the maximum daily consumption recommended by the WHO which corresponds to 2 g of sodium for an adult. • 63,25 mg (2,75 mmol) of sodium for each 250 mg +33,5 mg chewable tablet, equivalent to about 3% of the maximum daily consumption recommended by the WHO which corresponds to 2 g of sodium for an adult. • 142,6 mg (6,2 mmol) of sodium for each dose of 10 ml oral suspension and oral suspension aroma mint, equivalent to about 7% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. 391 mg of sodium (17 mmol) correspond approximately to 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 account in cases where a particularly poor diet of salt is recommended, for example in some cases of congestive heart failure and kidney impairment. Football: Each chewable 500 mg + 267 mg tablet contains 160 mg (1.6 mmol) of calcium carbonate. Each chewable 250 mg tablet +133,5 mg contains 80 mg (0.8 mmol) of calcium carbonate. Each dose of 10 ml oral suspension and oral suspension aroma mint contains 160 mg (1.6 mmol) of calcium carbonate. Every maximum recommended dose (2 tablets of 500 mg + 267 mg, 4 tablets of 250 mg +133,5 mg, 20 ml oral suspension and oral suspension aroma mint) contains 320 mg of calcium carbonate. Care should be taken to treat patients suffering from hypercalcemia, nephrocacinosis and relapse calculations containing calcium. Aspartame: Each chewable tablet of 500 mg + 267 mg contains 7.5 mg of aspartame. Each chewable 250 mg tablet +133,5 mg mint taste contains 3,75 mg aspartame. Each chewable 250 mg tablet +133,5 mg strawberry taste contains 8,8 mg aspartame. Aspartame is a source of phenylalanine and can be harmful to patients suffering from phenylketonuria. Parahydroxybenzoates: Oral suspension and oral suspension aroma mint contain metile parahydroxybenzoate (40 mg/10 ml suspension) and propile parahydroxybenzoate (6 mg/10 ml suspension) which can cause allergic reactions (also delayed) Benzyl alcohol: GAVISCON 500 mg/10 ml + 267 mg/ 10 ml oral suspension contains fennel aroma, in turn containing benzyl alcohol. Each dose of 10 ml oral suspension contains 1.1 mg of benzyl alcohol. Benzyl alcohol can cause allergic reactions. Large volumes should be used with caution and only if necessary, especially in pregnant, nursing patients, with liver or kidney failure 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.

Interactions

It is advisable to interpose a range of at least two hours between the intake of Gaviscon and that of other drugs, especially tetracycline, fluoroquine, iron salts, thyroid hormones, chlorochina, biphosphonate and estramustine (See also paragraph 4.4).

Effects

Below are the undesirable effects of Gaviscon, organized according to the organic systemic classification MedDRA. They are divided by frequency (very common (≥ 1/10), common (≥ 1/100 a ≤ 1/10), uncommon (≥ 1/1.000 a ≤ 1/100), rare (≥ 1/10.000 a 1/1.000), very rare (≤ 1/10.000), unknown (frequency cannot be defined on the basis of available data).

Classification for systems and organs	Frequency	Reaction
Immune system disorders	Very rare	anaphylactic or anaphylactic reactions. Reactions of hypersensitivity (such as nettle- ria).
Respiratory, chest and mediastinic pathologies	Very rare	respiratory symptoms such as bronchospasmo
Gastrointestinal diseases	Very rare	flatulence, nausea
Systemic pathologies and conditions for administration	Very rare	edema

Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The experience on overdosing is very limited. The only possible consequence of overdose is abdominal distension: in this case use symptomatic treatment by taking generic support measures.

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

Source: Farmadati