Gaviscon 250 mg + 133.5 mg 24 mint flavoured chewable tablets

Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets is an over-the-counter medicine specifically formulated for the symptomatic treatment of occasional heartburn and disorders related to gastroesophageal reflux . Each tablet contains sodium alginate (250 mg) and sodium bicarbonate (133.5 mg), two active ingredients that work synergistically to create a protective barrier on the gastric mucosa, preventing the rise of acids towards the esophagus and offering rapid relief from heartburn and symptoms of acid reflux.

The mint-flavored chewable tablets are convenient to take anywhere, without the need for water, and are ideal for those looking for an effective and fresh-tasting solution to combat gastric discomfort. Their antacid action helps neutralize excess acidity, promoting more comfortable digestion and reducing the feeling of heaviness after meals. Gaviscon is also particularly indicated in cases of difficult digestion and for the protection of the gastric mucosa in the presence of symptoms such as heartburn, acid regurgitation and epigastric pain.

Thanks to its alginate and bicarbonate formulation , Gaviscon acts quickly and in a targeted manner, offering effective protection against the symptoms of gastroesophageal reflux and heartburn. The 24-tablet pack is ideal for occasional use and for those who want to always have an antacid tablet of proven effectiveness on hand. Choose Gaviscon 250 mg + 133.5 mg mint-flavoured chewable tablets for rapid relief from gastric symptoms and reliable stomach protection.

ACTIVE INGREDIENTS

Active ingredients in Gaviscon 250 mg + 133.5 mg 24 mint-flavoured chewable tablets - What is the active ingredient in Gaviscon 250 mg + 133.5 mg 24 mint-flavoured chewable tablets?

Gaviscon 500 mg + 267 mg mint flavour chewable tablets . One tablet contains: Active ingredients : 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 mint flavour chewable tablets. One tablet contains: Active ingredients : 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 flavour chewable tablets . One tablet contains: Active ingredients : 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 ingredients : sodium alginate 500 mg; sodium bicarbonate 267 mg. Excipients with known effect: 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 oral suspension mint flavour . 10 ml contain: Active ingredients : 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

Composition of Gaviscon 250 mg + 133.5 mg 24 chewable tablets mint flavour - What does Gaviscon 250 mg + 133.5 mg 24 chewable tablets mint flavour contain?

Mint flavoured chewable tablets : Mannitol (E421), calcium carbonate, magnesium stearate, copovidone, aspartame (E951), acesulfame potassium, macrogol 20,000, mint flavouring. Strawberry flavoured chewable tablets : Xylitol, mannitol (E421), calcium carbonate, macrogol 20,000, strawberry flavouring, aspartame (E951), magnesium stearate, red iron oxide. Oral suspension : Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, fennel flavouring, sodium hydroxide, erythrosine, purified water. Oral suspension mint flavour: Calcium carbonate, carbomers, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavour, sodium hydroxide, purified water.

DIRECTIONS

Therapeutic indications Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets - Why is Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets used? What is it used for?

Symptomatic treatment of occasional heartburn

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets - When should Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets not be used?

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

DOSAGE

Quantity and method of taking Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets - How do you take Gaviscon 250 mg + 133.5 mg 24 mint-flavored chewable tablets?

Chewable tablets (strawberry and mint flavour). 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 must be chewed well (they can be broken and chewed a little at a time). You can then 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 medicine orally without water. Special populations. Elderly: No dose adjustment is necessary for this age group. Patients with renal insufficiency : The reduced ability to eliminate in the urine the exogenous saline supplement provided by antacids may cause potentially severe electrolyte imbalances (see section 4.4).

CONSERVATION

Storage Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets - How do you store Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets?

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

WARNINGS

Warnings Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets - About Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets it is important to know that:

In adolescents (12-18 years) use only if clearly needed and under strict medical supervision. Renal insufficiency: In case of renal insufficiency, the medicine should 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) of sodium per 500 mg + 267 mg chewable tablet, equivalent to approximately 6% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. • 63.25 mg (2.75 mmol) of sodium per 250 mg + 133.5 mg chewable tablet, equivalent to approximately 3% of the WHO recommended maximum daily intake of 2 g of 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 for an adult of 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. 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 flavour 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 oral suspension and mint flavour oral suspension) contains 320 mg calcium carbonate. Caution should be exercised when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing renal stones. Aspartame: Each 500 mg + 267 mg chewable tablet contains 7.5 mg aspartame. Each 250 mg + 133.5 mg mint flavour chewable tablet contains 3.75 mg aspartame. Each 250 mg + 133.5 mg strawberry flavour chewable tablet contains 8.8 mg aspartame. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria. Parahydroxybenzoates: The oral suspension and the mint flavour 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 flavour, 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 pregnant or breast-feeding patients, or in patients 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.

INTERACTIONS

Interactions Gaviscon 250 mg + 133.5 mg 24 chewable tablets mint flavour - Which medicines or foods can modify the effect of Gaviscon 250 mg + 133.5 mg 24 chewable tablets mint flavour?

It is advisable to leave an interval of at least two hours between taking Gaviscon and other drugs, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates and estramustine (See also section 4.4).

SIDE EFFECTS

Like all medicines, Gaviscon 250 mg + 133.5 mg 24 mint-flavoured chewable tablets can cause side effects - What are the side effects of Gaviscon 250 mg + 133.5 mg 24 mint-flavoured chewable tablets?

The following are the undesirable effects of Gaviscon, organised according to the MedDRA system organ classification. 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)).

Classification by systems and organs	Frequency	Adverse Reaction
Immune system disorders	Very rare	anaphylactic or anaphylactoid reactions. Hypersensitivity reactions (such as urticaria).
Respiratory, thoracic and mediastinal pathologies	Very rare	respiratory symptoms such as bronchospasm
Gastrointestinal disorders	Very rare	flatulence, nausea
Systemic disorders and conditions related to the administration site	Very rare	edema

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. 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.

OVERDOSE

Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets overdose - What are the risks of Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets in case of overdose?

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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Gaviscon 250 mg + 133.5 mg 24 mint-flavoured chewable tablets.

Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate that the active ingredients do not cause malformative or fetal/neonatal toxicity. Gaviscon can be used during pregnancy, if clinically necessary. Breastfeeding: No effect of the active ingredients on newborns/infants fed 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 do not suggest that Gaviscon has an effect on human fertility.

DRIVING AND USE OF MACHINERY

Taking Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets before driving or using machines - Does Gaviscon 250 mg + 133.5 mg 24 mint flavour chewable tablets affect driving or using machines?

Gaviscon has no or negligible influence on the ability to drive or use machines.