Gaviscon Heartburn and Indigestion 24 Sachets

Gaviscon Heartburn & Indigestion mint flavoured oral suspension in sachets is an over-the-counter anti-peptic ulcer medicine and to treat the symptoms of gastroesophageal reflux . Gaviscon Heartburn & Indigestion combines two antacids (calcium carbonate and sodium bicarbonate) and an alginate for a double synergistic action :

• It neutralizes excess acidity of gastric juices in the stomach and reduces acidity and discomfort .

• It forms a protective barrier on the walls of the stomach that prevents contact with gastric juices and significantly reduces heartburn and stomach pain .

Gaviscon Heartburn & Indigestion 24 Sachets is indicated for the treatment of acid -related symptoms of gastroesophageal reflux disease , such as acid regurgitation , heartburn and indigestion , for example after meals or during pregnancy.

ACTIVE INGREDIENTS

Active ingredients in Gaviscon Heartburn & Indigestion 24 Sachets - What is the active ingredient in Gaviscon Heartburn & Indigestion 24 Sachets?

Each 10 ml dose (1 sachet) contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg. Excipients with known effect: methyl parahydroxybenzoate (E218) 40 mg; propyl parahydroxybenzoate (E216) 6 mg; sodium 127.88 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Gaviscon Heartburn & Indigestion 24 Sachets - What does Gaviscon Heartburn & Indigestion 24 Sachets contain?

Carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavour, sodium hydroxide, purified water.

DIRECTIONS

Therapeutic indications Gaviscon Heartburn and Indigestion 24 Sachets - Why is Gaviscon Heartburn and Indigestion 24 Sachets used? What is it for?

Treatment of acid-related symptoms of gastroesophageal reflux disease, such as acid regurgitation, heartburn and indigestion, for example after meals or during pregnancy.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Gaviscon Heartburn and Indigestion 24 Sachets - When should Gaviscon Heartburn and Indigestion 24 Sachets not be used?

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

DOSAGE

Quantity and method of taking Gaviscon Heartburn and Indigestion 24 Sachets - How to take Gaviscon Heartburn and Indigestion 24 Sachets?

For oral administration. Adults and children aged 12 years and over: 10-20 ml (1 to 2 sachets) after meals and in the evening before going to bed, up to four times a day. Children under 12 years: should only be administered on medical advice. Elderly: it is not necessary to modify the doses for this age group.

CONSERVATION

Storage Gaviscon Heartburn & Indigestion 24 Sachets - How to store Gaviscon Heartburn & Indigestion 24 Sachets?

Do not store above 30 degrees C. Do not refrigerate or freeze.

WARNINGS

Warnings Gaviscon Heartburn and Indigestion 24 Sachets - About Gaviscon Heartburn and Indigestion 24 Sachets it is important to know that:

This medicinal product contains 127.88 mg sodium per 10 ml/ 1 sachet, equivalent to 6.39% of the WHO recommended maximum daily intake of sodium. The maximum daily dose of this medicinal product is equivalent to 51.15% of the WHO recommended maximum daily intake of sodium. This medicinal product is therefore considered high in sodium. This should be taken into account 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 (1 sachet) contains 130 mg (3.25 moles) of calcium. Caution should be exercised when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones. If symptoms do not improve after seven days, the clinical picture should be re-evaluated. Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed). Prolonged use should be avoided. As with other antacid medicinal products, taking Gaviscon Heartburn and Indigestion Mint Flavour Oral Suspension in Sachets may mask the symptoms of other more serious pre-existing conditions. Gaviscon Heartburn and Indigestion Mint Flavour Oral Suspension in Sachets should not be used in the following cases: patients with severe renal impairment/renal failure; patients with hypophosphatemia. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. There is an increased risk of hypernatraemia in children with gastroenteritis or suspected renal failure. Treatment of children under 12 years of age is not generally recommended, unless prescribed by a doctor.

INTERACTIONS

Interactions Gaviscon Heartburn and Indigestion 24 Sachets - Which medicines or foods can modify the effect of Gaviscon Heartburn and Indigestion 24 Sachets?'

Due to the presence of calcium and carbonates which act as antacids, it is necessary to consider a time interval of two hours between the intake of Gaviscon and the administration of other medicinal products, especially antihistamines-H2 blockers, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, tyrosine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine and bisphosphonates. See also paragraph 4.4.

SIDE EFFECTS

Like all medicines, Gaviscon Heartburn & Indigestion 24 Sachets can cause side effects - What are the side effects of Gaviscon Heartburn & Indigestion 24 Sachets?

Adverse reactions associated with the use of sodium alginate, sodium bicarbonate and calcium carbonate are listed below, according to system organ class and frequency. Frequencies are defined as: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. Immune system disorders. Very rare: anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria. Metabolism and nutrition disorders. Not known: alkalosis ^1, hypercalcaemia ^1, milk-alkali syndrome ^1. Respiratory, thoracic and mediastinal disorders. Not known: respiratory effects such as bronchospasm. Gastrointestinal disorders. Very rare: abdominal pain, acid reflux, diarrhoea, nausea, vomiting; not known: constipation ^1. Skin and subcutaneous tissue disorders. Very rare: itchy rash. Description of selected adverse reactions. ^1 They generally occur following the intake of doses higher than the recommended dose. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as 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.

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 Heartburn and Indigestion 24 Sachets.

Pregnancy: A moderate amount of data on pregnant women (between 300 and 1,000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of the active substances. Based on this and previous experience, the medicinal product can be used during pregnancy if clinically needed. However, due to the presence of calcium carbonate, it is recommended to limit the duration of treatment as much as possible. Breastfeeding: No effect of the active substances on newborns/infants breastfed by treated women has been shown. This product can be used during breastfeeding. Fertility: Preclinical studies in animals have shown that alginate has no adverse effect on fertility of the parental generation and offspring or on reproduction. Clinical data do not suggest that Gaviscon may have an effect on fertility in humans.