GAVISCON INDIG 24BS

GAVISCON BRUCIORE AND INDIGESTION 500MG/213MG/325MG ORAL SOSPENSION

active ingredients

Each dose of 10 ml (1 sachet) contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg. Excipients with known effects: Parahydroxybenzoate (E218) 4O mg Propile parahydroxybenzoate (E216) 6 mg Sodium 127,88 mg For full list of excipients, see paragraph 6.1.

Excellent

Carbomero 974P Metile parahydroxybenzoate (E218) Propile parahydroxybenzoato (E216) Saccarina sodica Aroma menta Sodium hydroxide Purified Water.

Therapeutic indications

Treatment of symptoms of gastro-esophageal reflux related to acidity, such as acid regurgitation, pyrosis and indigestion, for example after meals or during pregnancy.

Contraindications

This medicine is contraindicated in patients with known or suspected hypersensitivity to active ingredients or any of the excipients listed in the paragraph 6.1.

Population

For oral administration. Adults and children from 12 years up: 10-20 ml (from 1 to 2 sachets) after meals and the evening before going to bed, up to four times a day. Children under 12 years: should only be given on medical advice. Seniors: you do not need to change the doses for this age group.

Conservation

Do not store at temperature above 30°C. Do not refrigerate or freeze.

Warnings

This medicine contains 127.88 mg of sodium for 10ml/ 1 sachet, equivalent to 6.39% of the maximum daily sodium intake recommended by the WHO. The maximum daily dose of this medicine is 51.15% of the maximum daily sodium intake recommended by the WHO. 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. Each dose of 10 ml (1 sachet) contains 130 mg (3.25 mm) of calcium. Care should be taken to treat patients suffering from hypercalcemia, nephrocacinosis and relapse calculations containing calcium. If symptoms do not improve after seven days, the clinical picture should be reassessed. Contains parahydroxybenzoate methyl (E218) and parahydroxybenzoate propile (E216), which can cause allergic reactions (also delayed). Prolonged use should be avoided. As well as for other anti-acid medicines, the intake of Gaviscon Bruciore and Indigestion oral suspension flavor mint in sachets can mask the symptoms of other pre-existing more serious diseases. Gaviscon Burning and Indigestion oral suspension mint taste in sachets should not be used in the following cases: - patients with severe hornpromise of kidney function / kidney failure - patients with hypophosphateemia There is a possibility of reduced effectiveness in patients with very low levels of gastric acid. There is an increase in the risk of hypernatriemia in children with gastroenteritis or suspected kidney failure. Treatment of children under the age of 12 is generally not recommended, except for prescription.

Interactions

Due to the presence of calcium and carbonates acting as an antacids, it is necessary to consider a two-hour interval from the intake of Gaviscon and the administration of other medicinal products, especially antihistamine-antiH2, tetracycline, digoxin, fluoroquinolone, iron salts, thyroid hormones, ketoconazole, neuroleptics, tyrosine, pencylin, beta-blockers. See also paragraph 4.4.

Effects

Adverse reactions associated with the use of alginate sodium, bicarbonate sodium and carbonate calcium are shown below, according to the classification for systems and organs and frequency. The frequencies are defined: Very common (≥1/10); Common (≥1/100, Classification for Systems and Organs Frequency Adverse reactions Immune system disorders Very rare Anaphylactic reaction, anaphylactic reaction, reaction of hypersensitivity as hives Disorders of metabolism and nutrition Notable Alcalosi1, Hypercalcemia1, Milky Syndrome1 Respiratory, chest and mediastinic pathologies Notable Respiratory effects such as bronchospasmo Gastrointestinal diseases Very rare Abdominal pain, acid return, diarrhea, nausea, vomiting Notable Constipation1 Pathologies of skin and subcutaneous tissue Very rare Itching skin rash Description of selected adverse reactions: ¹ They usually occur as a result of higher doses than the recommended dose. 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- -reactions-adverse.

Overdosing

Synonyms You can highlight abdominal distension. Management In case of overdose, one must resort to symptomatic treatment.

Pregnancy A moderate number of data in pregnant women (between 300 and 1,000 exposed pregnancy) indicates that active ingredients do not cause malformation or fetal/neonatal toxicity. Based on this and previous experiences, the medicine can be used during pregnancy if clinically necessary. However, in view of the presence of calcium carbonate, it is recommended to limit as much as possible the duration of treatment. Food No effect has been shown on active ingredients on infants/ infants breastfeededed by treated women. This product can be used during breastfeeding. Fertility Pre-clinical investigations on animals have found that alginate has no negative effect on fertility of parental generation and offspring or reproduction. Clinical data suggests that Gaviscon may have an effect on fertility in humans.

Source: Farmadati