Gaviscon Strawberry Flavour 16 Chewable Tablets
Gaviscon Strawberry Flavour Tablets.
-Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg, calcium carbonate 80 mg.
-Excipient(s) with known effect:
Chewable tablet. (Tablet)
Pale pink, circular, flat with bevelled edges with the odour and flavour of strawberry.
-Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.
Posology and method of administration:
-For oral administration, after being thoroughly chewed.
-Adults and children 12 years and over: Two to four tablets after meals and at bedtime.
-Children under 12 years: Should be given only on medical advice.
-Elderly: No dose modifications necessary for this age group.
-Hepatic Impairment: No dose modification necessary.
-Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Special warnings and precautions for use:
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 254.84 mg (11.08 mmol) of sodium per four-tablet dose, equivalent to 12.74% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 50.96 % of the WHO adult recommended maximum daily intake for sodium. This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with phenylketonuria.
Interaction with other medicinal products and other forms of interaction:
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, biphosphonates (diphosphonates) and estramustine.
Fertility, pregnancy and lactation:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.
Effects on ability to drive and use machines: