Prolonged excessive ingestion of calcium carbonate may lead to hypercalcaemia. Patients with renal impairment are most at risk. Alkalosis is a potential but rare risk. There have been rare reports of the milk-alkali syndrome.
Symptoms of hypercalcaemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuriua, nephrocalcinosis, renal calculi and, in severe cases, cardiac arrhythmias and coma.
Treatment should be aimed at lowering serum calcium levels and may include full hydration, monitoring of other electrolytes and other standard symptomatic and supportive measures.
36 months
Settlers Antacid Chewable Tablets Peppermint Flavour are contra-indicated in patients on low phosphate diet, receiving cardiac glycosides or with impaired hepatic or renal function.
Contraindicated in hypersensitivity to any of the ingredients.
Contraindicated in hypercalcaemia, hypercalciuria (e.g. some forms of malignant disease), and calcium renal calculi.
None known.
Glucose
Icing Sugar (Sucrose)
Compressible Sugar (Sucrose and Maltodextrin)
Maize Starch
Talc
Magnesium Stearate
Peppermint Flavour
Adipic acid
Chewable tablets for oral administration.
A white tablet with a bevelled edge with “Setlers†engraved on both faces of the tablet.
Calcium compounds can cause gastro-intestinal disturbances including flatulence and constipation.
Calcium-containing antacids can induce rebound acid secretion; however, this is unlikely to be of clinical significance in normal use.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Not applicable.
For symptomatic relief from: acid indigestion, heartburn, flatulence and nausea.
Calcium carbonate is an antacid.
The product is formulated as a chewable tablet whose active has a local action in the gastrointestinal tract as an antacid.
11/09/2014
Setlers Antacid Chewable Tablets Peppermint Flavour
Thornton & Ross Limited
Linthwaite
Huddersfield
HD7 5QH
United Kingdom.
None
Coated paper lined foil roll wrapper containing 12 tablets per roll.
Three or eight rolls are contained in a boxboard carton
Pack sizes: 36 and 96 tablets.
PL 00240/0122
Animal studies are insufficient with respect to effects on pregnancy, embryonal foetal development, parturition and postnatal development. The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women.
Calcium carbonate 500mg
Excipients: Each tablet contains 0.47g sucrose
Keep out of reach and sight of children. If you take too many tablets, your symptoms persist or worsen, or you experience any undesirable effects with this product, seek medical advice. If symptoms persist consult your doctor or pharmacist.
Use with caution in diseases associated with hypercalcaemia such as sarcoidosis and some malignancies and in patients with a history of renal calculi.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
None known.
Adults, children over 12 years and elderly: one or two tablets to be sucked or chewed whenever required, up to a maximum of 16 tablets in any 24 hours.
Children aged 6 to under 12 years: one tablet to be sucked or chewed, up to a maximum of 4 tablets in any 24 hours. Not to be given to children under 6 years of age.
The normal adult dose can be taken by the elderly.
None.
13th August 2003
Antacids of this type are known to decrease the absorption of concomitantly administered drugs due to absorption or delaying of gastric emptying or alkalinisation of gastric juice. However the activity of cardiac glycosides such as digoxin may be increased due to the presence of calcium.
Calcium may reduce the absorption of tetracyclines, eltrombopag, bisphosphonates, fluoride, oral iron, zinc, levothyroxine and some fluoroquinolones.
Thiazide diuretics may reduce urinary calcium excretion and cause hypercalcaemia. Vitamin D increases the gastrointestinal absorption of calcium and can cause hypercalcaemia. Plasma-calcium concentrations should be monitored in patients receiving calcium together with thiazide diuretics or Vitamin D.
Antacids may damage enteric coatings designed to prevent dissolution in the stomach.
Interactions may be minimised by ensuring that Setlers Antacid Chewable Tablets Peppermint Flavour are not taken at the same time as, nor within three hours of other medications.
