Setlers

Setlers Antacid Chewable Tablets Peppermint Flavour

Calcium carbonate 500mg

Excipients: Each tablet contains sucrose and glucose

For the full list of excipients see section 6.1.

Chewable tablets for oral administration.

A white tablet with a bevelled edge with “Setlers” engraved on both faces of the tablet.

For symptomatic relief from: acid indigestion, heartburn, flatulence and nausea.

Adults, children over 12 years and elderly: one or two tablets to be sucked or chewed whenever required, up to a maximum of 8 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.

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.

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.

This medicine contains glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

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.

Animal studies are insufficient with respect to effects on pregnancy, embryonal foetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

None known.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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.

Not applicable.

Glucose

Icing Sugar (Sucrose)

Compressible Sugar (Sucrose and Maltodextrin)

Maize Starch

Talc

Magnesium Stearate

Peppermint Flavour

Adipic acid

None known.

36 months

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.

None.

Thornton & Ross Limited

Linthwaite

Huddersfield

HD7 5QH

United Kingdom.

PL 00240/0122

13^th August 2003

11/10/2019