- Approval Id
- c6ea1b8b3e24d62f
- Drug Approval Emc Name
- Setlers Antacid Chewable Tablets Peppermint Flavour
- Drug Name
- Setlers Antacid Chewable Tablets Peppermint Flavour
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Legal Category
- General Sales List
- Authorisation Holder
- Thornton & Ross Limited
Linthwaite
Huddersfield
HD7 5QH
United Kingdom.
- Authorisation Number
- PL 00240/0122
- Authorisation Date
- 13th August 2003
- Instruction Authorisation Holder
- Thornton & Ross Limited
Linthwaite
Huddersfield
HD7 5QH
United Kingdom.
- Instruction Authorisation Number
- PL 00240/0122
- Instruction Authorisation Date
- 13th August 2003
- Instruction Composition
- Calcium carbonate 500mg
Excipients: Each tablet contains sucrose and glucose
For the full list of excipients see section 6.1.
- Instruction Dosage Form
- Chewable tablets for oral administration.
A white tablet with a bevelled edge with “Setlers” engraved on both faces of the tablet.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For symptomatic relief from: acid indigestion, heartburn, flatulence and nausea.4.2 Posology and method of administration
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.4.3 Contraindications
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.4.4 Special warnings and precautions for use
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.4.5 Interaction with other medicinal products and other forms of interaction
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.4.6 Fertility, pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
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.4.9 Overdose
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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Calcium carbonate is an antacid.5.2 Pharmacokinetic properties
The product is formulated as a chewable tablet whose active has a local action in the gastrointestinal tract as an antacid.5.3 Preclinical safety data
Not applicable.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Glucose
Icing Sugar (Sucrose)
Compressible Sugar (Sucrose and Maltodextrin)
Maize Starch
Talc
Magnesium Stearate
Peppermint Flavour
Adipic acid6.2 Incompatibilities
None known.6.3 Shelf life
36 months6.4 Special precautions for storage
None6.5 Nature and contents of container
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.
Blister pack consisting of PVC film sealed with an aluminium foil with heat-seal lacquer containing 12 tablets per blister.
Two blisters are contained in a boxboard carton.
Pack sizes: 24 tablets.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
- Instruction Content
- ## Composition
Calcium carbonate 500mg
Excipients: Each tablet contains sucrose and glucose
For the full list of excipients see section 6.1.
## Pharmaceutical Form
Chewable tablets for oral administration.
A white tablet with a bevelled edge with “Setlers” engraved on both faces of the tablet.
## Clinical Particulars
4.1 Therapeutic indications
For symptomatic relief from: acid indigestion, heartburn, flatulence and nausea.4.2 Posology and method of administration
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.4.3 Contraindications
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.4.4 Special warnings and precautions for use
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.4.5 Interaction with other medicinal products and other forms of interaction
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.4.6 Fertility, pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
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.4.9 Overdose
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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Calcium carbonate is an antacid.5.2 Pharmacokinetic properties
The product is formulated as a chewable tablet whose active has a local action in the gastrointestinal tract as an antacid.5.3 Preclinical safety data
Not applicable.
## Pharmaceutical Particulars
6.1 List of excipients
Glucose
Icing Sugar (Sucrose)
Compressible Sugar (Sucrose and Maltodextrin)
Maize Starch
Talc
Magnesium Stearate
Peppermint Flavour
Adipic acid6.2 Incompatibilities
None known.6.3 Shelf life
36 months6.4 Special precautions for storage
None6.5 Nature and contents of container
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.
Blister pack consisting of PVC film sealed with an aluminium foil with heat-seal lacquer containing 12 tablets per blister.
Two blisters are contained in a boxboard carton.
Pack sizes: 24 tablets.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None.
- Company Detail Path
- /organization/thornton-and-ross-ltd
