Fruit Flavoured Antacid Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fruit Flavoured Antacid Tablets
Fruit Flavoured Indigestion Tablets
Superdrug Fruit Flavoured Indigestion Relief Tablets
Boots Indigestion Relief Tablets Fruit
Tums Assorted Fruit Antacid Tablets
Wilko Fruit Flavoured Antacid 500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENT QTY UNIT DOSE
Calcium Carbonate 500 mg tablet
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief from indigestion, dyspepsia, heartburn, acidity and flatulence.
4.2 Posology and method of administration
Take one or two tablets, as required, up to a maximum of 16 tablets a day.
Suck slowly or chew as preferred.
There is no distinction between adults and the elderly on the pack.
Not recommended for children under 12 years.
Pregnant women: One or two tablets to be sucked or chewed whenever required, up to a maximum of 7 tablets in 24 hours.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Patients with hypercalcaemia, hyperparathyroidism, hypercalciuria, nephrolithiasis and Zollinger-Ellison Syndrome.
Patients on a low phosphate diet.
Patients on cardiac glycosides.
Patients with impaired renal function.
Patients with rare glucose-galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Keep all medicines out of the sight and reach of children.
The leaflet shall say:
Each tablet contains 523mg of glucose (dextrose) per tablet. This should be taken into account in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
4.5. Interactions with other Medicaments and other forms of Interaction
Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed. Due to the presence of calcium carbonate which act as an antacid, a time-interval of 3 hours should be considered between peppermint antacid intake and the administration of other medicinal products.
The following are noted but are unlikely to apply when the product is used for short-term symptomatic relief, as directed:
Tetracyclines - Calcium Carbonate and other antacids may interfere with the absorption of concomitantly administered tetracycline preparations.
Bisphosphonates -Calcium Carbonate and other antacids reduce absorption of bisphosphonates.
Thiazide Diuretics -Calcium Carbonate may increase the risk of hypercalcaemia.
4.6 Fertility, pregnancy and lactation
Data on a large number of exposed pregnancies indicate no adverse effects of 500mg calcium carbonate tablets on pregnancy or on the health of the foetus/newborn child. To date no other epidemiological date are available.
No problems are anticipated when using this product during lactation.
4.7 Effects on ability to drive and use machines
None known
4.8. Undesirable Effects
Calcium Carbonate can cause constipation and flatulence.
Hypercalcaemia can occur as can alkalosis following the regular use of calcium carbonate.
The milk-alkali syndrome has occasionally occurred in patients taking large
doses.
‘Acid Rebound’ has been reported on cessation of calcium carbonate. 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.
4.9 Overdose
Hypercalcaemia - Remove source of calcium. Rehydration may be necessary (if necessary with intravenous 0.9% sodium chloride) and a loop diuretic may be given to increase urinary calcium excretion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antacid.
Mechanism of Action/Effect
Calcium Carbonate reacts chemically to neutralise or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. It also reduces acid concentration within the lumen of the oesophagus, thus causing an increase in intra-oesophageal pH and a decrease in pepsin activity, which aids the control of gastro-oesophageal reflux.
ATC code: A02AC01.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
All Flavour Tablets Microcrystalline Cellulose Maize Starch
Dextrose Monohydrate Sodium Saccharin Magnesium Stearate
Blackcurrant Flavour Tablets Patent Blue V Lake E131 Ponceau 4R Lake E124 Blackcurrant Flavour 9/696044
Cherry Flavour Tablets Ponceau 4R Lake E124 Cherry Flavour 630277F
Lemon Flavour Tablets Quinoline Yellow Lake E104 Lemon Flavour 610364E
Orange Flavour Tablets Sunset Yellow Lake E110 Orange Flavour 9/009175
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
250 micron clear white UPVC/ 20 micron hard temper, heat seal coated aluminium foil.
24, 48, 72, 96 tablets/carton.
Polypropylene bottle with polyethylene tamper evident caps.
72, 75, 95, 100 tablets/bottle.
Roll wrap of 20 tablets in 9 micron soft aluminium foil/ 6gsm wax/ 20gsm paper.
40, 60, 80, 100, 120 packs will be 2, 3, 4, 5, 6 rolls in a carton.
Roll wrap of 12 tablets in 9 micron soft aluminium foil/ 6gsm wax/ 20gsm paper.
24, 36, 48, 60, 72, 96 packs will be 2, 3, 4, 5, 6, 8 rolls in a carton.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
8 MARKETING AUTHORISATION NUMBER(S)
PL 12063/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/07/1993
10 DATE OF REVISION OF THE TEXT
28/05/2015