This information is intended for use by health professionals

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

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 523 mg 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 Interaction with other medicinal products 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 Pregnancy and lactation

Data on a large number of exposed pregnancies indicate no adverse effects of 500 mg calcium carbonate tablets on pregnancy or on the health of the fetus/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 655280 SD

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/6 gsm wax/20 gsm 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/6 gsm wax/20 gsm 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 and other handling

None.

ADMINISTRATION DETAILS

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 July1993

10. Date of revision of the text

03/01/2018