1. NAME OF THE MEDICINAL PRODUCT

Peppermint Antacid Tablets

Superdrug Original Indigestion Relief Tablets

Indigestion Relief Tablets

Paramed Peppermint Antacid Tablets

Paramed Indigestion Relief Tablets

Tesco Peppermint Flavoured Indigestion Tablets

Boots Indigestion Relief Tablets Peppermint

Setlers Antacid Tablets - Peppermint

The Co-Operative Peppermint Flavoured Indigestion Relief 500 mg 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

White smooth tablets free from specks and blemishes.

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.

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 heredity problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency 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.

Each tablet contains 615mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account in patients with diabetes.

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

There are no adequate safety data from the use of Calcium Carbonate in pregnant women. Calcium Carbonate has been in wide use from many years without ill consequence. Caution should be exercised when treating pregnant women with Calcium Carbonate, particularly during the first trimester.

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

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 intraoesophageal pH and a decrease in pepsin activity, which aids the control of gastro-oesophageal reflux.

ATC code: A02AC

5.2    Pharmacokinetic properties

Not applicable

5.3    Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose

Starch

Calcium Stearate Saccharin Sodium Peppermint Oil

6.2    Incompatibilities

None known

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 opaque white UPVC/20 micron hard temper, heat seal coated aluminium foil.

8, 24, 48, 72, 96 tablets/carton.

HDPE drum with polyethylene tamper evident caps.

72, 75, 96, 100 tablets/drum.

Roll wrap of 20 tablets in 0.2gsm Lacquer/ 0.009mm soft aluminium foil/ 7gsm wax/ 32gsm paper.

40, 60, 80, 100, 120 packs will be 2, 3, 4, 5, 6 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 12063/0011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/06/1993

10 DATE OF REVISION OF THE TEXT

28/05/2015