Boots Indigestion Relief Tablets Peppermint

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

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.

4.3 Contraindications

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

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.

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

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.

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 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 0.2 gsm lacquer/0.009 mm soft aluminium foil/7 gsm wax/32 gsm paper.

40, 60, 80, 100, 120 packs will be 2, 3, 4, 5, 6 rolls in a carton.

6.6 Special Precautions For Disposal And Other Handling

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

First Authorisation 17 June 1993.

10. Date Of Revision Of The Text

1 June 2009