Fruit Flavoured Antacid Tablets

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Document: leaflet MAH BRAND_PL 12063-0017 change

Calcium Carbonate

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1. What is this medicine and what is it used for?

This medicine contains:

• calcium carbonate which is an antacid and helps to reduce acidity in the stomach.

These tablets are for the relief of indigestion, heartburn, stomach pain or discomfort (dyspepsia), acidity and passing wind (flatulence).

2. Is this medicine suitable for you?

Do not take this product within two hours of taking other medicines by mouth, as it can interfere with the action of some other medicines.

Do not take this medicine if you:

• are allergic to calcium carbonate or any of the other ingredients

• have kidney problems, including kidney stones

• have an overactive parathyroid gland

• have heart problems and are taking cardiac glycosides (e.g. digoxin)

• are on a low phosphate diet

• have been told by your doctor that you have high levels of calcium or low levels of phosphate in your blood

• have Zollinger-Ellison syndrome (a tumour in the stomach that causes excess acid production)

• are under 12 years of age.

Please see your doctor or pharmacist before taking this medicine if you:

• have diabetes

• have an intolerance to some sugars.

If you are taking any of the following medicines please see your doctor:

• tetracycline antibiotics (e.g. sumycin and tetracyn)

• are taking any heart medicines (especially digoxin) or beta-blockers (e.g atenolol, metoprolol and propranolol)

• bisphosphonates, a group of medicines used to treat bone diseases (e.g. etidronate and pamidronate)

• thiazide diuretics, sometimes called water tablets, which are medicines used to treat high blood pressure and fluid retention (e.g. chlortalidone and metolazone)

• oral iron medicines used to treat anaemia

• thyroxine, used to treat an underactive thyroid gland.

Information about some of the ingredients in this medicine:

Each tablet contains 521 mg of glucose (dextrose) per tablet. 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.

This medicine contains the colour sunset yellow (E110). It may cause allergic reactions.

3. How to take this medicine

To be sucked or chewed as preferred.

Adults, the elderly and children over 12 years:

1 or 2 tablets, as required. Do not take more than 16 tablets in any 24 hour period.

Pregnant women:

1 or 2 tablets as required, up to a minimum of 7 tablets in 24 hours.

Do not give to children under 12 years.

Do not take more medicine than the label tells you to. If your symptoms persist or worsen for more than 7 days you must see a doctor or pharmacist.

If you take too many tablets by mistake, contact your doctor or pharmacist straight away.

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

• constipation, diarrhoea, belching and passing wind (flatulence)

•—constipation

•—passing wind (flatulence)

• fatigue, confusion, poor appetite, feeling sick or being sick as these may be signs of changes in the amount of calcium and the pH (measure of acidity or alkalinity) of your blood (this is only seen after regular use)

• heartburn (acid rebound)

• hypersensitivity reactions including rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store your medicine

Keep out of the sight and reach of children.

Do not use this medicine after the end of the month shown as an expiry date printed on the pack.

Do not store above 25°C.

6. What is in this medicine?

Each of the round antacid tablets contain the active ingredient: calcium carbonate 500 mg.

The other ingredients are: dextrose, maize starch, microcrystalline cellulose, magnesium stearate, sodium saccharin, orange flavour and the colour sunset yellow lake (E110).

This product is available in pack sizes of 24, 48, 72, 96 tablets/carton, 72, 75, 96, 100 tablets/drum and 40, 60, 80, 100, 120 packs will be 2, 3, 4, 5, 6 rolls in a carton.

7. Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, United Kingdom.

Text Revised: August 2015

PL 12063/0018