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CALCIUM CARBONATE TABLETS

Active substance(s): CALCIUM CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Calcium Carbonate Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate Ph Eur 500 mg per tablet

3.

PHARMACEUTICAL FORM
Tablet

4.1

Therapeutic indications

For the symptomatic treatment of conditions relating to stomach acidity
including: heartburn (pyrosis), acid indigestion and flatulence due to these
symptoms.
4.2

Posology and method of administration
Do not take for symptoms that persist for more than 7 days, unless advised by a

doctor.
The Maximum Daily Dose (MDD) of this product is equivalent to 8g calcium
carbonate (3.2g elemental calcium) for adults and children aged 12 and over; 3.5g
calcium carbonate (1.4g elemental calcium) for pregnant women.

Adults and children aged 12 years and over: one or two tablets to be sucked
or chewed as symptoms occur, up to as maximum of 16 tablets in any 24
hours, or as directed by a doctor.
Not to be given to children under 12 years of age.

Elderly: The normal adult dose can be taken by the elderly.

Pregnant women: one to two tablets to be sucked or chewed whenever
required as symptoms occur, up to a maximum of 7 tablets in any 24 hours, or
as directed by a doctor.

4.3

Contraindications

Contraindicated in patients with hypercalcaemia, hypercalciuria, or on a lowphosphate diet. Or those receiving cardiac glycosides or with impaired renal
function.
Contraindicated in patients with a prior hypersensitivity reaction to calcium
carbonate or any other ingredients of the preparation.

4.4

Special warnings and precautions for use
Prolonged use of higher than recommended doses may result in
hypercalcaemia and milk alkali syndrome, particularly in patients with renal
insufficiency.
If symptoms persist, consult your doctor.
Keep out of the sight and reach of children.
This product contains E110 (sunset yellow) and E124 (ponceau 4R red) which
may cause allergic reactions.
This product contains 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.

4.5 Interaction with other medicinal products and other forms of
interaction
Antacids of this type are known to decrease the absorption of concomitantly
administered drugs, such as bisphosphonates, tetracyclines and ciprofloxacin
due to adsorption or delaying of gastric emptying or alkalinisation of gastric
juice. This can be avoided by giving other drugs 2-3 hours before or after the
administration of calcium carbonate on the advice of a doctor. However, the
activity of cardiac glycosides such as digoxin may be increased due to the
presence of elevated calcium concentrations
The risk of hypercalcaemia should be considered in patients taking thiazide
diuretics since these drugs can reduce urinary calcium excretion.

4.6.

Fertility, Pregnancy and Lactation
Pregnancy
Data on a large number of exposed pregnancies indicate no adverse effects of
Calcium Carbonate Tablets on pregnancy or on the health of the
fetus/newborn child. To date, no other relevant epidemiological data are
available.
Breast Feeding
Calcium Carbonate Tablets are unlikely to present a risk to breastfeeding
women at recommended doses.

4.7

Effects on ability to drive and use machines
Calcium carbonate is unlikely to cause any effects on the ability to drive and
use machines.

4.8

Undesirable effects
Constipation, flatulence, nausea and belching are likely to occur rarely.
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
Overdose of calcium can lead to hypercalcaemia. Symptoms of
hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation,
abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia,
polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases,
cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death.

5.1

Treatment: withdrawal of the product and normal laxative measures. Further
management should be as clinically indicated or as recommended by the
national poisons centre, where available.
Pharmacodynamic Properties
Calcium carbonate is an antacid.

5.2

Pharmacokinetic Properties
Not applicable, since calcium carbonate acts locally in the gastrointestinal
tract.

5.3

Preclinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
TUMS Assorted Fruit Antacid tablets contain icing sugar, dextrose
monohydrate, compressible sugar, starch, talc, magnesium stearate and
anhydrous citric acid.
TUMS Lemon Flavour also contains lemon flavour J3790 and quinoline
yellow lake (E104).
TUMS Orange Flavour also contains orange flavour 52.570 and sunset yellow
lake (El10).
TUMS Blackcurrant Flavour also contains blackcurrant flavour J3045 and
lynlake violet KLS/1/39/l (E124, E131).

6.2

Incompatibilities
None

6.3

Shelf Life
36 months

6.4

Special Precautions for Storage

Store below 25ºC in a dry place.

6.5

Nature and contents of container
Roll:

Paper/aluminium foil laminate roll pack containing 12 tablets per roll.
Three rolls are contained in a boxboard carton with a cellophane
overwrap or one roll contained in a single cavity PVC blister with
cardboard backing.
Bottle: Polystyrene bottle, with a polyethylene cap, containing either 75 or
150 tablets.
As an occasional promtion a polypropylene roll-holder with a polypropylene
cap may be shrink wrapped to the 36 tablets carton with 40 µ PVC sleeve.
6.6

Instructions for Use, Handling and Disposal
None

7

MARKETING AUTHORISATION HOLDER
Beecham Group PLC
Four New Horizons Court
Harlequin Avenue
Brentford
MIDDLESEX
TW8 9EP
U.K
Trading As:
GlaxoSmithKline Consumer Healthcare
Brentford
TW8 9GS
U.K

8.

MARKETING AUTHORISATION NUMBER
PL 00079/0244

9.
DATE OF
AUTHORISATION

FIRST

AUTHORISATION/RENEWAL

26th August 1988 / 26th August 1993 / 25th November 1998

10

DATE OF REVISION OF THE TEXT
03/12/2015

OF

THE

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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