Skip to Content

UK Edition. Click here for US version.

STERWIN ANTACID TABLETS

Active substance(s): CALCIUM CARBONATE / MAGNESIUM CARBONATE HEAVY

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sterwin Antacid Tablets.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium carbonate 600 mg
Heavy Magnesium Carbonate 125 mg
For excipients see 6.1.

3

PHARMACEUTICAL FORM
Chewable tablets.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
Antacid neutralises excess acid in order to provide relief from heartburn, acid
indigestion and trapped wind.

4.2.

Posology and method of administration
Adults: Suck or chew 1-2 tablets as required.
Do not exceed 12 tablets per day.
Children: Antacid tablets are not recommended for children.

4.3

Contraindications
There are no specific contraindications.

4.4.

Special warnings and precautions for use
Keep out of reach of children.

4.5.

Interaction with other medicinal products and other forms of interaction
There have been no interactions reported with Antacid Tablets. Although large
doses of antacids can interfere with the absorption of some drugs, the amount
of antacid in the recommended dose is unlikely to react with any other drugs.

4.6.

Pregnancy and lactation
Data on a large number of exposed pregnancies indicate no adverse effects of
magnesium carbonate or calcium carbonate on pregnancy or on the health of
the foetus/newborn child. To date, no other relevant epidemiological data are
available.
Caution should be exercised if used by pregnant or breast-feeding women.

4.7.

Effects on ability to drive and use machines
None known.

4.8.

Undesirable effects
No significant side effects have been encountered with Antacid Tablets.

4.9.

Overdose
Overdose is unlikely to present a major problem. However, as with all antacids
there is a theoretical danger of alkalosis.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
ATC code: A02A H, Antacids with sodium bicarbonate

Magnesium carbonate and calcium carbonate are both antacids which may be
given in doses of up to about 1g each by mouth. Magnesium carbonate also
possesses laxative properties and is therefore often used with calcium
carbonate in order to reduce its constipating effects.

5.2.

Pharmacokinetic properties
Calcium carbonate is converted to calcium chloride by gastric acid. Some of
the calcium is absorbed from the intestines but about 85% is reconverted into
soluble calcium salts, such as the carbonate which are excreted in the faeces.
Magnesium carbonate reacts with gastric acid to form soluble magnesium
chloride and carbon dioxide. Some magnesium is absorbed but is usually
excreted rapidly in the urine.

5.3

Preclinical safety data
There is no clinically relevant preclinical safety data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Malic Acid, Microtal DCE Sugar, Magnesium Stearate, Talc, Saccharin
Sodium, Sodium Bicarbonate, Orange flavouring.

6.2.

Incompatibilities
No incompatibilities have been reported.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°C. Store in a dry place.

6.5

Nature and contents of container
Antacid tablets are packed into a tissue/foil roll wrap over-wrapped in paper
containing 15 tablets. Antacid tablets are available in cardboard cartons
containing two rolls of tablets (30 tablets per carton) or four rolls of tablets (60
tablets per carton).

6.6

Special precautions for disposal
There are no specific instructions regarding use or handling.

7

MARKETING AUTHORISATION HOLDER
Aspar Pharmaceuticals Limited
29-30 Capitol Way
Colindale
London
NW9 0EQ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 08977/0013

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
5 April 2003

10

DATE OF REVISION OF THE TEXT
February 2005

Expand view ⇕

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.

Hide