Summary of Product Characteristics (SmPC) - Sterwin Antacid tablets
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