Sure Shield Dyspepsia Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sure Shield Dyspepsia Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dried Aluminium Hydroxide BP 200 mg Magnesium Carbonate Heavy BP 400 mg.
3 PHARMACEUTICAL FORM
Chewable Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief of indigestion, flatulence and acidity.
4.2 Posology and method of administration
Adults and Elderly : Chew one or two tablets after meals Children (8-12 years) : Half to one tablet to be chewed after meals
Not recommended for use in children below 8 years of age.
4.3 Contraindications
Sure Shield Dyspepsia Tablets are contra-indicated in patients with hypophosphataemia and in patients with renal impairment.
4.4 Special warnings and precautions for use
Keep out of reach of children
Do not take the product for more than 7 days. If symptoms do not improve speak to your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Antacids interfere with the gastro-intestinal absorption of a number of other drugs by forming insoluble complexes, altering the gastric pH, or by effects on gastric emptying rates; changes in the urinary pH also affect tubular reabsorption. The interaction between the antacid and another orally administered drug may be minimised by giving the drug 2 to 3 hours before or after antacid administration.
4.6 Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. There are no adequate human data from the use of aluminium hydroxide and magnesium carbonate in pregnant women. Studies in animals have not been done. Caution should therefore be exercised when taken by pregnant women.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Aluminium Hydroxide can cause constipation and Magnesium Hydroxide can cause diarrhoea. Whilst a combination of the two minimises adverse gastro intestinal effects, some are still possible. Large doses of Aluminium Hydroxide may cause intestinal obstruction or phosphate depletion of bones.
4.9 Overdose
Excessive doses of Aluminium Hydroxide may lead to Phosphate depletion. Supportive treatment should be provided.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antacid.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
No relevant information additional to that included elsewhere in the SPC.
6.1 List of excipients
Acacia. Sodium Saccharin. Lactose, Corn Starch, Magnesium Stearate, Silica, Sorbitol. Natural Flavourings (Peppermint Oil, Cassia Oil, Nutmeg Oil. Spike Lavender Oil).
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
No special requirements.
6.5 Nature and contents of container
50 Tablets in polythene tube and cap.
6.6
Special precautions for disposal
No special requirement.
MARKETING AUTHORISATION HOLDER
7
Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth West Yorkshire HD9 2JT
8 MARKETING AUTHORISATION NUMBER(S)
PL 31308/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20th February 1991.
10 DATE OF REVISION OF THE TEXT
March 2004.