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SURE SHIELD DYSPEPSIA TABLETS

Active substance(s): DRIED ALUMINIUM HYDROXIDE / MAGNESIUM CARBONATE HEAVY

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Sure Shield Dyspepsia Tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Dried Aluminium Hydroxide
Magnesium Carbonate Heavy

3

BP 200 mg
BP 400 mg.

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
Children (8-12 years)

: Chew one or two tablets after meals
: 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

PHARMACEUTICAL PARTICULARS

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.

7

MARKETING AUTHORISATION HOLDER
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.

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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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