Hydrotalcite Suspension

1. Name Of The Medicinal Product

Hydrotalcite Suspension.

2. Qualitative And Quantitative Composition

Each 5ml contains 500mg of Hydrotalcite Light.

3. Pharmaceutical Form

Suspension

4. Clinical Particulars

4.1 Therapeutic Indications

Use as an antacid Hydrotalcite is indicated for symptomatic relief in the following conditions: peptic ulceration; dyspepsia; hyperacidity; gastritis, heartburn, especially when associated with reflux oesophagitis or hiatus hernia, and heartburn in pregnancy.

4.2 Posology And Method Of Administration

DOSAGE:

Adults

10ml between meals and at bedtime or as directed by the physician.

Elderly:

No specific recommendations.

Children (6-12 years)

Half the adult dose.

Children under 6 years:

Not recommended.

ADMINISTRATION:

Oral

4.3 Contraindications

None known

4.4 Special Warnings And Precautions For Use

None stated

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Hydrotalcite suspension may interfere with the intestinal absorption of tetracyclines.

4.6 Pregnancy And Lactation

For Hydrotalcite no clinical data on exposed pregnancies are available

Caution should be exercised when prescribing to pregnant women

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Side effects are uncommon. Diarrhoea and vomiting have been reported.

4.9 Overdose

There is no evidence of absorption of Hydrotalcite in man. Investigations in healthy human volunteers have shown no elevation of serum aluminium or magnesium levels on administering of Hydrotalcite at therapeutic dosage for a continuous period of 28 days.

The sodium content of Hydrotalcite is 0.22mmol per 5ml.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Raising the pH of gastric contents to above 3.5 significantly reduces the pain and discomfort of acid associated symptoms, especially heartburn, dyspepsia, peptic ulceration, gastritis, and reflux oesophagitis. Hydrotalcite, buffering in the range of pH 3-5 over two hours, combines those properties of magnesium and aluminium based antacids in producing effective rises in pH over a considerable period.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol USP, Carmellose Sodium BP, Veegum Regular, Sodium Propyl Hydroxybenzoate BP, Sodium Butyl Hydroxybenzoate BP, Hydrogen Peroxide 30% solution EP*, Crème de Menthe 1951 and Purified Water.

*Quantity includes an average of 70ppm.

6.2 Incompatibilities

None known

6.3 Shelf Life

24 Months.

6.4 Special Precautions For Storage

Store between 25^°C and 4^°C . Do not freeze.

6.5 Nature And Contents Of Container

Amber glass bottles and sealed by a white pigmented polypropylene tamper-evident closure.

Bottle of 500ml as a pharmacy item or 100ml and 250ml as a general sales item.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

Administrative Data

7. Marketing Authorisation Holder

Peckforton Pharmaceuticals Ltd.

Crewe Hall

Crewe

Cheshire

CW1 6UL

8. Marketing Authorisation Number(S)

PL 15760/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

3 June 1999

10. Date Of Revision Of The Text

November 2002

11. Legal Category

P