Gaviscon Cool Liquid

1. Name Of The Medicinal Product

Gaviscon Cool Liquid

2. Qualitative And Quantitative Composition

Gaviscon Cool Liquid contains 250mg sodium alginate BP, 133.5 mg sodium bicarbonate Ph. Eur. and 80 mg calcium carbonate Ph. Eur. per 5 ml.

3. Pharmaceutical Form

Oral suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Gastric reflux, hearburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children over 12: 10-20 ml after meals and at bedtime.

Elderly: No dose modification is required in this age group.

Children 6-12 years: 5-10 ml after meals and at bedtime.

Children under 6 years: Not recommended.

If symptoms persist consult your doctor.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

The sodium content of a l0ml dose is 141mg (6.2mmol). This should be taken into account when a highly restricted salt diet is recommended as in some renal and cardiovascular conditions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience this medicine may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.

4.9 Overdose

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

On ingestion Gaviscon Cool Liquid reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats (up to 4 hours) on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect.

5.2 Pharmacokinetic Properties

The mode of action of Gaviscon Cool Liquid is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported

6. Pharmaceutical Particulars

6.1 List Of Excipients

Carbomer

E218 (Methyl parahydroxybenzoate)

E216 (Propyl parahydroxybenzoate)

Saccharin sodium

Mint flavour no. 4

Mint flavour no. 5

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 30°C. Do not refrigerate or freeze.

6.5 Nature And Contents Of Container

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad and containing 100, 150, 200, 300, 500 or 600 ml.

6.6 Special Precautions For Disposal And Other Handling

To be taken orally. If desired the standard dose of Gaviscon Cool Liquid may be taken diluted with not more than an equal quantity of water well stirred.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Hamol Limited

103-105 Bath Road

Slough

Berkshire

SL1 3UH

United Kingdom

8. Marketing Authorisation Number(S)

PL 01839/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

06/02/2006

10. Date Of Revision Of The Text

22/09/2009