Gaviscon Original Aniseed Relief

1. Name Of The Medicinal Product

Gaviscon Original Aniseed Relief.

2. Qualitative And Quantitative Composition

Gaviscon Original Aniseed Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension.

An opaque, pink suspension with the odour and flavour of fennel.

4. Clinical Particulars

4.1 Therapeutic Indications

Gastric reflux, heartburn, 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 years: 10-20ml after meals and at bedtime.

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

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

Children under 6 years: Not recommended.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

The sodium content of a 10ml dose is 141mg (6.2mmol). Care to be exercised when a highly restricted salt diet is required 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 uncontrolled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon in the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience Liquid Gaviscon 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 sensitive to the ingredients 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 the product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively (up to 4 hours) 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 the product is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings relevant to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Carbomer

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Saccharin sodium

Fennel flavour

Erythrosine

Sodium hydroxide

Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years for 600ml pack size.

Two years for 100ml, 150ml, 200ml, 250ml and 300ml pack sizes.

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 Winchester bottle with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad containing 100, 150, 200, 250ml, 300 and 600 ml.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0126

9. Date Of First Authorisation/Renewal Of The Authorisation

27/02/2009

10. Date Of Revision Of The Text

18/06/2010