Gaviscon Double Action Mint

1. Name Of The Medicinal Product

Gaviscon Double Action Mint.

2. Qualitative And Quantitative Composition

Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.

Excipients : Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216). For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension.

Opaque, off-white to cream viscous suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity).

4.2 Posology And Method Of Administration

For oral administration.

Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to four times per day.

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates (parabens).

4.4 Special Warnings And Precautions For Use

Each 20 ml dose has a sodium content of 254.5 mg (11.06 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

If symptoms do not improve after seven days, the clinical situation should be reviewed.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake an the administration of other medicinal products, especially H2-antihistaminics tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates.

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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 the medicinal product may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

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.

Ingestion of large quantities of calcium carbonate may cause alkalosis, hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually occur following larger than recommended dosages.

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

Pharmacotherapeutic group: A02BX, Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

The medicinal product is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate.

On ingestion, the medicinal 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 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.

Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn. This effect is increased by the addition of sodium bicarbonate which also has a neutralising action. The total neutralising capacity of the product at the lowest dose of 10 ml is approximately 10 mEqH+.

5.2 Pharmacokinetic Properties

The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No pre-clinical findings of any relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Carbomer

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Mint flavour

Sodium hydroxide

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

Use within six months of opening.

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 150, 200, 300 and 600 ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0552.

9. Date Of First Authorisation/Renewal Of The Authorisation

24/06/2008

10. Date Of Revision Of The Text

14/09/2010