Gaviscon Cool Mint Tablets

1. Name Of The Medicinal Product

Gaviscon Cool Tablets.

Gaviscon Cool Mint Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains sodium alginate 250mg, sodium bicarbonate 133.5mg and calcium carbonate 80mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Chewable tablet.

An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint.

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.

4.2 Posology And Method Of Administration

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over: Two to four tablets after meals and at bedtime.

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

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

The sodium content of a four-tablet dose is 246 mg (10.6 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 four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Due to its aspartame content this product should not be given to patients with phenylketonuria.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

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

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

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 Gaviscon Cool Tablets 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

Pharmacotherapeutic classification: A02BX 13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease

On ingestion Gaviscon Cool Tablets react rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. 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 Tablets 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

Peppermint flavour (Trusil coolmint flavour 108406)

Polyethylene glycol 20,000

Mannitol

Aspartame

Magnesium stearate

Xylitol DC

Indigo carmine

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.

Blister tray containing two, four, six or eight sealed tablets.

Larger packs (e.g. 16, 24, 32, 48, 60, 64, 72 and 80) will be made up of multiples of the above units.

Polypropylene container containing 8, 10, 12, 14, 16 or 18 tablets.

Pack sizes 8, 10, 12, 14, 16, 18 tablets.

Larger packs i.e. 20's, 28's and 32's, will be made up of multiples of the above units and packed into cartons.

Not all pack sizes may be marketed.

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 00063/0140

9. Date Of First Authorisation/Renewal Of The Authorisation

7 October 2003

10. Date Of Revision Of The Text

August 2011