Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation,heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment withor following withdrawal of acid suppressing therapy.

For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets 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.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).

This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHOrecommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 44.71% of the WHO recommended maximum daily intake forsodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g.in some cases of congestive heart failure and renal impairment).
Each 4 tablet dose contains 300 mg (7.5 mmol) of calcium. Care needs to be taken in treating patients withhypercalcaemia, 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 persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medicalconditions.
This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people withphenylketonuria.
This medicine contains Carmoisine lake (E122). This may cause allergic reactions.

Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be consideredbetween intake of this product and the administration of other medicinal products, especially H2-antihistaminics,tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine,penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, andestramustine. See also section 4.4.

Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on thecourse of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinalproduct may be used during pregnancy, if clinically needed.
Breastfeeding
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product canbe used during breast-feeding if clinically needed.
Fertility
Clinical data do not suggest that this product has an effect on human fertility.

This product has no or negligible influence on the ability to drive and use machines.

Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are givenbelow, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common(≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Notknown (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented inorder of decreasing seriousness.

Description of Selected Adverse Reactions
¹ Usually occurs following larger than recommended dosages.

Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuedmonitoring of the benefit/risk balance of the medicinal product.

Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndromehas occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.

Pharmacotherapeutic classification: 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 neutralpH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing oesophagealacid exposure. The raft floats on the stomach contents effectively impeding gastro-oesophageal reflux, for up to 4 hours,and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into theoesophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence hasshown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting theoesophagus from these gastric components
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn. This effect is increasedby the addition of sodium bicarbonate which also has a neutralising action. The total neutralising capacity of the productat the lowest dose of two tablets is approximately 10mEqH+.

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

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

Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Mint flavour
Carmoisine Lake (E122)
Magnesium stearate
Xylitol DC

Not applicable.

Blister trays: Do not store above 30°C. Store in the original package.
Flip-top lid containers: Do not store above 25°C. Store in the original package.

Unprinted, glass, clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed intocartons.
Blister tray containing two, four, six or eight sealed tablets. Pack sizes: 4, 6, 8, 12, 16, 24, 32, 48, 60, 62, 64 and 80chewable tablets.
Coloured, opaque, injection-moulded, polypropylene flip-top lid containers containing 8, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.

No special instructions.