GAVISCON® PEPPERMINT TABLETS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Gaviscon® Peppermint tablets (Gaviscon® Peppermint tablets)

Composition:

Active substances: 1 chewable tablet contains 250 mg of sodium alginate, 133.5 mg of sodium bicarbonate, 80 mg of calcium carbonate;

Excipients: mannitol (E 421), macrogol 20 000, magnesium stearate, copovidone, potassium acesulfame, peppermint flavouring, aspartame (E 951).

Medicinal form. Chewable tablets.

Main physico-chemical characteristics: round, flat tablet with bevelled edges, almost white or cream-coloured, with small specks, peppermint-scented. The tablet has an embossed sword and circle on one side and "G 250" on the reverse.

Pharmacotherapeutic group. Medicinal products for the treatment of peptic ulcer and gastroesophageal reflux disease (GERD). ATC code A02B X13.

Pharmacological properties.

Pharmacodynamics.

After oral administration, Gaviscon® peppermint tablets rapidly interact with gastric juice, forming a layer of alginic acid gel on its surface. This gel has a pH close to neutral and effectively coats the stomach walls, preventing gastro-oesophageal reflux. In severe cases, this layer, distributed over the surface of gastric contents, rises into the oesophagus and prevents its irritation.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Treatment of symptoms of gastroesophageal reflux disease, namely: heartburn; acid regurgitation; reflux-related digestive disturbances, including during pregnancy.

Contraindications.

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium hydrogencarbonate, and calcium carbonate or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

At least 2 hours should elapse between the administration of Gaviscon® Peppermint Tablets and other medicinal products, especially tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine, and bisphosphonates.

Special precautions for use

4 tablets of the medicinal product contain 253 mg (11 mmol) of sodium, equivalent to 12.65% of the maximum daily sodium intake for adults recommended by the World Health Organization.

The maximum daily dose of the medicinal product is equivalent to 50.6% of the maximum daily sodium intake recommended by the World Health Organization.

This medicinal product has a high sodium content, which should be taken into account in patients on a low-salt diet, particularly in cases of kidney disease or congestive heart failure.

The dose equivalent to 4 tablets contains 320 mg (3.2 mmol) of calcium carbonate. Caution is advised when treating patients with hypercalcaemia, nephrocalcinosis, and recurrent formation of calcium-containing kidney stones.

One tablet of this medicinal product contains 3.75 mg of aspartame. After oral administration, aspartame is hydrolysed in the gastrointestinal tract. One of the main hydrolysis products is phenylalanine. Since the medicinal product contains aspartame (E 951), it is contraindicated in patients with phenylketonuria.

If there is no improvement in symptoms after 7 days of treatment, the clinical situation should be re-evaluated.

Use during pregnancy or breastfeeding

Clinical studies involving more than 500 pregnant women, as well as extensive post-marketing experience, indicate no toxic effects of the active substances on the foetus or newborn, and no teratogenic potential. Gaviscon® Peppermint Tablets may be used during pregnancy if clinically necessary.

Breastfeeding

Studies have shown no effects on newborns/infants breastfed by women taking this medicinal product. Gaviscon® Peppermint Tablets may be used during breastfeeding.

Fertility

Clinical experience has shown that use of therapeutic doses is not expected to affect human fertility.

Ability to influence reaction speed when driving or operating machinery

The medicinal product has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

The medicinal product is intended for oral administration. Tablets should be thoroughly chewed.

Adults and children aged 12 years and older: 2–4 tablets after meals and at bedtime.

Elderly patients: dose adjustment is not required for this age group.

Children.

Clinical data on use in children under 12 years of age are lacking.

Not recommended for use in children under 12 years of age.

Overdose.

Symptoms.

Symptoms may be mild; some abdominal discomfort may occur. Overdose may manifest as abdominal bloating.

Treatment.

In case of overdose, symptomatic treatment should be administered.

Adverse reactions.

Adverse reactions are listed according to the following frequency classification: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data):

Shelf life.

2 years.

For the polypropylene container: Store no longer than 3 months after first opening the container.

Storage conditions.

Keep out of reach of children and store at a temperature not exceeding 30 °C.

Packaging.

8 chewable tablets in a blister pack, 2 or 3 blisters per cardboard box. 16 chewable tablets in a polypropylene container.

Category of supply. Over-the-counter (without prescription).

Manufacturer.

Reckitt Benckiser Healthcare (UK) Limited
Reckitt Benckiser Healthcare (UK) Limited.

Manufacturer's address.

Dansom Lane, Hull, HU8 7DS, United Kingdom
Dansom Lane, Hull, HU8 7DS, United Kingdom.