Gaviscon® peppermint suspension

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GAVISCON® PEPPERMINT LIQUID

Composition:

Active substances: sodium alginate, sodium bicarbonate, calcium carbonate;

5 ml of suspension contain 250 mg of sodium alginate, 133.5 mg of sodium bicarbonate, 80 mg of calcium carbonate;

Excipients: carbomer 974P, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sodium saccharin, peppermint oil, sodium hydroxide, purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: viscous, opaque suspension, from almost white to creamy color, with a minty odor.

Pharmacotherapeutic group. Drugs for treatment of peptic ulcer and gastroesophageal reflux disease. ATC code A02B X13.

Pharmacological properties.

Pharmacodynamics

After oral administration, Gaviscon® mint suspension rapidly interacts with gastric juice, forming a layer of alginate gel on its surface with a pH close to neutral. This gel quickly and effectively coats the stomach walls (for up to 4 hours), preventing gastroesophageal reflux. In severe cases, this layer may rise into the esophagus instead of stomach contents and protects the esophageal walls.

Pharmacokinetics

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

Clinical characteristics.

Indications.

Symptomatic treatment of gastroesophageal reflux, heartburn, including in pregnant women.

Contraindications.

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216).

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use

If there is no improvement after 7 days, the clinical picture should be reassessed.

Each 20 ml of the preparation contains 285.2 mg (12.4 mmol) of sodium, equivalent to 14.26% of the maximum daily sodium intake for adults recommended by the World Health Organization.

The maximum daily dose of the preparation is equivalent to 57% of the maximum daily sodium intake for adults recommended by the World Health Organization.

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

Each 10 ml of the preparation contains 160 mg (1.6 mmol) of calcium carbonate. The medicinal product should be used with caution in patients with hypercalcaemia, nephrocalcinosis, and recurrent calcium-containing kidney stones.

Patients with impaired renal function require regular monitoring of calcium, potassium, and magnesium levels.

The medicinal product contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed) (see section "Contraindications").

Use during pregnancy or breastfeeding

Clinical studies involving more than 500 pregnant women, as well as extensive post-marketing data, indicate that the active substances do not cause developmental abnormalities and have no toxic effect on newborns/infants. Gaviscon® Peppermint Suspension may be used during pregnancy when clinically necessary, after consultation with a physician.

Breastfeeding
Studies have shown no effect on newborns/infants who are breastfed by mothers using this medicinal product. Gaviscon® Peppermint Suspension may be used during breastfeeding after consultation with a physician.

Fertility
Preclinical studies indicate that alginic acid has no negative effect on fertility or reproductive function in the studied animals or their offspring.

Clinical data do not indicate any effect on human fertility.

Ability to affect reaction speed when driving or operating machinery

The medicinal product does not affect the ability to drive vehicles or operate other complex machinery.

Method of Administration and Dosage

For adults and children aged 12 years and older, the drug is administered orally at a dose of 10–20 mL (2–4 teaspoons) after meals and at bedtime.

Elderly patients do not require dose adjustment.

Children aged 6 to 12 years: 5–10 mL (1–2 teaspoons) after meals and at bedtime.

The drug should not be used for more than 7 days. If symptoms persist or worsen during this period, the patient should consult a physician for clarification of the diagnosis and adjustment of the treatment regimen.

Patients with impaired liver function do not require dose adjustment.

Renal insufficiency: use with caution in patients on a low-salt diet (see section "Special Warnings").

Children. The drug is not recommended for children under 6 years of age. In children under 12 years of age, the drug should be used only as prescribed and under the supervision of a physician.

Overdose.

Symptoms.

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

Treatment.

In case of overdose, symptomatic treatment should be administered.

Side effects

Side effects are classified by frequency as follows:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).

Immune system disorders. Very rare: anaphylactic and anaphylactoid reactions, hypersensitivity reactions such as skin rash, urticaria.

Respiratory, thoracic and mediastinal disorders. Very rare: respiratory manifestations such as bronchospasm.

Gastrointestinal disorders. Frequency not known: abdominal distension, constipation.

Shelf life. 2 years.

An opened bottle should not be stored for more than 6 months.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Keep out of the reach and sight of children. Store at temperatures not exceeding 30 ºC. Do not store in the refrigerator and do not freeze.

Packaging.

150 ml and 300 ml in amber glass bottles with a polypropylene screw cap with a tamper-evident seal.

Pharmaceutical classification. Over-the-counter (without prescription).

Manufacturer: Reckitt Benckiser Healthcare (UK) Limited.

Manufacturer's address.

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