Gaviscon Mint oral suspension bottle 150 ml

Instructions Gaviscon Mint oral suspension bottle 150 ml

Composition

active ingredients: 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, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin, peppermint oil, sodium hydroxide, purified water.

Dosage form

Oral suspension.

Main physicochemical properties: viscous opaque suspension from almost white to cream color with a mint odor.

Pharmacotherapeutic group

Preparations for the treatment of peptic ulcer and gastroesophageal reflux disease. ATC code A02B X13.

Pharmacological properties

Pharmacodynamics

After oral administration, Gaviscon® mint suspension quickly begins to interact with gastric juice, forming a layer of alginic acid gel on its surface, which has a pH close to neutral, quickly and effectively coats the walls of the stomach (within 4 hours), preventing the occurrence of gastroesophageal reflux. In severe cases, this layer can rise to the esophagus instead of the stomach contents and protects the walls of the esophagus.

Pharmacokinetics.

The mechanism of action of the drug is physical and does not depend on the level of absorption into the systemic circulation.

Indication

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

Contraindication

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

Interaction with other medicinal products and other types of interactions

At least 2 hours should elapse between taking Gaviscon® mint suspension and taking other medications, especially H2-antihistamines, tetracyclines, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoids, chloroquine, bisphosphonates (diphosphonates) and estramustine.

Application features

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

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

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

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

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

Patients with impaired renal function should have their calcium, potassium and magnesium levels monitored regularly.

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 a large amount of data obtained during post-marketing use, indicate that the active substances do not cause developmental defects and do not have toxic effects on newborns/infants. Gaviscon® mint suspension can be used during pregnancy if clinically necessary after consultation with a doctor.

Breastfeeding. Studies have shown no effect on breastfed newborns/infants whose mothers have used this medicine. Gaviscon® Mint Suspension can be used during breast-feeding after consultation with a doctor.

Fertility: According to preclinical studies, alginate has no negative effect on the fertility or reproductive function of the test animals or their offspring.

Clinical data do not indicate any effect on human fertility.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the ability to drive or operate other complex mechanisms.

Method of administration and doses

Adults and children over 12 years of age are prescribed the drug orally in a dose of 10-20 ml (2-4 teaspoons) after meals and before bedtime.

Elderly patients do not require dose adjustment.

Children 6 to 12 years old: 5-10 ml (1-2 teaspoons) after meals and before bedtime.

The drug should not be used for more than 7 days. If the symptoms of the disease persist or worsen during this period, the patient should consult a doctor to clarify the diagnosis and adjust the treatment regimen.

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

Children. Not recommended for use in children under 6 years of age. Children under 12 years of age should only use the drug as directed and under the supervision of a physician.

Overdose

Symptoms.

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

Treatment.

In case of overdose, symptomatic treatment is used.

Side effects

Adverse reactions are classified by frequency as follows:

very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and frequency unknown (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 symptoms such as bronchospasm.

Gastrointestinal: Frequency unknown: abdominal bloating, constipation.

Expiration date

2 years.

Store an opened bottle for no more than 6 months.

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

Storage conditions

Store out of the reach of children at a temperature not exceeding 30 ° C. Do not refrigerate or freeze.

Packaging

150 and 300 ml in orange glass bottles with a tamper-evident polypropylene cap.

Vacation category

Without a prescription.

Producer

Reckitt Benckiser Healthcare (UK) Limited.

Address

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