Gaviscon® strawberry tablets

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Gaviscon® Strawberry Tablets (Gaviscon® strawberry tablets)

Composition:

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

One tablet contains 250 mg of sodium alginate, 133.5 mg of sodium hydrogen carbonate, 80 mg of calcium carbonate;

Excipients: xylitol DC, mannitol (E 421), macrogol 20000, strawberry flavor, aspartame (E 951), magnesium stearate, iron oxide red (E 172).

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: flat, round tablets with beveled edges, pale pink in color, with small specks, with a strawberry odor; one side of the tablet is embossed with a circle and a sword, the other side is embossed with GS 250.

Pharmacotherapeutic group. Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease.

ATC code: A02B X13.

Pharmacological properties.

Pharmacodynamics.

After oral administration, Gaviscon® strawberry tablets rapidly interact with gastric juice, forming a gel layer of alginic acid on its surface, which has a pH close to neutral and effectively coats the stomach walls, preventing gastroesophageal reflux for up to 4 hours. In gastroesophageal reflux, this layer, distributed over the surface of gastric contents, rises into the esophagus and prevents irritation of its mucosa.

Pharmacokinetics.

The mechanism of action of the medicinal product is physical and does not depend on systemic absorption. The preparation is not absorbed and does not exert systemic effects.

Clinical characteristics.

Indications. Treatment of symptoms of gastroesophageal reflux disease, namely: heartburn; acid regurgitation; digestive disturbances associated with reflux, including during pregnancy.

Contraindications. Hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interaction. Due to the presence of calcium carbonate, which acts as an antacid, at least 2 hours should elapse between the administration of Gaviscon® Strawberry Tablets and the administration of other medicinal products, especially H2-antihistamines, tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, bisphosphonates, and estramustine.

Special precautions for use.

4 tablets of the medicinal product contain 254.84 mg (11.08 mmol) of sodium, which corresponds to 12.74% 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 50.96% 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 kidney diseases or congestive heart failure.

Caution should be exercised when treating patients with hypercalcemia and nephrocalcinosis, as well as in those with recurrent formation of calcium-containing kidney stones, considering that 4 tablets of the medicinal product contain 320 mg (3.2 mmol) of calcium carbonate. Since the product contains aspartame, it is contraindicated in patients with phenylketonuria.

In patients with very low gastric acidity, a reduced efficacy of the medicinal product is possible.

If no improvement occurs within 7 days, medical advice should be sought.

Use during pregnancy or breastfeeding.

Gaviscon® Strawberry Flavour Tablets do not affect the course of pregnancy or the intrauterine and postnatal development of the fetus/child. Due to the presence of calcium carbonate, the product is recommended to be used for the shortest possible duration. The medicinal product may be used during pregnancy and breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

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

Method of Administration and Dosage.

For adults and children aged 12 years and older, the drug should be administered orally as 2–4 tablets after meals and at bedtime (up to 4 times daily). The tablets should be chewed. 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 diagnosis clarification and treatment adjustment.

Elderly patients.

Dosage adjustment is not required for elderly patients.

Patients with hepatic impairment.

Dosage adjustment is not necessary.

Patients with renal impairment.

Caution is advised in patients adhering to a low-sodium diet.

Children.
Not recommended for children under 6 years of age. For children aged 6 to 12 years, the drug should be used only as prescribed and under medical supervision.

For children aged 6 to 12 years, a suspension formulation is available.

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.

Adverse Reactions

Adverse reactions are classified by organ systems and frequency. Frequency is defined 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; not known (cannot be estimated from available data).

Immune system disorders.

Very rare: anaphylactic and anaphylactoid reactions, including allergic reactions presenting as urticaria.

Respiratory, thoracic and mediastinal disorders.

Very rare: bronchospasm.

Gastrointestinal disorders.

Not known: abdominal distension, constipation.

Reporting of suspected adverse reactions.

It is important to report suspected adverse reactions during the post-marketing period. This enables continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 2 years.

Storage conditions. Store at temperatures not exceeding 25 °C in the original packaging. Keep out of the reach of children.

Packaging. 8 chewable tablets in a blister, 2 or 3 blisters per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Reckitt Benckiser Healthcare (UK) Limited.

Manufacturer's address.

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