Gaviscon Mint chewable tablets blister No. 24

Instructions Gaviscon Mint chewable tablets blister No. 24

Composition

active ingredients: 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, acesulfame potassium, mint flavor, aspartame (E 951).

Dosage form

Chewable tablets.

Main physicochemical properties: the tablet is round, flat with a bevel, almost white or cream in color, with small inclusions, with a mint aroma. The tablet is embossed with a sword and a 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® mint tablets quickly begin to interact with gastric juice, forming a layer of alginic acid gel on its surface, which has a pH close to neutral and effectively coats the walls of the stomach, preventing the occurrence of gastroesophageal reflux. In severe cases, this layer, distributed over the surface of the stomach contents, rises to the esophagus and prevents its irritation.

Pharmacokinetics

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

Indication

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

Contraindication

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

Interaction with other medicinal products and other types of interactions

At least 2 hours should elapse between taking Gaviscon® mint tablets and other medications, especially tetracyclines, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, estramustine and bisphosphonates.

Application features

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

The maximum daily dose of the drug is equivalent to 50.6% of the maximum daily sodium intake 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.

A dose of 4 tablets contains 320 mg (3.2 mmol) of calcium carbonate. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis and recurrent formation of calcium-containing kidney stones.

1 tablet of this drug contains 3.75 mg of aspartame. When taken orally, aspartame is hydrolyzed in the gastrointestinal tract. One of the main hydrolysis products is phenylalanine. Since the drug contains aspartame (E 951), it cannot be prescribed to patients with phenylketonuria.

If there is no improvement in symptoms after 7 days of treatment, the clinical situation needs to be reviewed.

Use during pregnancy or breastfeeding

Clinical studies involving more than 500 pregnant women, as well as a large amount of post-marketing experience, indicate the absence of toxic effects of the active substances on the fetus or newborn, as well as their lack of ability to cause congenital malformations. Gaviscon® mint tablets can be used during pregnancy if clinically necessary.

Breast-feeding

Studies have shown no effects on newborns/infants breastfed by women who have used this medicine. Gaviscon® mint tablets can be used during breastfeeding.

Fertility.

Clinical experience has shown that no effect on human fertility is expected at therapeutic doses.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect or has a negligible effect on the ability to drive vehicles and work with other mechanisms.

Method of administration and doses

The medicine is intended for oral use. The tablets must be chewed thoroughly.

Adults and children over 12 years of age: 2–4 tablets after meals and before bedtime.

Elderly patients: No dose adjustment is necessary for this age group.

Children

There are no clinical data on the use in children under 12 years of age.

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 bloating.

Treatment.

In case of overdose, symptomatic treatment is used.

Adverse reactions are listed by frequency of occurrence according to the following classification: 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), frequency unknown (cannot be estimated from the available data):

Expiration date

2 years.

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

Storage conditions

Store out of the reach of children at a temperature not exceeding 30 ºС.

Packaging

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

Vacation category

Without a prescription.

Producer

Reckitt Benckiser Healthcare (UK) Limited.

Location of the manufacturer and its business address

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