Gaviscon Double Action chewable tablets blister pack No. 24

Instructions for Gaviscon Double Action chewable tablets blister No. 24

Composition

active ingredients: 1 tablet contains 250 mg of sodium alginate, 106.5 mg of sodium bicarbonate, 187.5 mg of calcium carbonate;

excipients: macrogol 20,000, mannitol (E 421), copovidone, acesulfame potassium, aspartame (E 951), mint flavoring J8696, carmoisine (E 122), magnesium stearate, xylitol DC.

Dosage form

Chewable tablets.

Main physicochemical properties: round, flat, two-layer tablets with beveled edges and a minty smell. One layer of the tablet is pink with small inclusions, the other is white. On one side of the tablet is a sword and a circle, on the other - GDA 250.

Pharmacotherapeutic group

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

Pharmacological properties

Pharmacodynamics

The medicine is a combination of two antacids (calcium carbonate and sodium bicarbonate) and sodium alginate.

During ingestion, the drug quickly reacts with gastric acid, forming a layer of alginic acid gel, which has a neutral pH value and effectively coats the stomach walls, preventing the occurrence of gastroesophageal reflux. In severe cases, the gel layer distributed over the surface of the stomach contents rises to the esophagus and prevents irritation of the esophagus. Calcium carbonate neutralizes gastric acid and provides rapid relief of symptoms of indigestion and heartburn. This effect is increased by the addition of sodium bicarbonate, which also has a neutralizing effect. The total neutralizing capacity of the drug at the lowest dose of 10 ml is about 10 mEqH +.

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 (GERD) associated with the acidity of stomach contents flowing back into the esophagus, such as acid regurgitation, heartburn, indigestion, for example, after meals or during pregnancy.

Contraindication

Hypersensitivity (allergy) to any of the components of the drug.

Interaction with other medicinal products and other types of interactions

Due to the presence of calcium carbonate, which acts as an antacid, it is necessary to maintain a 2-hour interval between taking Gaviscon® Double Action, chewable tablets and taking other medications, especially H2-antihistamines, tetracyclines, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine, diphosphonates and estramustine.

Application features

4 tablets of the drug contain 223.56 mg (9.72 mmol) of sodium, which is equivalent to 11.18% of the maximum daily sodium intake for adults recommended by the World Health Organization.

The maximum daily dose of the drug is equivalent to 44.71% 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 300 mg (7.5 mmol) of calcium. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis and recurrent formation of calcium-containing kidney stones.

This medicine contains aspartame (E 951), which is a source of phenylalanine. Therefore, the medicine may be dangerous for patients with phenylketonuria.

This medicine contains carmoisine (E 122), which may cause allergic reactions.

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

Taking the drug may mask the symptoms of other serious illnesses.

This medicine contains xylitol, which may have a laxative effect. The energy value of 1 g of xylitol is 2.4 kcal.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the ability to drive vehicles and work with other mechanisms.

Use during pregnancy or breastfeeding

Gaviscon® Dual Action, chewable tablets, do not affect the course of pregnancy, intrauterine and postnatal development of the child. The drug can be used by pregnant women and during breastfeeding.

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, up to 4 times a day in total.

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

Patients with impaired liver function do not require dose adjustment.

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 12 years of age.

Overdose

Symptoms are mild in acute overdose. Overdose may manifest as abdominal discomfort and bloating. Milk-alkali syndrome has been reported in individuals taking high daily doses of calcium carbonate for prolonged periods.

Treatment

In case of overdose, it is necessary to discontinue use of the drug and conduct symptomatic therapy.

Adverse reactions

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 urticaria.

Metabolism and digestive disorders: Frequency unknown: alkalosis1, acid reflux1, hypercalcemia1, milk-alkali syndrome1.

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

Gastrointestinal disorders Frequency unknown: constipation1.

Description of selected adverse reactions.

1 As a rule, such symptoms occur as a result of exceeding the recommended dose.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 30 ° C in the original packaging. Keep out of the reach of children.

Packaging

8 chewable tablets in a blister, 3 blisters in a cardboard box.

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.