Gaviscon® double action
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GAVISCON® DOUBLE ACTION (GAVISCON® DOUBLE ACTION)
Composition:
Active substances: Each 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, potassium acesulfame, aspartame (E 951), peppermint flavour J8696, carmoisine (E 122), magnesium stearate, xylitol DC.
Pharmaceutical form. Chewable tablets.
Main physicochemical properties: round, flat, two-layered tablets with bevelled edges and a peppermint odour. One layer of the tablet is pink with small specks, the other is white. A sword and a circle are imprinted on one side of the tablet, and "GDA 250" on the other.
Pharmacotherapeutic group. Medicinal products for the treatment of peptic ulcer and gastroesophageal reflux disease (GERD). ATC code: A02B X.
Pharmacological properties.
Pharmacodynamics.
The medicinal product is a combination of two antacids (calcium carbonate and sodium hydrocarbonate) and sodium alginate.
During food intake, the medicinal product rapidly reacts with gastric acid, forming a layer of alginic acid gel with neutral pH value, which effectively coats the stomach walls, preventing gastroesophageal reflux. In severe cases, the gel layer distributed over the surface of the stomach contents rises into the esophagus and prevents irritation of the esophageal mucosa. Calcium carbonate neutralizes gastric acid and provides rapid relief of stomach discomfort and heartburn symptoms. This effect is enhanced by the addition of sodium hydrocarbonate, which also exerts a neutralizing action. The total acid-neutralizing capacity of the product at the lowest dose of 10 mL is approximately 10 mEq H⁺.
Pharmacokinetics.
The mechanism of action of this medicinal product is physical and does not depend on absorption into the systemic circulation.
Clinical characteristics.
Indications. Treatment of symptoms of gastroesophageal reflux associated with acidic gastric contents regurgitating into the esophagus, such as acid regurgitation, heartburn, and indigestion, for example, after food intake or during pregnancy.
Contraindications.
Hypersensitivity (allergy) to any of the components of the medicinal product.
Interaction with other medicinal products and other forms of interaction.
Due to the presence of calcium carbonate, which acts as an antacid, a 2-hour interval should be maintained between the administration of Gaviscon® Double Action, chewable tablets, and the intake 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 223.56 mg (9.72 mmol) of sodium, equivalent to 11.18% 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 44.71% 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 disease or congestive heart failure.
The dose of 4 tablets contains 300 mg (7.5 mmol) of calcium. Caution is advised when treating patients with hypercalcemia, nephrocalcinosis, and recurrent formation of calcium-containing kidney stones.
This medicinal product contains aspartame (E 951), which is a source of phenylalanine. Therefore, the product may be hazardous for patients with phenylketonuria.
This medicinal product contains carmoisine (E 122), which may cause allergic reactions.
If there is no improvement in symptoms after 7 days of treatment, the clinical situation should be re-evaluated.
Use of the medicinal product may mask symptoms of other serious diseases.
This medicinal product contains xylitol, which may have a laxative effect. The energy value of 1 g of xylitol is 2.4 kcal.
Use during pregnancy or breastfeeding.
Gaviscon® Dual Action, chewable tablets, does not affect the course of pregnancy, intrauterine, or postnatal development of the child. 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 vehicles or operate machinery.
Dosage and Administration
The medicinal product is intended for oral administration. Tablets should be thoroughly chewed.
Adults and children aged 12 years and older: 2–4 tablets after meals and at bedtime, up to 4 times daily.
Elderly patients: dose adjustment is not required for this age group.
Patients with hepatic impairment: dose adjustment is not required.
Renal insufficiency: use with caution in patients on a low-sodium diet (see section "Special Warnings and Precautions for Use").
Children
Not recommended for children under 12 years of age.
Overdose
Symptoms
Symptoms are usually mild in acute overdose. Overdose may manifest as abdominal discomfort and bloating. Milk-alkali syndrome has been reported in individuals who took high daily doses of calcium carbonate over a prolonged period.
Treatment
In case of overdose, discontinue the drug and administer symptomatic therapy.
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 urticaria.
Metabolism and nutrition disorders. Frequency not known: alkalosis1, acid rebound1, hypercalcemia1, milk-alkali syndrome1.
Respiratory, thoracic and mediastinal disorders. Very rare: respiratory manifestations such as bronchospasm.
Gastrointestinal disorders. Frequency not known: constipation1.
Description of selected side effects.
1 These symptoms usually occur as a result of exceeding the recommended dose.
Shelf life.
2 years.
Storage conditions.
Store at a temperature not exceeding 30 °C in the original packaging. Keep out of reach of children.
Packaging.
8 chewable tablets in a blister pack, 2 or 3 blister packs in a cardboard box.
Pharmaceutical category.
Over-the-counter (without prescription).
Manufacturer.
Reckitt Benckiser Healthcare (UK) Limited.
Manufacturer's address.
Dansom Lane, Hull, HU8 7DS, United Kingdom.