Gaviscon® double action

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GAVISCON® DOUBLE ACTION (GAVISCON® DOUBLE ACTION)

Composition:

Active substances: 10 ml of suspension contains 500 mg of sodium alginate, 213 mg of sodium hydrogen carbonate, 325 mg of calcium carbonate;

Excipients: carbomer 974P, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sodium saccharin, peppermint flavor No. 2, sodium hydroxide, purified water.

Pharmaceutical form. Oral suspension.

Main physico-chemical properties: viscous, opaque, almost white to creamy-colored suspension with a minty odor.

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 hydrogencarbonate) and sodium alginate, which exerts adsorbing and protective coating effects.

After administration, the medicinal product rapidly reacts with gastric acid, forming a raft of alginic acid gel with nearly neutral pH, which covers the surface of gastric contents and effectively prevents symptoms of gastroesophageal reflux. In severe cases, this gel layer precedes gastric contents into the esophagus and prevents its irritation. Calcium carbonate neutralizes gastric acid and provides rapid relief from indigestion and heartburn. This effect is enhanced by sodium hydrogencarbonate, which also exerts a neutralizing action. The total acid-neutralizing capacity of the preparation 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 acidity of gastric contents regurgitating into the esophagus, such as acid burping, heartburn, and dyspepsia, for example, after food intake or during pregnancy.

Contraindications.

The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216).

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® Dual Action, oral suspension, 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

20 ml of the medicinal product contains 255.76 mg (11.12 mmol) of sodium, equivalent to 12.79% 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 51.15% 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.

20 ml of the suspension contain 260 mg (6.5 mmol) of calcium. Caution should be exercised when treating patients with hypercalcemia, nephrocalcinosis, and recurrent formation of calcium-containing kidney stones.

If there is no symptom improvement after 7 days of treatment, the clinical situation should be re-evaluated.

The use of this medicinal product may mask symptoms of other serious diseases.

The medicinal product contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

The container is made of glass – handle with care! Do not drink directly from the bottle.

Use during pregnancy or breastfeeding.

Gaviscon® Dual Action, oral suspension, does not affect the course of pregnancy or intrauterine and postnatal development of the child. The medicinal product may be used during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

The medicinal product is intended for oral administration.

Adults and children aged 12 years and older should take 10–20 mL (2–4 teaspoons) after meals and at bedtime, up to 4 times daily. Shake well before use.

Special patient populations:

Dosage adjustment is not required for elderly patients.

Patients with hepatic impairment do not require dosage adjustment.

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 generally 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 over a prolonged period.

Treatment

In case of overdose, discontinue the drug and administer symptomatic therapy.

Adverse reactions.

Adverse reactions are classified by frequency as follows:

very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), 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. Not known: alkalosis^1, acid rebound^1, hypercalcemia^1, milk-alkali syndrome^1.

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

Gastrointestinal disorders. Not known: constipation^1.

Description of selected adverse reactions.

^1 These symptoms usually occur as a result of exceeding the recommended dose.

Shelf life. 2 years.

Store no longer than 6 months after first opening of the bottle.

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

Storage conditions.

Store at temperatures not exceeding 30 ºC, in a place inaccessible to children. Do not store in the refrigerator and do not freeze.

Packaging.

150 ml in a bottle with a pink film applied directly onto the bottle or in a bottle with a pink coating, polypropylene cap with a polyethylene tamper-evident band, and a combined label – multilayer, containing the instructions for medical use; 10 ml in sachets, 10, 12, 20 or 24 sachets in a cardboard box together with the instructions for medical use.

Classification.

Available without prescription.

Manufacturer.

Reckitt Benckiser Healthcare (UK) Limited.

Manufacturer's address and place of business.

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