Gaviscon Double Action oral suspension sachet 10 ml No. 24

Instructions for Gaviscon Double Action oral suspension sachet 10 ml No. 24

Composition

active ingredients: 10 ml of suspension contain 500 mg of sodium alginate, 213 mg of sodium bicarbonate, 325 mg of calcium carbonate;

excipients: carbomer 974P, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin, peppermint flavoring No. 2, sodium hydroxide, purified water.

Dosage form

Oral suspension.

Main physicochemical properties: viscous, opaque, almost white to cream-colored suspension with a mint odor.

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, which has an adsorbing and enveloping effect.

After ingestion, the drug quickly reacts with gastric acid, forming a mass of alginic acid gel, which has an almost neutral pH value and covers the surface of the stomach contents, effectively preventing the manifestations of gastroesophageal reflux. In severe cases, the gel layer, preceding the stomach contents, rises to 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 bicarbonate, which also has a neutralizing effect. The total neutralizing capacity of the drug at the lowest dose of 10 ml is about 10 mEq H+

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

The drug is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients, including methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

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, oral suspension and taking other medications, especially H2-antihistamines, tetracyclines, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoids, chloroquine, diphosphonates and estramustine.

Application features

20 ml of the product contains 255.76 mg (11.12 mmol) of sodium, which is equivalent to 12.79% of the maximum daily sodium intake for adults recommended by the World Health Organization.

The maximum daily dose of the drug is equivalent to 51.15% 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.

20 ml of suspension contains 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 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 diseases.

The medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

Glass bottle – handle with care! Do not drink directly from the bottle.

Use during pregnancy or breastfeeding

Gaviscon® Double Action, oral suspension, does not affect the course of pregnancy, intrauterine and postnatal development of the child. The drug can be used by pregnant women and during breastfeeding.

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 complex mechanisms.

Method of administration and doses

The medicine is intended for oral use.

Adults and children over 12 years of age, take 10-20 ml (2-4 teaspoons) after meals and before bedtime, up to 4 times a day in total. Shake before use.

Special categories of patients:

No dose adjustment is required for elderly patients.

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 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.

Store no more than 6 months after first opening the bottle.

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

Storage conditions

Store at a temperature not exceeding 30 ° C, out of the reach of children. Do not refrigerate or freeze.

Packaging

150 ml in a bottle with a pink film applied (directly to the bottle) or in a bottle with a pink coating, a polypropylene cap with a polyethylene strip for first-time opening control and a combined label - multilayer, containing instructions for medical use; 10 ml in a sachet, 10, 12, 20 or 24 sachets in a cardboard box together with instructions for medical use.

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.