Composition and form of release
Composition
active ingredients: sodium alginate, potassium bicarbonate;
5 ml of suspension contain 500 mg of sodium alginate, 100 mg of potassium bicarbonate;
Excipients: calcium carbonate, carbomer 974P, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), mint flavoring, purified water.
Release form
Oral suspension.
Pharmacological properties
Pharmacodynamics. After oral administration, Gaviscon quickly interacts with gastric juice, forming a layer of alginic acid gel on its surface, which has a pH close to neutral, quickly and effectively covers the walls of the stomach (within 4 hours), preventing the occurrence of reflux. In severe cases, this layer can rise to the esophagus instead of the contents of the stomach and protect the walls of the esophagus. In addition, in vitro data have shown that the gel layer has a secondary effect and is able to retain bile and pepsin in its structure and thereby additionally protect the esophagus from these components of gastric juice.
Pharmacokinetics. The mechanism of action of the drug is physical and does not depend on the level of absorption into the systemic bloodstream.
Indication
Gaviscon Forte mint suspension: symptomatic treatment of reflux (acid belching, heartburn), reflux esophagitis, gastric dysfunctions that cause reflux: for example, after stomach surgery, as a result of hiatal hernia, during pregnancy.
Contraindication
Gaviscon mint suspension: this medicinal product 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).
Application
Gaviscon Forte mint suspension. Adults and children over 12 years of age are prescribed the drug orally. Take 5-10 ml (1-2 teaspoons) after meals and before bedtime up to 4 times a day.
The drug should not be used for more than 7 days. If the symptoms of the disease persist or worsen during this period, the patient should consult a doctor to clarify the diagnosis and correct the treatment regimen.
Special categories of patients
No dose adjustment is necessary in elderly patients.
Liver dysfunction: No dose adjustment is required.
Renal impairment: Use with caution in patients who need to follow a low-salt diet.
Special instructions
If there is no improvement after 7 days, the clinical picture should be reviewed. Patients on a low-salt diet, for example in renal failure or congestive heart failure, or when using drugs that can increase the level of potassium in the blood plasma, it should be taken into account that 10 ml of Gaviscon mint suspension contains 141 mg (6.2 mmol) of sodium, and 4 tablets of Gaviscon mint tablets and Gaviscon strawberry tablets contain 246 mg (10.6 mmol) of sodium, 10 ml of Gaviscon forte mint suspension contains 106 mg (4.6 mmol) of sodium and 78 mg (2.0 mmol) of potassium. It should also be noted that 10 ml of Gaviscon Mint Suspension suspension contains 160 mg (1.6 mmol) of calcium carbonate, 10 ml of Gaviscon Forte Mint Suspension contains 200 mg (2.0 mmol) of calcium carbonate, and 4 tablets of Gaviscon Mint Tablets and Gaviscon Strawberry Tablets contain 320 mg (3.2 mmol) of calcium carbonate, therefore the drug should be prescribed with caution to patients with hypercalcemia, nephrocalcinosis, and recurrent calcium-induced urolithiasis.
Gaviscon mint suspension: patients with impaired renal function should have their calcium, potassium and magnesium levels regularly monitored. Gaviscon mint suspension, Gaviscon Forte mint suspension: the medicinal product contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed) (see Side effects).
Use during pregnancy and 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 newborn / infant, as well as their lack of ability to cause congenital malformations. The drug can be used during pregnancy if clinically necessary after consultation with a doctor.
Breastfeeding. Studies have shown no effects on newborns/infants breastfed by mothers who have used this drug. The drug can be used during breastfeeding after consulting a doctor.
Fertility: Preclinical studies have shown that alginate does not adversely affect the fertility or reproductive function of test animals or their offspring. Clinical data do not indicate an effect on human fertility.
Drivers
The drug does not affect the ability to drive vehicles and work with other mechanisms.
Children. The drug is contraindicated in children under 6 years of age. In children under 12 years of age, the drug can be used only as prescribed and under the supervision of a doctor. Gaviscon mint suspension is indicated for children over 6 years of age.
Overdose
It occurs very rarely and manifests itself in the form of discomfort and a feeling of bloating.
The drug should be discontinued and symptomatic therapy should be administered.
Side effects
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).
On the part of the immune system: very rarely – anaphylactic and anaphylactoid reactions, hypersensitivity reactions such as rash, urticaria.
Respiratory, thoracic and mediastinal disorders: very rarely – respiratory symptoms such as bronchospasm.
Gastrointestinal tract: frequency unknown – bloating, constipation.
Interactions
Due to the presence of calcium carbonate, which acts as an antacid, at least 2 hours should elapse between taking Gaviscon and taking other medications, especially H2-histamine receptor blockers, tetracycline, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, β-adrenoceptor blockers (atenolol, metoprolol, propranolol), corticosteroids, chloroquine, diphosphonates and estramustine.
Storage conditions
Suspension – at a temperature not exceeding 30 °C. Do not store in the refrigerator. Do not freeze. After first opening the bottle, store for no more than 6 months.
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