Composition, form of production and packaging
? Suspension for oral administration (mint) is viscous, opaque, from almost white to cream-colored, with a mint smell.
10 ml
sodium alginate 500 mg
sodium bicarbonate 267 mg
calcium carbonate 160 mg
Excipients: carbomer - 65 mg, methylparahydroxybenzoate - 40 mg, propylparahydroxybenzoate - 6 mg, sodium saccharinate - 10 mg, peppermint oil - 1 mg, sodium hydroxide - 26.667 mg, purified water - up to 10 ml.
100 ml - vials of dark glass with the control of the first opening.
150 ml - bottles of dark glass with the control of the first opening.
300 ml - bottles of dark glass with control of the first opening.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Antacid preparation. After ingestion, the drug quickly interacts with the acid content of the stomach. In this case, the alginate gel is formed, which has an almost neutral pH value. The gel forms a protective coating on the surface of the stomach contents and lasts up to 4 hours, effectively preventing the occurrence of gastroesophageal reflux. With regurgitation, the gel is more likely than the contents of the stomach to enter the esophagus, where it reduces irritation of the mucous membrane.
PHARMACOKINETICS
The mechanism of action of the drug Gaviscon В® does not depend on the absorption in the systemic bloodstream.
INDICATIONS
- symptomatic treatment of dyspepsia associated with high acidity of gastric juice and gastroesophageal reflux (heartburn, acidic eructation, a feeling of heaviness in the stomach after eating), incl. during pregnancy.
DOSING MODE
The drug is used inside.
Adults and children over 12 years of age are prescribed 10-20 ml of the suspension after meals and at bedtime. The maximum daily dose is 80 ml.
Children aged 6-12 years are prescribed 5-10 ml after meals and at bedtime. The maximum daily dose is 40 ml.
For elderly patients, dose adjustment is not required.
SIDE EFFECT
Perhaps: allergic reactions - urticaria, bronchospasm, anaphylactic reactions.
CONTRAINDICATIONS
- children's age till 6 years;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The open controlled trials involving 281 pregnant women and the experience gained did not show any significant undesirable effects of Gaviscon В® during pregnancy or fetal and newborn health.
Gaviscon В® can be used during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with impaired renal function, if a diet with a limited salt content is necessary, it should be noted that 10 ml of the suspension contains 141 mg (6.2 mmol) of sodium.
APPLICATION FOR CHILDREN
Contraindicated the use of the drug in childhood to 6 years .
APPLICATION IN ELDERLY PATIENTS
For elderly patients, dose changes are not required.
SPECIAL INSTRUCTIONS
In 10 ml of the suspension contains 141 mg (6.2 mmol) of sodium, which should be considered when it is necessary to comply with a diet with a limited salt content (with congestive heart failure, with kidney dysfunction).
If there is no improvement within 7 days, consult a doctor.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and mechanisms, as well as to engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: bloating.
Treatment: symptomatic therapy.
DRUG INTERACTION
The composition of the drug includes calcium carbonate, which shows antacid activity, so between taking the drug Gaviscon В® and other drugs should be at least 2 hours, especially with simultaneous use with blockers of histamine H 2 -receptors, antibiotics from the tetracycline group, digoxin, fluoroquinolones, salts iron, ketoconazole, neuroleptics, levothyroxine sodium, penicillamine, beta-adrenoblockers, GCS, chloroquine, diphosphates.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 3 years.
