Composition, form of production and packaging
? Tablets are chewy (mint) from almost white to cream color with small impregnations, round, flat, with bevelled edges, with a circle and sword on one side and "G 250" on the other, with a minty smell.
1 tab.
sodium alginate 250 mg
sodium bicarbonate 133.5 mg
calcium carbonate 80 mg
Auxiliary substances: mannitol - 255 mg, macrogol 20 000 - 30 mg, magnesium stearate - 4 mg, aspartame - 3.75 mg, kapovidone - 28 mg, potassium acesulfame - 3.75 mg, flavoring mint - 12 mg.
4 things. - blisters (1) - packs of cardboard.
4 things. - blisters (2) - packs of cardboard.
4 things. - blisters (3) - packs of cardboard.
4 things. - blisters (4) - packs of cardboard.
6 pcs. - blisters (1) - packs of cardboard.
6 pcs. - blisters (2) - packs of cardboard.
6 pcs. - blisters (3) - packs of cardboard.
6 pcs. - blisters (4) - packs of cardboard.
8 pcs. - blisters (1) - packs of cardboard.
8 pcs. - blisters (2) - packs of cardboard.
8 pcs. - blisters (3) - packs of cardboard.
8 pcs. - blisters (4) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (4) - packs of cardboard.
16 pcs. - polypropylene containers (2) - cardboard packs.
20 pcs. - polypropylene containers (2) - cardboard packs.
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 barrier on the surface of the stomach contents, preventing the occurrence of gastroesophageal reflux for up to 4 hours. In case of regurgitation, the gel is more likely to enter the esophagus, where it reduces irritation of the mucous membrane.
Reduction of irritation of the mucosa of the esophagus is felt 3-4 minutes after taking the drug.
PHARMACOKINETICS
The drug does not have systemic bioavailability (not absorbed).
INDICATIONS
- Treatment of such symptoms as acidic eructation, heartburn, indigestion, a feeling of heaviness in the stomach, arising after eating, in patients with gastroesophageal reflux or in pregnancy.
DOSING MODE
The drug is taken orally. The tablet should be thoroughly chewed.
Adults and children over 12 years of age are prescribed 2-4 tablets. after meals and at bedtime (up to 4 times / day).
If symptoms persist after 7 days of using the drug, the patient should consult a doctor to review the therapy.
Older patients do not need a dose adjustment.
Patients with impaired hepatic function correction of the dose is not required.
Patients with impaired renal function, if it is necessary to comply with a diet with a low salt content, the drug should be taken with caution.
SIDE EFFECT
The incidence of adverse reactions was estimated on the basis of the following criteria: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1 / 10 000, <1/1000), very rarely (<1/10 000) and the frequency is unknown (the frequency can not be calculated from the available data).
On the part of the immune system: the frequency is unknown - anaphylactic and anaphylactoid reactions, hypersensitivity reactions (urticaria).
From the respiratory system: the frequency is unknown - respiratory effects (bronchospasm).
If any of the side effects indicated in the manual are aggravated or other side effects not indicated in the instructions are noted, the patient should be informed about this to the doctor.
CONTRAINDICATIONS
- phenylketonuria;
- children's age till 12 years;
- Hypersensitivity to the components of the drug.
With caution should apply the drug for hypercalcemia, nephrocalcinosis and urolithiasis with the formation of oxalate stones, congestive heart failure, impaired renal function. In the presence of these diseases or conditions, the patient should consult a doctor before using the drug.
PREGNANCY AND LACTATION
Clinical studies involving more than 500 pregnant women and the amount of data obtained during the post-registration period did not show feto- and neonatal toxicity of the active substances. Gaviscon В® can be used in pregnancy with clinical need and after consulting a doctor.
Gaviscon В® can be used during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should apply the drug for nephrocalcinosis and urolithiasis with the formation of oxalate stones, impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Patients with a violation of liver function correction of the dose is not required.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in childhood to 12 years .
APPLICATION IN ELDERLY PATIENTS
For elderly patients, dose adjustment is not required.
SPECIAL INSTRUCTIONS
In a dose of 4 tablets, the sodium content is 246 mg, which should be considered when it is necessary to maintain a diet with a limited salt content (with congestive heart failure, with kidney dysfunction).
Each dose of 4 tablets contains 320 mg of calcium carbonate. Care must be taken when treating patients with hypercalcemia, nephrocalcinosis and urolithiasis with the formation of oxalate stones.
The drug contains aspartame, so it should not be used in patients with phenylketonuria. Because aspartame is a nonspecific sweetener, patients with diabetes can use Gaviscon В® .
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, thyroid hormones, penicillamine, beta-adrenoblockers (atenolol, metoprolol, propranolol), GCS, chloroquine, bisphosphonates and estramustine.
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 no higher than 30 В° C. Shelf life - 2 years.
