Producer: Teva (Tev) Israel
Code of automatic telephone exchange: A02AX
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agents: carbonate magnesium hydroxide aluminum gel of 450,0 mg, magnesium hydroxide of 300,0 mg;
excipients: Mannitolum (E421) of 120,00 mg, sorbitol (E420) of 50,00 mg, lactoses monohydrate of 30,00 mg, starch of corn 75,80 mg, sodium цикпамат 7,00 mg, sodium saccharinate of 0,20 mg, talc of 28,00 mg, magnesium stearate of 6,00 mg, fragrance of a peppermint of 3,00 mg.
Description: Round tablets from white till cream color with a smooth surface and a facet.
Pharmacodynamics. Drug Gastal - the combined antiacid means which reduces a hyperoxemia of a gastric juice and does not exert the stimulating impact on secretion of a gastric juice.
Carbonate magnesium hydroxide aluminum gel and magnesium hydroxide provide immediate (at once after reception) and long (about 2 hours) neutralization of hydrochloric acid of a gastric juice, with maintenance of acidity in a stomach at the physiological level (рН 3-5). One tablet of drug Gastal neutralizes 21,5 mmol of hydrochloric acid.
The drug Gastal® suppresses effect of pepsin, lysolecithin and bile acids, eliminates the dispepsichesky phenomena. Strengthens protective and regenerative processes in a mucous membrane of a stomach. Ions of aluminum have the cytoprotective effect due to increase in secretion of mucin and Natrii hydrocarbonas, activation of E2 and NO prostaglandin, accumulation of an epidermal growth factor in the place of injury of a mucous membrane, increase in concentration of phospholipids in stomach walls.
Pharmacokinetics. Drug Gastal has no systemic action at patients with normal function of kidneys. After interaction with hydrochloric acid of a gastric juice, aluminum hydroxide reacts with phosphates and carbonates in the alkaline environment of intestines and is emitted with a stake in the form of insoluble salts. Magnesium hydroxide reacts with hydrochloric acid in a gastric juice with formation of magnesium of the chloride having osmotic properties and soft laxative action which neutralizes the fixing effect of aluminum of hydroxide in a small intestine. Ions of magnesium are allocated with a stake in the form of an insoluble carbonate.
Indications to use:
Heartburn, the dispepsichesky phenomena (after reception of medicines, alcohol, coffee, errors in food, smoking); the states which are followed by the raised kislotoobrazovaniye: peptic ulcer of a stomach and duodenum, gastritis; reflux esophagitis; hernia of an esophageal opening of a diaphragm
Route of administration and doses:
Inside, gradually rassasyvy in a mouth.
Adults and children are more senior than 12 years with body weight not less than 50 kg
On 1-2 tablets of 4-6 times a day approximately in 1 hour after meal and before going to bed, but no more than 8 tablets a day. Duration of reception is no more than 2 weeks.
Similar doses are recommended for treatment of heartburn irrespective of meal.
Adults and children are more senior than 12 years with body weight less than 50 kg, children aged from 6 up to 12 years
The dose makes a half from the recommended dose for adults and children 12 years with body weight not less than 50 kg are more senior. Duration of reception is no more than 2 weeks.
Patients with HPN
Dose adjustment is not required. Duration of reception is no more than 2 weeks.
Features of use:
It is not necessary to exceed the recommended doses and duration of treatment at use for patients with a renal failure.
Influence on ability to management of transport and work with the equipment
Drug use Gastal does not exert impact on ability to driving of motor transport and to control of other mechanisms.
When using drug in the recommended doses side reactions meet seldom (not less than 0,01%, but less than 0,1%): nausea, lock, diarrhea, change of flavoring feelings. Allergic reactions are in exceptional cases possible.
Interaction with other medicines:
Drug Gastal at simultaneous use increases activity of a levodopa and Acidum nalidixicum, reduces and slows down absorption of hinolon, an isoniazid, Naproxenum, iron preparations, indometacin, aminazine, beta adrenoblockers, a diflunisal, blockers of H2-histamine receptors, fat-soluble vitamins, indirect anticoagulants, barbiturates.
At interaction with ions of the metals which are a part of antacids, tetracyclines form insoluble chelate complexes; as a result of this interaction absorption of tetracyclines decreases more than by 90%. The concomitant use of these drugs is impossible. In need of the combined use, it is necessary to accept tetracycline not less than in 2 hours prior to reception of an antacid.
In the presence of the hydroxides of aluminum and magnesium which are contained in an antacid, absorption of ciprofloxacin and an ofloksatsin decreases by 50-90%.
In the presence of antacids bioavailability of captopril significantly decreases, and the combined use of antacids and a metoprolol leads to reduction of concentration of a metoprolol in a blood plasma.
Simultaneous use of high doses of antacids can lower absorption of ranitidine by 10-33%.
Use of antacids does not influence bioavailability of amoxicillin, cefalexin and combination of amoxicillin and clavulanic acid, however can significantly reduce absorption of doxycycline from a GIT.
Increase рН urine against the background of therapy by antacids can promote increase in a canalicular reabsorption of the fixed (alkaline) medicines and reduce a reabsorption of acid connections. Antacids can reduce and slow down absorption of salicylates, including acetylsalicylic acid, and also, raising рН urine, to promote more bystry removal of salicylates with urine from an organism, with the accompanying decrease in their concentration in blood serum for 30-70%. Absorption of cardiac glycosides, including digoxin and digitoxin, at simultaneous use with antacids significantly does not decrease. M-holinoblokatory, slowing down motility of a stomach, increase duration of effect of the drug Gastal®.
For the purpose of prevention of possible interaction of the drug Gastal® with other medicines its reception in 1 hour prior to or in 1 hour after their use is recommended.
Hypersensitivity to salts of aluminum, magnesium or other components of drug; heavy renal failure; Alzheimer's disease; hypophosphatemia; lactose intolerance, deficit of lactase or or glyukozo-galaktozny malabsorption; children's age up to 6 years.
At the chronic renal failure (CRF), pregnancy and during breastfeeding, adults and children are more senior than 12 years with body weight less than 50 kg, children's age from 6 to 12 years, advanced age.
Use during pregnancy and during breastfeeding
Drug Gastal is not emitted with breast milk. At use during pregnancy and during breastfeeding it is necessary to estimate an advantage ratio for mother and risk for a fruit and the baby.
Symptoms of acute overdose are not described.
At prolonged use of high doses of the drugs containing aluminum and magnesium development of a hypophosphatemia, hypocalcemia, hypercalcuria, osteomalacy, osteoporosis, a gipermagniyemiya, giperalyuminiyemiya, encephalopathy, a nephrocalcinosis and a renal failure is possible. Development of more expressed undesirable reactions from the digestive tract (DT) (a lock, diarrhea) is possible, patients with a renal failure have thirst, lowerings of arterial pressure, hyporeflexias. Treatment: symptomatic therapy.
To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to apply after the expiry date specified on packaging.
Tablets for a rassasyvaniye.
On 6 tablets in the blister from PVC / aluminum foil.
On 2, 4, 5, 8 or 10 blisters together with the application instruction in a cardboard pack.