Description
Pharmacological action
Gastal ® is a combined antacid that reduces the increased acidity of gastric juice and does not have a stimulating effect on the secretion of gastric juice. Aluminum hydroxide-magnesium carbonate gel and magnesium hydroxide provide immediate (immediately after administration) and long-term (about 2 hours) neutralization of hydrochloric acid of gastric juice, with maintaining acidity in the stomach at a physiological level (pH 3-5). One Gastal ® tablet neutralizes 21.5 mmol of hydrochloric acid.
The drug Gastal ® suppresses the effects of pince, lysolecithin and bile acids, eliminates dyspeptic symptoms. Enhances protective and regenerative processes in the gastric mucosa. Aluminum ions have a cytoprotective effect due to increased secretion of mucin and sodium bicarbonate, activation of prostaglandin E2 and N0, the accumulation of epidermal growth factor at the site of damage to the mucous membrane, and an increase in the concentration of phospholipids in the walls of the stomach.
Indications
– Dyspepsia, such as discomfort or pain in the epigastrium, heartburn, sour belching after errors in the diet, excessive consumption of ethanol, coffee, nicotine, etc.
– dyspeptic symptoms, such as discomfort or pain in the epigastrium, heartburn, sour belching (and their prevention), resulting from the use of certain drugs (non-steroidal anti-inflammatory drugs, glucocorticosteroids, etc.)
– conditions accompanied by increased acidification: stomach, gastritis, reflux esophagitis hernia of the esophageal opening of the diaphragm.
Contraindications
Hypersensitivity to aluminum, magnesium salts or other components of the drug severe renal failure Alzheimer’s disease hypophosphatemia lactose intolerance, lactase deficiency or glucose-galactose malabsorption children under 6 years of age.
Precautions:
In case of chronic renal failure (CRF), pregnancy and lactation, adults and children over 12 years old with body weight less than 50 kg, children from 6 to 12 years old, old age.
Use during pregnancy and lactation
Gastal ® is not excreted in breast milk. When used during pregnancy and during breastfeeding, it is necessary to assess the ratio of benefits for the mother and risk for the fetus and baby.
Special instructions
The recommended doses and duration of treatment should not be exceeded when used in patients with impaired renal function.
Composition of
One tablet contains: active substances: aluminum hydroxide-magnesium carbonate gel 450.0 mg, magnesium hydroxide 300.0 mg excipients: mannitol (E421) 120.0 mg, sorbitol (E420) 50.00 mg, lactose monohydrate 30.00 mg, corn starch 75.80 mg, sodium cyclamate 7.00 mg, sodium saccharin 0.20 mg, talc 28.00 mg, magnesium stearate 6.00 mg, orange flavor 3.00 mg.
Dosage and administration
Inside, gradually dissolving in the mouth.
Adults and children over 12 years old with a body weight of at least 50 kg
1-2 tablets 4-6 times a day, approximately 1 hour after eating and at bedtime, but not more than 8 tablets per day. Duration of admission is no more than 2 weeks. Similar doses are recommended for treating heartburn, regardless of food intake.
Adults and children over 12 years old with a body weight of less than 50 kg, children aged 6 to 12 years
The dose is half the recommended dose for adults and children over 12 years of age with a body weight of at least 50 kg. Duration of admission is no more than 2 weeks.
Patients with PCN
Dose adjustment not required. Duration of admission is no more than 2 weeks.
Side effects
When using the drug in recommended doses, adverse reactions are rare (not less than 0.01%, but less than 0.1%): nausea, constipation, diarrhea, a change in taste. In exceptional cases, allergic reactions are possible.
Drug interaction
The Gastal ® drug with simultaneous use enhances the activity of levodopa and nalidixic acid, reduces and slows down the absorption of quinolones, isoniazid, naproxen, iron preparations, indomethacin, aminazine, beta-adrenergic blocking agents, difluorinum, diflorinum, and receptor fluorisinal indirect anticoagulants, barbiturates.
When interacting with metal ions that make up antacids, tetracyclines form insoluble chelate complexes as a result of this interaction, the absorption of tetracyclines decreases by more than 90%. Simultaneous administration of these drugs is not possible. If combined use is necessary, tetracycline should be taken at least 2 hours before taking antacid.
In the presence of aluminum and magnesium hydroxides contained in the antacid, the absorption of ciprofloxacin and ofloxacin is reduced by 50-90%.
In the presence of antacids, the bioavailability of captopril is significantly reduced, and the combined use of antacids and metoprolol leads to a decrease in the concentration of metoprolol in blood plasma.
The simultaneous use of high doses of antacids can reduce the absorption of ranitidine by 10-33%.
The use of antacids will not affect the bioavailability of amoxicillin, cevalexin and a combination of amoxicillin and clavulanic acid, however, can significantly reduce the absorption of doxycycline from the digestive tract.
An increase in urine pH during antacid therapy can increase tubular reabsorption of basic (alkaline) drugs and reduce reabsorption of acidic compounds. Antacids can reduce and slow down the absorption of salicylates, including acetylsalicylic acid, and also, increasing the pH of urine, contribute to a more rapid excretion of salicylates in the urine from the body, with a concomitant decrease in their concentration in the blood serum by 30-70%.
Absorption of cardiac glycosides, including digoxin and digitoxin, while the use of antacids is not significantly reduced. M-anticholinergics, slowing down the motility of the stomach, increase the duration of the drug Gastal ®.
In order to prevent possible interaction of Gastal ® with other drugs, it is recommended to take it 1 hour before or 1 hour after their use.
Overdose
Symptoms of acute overdose are not described.
With prolonged use of high doses of drugs containing aluminum and magnesium, hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis and impaired renal function are possible. Perhaps the development of more pronounced adverse reactions from the gastrointestinal tract (GIT) (constipation, diarrhea), in patients with renal failure – thirst, lowering blood pressure, hyperoflexion.
Treatment: symptomatic therapy.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Expiration
3 years.
Do not use after the expiry date stated on the package.
Deystvuyuschee substances
Hydrotaltsyt, magnesium hydroxide
pharmacy terms and conditions without a prescription
Form of Treatment
tablets dlya rassas vaniya
Teva Pharmaceutical Enterprises Co., Ltd., Israel
