Gastal, tablets 60 pcs.

Pharmacotherapeutic group: antacid Drug ATX code: A02AD01 Pharmacological properties Pharmacodynamics Gastal® is a combined antacid drug that reduces increased acidity of gastric juice and has no stimulating effect on gastric juice secretion. Aluminum hydroxide-magnesium carbonate gel and magnesium hydroxide provide immediate (immediately after intake) and long-term (about 2 hours) neutralization of gastric hydrochloric acid, and maintenance of gastric acidity at physiological level (pH 3-5). One tablet of Gastal® neutralizes 21.5 mmol of hydrochloric acid. Gastal® inhibits the action of pepsin, lysolecithin and bile acids, eliminates dyspeptic symptoms. Strengthens protective and regenerative processes in gastric mucosa. Aluminum ions have cytoprotective effect due to increased secretion of mucin and sodium hydrocarbonate, activation of prostaglandin E2 and NO, accumulation of epidermal growth factor in place of mucous membrane injury, increased concentration of phospholipids in gastric walls. Pharmacokinetics Gastal® has no systemic effect in patients with normal renal function. After interaction with hydrochloric acid of gastric juice aluminum hydroxide reacts with phosphates and carbonates in alkaline intestinal environment and is excreted with feces as insoluble salts. Magnesium hydroxide reacts with hydrochloric acid in gastric juice to form magnesium chloride, which has osmotic properties and a mild laxative effect, which neutralizes the fixing effect of aluminum hydroxide in the small intestine. Magnesium ions are excreted with feces in the form of insoluble carbonate.

Indications

Chronic pancreatitis, Gastritis, Reflux esophagitis, Sour belching, Gastric and duodenal ulcers, Heartburn- Dyspeptic conditions such as: epigastric discomfort or pain, heartburn, sour belching following errors in diet, excessive consumption of alcohol, coffee, nicotine, etc. – dyspeptic phenomena, such as: discomfort or pain in the epigastrium, heartburn, sour belching (and their prevention), resulting from the use of certain medications (nonsteroidal anti-inflammatory drugs, glucocorticosteroids, etc.) – conditions accompanied by increased acid production: gastric ulcer, gastritis, reflux esophagitis; hernia of the esophageal opening of the diaphragm.

Active ingredient

Hydrotalcite, Magnesium hydroxide

Composition

One tablet contains: active ingredients: aluminum hydroxide-magnesium carbonate gel 450.00 mg, magnesium hydroxide 300.00 mg; excipients: Mannitol (E421) 120.00 mg, sorbitol (E420) 50.00 mg, lactose monohydrate 30.00 mg, corn starch 75.80 mg, sodium cyclamate 7.00 mg, sodium saccharinate 0.20 mg, talc 28.00 mg, magnesium stearate 6.00 mg, peppermint flavoring 3.00 mg.

How to take, the dosage

Orally, gradually dissolving in the mouth. Adults and children over 12 years of age with body mass at least 50 kg 1-2 tablets 4-6 times a day about 1 hour after meals and before going to bed, but not more than 8 tablets a day. The duration of intake of no more than 2 weeks. Similar doses are recommended for heartburn treatment, regardless of meals. Adults and children over 12 years of age with body weight less than 50 kg, children aged 6 to 12 years The dose is half of the recommended one for adults and children over 12 years of age with a body weight of at least 50 kg. The duration of treatment should not exceed 2 weeks. Patients with CKD The dose adjustment is not required. The duration of treatment is not more than 2 weeks.

Interaction

When concomitant use of Gastal® increases the activity of levodopa and nalidixic acid, reduces and delays absorption of quinolones, isoniazid, naproxen, iron drugs, indomethacin, aminazine, beta-adrenoblockers, diflunisal, H2-histamine receptor blockers, fat-soluble vitamins, indirect anticoagulants, barbiturates. Tetracyclines form insoluble chelate complexes with metal ions that are part of antacids; as a result of this interaction, absorption of tetracyclines is reduced by more than 90%. Simultaneous administration of these drugs is not possible. If combined administration is necessary, tetracycline should be taken at least 2 hours before taking the antacid. In the presence of aluminum and magnesium hydroxides contained in the antacid, 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 plasma concentrations of metoprolol. Concomitant use of high doses of antacids may reduce the absorption of ranitidine by 10-33%. Antacids do not affect the bioavailability of amoxicillin, cephalexin and combination of amoxicillin and clavulanic acid, but may significantly reduce absorption of doxycycline from the gastrointestinal tract. Increased urinary pH during antacid therapy may increase tubular reabsorption of basic (alkaline) drugs and decrease reabsorption of acidic compounds. Antacids may decrease and slow absorption of salicylates, including acetylsalicylic acid, and by increasing the urinary pH, contribute to more rapid urinary excretion of salicylates from the body, with an accompanying decrease in their serum concentrations by 30-70%. Absorption of cardiac glycosides, including digoxin and digitoxin, when concomitant use with antacids is not significantly reduced. M-cholinoblockers, by slowing down gastric motility, increase the duration of action of the drug Gastal®. To prevent possible interaction of the drug Gastal® with other drugs, it is recommended to take it 1 hour before or 1 hour after their administration.

Special Instructions

The recommended doses and duration of treatment should not be exceeded when used in patients with impaired renal function. In young children, the use of magnesium hydroxide may lead to hypermagnesemia, especially if they have renal failure or dehydration. Influence on the ability to drive vehicles, mechanisms Use of the drug Gastal® has no effect on the ability to drive vehicles and operate other mechanisms.

Synopsis

Round white to cream-colored tablets with a smooth surface and bevel.

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. Caution In chronic renal failure (CKD), pregnancy and during breast-feeding, adults and children over 12 years of age with body weight less than 50 kg, children from 6 to 12 years of age, the elderly.

Side effects

Adverse reactions are categorized according to the World Health Organization (WHO) classification: very common (?1/10); common (?1/100, < 1/10); infrequent (?1/1000, < 1/100); rare (?1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined based on available data). Immune system disorders: very rare – allergic reactions. Metabolic and nutritional disorders: very rare – hypermagnesemia. Observed after prolonged use of magnesium hydroxide in patients with renal failure Gastrointestinal tract disorders: frequency unknown – abdominal pain; rarely – nausea, diarrhea, constipation.

Overdose

Symptoms of acute overdose are not described. With long-term use of high doses of drugs containing aluminum and magnesium, hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis and renal function disorders may develop. The development of more pronounced adverse reactions from the gastrointestinal tract (GIT) (constipation, diarrhea), in patients with renal failure – thirst, decreased blood pressure, hyporeflexia are possible. Treatment: symptomatic therapy.

Pregnancy use

Gastal® is not excreted with breast milk. When using during pregnancy and breastfeeding it is necessary to assess the ratio of benefits to mother and risks to fetus and infant. The drug should be used during pregnancy only if necessary and only on the doctor’s recommendation.