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Dosage form: & nbsplozenges
Composition:

1 tablet contains:

active substances: aluminum hydroxide-magnesium carbonate gel 450.0 mg, magnesium hydroxide 300.0 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.

Description:

Round tablets from white to cream color, with a smooth surface and bevel.

Pharmacotherapeutic group:Antacid agent
ATX: & nbsp
  • Antacids in combination with other drugs
  • Pharmacodynamics:

    The drug Gastal® is a combined antacid, which 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 prolonged (about 2 hours) neutralization of hydrochloric acid of gastric juice, maintaining acidity in the stomach at a physiological level (pH 3-5). One tablet of Gastal® neutralizes 21.5 mmol of hydrochloric acid.

    The drug Gastal® suppresses the action of pepsin, lysolecithin and bile acids, eliminates diarrheal phenomena. Strengthens protective and regenerative processes in the mucous membrane of the stomach.Aluminum ions have a cytoprotective effect due to increased secretion of mucin and sodium bicarbonate, activation of prostaglandin E2 and NO, the accumulation of epidermal growth factor at the site of damage to the mucous membrane, increasing the concentration of phospholipids in the walls of the stomach.

    Pharmacokinetics:

    The drug Gastal® does not have a systemic effect in patients with normal renal function.

    After interaction with hydrochloric acid of gastric juice of aluminum, the hydroxide reacts with phosphates and carbonates in the alkaline medium of the intestine and is released with feces in the form of insoluble salts.

    Magnesium hydroxide reacts with hydrochloric acid in the gastric juice to form magnesium chloride, which has osmotic properties and a mild laxative effect that neutralizes the fixing action of aluminum hydroxide in the small intestine. Magnesium ions are released with feces in the form of insoluble carbonate.

    Indications:

    - Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, acidic eructations after dietary errors, excessive consumption of ethanol, coffee, nicotine, etc .;

    - dyspepsia, such as discomfort or epigastric pain, heartburn, acidic eructations (and their prevention), resulting from the use of certain medications (nonsteroidal anti-inflammatory drugs, glucocorticosteroids, etc.);

    - conditions, accompanied by increased acid formation: gastric ulcer, gastritis, reflux esophagitis; hernia an esophageal aperture of a diaphragm.

    Contraindications:

    Hypersensitivity to salts of aluminum, magnesium or other components of the drug; severe renal insufficiency; Alzheimer's disease; hypophosphatemia; lactose intolerance, lactase deficiency or glucose-galactose malabsorption; children's age till 6 years.

    Carefully:

    In chronic renal failure (CRF), pregnancy and during breastfeeding, adults and children over 12 years of age with a body weight of less than 50 kg, a child of 6 to 12 years of age, and elderly.

    Pregnancy and lactation:

    The drug Gastal® is not excreted in breast milk. When used during pregnancy and during breastfeeding, it is necessary to assess the ratio of benefit to the mother and the risk to the fetus and infant.

    Dosing and Administration:

    Inside, gradually dissolving in the mouth.

    Adults and children over 12 years of age with a body weight of at least 50 kg

    1-2 tablets 4-6 times a day about 1 hour after meals and at bedtime, but not more than 8 tablets per day. Duration of reception no more than 2 weeks. Similar doses are recommended for the treatment of heartburn regardless of food intake.

    Adults and children over 12 years of age with a body weight of less than 50 kg, children aged 6 to 12 years

    The dose is half of the recommended dose for adults and children over 12 years of age with a body weight of at least 50 kg. Duration of reception no more than 2 weeks.

    Patients with CRF

    Correction of the dose is not required. Duration of reception no more than 2 weeks.

    Side effects:

    When using the drug at recommended doses, adverse reactions are rare (not less than 0.01%, but less than 0.1%): nausea, constipation, diarrhea, changes in taste.

    In exceptional cases, allergic reactions are possible.

    Overdose:

    Symptoms of acute overdose are not described.

    With prolonged use of high doses of preparations containing aluminum and magnesium, hypophosphatemia, hypocalcaemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminia, encephalopathy, nephrocalcinosis and renal dysfunction are possible.

    It is possible to develop more severe unwanted reactions from the gastrointestinal tract (gastrointestinal tract) (constipation, diarrhea), in patients with renal insufficiency - thirst, lowering blood pressure, hyporeflexia.

    Treatment: symptomatic therapy.

    Interaction:

    The drug Gastal® with simultaneous application increases the activity of levodopa and nalidixic acid, reduces and slows the absorption of quinolones, isoniazid, naproxen, iron preparations, indomethacin, aminazine, beta adrenoblockers, diflunisal, H blockers2-gistaminovyh receptors, fat-soluble vitamins, indirect anticoagulants, barbiturates.

    When interacting with the metal ions that make up the antacids, tetracyclines form insoluble chelate complexes; as a result of this interaction, the absorption of tetracyclines decreases by more than 90%. Simultaneous reception of these drugs is impossible. If necessary, combined use tetracycline should be taken at least 2 hours before taking the antacid.

    In the presence of aluminum and magnesium hydroxides contained in the antacid, the absorption of ciprofloxacin and ofloxacin decreases 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 the blood plasma.

    The simultaneous use of high doses of antacids can reduce the absorption of ranitidine by 10-33%.

    The use of antacids does not affect the bioavailability of amoxicillin, cephalexin and the combination of amoxicillin and clavulanic acid, but it can significantly reduce the absorption of doxycycline from the gastrointestinal tract.

    Increasing the pH of urine against antacid therapy may increase the tubular reabsorption of basic (alkaline) drugs and reduce the reabsorption of acidic compounds. Antacids can reduce and slow down the absorption of salicylates, including acetylsalicylic acid, and, by increasing the pH of urine, promote faster removal of salicylates with urine from the body, with a concomitant decrease in their serum concentration by 30-70%.

    Absorption of cardiac glycosides, including digoxin and digitoxin, with simultaneous use with antacids does not significantly decrease.

    M-holinoblokatory, slowing the motility of the stomach, increase the duration of the drug Gastal®.

    To prevent possible interaction between Gastal® and other medications, it is recommended to take it 1 hour before or 1 hour after use.

    Special instructions:

    Do not exceed the recommended dose and duration of treatment when used in patients with impaired renal function.

    Effect on the ability to drive transp. cf. and fur:

    The use of Gastal® does not affect the ability to drive vehicles and control other mechanisms.

    Form release / dosage:

    Lozenges.

    Packaging:

    For 6 tablets in a blister of PVC / aluminum foil.

    By 2, 4, 5, 8 or 10 blisters together with instructions for use in a cardboard box.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014448 / 01
    Date of registration:12.05.2011 / 12.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp15.03.2017
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