Gastal tablets №6×10

NameGastal tabl in a blister. in pack. No. 6×10 Manufacturer Teva Operation Poland Sr.z.o.o. Plant manufacturerTeva Operation Poland Sr.z.o.o., st. Mogilska 80, 31-546 Krakow, Poland. Country of originPoland Main active ingredientHydrotalcite+magnesium hydroxide Release formPills of white or almost white color, round shape with even and smooth surface and bevelled edges. 6 tablets in a blister. 2, 4, 5, 8, 10 blisters in a cardboard box along with instructions for use. Release of the drug Without a prescription Pharmacological action Pharmacodynamics The drug neutralizes free hydrochloric acid, which leads to a decrease in the peptic activity of gastric juice. Aluminum hydroxide, helping to slow down intestinal motility, balances the laxative effect of magnesium hydroxide. Pharmacokinetics Orally administered aluminum hydroxide and magnesium hydroxide react with hydrochloric acid in the stomach to form salts that are only partially absorbed. Excretion of absorbed salts occurs mainly in the urine. Preclinical Safety Data Animal data have not found any hazard to humans based on conventional studies of pharmacology, safety, repeated dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity. Indications for use Antacid therapy for heartburn and gastroesophageal reflux in patients over 15 years of age. Use during pregnancy and lactation Pregnancy There are no reliable data on teratogenic effects in animals. To date, in clinical practice, there is no evidence of the development of birth defects and fetotoxic effects. On the other hand, the possibility of monitoring pregnancies during which the use of the drug has taken place is too limited to exclude the possibility of a risk. Thus, for safety reasons, the use of the drug during pregnancy is possible only if the potential benefit from its use for the mother justifies the potential risk to the fetus. Breast-feeding During treatment, breast-feeding can be continued, since when used as recommended, the absorption of combinations of aluminum hydroxide and magnesium salts in the mother is limited. PrecautionsDuration of treatment without consulting a doctor should not exceed 10 days. If symptoms persist after 10 days of treatment or the condition worsens, the cause should be determined and treatment reviewed. Aluminum hydroxide can cause constipation, an overdose of magnesium salts can lead to intestinal hypokinesia; taking high doses of the drug may cause or aggravate intestinal obstruction in patients with an increased risk of such complications, i.e. in patients with renal insufficiency, with persistent constipation, in children under 2 years of age or in the elderly. Aluminum hydroxide is poorly absorbed from the gastrointestinal tract, so systemic effects are rarely observed in patients with normal renal function. However, high doses or long-term use of the drug, as well as the use of recommended doses in patients with a low phosphorus content in the diet or in children under 2 years of age, can lead to a phosphate deficiency (due to the ability of aluminum to bind phosphate ions), accompanied by increased bone resorption, hypercalciuria and the risk of osteomalacia. In this regard, it is recommended to consult a doctor in case of long-term use of the drug, as well as in case of a risk of phosphate deficiency. In the case of patients with renal insufficiency or those on chronic dialysis, it is necessary to take into account the content of aluminum and magnesium in the preparation. With prolonged use at high doses, including high therapeutic doses, encephalopathy, dementia, microcytic anemia, or worsening of dialysis-induced osteomalacia may develop. Patients with mild to moderate renal insufficiency are advised to take the drug under the direct supervision of a physician. Long-term administration of the drug in case of impaired renal function should be avoided. Aluminum hydroxide may not be safe for porphyria patients on hemodialysis. Interactions with other drugs Antacids interact with some other oral medications. Since aluminum and magnesium salts reduce the gastrointestinal absorption of tetracycline, it is recommended to avoid use during oral tetracycline therapy. Combinations requiring precautionary measures With quinidine With simultaneous use with quinidine, an increase in serum concentrations of quinidine and the development of an overdose of quinidine are possible. In the case of simultaneous oral administration, Gastal may reduce the absorption of various drugs. Therefore, as a precautionary measure, the following drugs are recommended to be taken 2 hours before or 2 hours after taking Gastal: H2-antihistamines, ethambutol, isoniazid (oral), atenolol, metoprolol, propranolol, cefdinir, cefpodoxin, chlorochip, cyclins, tetracyclines , diflunisal, digoxin, diphosphonates, iron salts, fluoroquinolones, sodium fluoride, glucocorticosteroids (prednisolone and decaamethasone), indomethacin, ketoconazole, levothyroxine, lincosamides, phenothiazine neuroleptics, penicillamine, rosuvastatin. With polysulfonates (kayexalates) Caution should be exercised when co-administering the drug with polystyrene sulfonates (kyexalates) due to the possible risk of reducing the efficiency of potassium binding by the resin and the development of metabolic alkalosis in patients with renal insufficiency (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide). With citrates When combining aluminum hydroxide with citrates, an increase in plasma concentrations of aluminum is possible, which can lead to hyperaluminemia, especially in patients with renal insufficiency. When taken simultaneously with Gastal, the absorption of the above drugs in the gastrointestinal tract is reduced. In the case of a 2-hour interval between taking these drugs and Gastal tablets (and a 4-hour interval between taking fluoroquinolones and Gastal tablets), in most cases this undesirable interaction can be avoided. Contraindications Hypersensitivity to the components of the drug Severe renal failure (because the drug contains magnesium) Age up to 15 years Porfiria Cachexia. Special instructions A 2-hour interval between the use of Gastal and other drugs should be observed. The patient should consult a doctor for advice in case of: weight loss; difficulty in swallowing and prolonged discomfort in the abdomen; indigestion that appeared for the first time, changes in existing digestive disorders; renal failure. Gastal contains mannitol and lactose. The drug is contraindicated in fructose intolerance, glucose or galactose malabsorption syndrome, or sucrase-isomaltase deficiency, and should be used with caution in diabetic patients due to the presence of sorbitol and sucrose in the composition. Composition 1 tablet contains the active substance: 450 mg of aluminum hydroxide – magnesium carbonate gel and 300 mg of magnesium hydroxide (95.26 mg A13 + and 141.11 mg Mg2 +) and excipients: mannitol, sorbitol, lactose, corn starch, sodium cyclamate, saccharin- sodium, talc, magnesium stearate, mint flavor. Dosage and administration The drug is intended for use only in patients over 15 years of age! Gastal is intended for oral administration. The tablet should be gradually dissolved (not swallowed whole), which makes it possible to get a quick effect from taking the drug and makes it more effective. Take 1-2 tablets no more than 6 times a day (no more than 12 tablets in 24 hours), approximately 1 hour after meals and in the evening before bedtime (another dosing regimen may be prescribed on the recommendation of a doctor!). With occasional use (for example, with discomfort after errors in the diet) – take 1-2 tablets once. Overdose Overdose of aluminum salts can more easily develop in patients with severe renal insufficiency with the following symptoms: encephalopathy, convulsions, dementia and hypermagnesemia. Symptoms of an acute overdose of aluminum hydroxide and magnesium hydroxide combination most commonly include diarrhea, abdominal pain, and vomiting. In patients at risk, taking high doses of the drug may cause or exacerbate intestinal obstruction or intestinal obstruction. As in all cases of overdose treatment, treatment should be symptomatic and general supportive measures should be taken. Aluminum and magnesium are excreted in the urine. Acute overdose is treated with fluid replacement (rehydration) and forced diuresis. Patients with renal insufficiency require hemodialysis or peritoneal dialysis. Side effects Side effects observed with the use of the drug are classified according to the frequency of their occurrence: very often? 10% often ? 1 and <10%, infrequently? 0.1 and <1%, rarely? 0.01 and < 0.1%, very rarely < 0.01%, frequency not known (frequency cannot be estimated from the available data). Immune system disorders Not known: hypersensitivity reactions such as pruritus, urticaria, Quincke's edema, anaphylactic reactions. Gastrointestinal disorders Uncommon: diarrhea, constipation. Metabolic and nutritional disorders Not known: hypermagnesemia, hyperaluminemia, hypophosphatemia, may develop after long-term use or high doses, or use at recommended doses in patients whose diet is characterized by a low phosphorus content or in children under two years of age, which may lead to to increased bone resorption processes and the occurrence of hypercalciuria with an increased risk of osteomalacia. Storage conditions Store in a place protected from moisture at a temperature not exceeding 25 ° C. Keep out of the reach of children! Expiry date from date of manufacture Expiry date 3 years. Do not use the drug after the expiration date. Buy Gastal tablets No. 6x10 Price for Gastal tablets No. 6x10 Instructions for use for Gastal tablets No. 6x10