Composition, form of production and packaging
? Tablets chewing white, round, flat-cylindrical, with a facet and an engraving "Mx".
1 tab.
algoldrate (in the form of aluminum hydrated oxide) 400 mg,
which corresponds to an aluminum oxide content of 200 mg
magnesium hydroxide 400 mg
Auxiliary substances: starch with sucrose (sugar confectionery) - 192 mg, sorbitol - 125 mg, mannitol - 10 mg, magnesium stearate - 7.2 mg, flavor of peppermint - 3.6 mg, sodium saccharinate - 3 mg, sucrose - 59.2 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (4) - packs of cardboard.
? Tablets are chewable (without sugar) from white to yellowish color with insignificant marble, round, flat-cylindrical, with a facet, with engraving "MAALOX" on one side and "sans sucre" on the other, with the smell of lemon.
1 tab.
algoldrate (in the form of aluminum hydrated oxide) 400 mg,
which corresponds to an aluminum oxide content of 200 mg
magnesium hydroxide 400 mg
Auxiliary substances: sorbitol liquid (non-crystallizing) - 157 mg (equivalent to 109.9 mg of sorbitol), maltitol - 632.62 mg, magnesium stearate - 16.36 mg, flavoring lemon (flavorings, natural flavors, acacia gum (E414), citric acid (E330) , butyl hydroxy anisole (E320)) 17 mg, sodium saccharinate 1.9 mg, glycerol 85% 30 mg (equivalent to 25.5 mg glycerol), talc 32.72 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antacid preparation. Neutralizes free hydrochloric acid of gastric juice without causing its secondary hypersecretion. In connection with the increase in the pH of gastric juice with the preparation Maalox В® peptic activity decreases gastric juice. The drug also has an adsorbent and enveloping action, due to which the effect of damaging factors on the mucous membrane of the esophagus and stomach decreases.
PHARMACOKINETICS
Magnesium hydroxide and aluminum hydroxide are considered local action antacids, which are practically not absorbed when taken in recommended doses and, accordingly, do not have systemic effects.
INDICATIONS
- Stomach ulcer and duodenal ulcer in the phase of exacerbation;
- Acute gastroduodenitis;
- chronic gastroduodenitis with normal or increased secretory function in the exacerbation phase;
- hernia of the esophageal aperture of the diaphragm;
- reflux esophagitis;
- Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, acidic eructation after errors in the diet, excessive consumption of ethanol, coffee, nicotine, etc .;
- Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, acidic eructation (and their prevention), resulting from the use of certain medicines (including NSAIDs, GCS).
DOSING MODE
Tablets should be resorbed or thoroughly chewed.
Adults and adolescents over 15 years of age, the drug is prescribed for 1-2 tablets. 3-4 times / day 1-2 hours after meals and at night.
When reflux-esophagitis the drug is taken after a short time after eating.
The maximum frequency of reception is 6 times / day. Do not take more than 12 tablets / day.
Duration of reception should not exceed 2-3 months.
With occasional use, for example, with discomfort after errors in the diet , take 1-2 tables. once.
SIDE EFFECT
While observing the recommended dosing regimen, side effects are negligible.
Definition of the frequency of adverse effects (according to the WHO classification): infrequently (≤ 0.1% and <1%); the frequency is unknown (it is not possible to estimate the incidence from the available data).
On the part of the immune system: the frequency is unknown - hypersensitivity reactions, anaphylactic reactions.
Allergic reactions: the frequency is unknown - itching, hives, angioedema.
From the digestive system: infrequently - diarrhea, constipation.
From the side of metabolism: frequency is unknown - hypermagnesia, hyperaluminia, hypophosphatemia (with long-term treatment or intake in high doses, or when taken in standard doses at low phosphate levels in food), which can lead to increased bone resorption, hypercalciuria, osteomalacia.
CONTRAINDICATIONS
- severe renal failure;
- hypersensitivity to active substances and other components of the drug;
- hypophosphatemia;
- intolerance to fructose (due to the presence of sorbitol in the formulation);
- glucose-galactose malabsorption syndrome, sugarase / isomaltase insufficiency, (due to the presence of sucrose in the formulation) (for chewing tablets);
- intolerance to maltitol (for tablets chewing (without sugar));
- Children and adolescence up to 15 years.
With caution should be used in patients with porphyria, who are on hemodialysis; Alzheimer's disease; during pregnancy; for chewing tablets - for diabetes mellitus (due to the presence of sucrose in the formulation).
PREGNANCY AND LACTATION
To date, no specific teratogenic effects have been identified with the use of Maalox В® during pregnancy, however, due to the lack of clinical experience of its use in pregnancy, appointment is possible only if the potential benefit of therapy for the mother justifies the potential risk to the fetus.
When using the drug in accordance with the dosing regimen, the absorption of aluminum hydroxide and magnesium salts in the mother's body is limited, so MaaloxВ® is recognized as compatible with breastfeeding.
In pre-clinical studies in animals, there is no clear indication of a teratogenic effect in aluminum hydroxide and magnesium hydroxide.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe impairment of kidney function.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under the age of 15 years.
APPLICATION IN ELDERLY PATIENTS
In the elderly, there may be an exacerbation of diseases of the musculoskeletal system, Alzheimer's disease.
SPECIAL INSTRUCTIONS
Aluminum hydroxide can cause constipation, an overdose of magnesium salts can lead to a weakening of intestinal peristalsis; in patients from the high-risk group (patients with renal insufficiency, elderly people), taking high doses of the drug may cause or aggravate bowel obstruction and intestinal obstruction.
Aluminum hydroxide is poorly absorbed from the digestive tract, therefore in patients with normal renal function systemic exposure is rare. However, long-term treatment, the use of the drug in excessively high doses, or the use of the drug in usual doses against the background of a decrease in the intake of phosphates with food, can lead to phosphate deficiency (due to binding of aluminum to phosphate), which is accompanied by increased bone resorption and hypercalciuria with a risk of developing osteomalacia. Treatment of patients at risk of developing phosphate deficiency or prolonged use of the drug should be performed under medical supervision.
If there is a violation of renal failure, an increase in plasma concentrations of magnesium and aluminum is possible. In these patients with prolonged use of Maalox В®in high doses, it is possible to develop encephalopathy, dementia, microcytic anemia or aggravation of osteomalacia caused by dialysis.
If, during treatment, GI symptoms persist for more than 10 days or if the condition worsens, the diagnosis should be clarified and treatment adjusted.
A 2-hour interval between use of Maalox В® and other preparations should be observed.
Avoid prolonged use of Maalox В® in renal failure.
Despite the fact that the drug is dispensed without a prescription, before using the drug during pregnancy and lactation (breastfeeding), as well as in adolescents, it is recommended to consult a doctor.
Aluminum hydroxide with a low phosphate content in food can lead to the development of phosphorus deficiency in the body. Therefore, when it is used, especially long-term, it is necessary to ensure sufficient supply of phosphates with food.
The drug is permeable to X-rays.
When using the drug in patients with diabetes mellitus, the presence of sucrose in the tablets of chewable preparations Maalox В® should be taken into account.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and work with mechanisms.
OVERDOSE
Symptoms: diarrhea, abdominal pain and vomiting are possible. In patients at risk of taking the drug in high doses can cause or aggravate bowel obstruction or intestinal obstruction.
Treatment: aluminum and magnesium are excreted in the urine. A loss of fluid and forced diuresis are performed. Patients with renal failure need hemodialysis or peritoneal dialysis.
DRUG INTERACTION
With simultaneous application with quinidine, it is possible to increase the serum concentrations of quinidine and the development of an overdose of quinidine.
With the simultaneous administration of Maalox В®, the absorption of the following drugs is reduced: the blockers of histamine H 2 receptors, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclin, diflunizal, digoxin, bisphosphonates, ethambutol, isoniazid, fluoroquinolones, sodium fluoride , GCS (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, neuroleptics derivatives of phenothiazine, penicillamine, rosuvastatin, iron salts, levothyroxine sodium. In the case of a 2-hour interval between the administration of these preparations and the MaaloxВ® preparation and the 4-hour interval between administration of fluoroquinolones and MaaloxВ® preparation, this undesirable interaction can in most cases be avoided.
When using Maalox В® with polystyrene sulfonate (cayexalate) together , care should be taken because of the possible risk of decreased potassium binding by tar and the development of metabolic alkalosis in patients with renal insufficiency (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide).
When aluminum hydroxide is combined with citrates, it is possible to increase plasma concentrations of aluminum, especially in patients with renal insufficiency.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life of the chewing tablets is 5 years, for chewing tablets (without sugar) - 3 years.
