Maalox oral suspension, 250ml

• peptic ulcer of the stomach and duodenum in the acute phase;

• acute gastroduodenitis;

• chronic gastroduodenitis with normal or increased secretory function in the exacerbation phase;

• hernia of the esophageal opening of the diaphragm;

• reflux esophagitis;

• dyspeptic phenomena such as discomfort, gastralgia, heartburn, sour belching (after excessive consumption of ethanol, nicotine, coffee, medication / including NSAIDs, GCS /, diet errors).

Shake the bottle before use.

Assign 15 ml (1 tablespoon) 3-4 times a day 1-2 hours after meals and at night. The dose should not exceed 6 tablespoons per day.

With reflux esophagitis, the drug is taken shortly after a meal.

The course of treatment should not exceed 2-3 months.

With occasional use, for example, with discomfort after errors in the diet, take 15 ml once.

• Aluminum hydroxide (in the form of a gel) - 3.5 g, which corresponds to the content of aluminum oxide - 2.3 g

• Magnesium hydroxide (gel) 4 g

Excipients : hydrochloric acid 10% - 0.52815 g, citric acid monohydrate - 0.0655 g, peppermint leaf oil - 0.0126 g, mannitol - 0.25 g, domiphene bromide - 0.00422 g, sodium saccharinate - 0.028 g, sorbitol 70% - 1.429 g, hydrogen peroxide 30% - 0.065 g, purified water - up to 100 ml.

• severe renal failure;

• hypophosphatemia;

• intolerance to fructose;

• glucose-galactose malabsorption syndrome, sucrase / isomaltase deficiency (due to the presence of sucrose and sorbitol in the preparation) (for chewable tablets, for suspension in sachets, for suspension in vials);

• intolerance to maltitol (for sugar-free chewable tablets);

• children and adolescents up to 15 years old;

• hypersensitivity to active substances and other components of the drug.

The drug should be used with caution in patients with porphyria on hemodialysis; with Alzheimer's disease; during pregnancy; for chewable tablets - for diabetes mellitus (due to the presence of sucrose in the preparation).

Clinical and pharmacological group: Antacid drug

Pharmaco-therapeutic group: Antacid

pharmachologic effect

Antacid drug. Neutralizes free hydrochloric acid of gastric juice, without causing its secondary hypersecretion. In addition, an increase in the pH of gastric juice while taking MaaloxЃ leads to a decrease in the activity of pepsin in the gastric juice. The drug also has an absorbent and enveloping effect, due to which the effect of damaging factors on the mucous membrane of the esophagus and stomach is reduced.

Pharmacokinetics

Magnesium hydroxide and aluminum hydroxide are considered topical antacids, which are practically not absorbed when taken in recommended doses and, accordingly, do not have systemic effects.

Indications

• peptic ulcer of the stomach and duodenum in the acute phase;

• acute gastroduodenitis;

• chronic gastroduodenitis with normal or increased secretory function in the exacerbation phase;

• hernia of the esophageal opening of the diaphragm;

• reflux esophagitis;

• dyspeptic phenomena such as discomfort, gastralgia, heartburn, sour belching (after excessive consumption of ethanol, nicotine, coffee, medication / including NSAIDs, GCS /, diet errors).

Dosage regimen

Pills

The tablets should be sucked or chewed thoroughly.

Adults and adolescents over 15 years of age, the drug is prescribed 1-2 tablets. 3-4 times / day 1-2 hours after meals and at night.

With reflux esophagitis, the drug is taken shortly after a meal.

The maximum frequency of admission is 6 times / day. Do not take more than 12 tablets / day.

The duration of admission should not exceed 2-3 months.

With occasional use, for example, with discomfort after errors in the diet , take 1-2 tablets. once.

Suspension in sachets

Before use, the suspension in the sachet should be homogenized by carefully kneading it between the fingers. The contents of the sachet are taken undissolved.

MaaloxЃ is taken in 1 sachet with suspension (15 ml), usually 1-2 hours after meals and at night, as well as in case of epigastric pain or heartburn. The daily dose should not exceed 6 sachets (90 ml of suspension per day).

With reflux esophagitis, the drug is taken 30-60 minutes after eating.

In case of gastric ulcer, the drug is taken 30 minutes before a meal.

The course of treatment should not exceed 2-3 months.

With occasional use, for example, with discomfort after errors in the diet, take 15 ml once.

In patients with impaired renal function , the use of MaaloxЃ in the form of a suspension in a sachet in high doses and / or for a long time should be avoided.

Suspension in vials

Shake the bottle before use.

Assign 15 ml (1 tablespoon) 3-4 times a day 1-2 hours after meals and at night. The dose should not exceed 6 tablespoons per day.

With reflux esophagitis, the drug is taken shortly after a meal.

The course of treatment should not exceed 2-3 months.

With occasional use, for example, with discomfort after errors in the diet, take 15 ml once.

Side effect

Subject to the recommended dosage regimen, side effects are insignificant (rare).

Determination of the frequency of undesirable effects (according to the WHO classification): infrequently (? 0.1% and <1%); the frequency is unknown (according to the available data, it is not possible to estimate the frequency of occurrence).

From the immune system: the frequency is unknown - hypersensitivity reactions, anaphylactic reactions.

Allergic reactions: frequency unknown - itching, urticaria, angioedema.

From the gastrointestinal tract: infrequently - diarrhea, constipation.

From the side of metabolism: the frequency is unknown - hypermagnesemia, hyperaluminaemia, hypophosphatemia (with prolonged treatment or taken in high doses, or when taken in standard doses with a low phosphate content in food), which can lead to increased bone resorption, hypercalciuria, osteomalacia.

Contraindications for use

• severe renal failure;

• hypophosphatemia;

• intolerance to fructose;

• glucose-galactose malabsorption syndrome, sucrase / isomaltase deficiency (due to the presence of sucrose and sorbitol in the preparation) (for chewable tablets, for suspension in sachets, for suspension in vials);

• intolerance to maltitol (for sugar-free chewable tablets);

• children and adolescents up to 15 years old;

• hypersensitivity to active substances and other components of the drug.

The drug should be used with caution in patients with porphyria on hemodialysis; with Alzheimer's disease; during pregnancy; for chewable tablets - for diabetes mellitus (due to the presence of sucrose in the preparation).

Application during pregnancy and lactation

To date, no specific teratogenic effects have been identified when using the drug MaaloxЃ during pregnancy, however, due to the lack of clinical experience of its use during pregnancy, prescribing is possible only if the potential benefit of therapy to the mother justifies the potential risk to the fetus.

When using the drug in accordance with the dosing regimen, the absorption of combinations of aluminum hydroxide and magnesium salts in the mother's body is limited, therefore MaaloxЃ is recognized as compatible with breastfeeding.

In preclinical studies in animals, no clear indications of the presence of a teratogenic effect in aluminum hydroxide and magnesium hydroxide have been obtained.

Application for impaired renal function

Contraindicated in severe renal failure.

Application in children

Contraindicated for use in children and adolescents under the age of 15 years.

Use in elderly patients

In elderly patients, the use of the drug in high doses can cause or aggravate intestinal obstruction and intestinal obstruction.

special instructions

Aluminum hydroxide can cause constipation, an overdose of magnesium salts can lead to a weakening of intestinal motility; in high-risk patients (patients with renal insufficiency, the elderly), taking high doses of the drug can cause or aggravate intestinal obstruction and intestinal obstruction.

Aluminum hydroxide is poorly absorbed from the gastrointestinal 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 at usual doses against the background of a decrease in the intake of phosphate from food can lead to phosphate deficiency (due to the binding of aluminum to phosphate), which is accompanied by increased bone resorption and hypercalciuria with the risk of developing osteomalacia. Treatment of patients at risk of developing phosphate deficiency or long-term use of the drug should be carried out under medical supervision.

With renal failure, an increase in plasma concentrations of magnesium and aluminum is possible. With long-term use of MaaloxЃ in high doses, these patients may develop encephalopathy, dementia, microcytic anemia, or aggravated osteomalacia caused by dialysis.

If, during treatment, symptoms from the gastrointestinal tract persist for more than 10 days or there is a deterioration in the condition, then the diagnosis should be clarified and the treatment should be corrected.

The 2-hour interval between the use of MaaloxЃ and other drugs and the 4-hour interval between the administration of MaaloxЃ and fluoroquinolones should be observed (see the section on Drug Interactions).

Long-term use of MaaloxЃ should be avoided in case of renal failure. When prescribing MaaloxЃ to patients with mild and moderate renal insufficiency, it is necessary to carefully monitor the plasma concentrations of aluminum and magnesium, and if they increase, the drug should be discontinued immediately.

Despite the fact that the drug is dispensed without a prescription, it is recommended to consult a doctor before using the drug during pregnancy and lactation (breastfeeding), as well as in adolescents.

Aluminum hydroxide with a low phosphate content in food can lead to the development of phosphorus deficiency in the body. Therefore, when using it, especially for a long time, you should ensure a sufficient intake of phosphates from food.

The drug is permeable to X-rays.

When using the drug in patients with diabetes mellitus, the presence of sucrose in the composition of MaaloxЃ chewable tablets should be taken into account.

Influence on the ability to drive vehicles and use mechanisms

The drug in the form of a suspension in sachets does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Symptoms: Possible diarrhea, abdominal pain and vomiting. In patients at risk, taking high doses of the drug may cause or worsen bowel obstruction or intestinal obstruction.

Treatment: aluminum and magnesium are excreted in the urine. Replenishment of fluid loss and forced diuresis are performed. Patients with renal failure require hemodialysis or peritoneal dialysis.

Drug interactions

With simultaneous use with quinidine, an increase in serum concentrations of quinidine and the development of an overdose of quinidine are possible.

When taken simultaneously with MaaloxЃ, the absorption of the following drugs from the gastrointestinal tract decreases: histamine H2-receptor blockers, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclins, diflunisal, digoxin, bisphosphonates, ethazidonovol GCS (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, neuroleptics derivatives of phenothiazine, penicillamine, rosuvastatin, iron salts, levothyroxine. In the case of a 2-hour interval between taking these drugs and MaaloxЃ and a 4-hour interval between taking fluoroquinolones and MaaloxЃ, in most cases this unwanted interaction can be avoided.

When using the drug MaaloxЃ together with polystyrene sulfonate (kayexalate) , care should be taken because of the possible risk of a decrease in the efficiency of potassium binding by resin and the development of metabolic alkalosis in patients with renal failure (for aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (for aluminum hydroxide).

When aluminum hydroxide is combined with citrates, an increase in plasma concentrations of aluminum is possible, especially in patients with renal insufficiency.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C. Do not freeze (for suspension in a vial).

Shelf life

Shelf life for chewable tablets is 5 years, for chewable tablets (sugar-free) - 3 years; for suspension - 3 years. The shelf life of the suspension after the first opening of the bottle is 6 months.

Do not use the drug after the expiry date indicated on the package.

Terms of sale

The drug is dispensed without a prescription.