Maalox - instructions for use, dose, side effects, contraindications

active substances: magnesium hydroxide 400 mg; Algoldrate (in the form of aluminum hydrated oxide) - 400 mg (equivalent to 200 mg of aluminum oxide);

Excipients: starch with sucrose (sugar confectionery) - 192 mg, sorbitol - 125 mg, mannitol - 10 mg, magnesium stearate - 7.2 mg, peppermint flavor - 3.6 mg, sodium saccharinate - 3 mg, sucrose - 59.2 mg.

One chewable tablet [without sugar] contains:

active substances: magnesium hydroxide 400 mg; Algoldrate (in the form of aluminum hydrated oxide) - 400 mg (equivalent to 200 mg of aluminum oxide);

Excipients: sorbitol liquid (pecrystallized) - 157.00 mg (equivalent to 109.9 mg of sorbitol), maltitol - 632.62 mg, magnesium stearate - 16.36 mg, flavoring lemon (flavoring preparations, natural flavors, acacia gum E414, citric acid E330, butylhydroxyanisole E320) - 17.00 mg.sodium saccharinate - 1.90 mg, glycerol (85%) - 30.00 mg (equivalent to 25.5 mg of glycerol), talc - 32.72 mg.

Description:

Chewable tablets: Tablets of white color, round, flat-cylindrical forms with a facet and an engraving "Mх".

Tablets chewing [without sugar]: tablets from white to yellowish color with an insignificant marble, round, flat-cylindrical forms with a facet, with an engraving "MAALOX" on one side and "sans sucre" on the other, with the smell of lemon.

Pharmacotherapeutic group:Antacid agent

ATX: & nbsp

A.02.A.X Antacids in combination with other drugs

Pharmacodynamics:

The drug neutralizes free hydrochloric acid, without causing secondary hypersecretion of hydrochloric acid. In connection with the increase in pH during its intake, the peptic activity of gastric juice decreases. It also has an adsorbent and enveloping action, due to which the effect of damaging factors on the mucosa decreases.

Pharmacokinetics:

Magnesium and aluminum hydroxides 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 opening of the diaphragm, reflux esophagitis.

- Dyspeptic phenomena, such as discomfort or epigastric pain, heartburn, sour belch after errors in the diet, excessive consumption of ethanol, coffee, nicotine, etc.

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

Contraindications:

- Severe renal insufficiency.

- Hypersensitivity to active substances and other components of the drug.

- Hypophosphatemia.

- Intolerance to fructose (due to the presence of sorbitol in the formulation).

- Children and adolescence up to 15 years.

For chewing tablets:

- Syndrome of malabsorption of glucose-galactose, insufficiency of sucrose-isomaltase (due to the presence of sucrose in the formulation)

For tablets chewing [without sugar]:

- Intolerance to maltitol.

Carefully:

- With renal failure.

- Patients with porphyria who are on hemodialysis.

- In pregnancy (see the section "Application during pregnancy and during breastfeeding"),

- With Alzheimer's disease.

For tablets chewing

- With diabetes (due to the presence of sucrose in the formulation).

Pregnancy and lactation:

In animals, there is no clear indication of a teratogenic effect in aluminum hydroxide and magnesium hydroxide. To date, no specific teratogenic effects have been identified with Maalox® during pregnancy, however, due to the lack of clinical experience, its use during pregnancy is possible only if the potential benefit from its use for the mother justifies the potential risk to the fetus.

Avoid prescribing the drug during pregnancy in large doses and for a long time.

When used according to the recommendations, the absorption of aluminum combinations of hydroxide and magnesium salts in the mother is limited,so the preparation Maalox® is recognized as compatible with breastfeeding.

Dosing and Administration:

Tablets should be resorbed or thoroughly chewed.

Adults and adolescents over 15 years: 1-2 tablets 3-4 times a day 1-2 hours after meals and at night. When reflux-esophagitis the drug is taken a short time after eating. The maximum number of medications is 6 times a day. Do not take more than 12 tablets per day. The course of treatment should not exceed 2-3 months. With episodic use (for example, with discomfort after errors in the diet) - take 1 to 2 tablets once.

Side effects:

While observing the recommended dosing regimen, side effects are negligible.

To indicate the frequency of unwanted side effects, the following classification of the World Health Organization is used: - infrequent> 0.1% and <1%; - unknown frequency (according to the available data, it is not possible to estimate the frequency of occurrence).

Immune system disorders:

Unknown frequency: hypersensitivity reactions such as pruritus, urticaria, angioedema and anaphylactic reactions.

Disorders from the gastrointestinal tract:

Infrequent: diarrhea, constipation.

Metabolic and nutritional disorders:

Unknown frequency: hypermagnesia, hyperaluminia, hypophosphatemia (with long-term treatment or high doses, or when taking standard doses at low phosphate levels in food), which can lead to increased bone resorption, hypercalciuria, and osteomalacia.

Overdose:

Symptoms

Symptoms of acute overdose with a combination of aluminum hydroxide and magnesium salts include diarrhea, abdominal pain, and vomiting. In patients at risk, taking high doses of the drug may cause or aggravate bowel obstruction or intestinal obstruction (see the section "With caution").

Treatment

Aluminum and magnesium are excreted in the urine. Treatment of acute overdose is carried out by replenishing fluid loss and forced diuresis. Patients with renal failure need hemodialysis or peritoneal dialysis.

Interaction:

- With quinidine

With simultaneous application with quinidine, it is possible to increase the serum concentrations of quinidine and the development of an overdose of quinidine.

- With H blockers₂-histamine receptors, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol, chloroquine, prostacyclin, diflunisal, digoxin, bisphosphonates, ethambutol, isoniazid, fluoroquinolones, sodium fluoride, glucocorticosteroids (described for prednisolone and dexamethasone), indomethacin, ketoconazole, lincosamides, phenothiazine antipsychotics , penicillamine, rosuvastatin, iron salts, levothyroxine.

With simultaneous administration with the preparation Maalox®, the absorption of the above drugs in the gastrointestinal tract decreases.

In the case of a 2-hour interval between taking these preparations and the Maalox preparation and a 4-hour interval between taking fluoroquinolones and Maalox®, in most cases this undesired interaction can be avoided.

- With polystyrenesulphonate (cayexalate)

When using Maalox® together with polystyrene sulfonate (cayexalate), 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).

- With citrates

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

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 in the gastrointestinal tract, therefore in patients with normal renal function systemic exposure is rare. However, long-term treatment, the use of excessively high doses of the drug or the use of normal doses of the drug against a background of low intake of phosphates with a beggar 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 osteomalacia . Treatment of patients at risk of developing phosphate deficiency or prolonged use of the drug should be carried out under medical supervision.

With renal insufficiency, an increase in plasma concentrations of magnesium and aluminum is possible. In these patients with prolonged use of the drug in high doses, it is possible to develop encephalopathy, dementia, microcytic anemia or aggravation of osteomalacia caused by dialysis.

A two-hour interval should be observed between the use of Maalox® and other preparations and a four-hour interval between the administration of Maalox® and fluoroquinolones (see "Interaction with other medicine by other means ").

Avoid prolonged administration of Maalox® in renal failure.

Despite the fact that the drug is dispensed without a prescription, before applying the drug during pregnancy and lactation (breastfeeding), as well as in adolescents is recommended 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 using aluminum hydroxide, especially long-term, it is necessary to ensure sufficient supply of phosphates with food.

If the symptoms of the disease increase or persist for 10 days of treatment,should consult a doctor to determine the cause and possibly correction of treatment.

The drug is permeable to X-rays.

For chewing tablets:

Patients with diabetes should take into account the presence of sucrose in the formulation.

Form release / dosage:Tablets are chewable. Tablets are chewable [without sugar].

Packaging:Tablets, chewing. For 10 tablets in a blister of PVC / aluminum foil. For 1, 2 or 4 blisters together with instructions for use are placed in a cardboard box.

Chewable tablets [without sugar]. For 10 tablets in a blister of PVC / PVDC and aluminum foil. For 1, 2 or 4 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

For tablets chewing: 5 years. Do not use after the expiry date printed on the package.

For chewable tablets [without sugar]: 3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014986 / 01

Date of registration:15.12.2008 / 16.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France

Manufacturer: & nbsp

SANOFI-AVENTIS, S.p.A. Italy

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp21.03.2018

Illustrated instructions

Instructions

Maalox® (Maalox®)