Maalox mini suspension in sachet 4.3 ml № 6 black currant

Composition

Oral suspension [with lemon flavor]:

One mini package contains:

active substances:

• active substances:
• allegrite (aluminum hydroxide) (in the form of hydrated aluminum oxide) - 460.0 mg (equivalent to 230.0 mg of aluminum oxide),
• Magnesium hydroxide - 400.0 mg;
• Excipients:
• sucrose solution 64% - 4913.0 mg,
• Sorbitol liquid (non-crystallizing) - 200.0 mg,
• xanthan gum - 2.4 mg,
• guar - 5.6 mg,
• natural lemon-lime flavor - 13.2 mg,
• sodium chloride - 4.8 mg.

Oral suspension [with black currant flavor]:

One mini package contains:

• active substances:
• allegrite (aluminum hydroxide) (in the form of hydrated aluminum oxide) - 460.0 mg (equivalent to 230.0 mg of aluminum oxide),
• magnesium hydroxide - 400.0 mg;
• Excipients:
• sucrose solution 64% - 4913.0 mg,
• Sorbitol liquid (non-crystallizing) - 200.0 mg,
• xanthan gum - 2.4 mg,
• guar - 5.6 mg,
• black currant flavoring - 13.2 mg,
• sodium chloride - 4.8 mg.

Description

White to pale yellow homogeneous suspension.

Pharmacotherapeutic group

Antacid.

Pharmacological properties

Pharmacodynamics

Maalox^® mini is an antacid that has no systemic effect. Its antacid capacity is 20 meq H⁺ on mini-package [definition in vitro by the method of Rosset-Rice (Rosset-Rice)].The drug neutralizes free hydrochloric acid without causing secondary hypersecretion of hydrochloric acid. In connection with the increase in pH when it is taken, the peptic activity of gastric juice decreases. It also has an adsorbing and enveloping effect, due to which the effect of damaging factors on the mucous membrane of the stomach and duodenum is reduced.

Maalox^® mini able to eliminate or alleviate heartburn for several hours. Due to the balance of its composition in relation to the influence on the motility of the gastrointestinal tract Maalox ^® mini does not usually cause constipation.

Magnesium hydroxide and algaldrat pass x-rays.

Pharmacokinetics

Magnesium and aluminum hydroxides are considered to be local antacids that are practically not absorbed when taken in recommended doses and, accordingly, do not have systemic effects.

Indications

• Heartburn, belching sour contents.

Contraindications

• Hypersensitivity to active substances and other components of the drug.
• Severe renal failure.
• Hypophosphatemia.
• Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sorbitol and sucrose in the formulation).
• Children and adolescents (up to 15 years).

Carefully

• Aluminum hydroxide can cause constipation, an overdose of magnesium salts can lead to a weakening of intestinal peristalsis; in high-risk patients (patients with renalinsufficiency, the elderly) taking high doses of the drug may cause or exacerbate bowel obstruction and intestinal obstruction.
• Aluminum hydroxide is poorly absorbed in the gastrointestinal tract, therefore, in patients with normal renal function, systemic exposure rarely occurs. Long-term treatment, the use of excessively high doses of the drug or the use of normal doses of the drug against the background of low intake of phosphates from food can lead to phosphate deficiency (due to aluminum binding to phosphate), which is accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Treatment of patients at risk of developing phosphate deficiency or long-term use of the drug should be carried out under medical supervision.
• In case of renal dysfunction (when taking Maalox® mini, plasma concentrations of magnesium and aluminum can be increased; and with long-term use of Maalox® mini in high doses, including high therapeutic doses, encephalopathy, dementia, microcytic anemia or aggravation are possible osteomalacia caused by dialysis).
• In patients with porphyria who are on hemodialysis.
• During pregnancy (see the section “Use during pregnancy and during breastfeeding”).
• With Alzheimer's disease.
• In case of diabetes mellitus (due to the content of sucrose in the preparation) (see section “Special Instructions”).

Use during pregnancy and during breastfeeding

Pregnancy

Animals have not received clear indications of the teratogenic effect of aluminum hydroxide and magnesium hydroxide. To date, no specific teratogenic effects have been identified with the use of the drug Maalox.^® mini during pregnancy, however, due to lack of clinical experience, its use during pregnancy is possible only in low doses and for a short time and in cases where the potential benefit of its use for the mother justifies the potential risk to the fetus.

Breastfeeding period

When used as recommended, absorption of combinations of aluminum hydroxide and magnesium salts in the mother is limited, so the drug Maalox^® The mini is found compatible with breastfeeding.

Dosage and administration

Adults and children over 15 years.

Contents 1-2 mini packs in 1-1.5 hours after a meal or when heartburn occurs. Before opening the mini-package, you should gently mix its contents, carefully kneading the package between your fingers. Squeeze the contents of the package in a spoon or mouth (take the suspension without prior dilution). If necessary, you can take an additional dose of the drug two hours after the previous dose. The maximum daily dose is 12 mini-packs.

The course of treatment should not exceed 2-3 months. For occasional use (for example, for discomfort after errors in the diet) - take 1-2 mini-package once.

In cases of mild renal insufficiency, the maximum daily dose is 8 mini-packets, and in case of moderate renal failure, the maximum daily dose is 6 mini-packets.

Side effect

If the recommended dosing regimen is observed, side effects are rare.

To indicate the frequency of undesirable 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).

Immune system disorders:

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

Violations of the gastrointestinal tract:

Infrequent: diarrhea, constipation.

Metabolism and nutrition disorders:

Unknown frequency: hypermagnesemia, hyperaluminemia, hypophosphatemia (with long-term treatment or taking high doses, or taking standard doses with low phosphate content in food), which can lead to increased bone resorption, hypercalciuria, osteomalacia.

Overdose

Symptoms

Symptoms of an 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 intestinal obstruction or intestinal obstruction (seesection "with caution").

Treatment

Aluminum and magnesium are excreted in the urine. Treatment of acute overdose is carried out with the help of filling up fluid loss and forced diuresis. Patients with renal failure must undergo hemodialysis or peritoneal dialysis.

Interaction with other drugs

• With quinidine

With simultaneous use with quinidine, it is possible to increase serum concentrations of quinidine and develop an overdose of quinidine.

• With H blockers₂histamine, propranol, atenolom , penicillamine, Rosuvastatin , iron salts, levothyroxine.

When taken simultaneously with the drug Maalox^® mini reduced absorption of the above drugs in the gastrointestinal tract. In the case of a 2-hour interval between taking these drugs and the drug Maalox^® mini and 4-hour interval between taking fluoroquinolones and the drug Maalox^® mini in most cases this undesirable interaction can be avoided.

• With polystyrenesulfonate (kayeksalat)

With the joint use of the drug Maalox^® mini with polystyrenesulfonate (kayeksalat) care should be taken because of the possible risk of reducing the effectiveness of potassium binding 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 combined with aluminum hydroxide and citrates, it is possible to increase the plasma concentrations of aluminum, especially in patients with renal insufficiency.

special instructions

If during treatment, symptoms of the gastrointestinal tract persist for more than 10 days or a worsening of the condition is observed, then the diagnosis should be clarified and therapeutic measures should be corrected.

Observe the 2-hour interval between use of the drug Maalox^® mini and other drugs and the 4-hour interval between taking the drug Maalox^® mini and fluoroquinolones (see "Interaction with other drugs").

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 and patients with mild to moderate renal insufficiency, it is recommended to consult a doctor.

Long-term administration of the drug Maalox should be avoided.^® mini with impaired renal function. When prescribing the drug Maalox^® mini patients with mild to moderate renal insufficiency needcarefully monitor plasma concentrations of aluminum and magnesium, and in case of their increase, the use of the drug should be immediately discontinued.

Algeldrat with a low phosphate content in food can lead to the development of phosphorus deficiency in the body. Therefore, in its application, especially long-term, it is necessary to ensure adequate intake of phosphates from food.

One mini-pack contains 3.15 g of sucrose and 0.2 g of sorbitol (respectively, the maximum daily dose contains 37.80 g of sucrose and 2.4 g of sorbitol).

Influence on ability to drive vehicles and work with mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Storage conditions

Store at a temperature not higher than 25 ºС.

Keep out of the reach of children.

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

Working conditions

Over the counter.