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

active substances: Algebra (Aluminum hydroxide) (in the form of aluminum hydrated 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.

Suspension for oral administration [with taste of black currant]:

One mini-package contains:

active substances: Algebra (Aluminum hydroxide) (in the form of aluminum hydrated 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, flavor of blackcurrant - 13.2 mg, sodium chloride - 4 , 8 mg.

Description:Homogenous suspension from white to pale yellow.

Pharmacotherapeutic group:Antacid agent

ATX: & nbsp

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

Pharmacodynamics:

Maalox® mini is an antacid that does not have systemic effects. Its antacid capacity is 20 meq H⁺ on a 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 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 mucous membrane of the stomach and duodenum decreases.

Maalox® mini is able to eliminate or relieve heartburn for several hours. Due to the balance of its composition with respect to the effect on gastrointestinal motility, the Maalox® mini usually does not cause constipation.

Magnesium hydroxide and algebra X-rays are missed.

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:

Heartburn, belching with acidic contents.

Contraindications:

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

- Severe renal insufficiency.

- Hypophosphatemia.

- Saccharide deficiency / isomaltase, fructose intolerance, glucose-galactose malabsorption (due to the presence of sorbitol and sucrose in the formulation).

- Children and adolescence (up to 15 years).

Carefully:

- 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.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 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 osteomalacia. Treatment of patients at risk of developing phosphate deficiency or prolonged use of the drug should be carried out under medical supervision.

- If the kidney function is impaired (with the Maalox® mini preparation, an increase in plasma concentrations of magnesium and aluminum is possible, and with prolonged use of Maalox® mini preparation in high doses, including high therapeutic doses, it is possible to develop encephalopathy, dementia, microcytic anemia or aggravation of osteomalacia caused by dialysis).

- Patients with porphyria on hemodialysis.

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

- With Alzheimer's disease

- With diabetes (in connection with the content of the preparation of sucrose) (see section "Special instructions").

Pregnancy and lactation:

Pregnancy

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 the use of Maalox® mini during pregnancy, however, due to the 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 from its use for the mother justifies the potential risk to the fetus.

Breastfeeding period

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® mini is recognized as compatible with breastfeeding.

Dosing and Administration:

Adults and children over 15 years.

The contents of 1-2 mini-packages after 1-1.5 hours after a meal or when heartburn occurs. Before opening the mini-package, you should carefully mix its contents, carefully stretching the bag between the fingers. Package contents squeezed into a spoon or into the mouth (take the suspension without first diluting).If necessary, you can take an additional dose of the drug two hours after the previous reception. The maximum daily dose is 12 mini-packs.

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

With renal insufficiency of mild severity the maximum daily dose is 8 mini-packets, with a moderate level of renal insufficiency the maximum daily dose is 6 mini-packs.

Side effects:

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

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).

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, 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 blockers H₂-gistamine receptors, propranolol, atenolol, cefdinir, cefpodoxime, metoprolol,chloroquine, prostacyclin diflunisalom, 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® mini, the absorption of the above drugs in the gastrointestinal tract is reduced. In the case of a 2-hour interval between the administration of these drugs and the Maalox® mini preparation and the 4-hour interval between the administration of fluoroquinolones and the Maalox® mini preparation, this undesirable interaction can in most cases be avoided.

- With polystyrenesulphonate (cayexalate)

When using Maalox® mini with polystyrenesulphonate (cayexalate) together, care should be taken because of the possible risk of decreased potassium binding potency 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:

If, during treatment, symptoms from the gastrointestinal tract persist for more than 10 days or if the condition worsens, then the diagnosis should be clarified and correction of treatment measures should be carried out.

A 2-hour interval between the use of Maalox® mini preparation and other drugs and a 4-hour interval between taking Maalox® mini and fluoroquinolones should be observed (see "Interaction with other drugs").

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 and patients with mild and moderate renal insufficiency.

Avoid prolonged administration of Maalox® mini for renal dysfunction. When prescribing Maalox® mini preparation for patients with mild to moderate renal insufficiency, it is necessary to carefully monitor plasma concentrations of aluminum and magnesium,and in case of their increase the use of the drug should be immediately stopped: Algeldrat 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.

One mini-package 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).

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Suspension for oral administration [with a taste of lemon], suspension for oral administration [with the taste of black currant].

Packaging:

4.3 ml (6 g) of the suspension in a mini-bag (sachets) of aluminum foil coated with polypropylene / polyethylene terephthalate and polyethylene.

For 6, 10, 20, 30 or 40 mini-bags (sachets) with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:LSR-009034/10

Date of registration:31.08.2010 / 17.01.2018

Expiration Date:Unlimited

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

Manufacturer: & nbsp

SANOFI-AVENTIS, S.p.A. Italy

A.NATTERMANN and Cie., GmbH Germany

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp21.03.2018

Illustrated instructions

Instructions

Maalox® mini (Maalox® mini)