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

Excipients: hydrochloric acid concentrated, citric acid monohydrate, peppermint mint oil, mannitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharinate, sorbitol (70%), hydrogen peroxide (30%), purified water.

Description:White, or almost white, milk-like liquid with the smell of mint.

Pharmacotherapeutic group:Antacid agent

ATX: & nbsp

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

Pharmacodynamics:Aluminum hydroxide and magnesium hydroxide neutralize the free hydrochloric acid of gastric juice without causing its secondary hypersecretion.In addition, an increase in the pH of the gastric juice when taking Maalox® results in a decrease in the activity of pepsin in 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. Because of low absorption, no systemic effect is provided.

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, acidic eructations after dietary errors, excessive consumption of ethanol, coffee, nicotine, etc.

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

Contraindications:

- Severe renal insufficiency.

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

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

- Children and adolescence up to 15 years.

- Hypophosphatemia.

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.

- In case of impaired renal function (when Maalox® is taken in such patients, plasma concentrations of magnesium and aluminum may be increased, and with prolonged use of Maalox® in high doses, including high therapeutic doses, it is possible to develop encephalopathy, dementia, microcytic anemia or worsening of osteomalacia caused by dialysis).

- Patients with porphyria on hemodialysis.

- When pregnant and breast-feeding (see the section "Application during pregnancy and during breast-feeding").

- With Alzheimer's disease.

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 Maalox® during pregnancy, but due to the lack of clinical experience of its use during pregnancy, it is only possible,if 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 Maalox® is recognized as compatible with breastfeeding.

Dosing and Administration:

The drug is intended for oral administration only by persons over 15 years of age.

Before use, the suspension in the bag should be homogenized, carefully stretching it between the fingers. The contents of the sachet are taken in an undissolved form.

Maalox® ingest one packet with a suspension (15 ml), usually 1-2 hours after meals and at night, as well as with epigastric pain or heartburn. The daily dose should not exceed 6 packets (90 ml of suspension per day). When reflux-esophagitis drug take 30-60 minutes after eating. With gastric ulcer, the drug is taken 30 minutes before meals.

The course of treatment should not exceed 2-3 months. With an episodic use of f (for example, with discomfort after errors in the diet) - take 15 ml once.

Patients with impaired renal function

Avoid using the drug in high doses and / or for a long time (see "With caution").

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, 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 blockers H₂histamine 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 neuroleptics , 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 Maalox® and a 4-hour interval between taking fluoroquinolones and Maalox®, this undesirable interaction can be avoided in most cases.

- 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:

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.

It should be observed a 2-hour interval between the use of Maalox® and other preparations and a 4-hour interval between admissionpreparation Maalox® and fluoroquinolones (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 administering Maalox® mini to patients with mild and moderate renal insufficiency, it is necessary to carefully monitor plasma concentrations of aluminum and magnesium, and in the case of their increase, the drug should be discontinued immediately. 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.

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 in bags (sachets), 15 ml.

Packaging:

15 ml of the drug are placed in sachets of paper / aluminum foil, laminated with polyethylene. For 30 bags (sachets), together with the instructions for use are placed 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:П N016126 / 01

Date of registration:04.03.2010 / 12.02.2018

Expiration Date:Unlimited

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

Manufacturer: & nbsp

PHARMATIS France

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp21.03.2018

Illustrated instructions

Instructions

Maalox® (Maalox®)