The instruction for medical use of MAALOKS® medicine the Trade name of Maaloks® the International non-proprietary name Is not present the Dosage form Suspension for intake, 15 ml Structure 1 bag contain active agents: magnesium of hydroxide of 12% of gel of 5.00 g (it is equivalent magnesium to hydroxide of 0.600 g) aluminum of hydroxide of 6% of gel of 5.75 g (it is equivalent aluminum to hydroxide of 0.525 g), excipients: Acidum hydrochloricum the concentrated, citric acid monohydrate, peppermint oil, a mannitol, methyl-parahydroxybenzoate, propilparagidroksibenzoat, sodium saccharinate, sorbitol of 70% solution (uncrystallizable), hydrogen peroxide of 30%, water the Suspension of milky-white color purified the Description, with sweet taste and a smell of mint Pharmacotherapeutic group Drugs for treatment of the diseases connected with disturbance of acidity. Combination of drugs of aluminum, calcium and magnesium. Simple combination of salts. The ATX A02AD01 code the Pharmacological Aluminium Pharmacokinetics properties hydroxide and magnesium hydroxide is badly soaked up in a GIT. The insignificant amount of soluble salts of aluminum is soaked up in digestive tract, then removed with urine. Absobirovanny magnesium in intestines is also removed with urine. The pharmacodynamics Drug neutralizes free hydrochloric acid that leads to reduction of activity of gastric juice. Does not cause secondary hypersecretion. Also has the adsorbing and enveloping effect, reducing influence of disturbing factors on a mucous membrane. Indications - heartburn and an acid eructation at adults and children are more senior than 15 years the Route of administration and doses Children from 15-year age and adults: on 1 bag (15 ml) in heartburn and an acid eructation, no more than 6 bags a day. Duration of a course of treatment is 10 days. It is careful to mix bag contents before its opening. To drink suspension, without dissolving. At preservation of symptoms within 10 days against the background of treatment by Maaloks or at aggravation of symptoms, it is necessary to find out the reason and to reconsider therapy. Side effects - disturbances of motility of digestive tract (diarrhea or a constipation) - exhaustion of reserves of phosphorus in case of long or in high doses of administration of drug as it contains aluminum. Contraindications - hypersensitivity to active agents or to any of fillers. - a heavy renal failure (clearance of creatinine & lt, 30 ml/min. / 1.73 sq.m) as drug contains magnesium. Medicinal interactions At simultaneous use with other medicines the decrease in gastrointestinal absorption of the last is observed. Due to the above, the interval between reception of antacids and other drugs is necessary. As far as possible, the interval has to make more than 2 hours between reception of Maaloksa® and acetylsalicylic acid, blockers of H2-histamine receptors, atenolol, biphosphonates, cation exchanger of sodium sulphonate, chloroquine, tsiklin, cardiac glycosides, Ethambutolum, a feksofenadin, iron preparations, fluorine, ftorkhinolon, glucocorticoids, excepting replacement therapy by a hydrocortisone (it is described for Prednisolonum and dexamethasone), thyroid hormones, indometacin, an isoniazid, ketokonazol (reduced gastrointestinal absorption of a ketokonazol because of raised gastric rn), a lansoprazola, linkozamid, a metoprolol, fenotiazinovy neuroleptics, drugs of phosphorus, propranolol, Sulpiridum. Joint reception with citrates (ulipristat) combinations which need to be taken into account At patients with a renal failure can cause increase in level of aluminum in blood plasma. The therapeutic effect of an ulipristal can be weakened in connection with the lowered gastrointestinal absorption. Special instructions Patients need to see immediately a doctor at: - decrease in body weight - emergence of difficulties when swallowing or enduring sensation of discomfort in a stomach, - appearance of the new digestive disturbances or change which were earlier existing - a renal failure. Precautionary measures at use It is necessary to take into account the content of salts of aluminum and magnesium in drug at treatment of patients with a renal failure or being on dialysis. Long intake of these substances in high doses can lead ment of encephalopathy, dementia, microcytic anemia or can worsen the osteomalacy caused by dialysis. Intake of aluminum hydroxide can be dangerous to the patients with a porphyria who are on a hemodialysis. It is not recommended to use for patients with intolerance of fructose (rare hereditary disease) as contains sorbitol. If complaints keep for 10 days of therapy or deterioration is observed, additional inspection and revision of tactics of treatment is necessary. At patients with a renal failure the concomitant use with citrates can lead to increase in level of aluminum in plasma (see. Interaction with other medicinal products and other forms of interaction). Pregnancy and the period of a lactation during pregnancy the drug can be taken only in case of need. The doctor solves a possibility of use of Maaloks at pregnancy individually. It is necessary to avoid prolonged use and high doses of drug. During treatment it is possible to continue feeding by a breast. This medicine contains ions of aluminum or magnesium which can influence transit of food on digestive tract that, respectively, has to be taken into account. Salts of magnesium hydroxide can cause diarrhea. Salts of aluminum can cause the constipation often observable during pregnancy. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Overdose does not influence the Oral overdose of magnesium does not cause toxic reactions in patients with normally functioning kidneys. At patients with a heavy renal failure the clinical picture of intoxication magnesium can develop (see the section Special instructions). Toxic effects are defined by concentration of magnesium in serum. Intoxication symptoms following: the lowered blood pressure, nausea, vomiting, dizziness, reduced reflexes, muscle weakness, neuromuscular paralysis, bradycardia, disturbances in the ECG, hypoventilation of lungs, in the most serious cases, respiratory paralysis, a coma, renal or heart failure, an anuretic syndrome. Overdose treatment by magnesium: effects of a gipermagniyemiya can be eliminated by intravenous administration of a gluconate of calcium. At patients with a renal failure the hemodialysis or peritoneal dialysis is necessary. A form of release and packing On 15 ml of suspension in bags from paper/aluminium/polyethylene. On 30 bags together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25ºС to Store out of children's reach! 2 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer Pharmatis, France Zone Activite Est n ° 1, 60190 ESTREES-SAINT-DENIS, FRANCE Owner of the registration certificate Sanofi-Aventis, France the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187 of B, phone: 8-727-244-50-96факс: 8-727-258-25-96e-mail: quality.info@sanofi.com
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