The instruction for medical use
of Maaloks® medicine
the Trade name
of Maaloks®
the International non-proprietary name
Is not present
the Dosage form
chewable tablets
Structure
One tablet contains
active agents: aluminum hydroxide (it is equivalent aluminum of oxide of 200.0 mg) 400.0 mg
of magnesium hydroxide of 400.0 mg,
excipients: confectionery sugar with starch, Mannitolum, sorbitol, magnesium stearate, mint fragrance powder, sodium saccharinate, sucrose (for direct pressing).
The description
Round, flat chewable tablets of white color with a facet and an engraving of MX on both parties, with a mint smell.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Combination of drugs of aluminum, calcium and magnesium.
The code of automatic telephone exchange A02AD01
the Pharmacological
Pharmacokinetics Hydroxides properties of magnesium and aluminum - locally acting, non-systemic antiacid means which absorption is insignificant under normal conditions uses. Maaloks chewable tablets are badly soaked up from digestive tract. In the course of neutralization the ions of magnesium and aluminum are released in insignificant degree. Generally they turn into almost insoluble phosphates during passing through intestines and are removed in such view with excrements. A number of ions of magnesium and aluminum are soaked up that leads to temporary increase in concentration of aluminum in blood plasma and to increase in its renal excretion. Aluminum levels in blood plasma remain lower than the range of toxicity and return to normal values within 3-5 days after the treatment termination. The small fraction of magnesium is soaked up. Concentration of magnesium in blood plasma, as a rule, remain constants owing to removal by kidneys. In cases of a renal failure and long reception of high doses can take place a gipermagniyemiya and even intoxication magnesium, besides, aluminum deposits, especially in a nervous and bone tissue can gradually be formed.
The pharmacodynamics
of Maaloks protects a mucous membrane of a gullet, a stomach and a 12-pyorstny gut. Effect of aluminum hydroxides and magnesium is based on neutralization of hydrochloric acid of gastric juice. The combination of aluminum hydroxide and magnesium hydroxide uses various reactions of active agents against acid. Magnesium hydroxide leads to fast and short-term increase intragastric rn within not physiological values (rn 7-8) while aluminum hydroxide is too weak to use only it. The combination of both hydroxides leads to long binding of protons which total amount is equal to total number of ions of aluminum and magnesium. Hydroxides of magnesium and aluminum affect sokratitelny ability of intestines in various ways. Magnesium hydroxide possesses laxative action whereas aluminum hydroxide leads to a constipation. Maaloks we pass for X-rays. The general antiacid ability of one dose (titration at rn 1) 14.71 mmol of H+ (by the Vatier method).
Indications
- heartburn and an acid eructation at adults and children from 15-summer age
the Route of administration and doses
Children from 15-year age and adults:
On 1-2 tablets to rassasyvat or chew in heartburn and an acid eructation.
The maximum quantity of doses in day: 6 doses (1 dose may contain 1-2 tablets, therefore, 6 doses x 1-2 tablets = 6 - 12 tablets a day).
It is not necessary to take more than 12 pill a day.
By-effects
- disturbances of transit in digestive tract (diarrhea or a constipation)
- a hypophosphatemia after long use or after high doses of drug because of aluminum content in this drug
of the Contraindication
- hypersensitivity to any of drug components
- a heavy renal failure (KK & lt, 30 ml/min. / 1.73м2) as drug contains magnesium and aluminum
the Medicinal interactions
of the Combination demanding observance of precautionary measures at use
noted decrease in gastrointestinal absorption of at the same time taken medicines. As a precautionary measure, it is desirable to observe an interval between reception of antacids and other medicines. As far as possible it is necessary to observe an interval more than 2 hours between intake of this drug and the following medicines: H2 - antihistamines, antitubercular drugs: Ethambutolum, an isoniazid (peroral), atenolol, metoprolol, propranolol, chloroquine, tsiklina, diflunizat, digoxin, diphosphonates, feksofenadin, iron (salts), ftorkhinolona, fluoric sodium, glucocorticoid drugs (it is described in connection with Prednisolonum and dexamethasone), indometacin, keyiksalat, ketokonazol, lanzoprazol, linkozamida, fenotiazinovy neuroleptics, Penicillaminum, phosphorus (additives), thyroxine.
Combinations which it is necessary to consider
salicylates (the strengthened removal of salicylates kidneys as a result of urine alkalization).
Special instructions
Patients have to see a doctor behind council in a case:
- weight reduction of a body
- difficulties when swallowing and persistent feeling of discomfort in a stomach
- disturbances of the digestion which appeared for the first time or changes in the available digestion disturbances
- a renal failure.
In view of the content of sorbitol and sucrose in this medicine, it is not recommended to patients with intolerance of fructose, a syndrome of malabsorption of glucose galactose or deficiency of invertase-isomaltase, patients with diabetes are recommended to take with caution.
Precautionary measures at use
in case of patients with a renal failure or being on chronic dialysis, it is necessary to consider aluminum content in drug (danger of development of encephalopathy).
If during treatment the symptoms remain more than 10 days or if deterioration follows, it is necessary to check an etiology of a disease and to reconsider treatment.
Use in pediatrics
the Published clinical data on experience of use of magnesium of a hydrochloride and aluminum of hydroxide at children up to 15 years are limited.
Pregnancy and the period of a lactation
Reliable data about teratogenic action in preclinical trials are absent.
So far teratogenic and fetotoksichesky effects in clinical practice were not observed. However, observations of pregnancies during which exposure by this medicine insufficiently for a risk exception took place.
Therefore, at pregnancy this medicine can be used during pregnancy only in case of need.
It is necessary to consider that this medicine contains ions of aluminum and magnesium which can change transit on digestive tract:
- salt of magnesium can cause diarrhea
- salts of aluminum can be the cause of a constipation that can worsen a course of the constipations often observable during pregnancy.
It is necessary to avoid long intake and high doses of this medicine.
During treatment it is possible to continue feeding by a breast.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
Symptoms: strengthening of by-effects is possible.
Treatment: symptomatic (at overdose, magnesium carries out rehydration, an artificial diuresis, in case of a renal failure the hemodialysis or peritoneal dialysis is necessary).
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 or 4 blister strip packagings together with the instruction for use in the state and Russian languages put in a cardboard pack.
To Store storage conditions at a temperature not above 25ºС
to Store out of children's reach!
Not to apply a period of storage of 5 years after the expiration date specified on packing.
Prescription status
Without prescription
the Producer Sanofi-Aventis of page of the item. And., Italy for SANOFI AVENTIS FRANCE, France
Viale Europa, 11, 21040 Origgio (VA), Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
050016 Almaty, Kunayev St. 21B
phone number: 8-727-244-50-96
fax: 8-727-258-25-96
e-mail: quality.info@sanofi-aventis.com
of Maaloks® medicine
the Trade name
of Maaloks®
the International non-proprietary name
Is not present
the Dosage form
chewable tablets
Structure
One tablet contains
active agents: aluminum hydroxide (it is equivalent aluminum of oxide of 200.0 mg) 400.0 mg
of magnesium hydroxide of 400.0 mg,
excipients: confectionery sugar with starch, Mannitolum, sorbitol, magnesium stearate, mint fragrance powder, sodium saccharinate, sucrose (for direct pressing).
The description
Round, flat chewable tablets of white color with a facet and an engraving of MX on both parties, with a mint smell.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Combination of drugs of aluminum, calcium and magnesium.
The code of automatic telephone exchange A02AD01
the Pharmacological
Pharmacokinetics Hydroxides properties of magnesium and aluminum - locally acting, non-systemic antiacid means which absorption is insignificant under normal conditions uses. Maaloks chewable tablets are badly soaked up from digestive tract. In the course of neutralization the ions of magnesium and aluminum are released in insignificant degree. Generally they turn into almost insoluble phosphates during passing through intestines and are removed in such view with excrements. A number of ions of magnesium and aluminum are soaked up that leads to temporary increase in concentration of aluminum in blood plasma and to increase in its renal excretion. Aluminum levels in blood plasma remain lower than the range of toxicity and return to normal values within 3-5 days after the treatment termination. The small fraction of magnesium is soaked up. Concentration of magnesium in blood plasma, as a rule, remain constants owing to removal by kidneys. In cases of a renal failure and long reception of high doses can take place a gipermagniyemiya and even intoxication magnesium, besides, aluminum deposits, especially in a nervous and bone tissue can gradually be formed.
The pharmacodynamics
of Maaloks protects a mucous membrane of a gullet, a stomach and a 12-pyorstny gut. Effect of aluminum hydroxides and magnesium is based on neutralization of hydrochloric acid of gastric juice. The combination of aluminum hydroxide and magnesium hydroxide uses various reactions of active agents against acid. Magnesium hydroxide leads to fast and short-term increase intragastric rn within not physiological values (rn 7-8) while aluminum hydroxide is too weak to use only it. The combination of both hydroxides leads to long binding of protons which total amount is equal to total number of ions of aluminum and magnesium. Hydroxides of magnesium and aluminum affect sokratitelny ability of intestines in various ways. Magnesium hydroxide possesses laxative action whereas aluminum hydroxide leads to a constipation. Maaloks we pass for X-rays. The general antiacid ability of one dose (titration at rn 1) 14.71 mmol of H+ (by the Vatier method).
Indications
- heartburn and an acid eructation at adults and children from 15-summer age
the Route of administration and doses
Children from 15-year age and adults:
On 1-2 tablets to rassasyvat or chew in heartburn and an acid eructation.
The maximum quantity of doses in day: 6 doses (1 dose may contain 1-2 tablets, therefore, 6 doses x 1-2 tablets = 6 - 12 tablets a day).
It is not necessary to take more than 12 pill a day.
By-effects
- disturbances of transit in digestive tract (diarrhea or a constipation)
- a hypophosphatemia after long use or after high doses of drug because of aluminum content in this drug
of the Contraindication
- hypersensitivity to any of drug components
- a heavy renal failure (KK & lt, 30 ml/min. / 1.73м2) as drug contains magnesium and aluminum
the Medicinal interactions
of the Combination demanding observance of precautionary measures at use
noted decrease in gastrointestinal absorption of at the same time taken medicines. As a precautionary measure, it is desirable to observe an interval between reception of antacids and other medicines. As far as possible it is necessary to observe an interval more than 2 hours between intake of this drug and the following medicines: H2 - antihistamines, antitubercular drugs: Ethambutolum, an isoniazid (peroral), atenolol, metoprolol, propranolol, chloroquine, tsiklina, diflunizat, digoxin, diphosphonates, feksofenadin, iron (salts), ftorkhinolona, fluoric sodium, glucocorticoid drugs (it is described in connection with Prednisolonum and dexamethasone), indometacin, keyiksalat, ketokonazol, lanzoprazol, linkozamida, fenotiazinovy neuroleptics, Penicillaminum, phosphorus (additives), thyroxine.
Combinations which it is necessary to consider
salicylates (the strengthened removal of salicylates kidneys as a result of urine alkalization).
Special instructions
Patients have to see a doctor behind council in a case:
- weight reduction of a body
- difficulties when swallowing and persistent feeling of discomfort in a stomach
- disturbances of the digestion which appeared for the first time or changes in the available digestion disturbances
- a renal failure.
In view of the content of sorbitol and sucrose in this medicine, it is not recommended to patients with intolerance of fructose, a syndrome of malabsorption of glucose galactose or deficiency of invertase-isomaltase, patients with diabetes are recommended to take with caution.
Precautionary measures at use
in case of patients with a renal failure or being on chronic dialysis, it is necessary to consider aluminum content in drug (danger of development of encephalopathy).
If during treatment the symptoms remain more than 10 days or if deterioration follows, it is necessary to check an etiology of a disease and to reconsider treatment.
Use in pediatrics
the Published clinical data on experience of use of magnesium of a hydrochloride and aluminum of hydroxide at children up to 15 years are limited.
Pregnancy and the period of a lactation
Reliable data about teratogenic action in preclinical trials are absent.
So far teratogenic and fetotoksichesky effects in clinical practice were not observed. However, observations of pregnancies during which exposure by this medicine insufficiently for a risk exception took place.
Therefore, at pregnancy this medicine can be used during pregnancy only in case of need.
It is necessary to consider that this medicine contains ions of aluminum and magnesium which can change transit on digestive tract:
- salt of magnesium can cause diarrhea
- salts of aluminum can be the cause of a constipation that can worsen a course of the constipations often observable during pregnancy.
It is necessary to avoid long intake and high doses of this medicine.
During treatment it is possible to continue feeding by a breast.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
Symptoms: strengthening of by-effects is possible.
Treatment: symptomatic (at overdose, magnesium carries out rehydration, an artificial diuresis, in case of a renal failure the hemodialysis or peritoneal dialysis is necessary).
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 or 4 blister strip packagings together with the instruction for use in the state and Russian languages put in a cardboard pack.
To Store storage conditions at a temperature not above 25ºС
to Store out of children's reach!
Not to apply a period of storage of 5 years after the expiration date specified on packing.
Prescription status
Without prescription
the Producer Sanofi-Aventis of page of the item. And., Italy for SANOFI AVENTIS FRANCE, France
Viale Europa, 11, 21040 Origgio (VA), Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
050016 Almaty, Kunayev St. 21B
phone number: 8-727-244-50-96
fax: 8-727-258-25-96
e-mail: quality.info@sanofi-aventis.com
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