The instruction for medical use
of medicine
of Maaloks® Plus Torgovoye nazvaniye Maaloks® Plus
the International unlicensed name
Is not present
the Dosage form
chewable tablets
Structure
One tablet contains
active agents: magnesium hydroxide of 200.0 mg, aluminum hydroxide of 200.0 mg, dimetikon (26.25 mg are equivalent to a simetikon *) 25.0 mg,
excipients: Mannitolum, sucrose, sorbitol liquid uncrystallizable **, sodium saccharinate, talc, magnesium stearate, starch corn peptized, starch corn, sorbitol, fragrance limmony, fragrance of the Swiss cream, anhydrous citric acid, glucose anhydrous, ferrous oxide yellow (E 172).
*-not including admissible surplus,
**-there correspond 22.960 mg of sorbitol powdery
the Description
Two-layer chewable tablets of white/yellow color with an engraving of Maalox on one party.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Antacids. Antacids in combination with carminative drugs. Simple combination of salts and carminative drugs.
The ATX A02AF02 code
the Pharmacological
Pharmacokinetics Hydroxides properties of magnesium and aluminum - locally acting, non-systemic antiacid means which absorption is insignificant under normal conditions uses. Dimetikon is not absorbed by a mucous membrane of intestines.
The pharmacodynamics
the Combined means which action is caused by the components which are its part renders the antiacid, adsorbing, enveloping and carminative action. Reduces gas generation in intestines. Aperient effect of magnesium of hydroxide counterbalances effect of aluminum of the hydroxide having the return impact on motility of intestines. Neutralizes free hydrochloric acid in a stomach, lowers activity of gastric juice. Dimetikon possesses the stviye destroying Tay on vials of gas in intestines.
Indications
Symptomatic therapy:
- dyspepsia (the syndrome of dyspepsia is defined as feeling of pain or discomfort in a stomach, weight, overflow, early saturation, nausea).
- heartburn
- an acid eructation
- a meteorism (an abdominal distension, the increased gas generation in intestines)
the Route of administration and doses
For intake.
Adults (including elderly): On 1-2 tablets 4 times a day. It is good to chew. To accept 20 minutes-1 an hour later after a meal and before going to bed (or on requirement). Children: it is not recommended.
Side effects
Infrequently (from ≥1/10000 to ˂1/1000):
diarrhea, a constipation
Frequency is unknown (it is impossible to estimate on the available data):
reactions of hypersensitivity (the itching, urticaria, agionevrotichesky swelled, anaphylactic reactions), a gipermagniyemiya, a giperalyuminiyemiya, a hypophosphatemia (at long reception of high doses or usual doses at patients on a low-phosphatic diet) that can lead to strengthening of a bone resorption, hypercalcuria and osteomalacy.
Contraindications
- strongly weakened patients and patients with a renal failure
- inherited disorders of tolerance to fructose, the glucose galactose sprue, insufficiency of invertase-isomaltase
- hypersensitivity to any of drug components
Medicinal interactions
of Maaloks Plyus® should not be accepted along with other medicines: if the drugs are taken within one hour, Maaloks Plyus®mozhet to break absorption of other medicines.
The antacids containing aluminum can reduce absorption of vitamins.
The combinations demanding observance of precautionary measures at use
decrease in gastrointestinal absorption of other medicines at a concomitant use Is noted. As a precautionary measure, it is necessary to observe, as far as possible, an interval more than 2 hours between intake of this drug and other medicines: acetylsalicylic acid, H2 - antihistamines, antitubercular drugs: Ethambutolum, an isoniazid (peroral), rifampicin, atenolol, metoprolol, propranolol, chloroquine, tsiklina, diflunizat, digitalis glycosides, bisfosfonata, feksofenadin, iron (salts), ftorkhinolona, tetracyclines, fluoric sodium, glucocorticoid drugs except for replacement therapy by a hydrocortisone (it is described for Prednisolonum and dexamethasone), indometacin, ketokonazol, lansoprazol, linkozamida, fenotiazinovy neuroleptics, Penicillaminum, phosphorus (nutritional supplements), thyroid hormones, Sulpiridum, rosuvastatin, sodium sulfate cations, tsefdinir, tsefpodoksy.
Combinations which it is necessary to consider
salicylates (the strengthened removal of salicylates kidneys as a result of urine alkalization),
It is necessary to be careful at combined use with polystyrene sulphonate because of potential risk of decrease in efficiency of binding of potassium pitch and development of a metabolic alkalosis in patients with a renal failure (there are messages for aluminum of hydroxide and magnesium of hydroxide) and intestinal obstruction (for hydroxide magnesium).
At a hydroxide aluminum combination to citrates the increase plasma concentration of aluminum, in particular, at patients with a renal failure is possible.
Ulipristal: actions of an ulipristal can decrease as result of reduction of absorption.
Special instructions
At the following symptoms the additional consultation of the doctor is necessary:
- decrease in body weight,
- difficulty of swallowing and the repeating episodes of feeling of discomfort in a stomach,
- the digestion disturbance which appeared for the first time, or changes in already available digestion disturbances,
- a renal failure.
In view of the content of sorbitol, glucose and sucrose in medicine, it is not recommended to patients with intolerance of fructose, a sprue of glucose galactose or deficiency of invertase-isomaltase, patients with diabetes are recommended to take with caution.
Precautionary measures at
Aluminium use hydroxide can cause development of constipations. The overdose of salts of magnesium can also lead to decrease in motility of intestines. High doses of this medicine can provoke development or strengthen symptoms of intestinal impassability at patients with the corresponding predisposition, for example, at elderly or with renal pathology.
Aluminum hydroxide is badly soaked up from digestive tract thereof its system influence at normal function of kidneys is not considerable. However, excess doses or long use, or even use of usual doses for patients on a hypophosphatic diet, can lead to exhaustion of a reserve of phosphates (owing to binding of phosphates aluminum) that is followed by a resorption of a bone tissue, a hypercalcuria and risk of development of osteomalacy. To the patients subject to this risk, medical observation is recommended.
At patients with reduced function of kidneys is concentration and aluminum, and magnesium in plasma raise. These patients in case of long use of drug in high doses have a risk of developing dementia, microcytic anemia.
Hydroxide aluminum use to the patients with a porphyria who are on a hemodialysis can be dangerous.
At patients with a renal failure the concomitant use of citrates can lead to increase in level of aluminum in blood.
If symptoms remain within ten days of treatment, additional medical examination and revision of tactics of treatment is necessary.
Pregnancy and the period of a lactation
Safety of use of drug at pregnancy is not established. During pregnancy the drug can be taken only in case of need. The issue of need of use of drug by pregnant women is resolved by the doctor individually. This medicine contains ions of aluminum or magnesium which can influence transit of food on digestive tract. Salts of magnesium can cause diarrhea. Salts of aluminum can cause the constipation often observable during pregnancy. It is necessary to avoid use of this medicine for a long time and in high doses.
In breast milk the detection of insignificant amounts of aluminum of hydroxide and magnesium of hydroxide at Maaloks's use plus in the recommended doses is possible. Negative impact on the child when breastfeeding is not expected as system influence on the feeding woman of aluminum of hydroxide, hydroxide magnesium slightly. Simetikon is not soaked up from digestive tract. 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.
The overdose
System adsorption of components of drug is minimum, development of heavy symptoms owing to overdose is improbable. The symptoms described at overdose include diarrhea, an abdominal pain, vomiting. High doses of this medicine can cause or aggravate obstruction of intestines or intestinal impassability.
Treatment: aluminum and magnesium are removed with urine. Treatment of acute overdose is performed by means of intravenous administration of calcium of a gluconate, 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 3 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 25ºС
to Store out of children's reach!
3 years
not to apply a period of storage after the expiration date specified on packing.
Prescription status
Without prescription
the Producer Sanofi-Aventis S.P.A., Italy
SS17 KM22-67019 Scoppito (AQ), Italy
the Owner of the registration certificate
S.P.A. Sanofi-Aventis, Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) 050013 Almaty, Furmanov St. 187 of B phone: 8-727-244-50-96факс: 8-727-258-25-96e-mail:
To Develop quality.info@sanofi-aventis.com
of medicine
of Maaloks® Plus Torgovoye nazvaniye Maaloks® Plus
the International unlicensed name
Is not present
the Dosage form
chewable tablets
Structure
One tablet contains
active agents: magnesium hydroxide of 200.0 mg, aluminum hydroxide of 200.0 mg, dimetikon (26.25 mg are equivalent to a simetikon *) 25.0 mg,
excipients: Mannitolum, sucrose, sorbitol liquid uncrystallizable **, sodium saccharinate, talc, magnesium stearate, starch corn peptized, starch corn, sorbitol, fragrance limmony, fragrance of the Swiss cream, anhydrous citric acid, glucose anhydrous, ferrous oxide yellow (E 172).
*-not including admissible surplus,
**-there correspond 22.960 mg of sorbitol powdery
the Description
Two-layer chewable tablets of white/yellow color with an engraving of Maalox on one party.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Antacids. Antacids in combination with carminative drugs. Simple combination of salts and carminative drugs.
The ATX A02AF02 code
the Pharmacological
Pharmacokinetics Hydroxides properties of magnesium and aluminum - locally acting, non-systemic antiacid means which absorption is insignificant under normal conditions uses. Dimetikon is not absorbed by a mucous membrane of intestines.
The pharmacodynamics
the Combined means which action is caused by the components which are its part renders the antiacid, adsorbing, enveloping and carminative action. Reduces gas generation in intestines. Aperient effect of magnesium of hydroxide counterbalances effect of aluminum of the hydroxide having the return impact on motility of intestines. Neutralizes free hydrochloric acid in a stomach, lowers activity of gastric juice. Dimetikon possesses the stviye destroying Tay on vials of gas in intestines.
Indications
Symptomatic therapy:
- dyspepsia (the syndrome of dyspepsia is defined as feeling of pain or discomfort in a stomach, weight, overflow, early saturation, nausea).
- heartburn
- an acid eructation
- a meteorism (an abdominal distension, the increased gas generation in intestines)
the Route of administration and doses
For intake.
Adults (including elderly): On 1-2 tablets 4 times a day. It is good to chew. To accept 20 minutes-1 an hour later after a meal and before going to bed (or on requirement). Children: it is not recommended.
Side effects
Infrequently (from ≥1/10000 to ˂1/1000):
diarrhea, a constipation
Frequency is unknown (it is impossible to estimate on the available data):
reactions of hypersensitivity (the itching, urticaria, agionevrotichesky swelled, anaphylactic reactions), a gipermagniyemiya, a giperalyuminiyemiya, a hypophosphatemia (at long reception of high doses or usual doses at patients on a low-phosphatic diet) that can lead to strengthening of a bone resorption, hypercalcuria and osteomalacy.
Contraindications
- strongly weakened patients and patients with a renal failure
- inherited disorders of tolerance to fructose, the glucose galactose sprue, insufficiency of invertase-isomaltase
- hypersensitivity to any of drug components
Medicinal interactions
of Maaloks Plyus® should not be accepted along with other medicines: if the drugs are taken within one hour, Maaloks Plyus®mozhet to break absorption of other medicines.
The antacids containing aluminum can reduce absorption of vitamins.
The combinations demanding observance of precautionary measures at use
decrease in gastrointestinal absorption of other medicines at a concomitant use Is noted. As a precautionary measure, it is necessary to observe, as far as possible, an interval more than 2 hours between intake of this drug and other medicines: acetylsalicylic acid, H2 - antihistamines, antitubercular drugs: Ethambutolum, an isoniazid (peroral), rifampicin, atenolol, metoprolol, propranolol, chloroquine, tsiklina, diflunizat, digitalis glycosides, bisfosfonata, feksofenadin, iron (salts), ftorkhinolona, tetracyclines, fluoric sodium, glucocorticoid drugs except for replacement therapy by a hydrocortisone (it is described for Prednisolonum and dexamethasone), indometacin, ketokonazol, lansoprazol, linkozamida, fenotiazinovy neuroleptics, Penicillaminum, phosphorus (nutritional supplements), thyroid hormones, Sulpiridum, rosuvastatin, sodium sulfate cations, tsefdinir, tsefpodoksy.
Combinations which it is necessary to consider
salicylates (the strengthened removal of salicylates kidneys as a result of urine alkalization),
It is necessary to be careful at combined use with polystyrene sulphonate because of potential risk of decrease in efficiency of binding of potassium pitch and development of a metabolic alkalosis in patients with a renal failure (there are messages for aluminum of hydroxide and magnesium of hydroxide) and intestinal obstruction (for hydroxide magnesium).
At a hydroxide aluminum combination to citrates the increase plasma concentration of aluminum, in particular, at patients with a renal failure is possible.
Ulipristal: actions of an ulipristal can decrease as result of reduction of absorption.
Special instructions
At the following symptoms the additional consultation of the doctor is necessary:
- decrease in body weight,
- difficulty of swallowing and the repeating episodes of feeling of discomfort in a stomach,
- the digestion disturbance which appeared for the first time, or changes in already available digestion disturbances,
- a renal failure.
In view of the content of sorbitol, glucose and sucrose in medicine, it is not recommended to patients with intolerance of fructose, a sprue of glucose galactose or deficiency of invertase-isomaltase, patients with diabetes are recommended to take with caution.
Precautionary measures at
Aluminium use hydroxide can cause development of constipations. The overdose of salts of magnesium can also lead to decrease in motility of intestines. High doses of this medicine can provoke development or strengthen symptoms of intestinal impassability at patients with the corresponding predisposition, for example, at elderly or with renal pathology.
Aluminum hydroxide is badly soaked up from digestive tract thereof its system influence at normal function of kidneys is not considerable. However, excess doses or long use, or even use of usual doses for patients on a hypophosphatic diet, can lead to exhaustion of a reserve of phosphates (owing to binding of phosphates aluminum) that is followed by a resorption of a bone tissue, a hypercalcuria and risk of development of osteomalacy. To the patients subject to this risk, medical observation is recommended.
At patients with reduced function of kidneys is concentration and aluminum, and magnesium in plasma raise. These patients in case of long use of drug in high doses have a risk of developing dementia, microcytic anemia.
Hydroxide aluminum use to the patients with a porphyria who are on a hemodialysis can be dangerous.
At patients with a renal failure the concomitant use of citrates can lead to increase in level of aluminum in blood.
If symptoms remain within ten days of treatment, additional medical examination and revision of tactics of treatment is necessary.
Pregnancy and the period of a lactation
Safety of use of drug at pregnancy is not established. During pregnancy the drug can be taken only in case of need. The issue of need of use of drug by pregnant women is resolved by the doctor individually. This medicine contains ions of aluminum or magnesium which can influence transit of food on digestive tract. Salts of magnesium can cause diarrhea. Salts of aluminum can cause the constipation often observable during pregnancy. It is necessary to avoid use of this medicine for a long time and in high doses.
In breast milk the detection of insignificant amounts of aluminum of hydroxide and magnesium of hydroxide at Maaloks's use plus in the recommended doses is possible. Negative impact on the child when breastfeeding is not expected as system influence on the feeding woman of aluminum of hydroxide, hydroxide magnesium slightly. Simetikon is not soaked up from digestive tract. 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.
The overdose
System adsorption of components of drug is minimum, development of heavy symptoms owing to overdose is improbable. The symptoms described at overdose include diarrhea, an abdominal pain, vomiting. High doses of this medicine can cause or aggravate obstruction of intestines or intestinal impassability.
Treatment: aluminum and magnesium are removed with urine. Treatment of acute overdose is performed by means of intravenous administration of calcium of a gluconate, 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 3 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
To Store storage conditions at a temperature not above 25ºС
to Store out of children's reach!
3 years
not to apply a period of storage after the expiration date specified on packing.
Prescription status
Without prescription
the Producer Sanofi-Aventis S.P.A., Italy
SS17 KM22-67019 Scoppito (AQ), Italy
the Owner of the registration certificate
S.P.A. Sanofi-Aventis, Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) 050013 Almaty, Furmanov St. 187 of B phone: 8-727-244-50-96факс: 8-727-258-25-96e-mail:
To Develop quality.info@sanofi-aventis.com
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