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Description
The instruction for medical use of MaksiGrippin® medicine for children the Trade name of MaksiGrippin® for children the International unlicensed name Is not present the Dosage form of the Tablet sparkling Structure One tablet contains active agents: paracetamol of 250.00 mg, chlorphenaminum maleate of 3.00 mg, ascorbic acid of 50.00 mg excipients: Natrii hydrocarbonas, citric acid, sorbitol, povidone, sodium saccharinate, sodium carbonate, macrogoal, silicon dioxide, aromatic fruit additive Red Fruit. The description of the Tablet round, flat, with slanted edge and dividing risky on the one hand, pink color with lighter and more dark impregnations located chaotically with a fruit smell. Pharmacotherapeutic group Analgetics. Other analgetics-antipyretics. Anilides. Paracetamol in a combination with other drugs (excepting psikholeptik). The ATX N02BE51 code the Pharmacological Pharmacokinetics Paracetamol properties quickly and almost completely (95%) is soaked up after oral administration, peak concentration in blood plasma are reached in 30-60 min. after reception. The bioavailability is about 80%, linking with proteins of plasma – 20%, elimination half-life – 2-2.5 hours. Paracetamol is metabolized, mainly, in a liver, metabolites are removed mainly with urine. Chlorphenaminum after oral administration is slowly soaked up from digestive tract, the level of absorption is 80%, peak concentration in blood plasma are reached throughout 2.5-6 hour. Level of linking with proteins of blood plasma is 45%. Chlorphenaminum is mainly metabolized in a liver, not changed drug and its metabolites are removed with urine, semi-removal time the 30th hour. Ascorbic acid is quickly soaked up in intestines. After absorption, vitamin C quickly passes into blood and is distributed on all body tissues. Concentration of vitamin C in fabrics and lymphocytes exceeds its concentration in blood plasma ten times. Removal is carried out with urine in not changed look and in the form of metabolites. At intake in physiological doses the main metabolite is oxalic acid (55%). The pharmacodynamics of MaksiGrippin® – the combined drug, has anesthetic, febrifugal effect, removes symptoms of dacryagogue, cold in catarrhal diseases and flu, reduces hypostasis of a mucous membrane of upper airways. Paracetamol – analgetic-antipyretic. Renders the anesthetizing and febrifugal effect by suppression of synthesis of prostaglandins in a hypothalamus. Has weak anti-inflammatory activity. Chlorphenaminum the maleate is a blocker of H1 of histamine receptors. Possesses antiallergic action, reduces hypostasis of a mucous membrane of upper airways, eliminates dacryagogue and cold. Ascorbic acid (vitamin C) usually joins in a combination of anti-cold components, offsetting vitamin C losses which happen in viral diseases, including cold. Ascorbic acid belongs to antioxidants, participates in numerous metabolic processes, including in exchange of carbohydrates, proteins and lipids. Ascorbic acid is necessary for maintenance of function of the immune system, normalizes permeability of vessels, participates in regulation of oxidation-reduction processes, synthesis of collagen and angenesis, slows down release and accelerates disintegration of a histamine, synthesis of prostaglandins and other mediators of inflammation and an anaphylaxis oppresses. Indications – the symptoms of cold and flu which are followed by the increased temperature, a fever, a headache, joint and muscles pains, congestion of a nose and a sore throat. Route of administration and doses Inside. Children are from 3 to 5 years old on 1/2 tablet 2 times a day. Children are from 5 to 10 years old on 1 tablet 2 times a day. Children are from 10 to 15 years old on 1 tablet 2-3 times a day. The tablet should be dissolved completely in a glass (200 ml) of warm water (50-60 0C) and at once to drink the received solution. It is better to take the drug between meals. The maximum daily dose – 3 tablets. The interval between administrations of drug has to be not less than 4 hours. At patients with abnormal liver functions or kidneys the interval between administrations of drug has to make not less than 8 hours. Reception duration without consultation with the doctor no more than 5 days when assigning as anesthetic and 3 days as febrifuge. Side effects – a headache, feeling of fatigue – nausea, pain in epigastric area – a hypoglycemia – anemia, hemolytic anemia (especially for patients with deficit glyukozo-6-fosfatdegidrogenazy) – skin rash, an itching, a small tortoiseshell, a Quincke’s edema, anaphylactoid reactions – feeling of heat, dryness in a mouth, drowsiness. It is necessary to report about all side effects of drug to the doctor. Contraindications – hypersensitivity to paracetamol, ascorbic acid, chlorphenaminum or other component of drug – a concomitant use of other paratsetamolsoderzhashchy drugs – digestive tract erosive cankers (in an aggravation phase) – the profound renal and/or liver failure – alcoholism – closed-angle glaucoma – children’s age up to 3 years – pregnancy and the period of a lactation With care: renal and/or liver failure, deficit glyukozo-6-fosfatdegidrogenazy, congenital hyperbilirubinemias (Gilbert’s syndromes, Cudgel Johnson and Rotara), viral hepatitis, alcoholic hepatitis, advanced age. Medicinal interactions It is impossible to apply MaksiGrippin® at the same time: – with other drugs containing paracetamol in structure with the means operating on the central nervous system: antidepressants, protivoparkinsonichesky means, antipsychotic means (derivatives of a fenotiazin) – risk of development of side effects (an ischuria, dryness in a mouth, constipations), amphetamines and tricyclic antidepressants increases – their canalicular reasorbtion – glucocorticosteroids decreases – risk of developing glaucoma – izoprenaliny increases – its chronotropic action – diflunisaly decreases – concentration of paracetamol in blood plasma increases by 50%, its hepatotoxicity – barbiturates amplifies – the efficiency of paracetamol decreases, removal of ascorbic acid with urine – inhibitors of microsomal oxidation amplifies (fenotoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, Cimetidinum) – the risk of hepatotoxic action – ethanol increases – sedative effect of antihistaminic drugs and side effects of paracetamol (development of acute pancreatitis) amplifies. Paracetamol reduces efficiency of uricosuric drugs, and at simultaneous use with a zidovudine their toxicity (granulocytopenia) raises. At simultaneous use of ascorbic acid with: – penicillin – its absorption – heparin and anticoagulants of indirect action increases (warfarin) – their action – salicylates is weakened – the risk of emergence of a crystalluria – oral contraceptives increases – concentration of ascorbic acid in blood plasma – iron preparations decreases – iron absorption increases that can lead to increase in its toxicity – acetylsalicylic acid – absorption of ascorbic acid decreases. Special instructions At prolonged use in the doses considerably exceeding recommended the control of a peripheral picture of blood is necessary, the probability of an abnormal liver function and kidneys increases. Paracetamol and ascorbic acid can distort indicators of laboratory researches (quantitative determination of content of glucose and uric acid in blood plasma, bilirubin, activity of hepatic transaminases). In order to avoid toxic damage of a liver, paracetamol should not be combined with intake of alcoholic beverages and also to accept to the persons inclined to chronic consumption of alcohol. The risk of development of injuries of a liver increases at patients with an alcoholic hepatosis. Prescribing of ascorbic acid to patients with quickly proliferating and intensively metastasizing tumors can aggravate a process course. At patients with the increased iron content in an organism it is necessary to accept ascorbic acid in the minimum doses. Overdose Symptoms: pallor of integuments, anorexia, nausea, vomiting, gepatonekroz (the severity of necrosis directly depends on extent of overdose). Toxic effect of drug at adults perhaps after reception over 10-15 g of paracetamol: increase in activity of hepatic transaminases, increase in a prothrombin time, the developed clinical picture of damage of a liver is shown in 1-6 days. Seldom the abnormal liver function develops immediately and can be complicated by a renal failure (tubular necrosis). Also chlorphenaminum overdose manifestations are possible: dizziness, excitement, sleep disorder, depression, spasms. Treatment: to stop administration of drug, to make gastric lavage, to accept activated carbon. Further therapeutic events should be held in the conditions of medical institution: introduction of donators of SH-group and predecessors of synthesis of glutathione – methionine in 8-9 h after overdose and N-Acetylcysteinum – in 12 h. A form of release and packing of the Tablet sparkling On 10 tablets in a plastic case or on 6 tablets in planimetric bezjyacheykovy packing from printing aluminum foil. On 1 case or on 5 planimetric packs together with the instruction for use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature of 10-30 of 0C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer of Natures the Europe Product B.V. Tveyberg 17, 5246 XL Rozmalen, the Netherlands the Owner of the registration certificate of LLC Valeant, Russia
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of LLC Valeant in Republic of Kazakhstan 050059, Republic of Kazakhstan, Almaty, Al-Farabi Avenue, 17, Business center Nurly-Tau, block 4B, office 1104
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