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Description
The instruction for medical use of MaksiGrippin® medicine the Trade name of MaksiGrippin® the International unlicensed name Is not present the Dosage form of the Tablet sparkling Structure One tablet contains active agents: paracetamol of 500.00 mg, chlorphenaminum maleate of 10.00 mg, ascorbic acid of 200.00 mg excipients: Natrii hydrocarbonas, citric acid, sorbitol, povidone, sodium saccharinate, sodium carbonate, macrogoal, sodium lauryl sulfate, aromatic fruit Lime additive. The description of the Tablet round, flat, with slanted edge and dividing risky on the one hand, white or almost white color, with hardly noticeable marbling, with a fruit smell. Pharmacotherapeutic group Drugs for treatment of diseases of nervous system. 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, the maximum concentration in blood plasma are reached in 0.5-2 hours after reception. The bioavailability is about 80%, linking with proteins of plasma – 20%, elimination half-life – 1-4 hours. Paracetamol is metabolized, mainly, in a liver, metabolites are removed mainly with urine. Chlorphenaminum after oral administration is well soaked up from digestive tract, the level of absorption is 80%, the maximum effect occurs within 1-2 hours, and proceeds from 4 to 6 hours. 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, time of semi-removal of 12-15 hours. Ascorbic acid is quickly soaked up from digestive tract. After absorption, vitamin C quickly passes into blood and is distributed on all body tissues. Concentration of vitamin C in fabrics, leukocytes and thrombocytes exceeds its concentration in blood plasma and erythrocytes 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 – symptomatic treatment of cold and flu, 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. To adults and children 15 years on 1 tablet 2-3 times a day are more senior. 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, disturbance of concentration of attention, dizziness, fatigue – nausea, pain in epigastric area, anorexia, dyspepsia, vomiting – 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, photosensitivity – feeling of heat, dryness in a mouth, drowsiness – a depression, confusion of consciousness, excitement, irritability – a ring in ears – tachycardia, arrhythmias – hypotension – muscle weakness, muscular spasms – turbidity of sight – condensation of a bronchial secret – an incoordination – hepatitis, jaundice – exfoliative dermatitis – an ischuria – hemolytic anemia – nightmares Are possible the general disturbances: a sdavlennost in breasts, paradoxical excitement. 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 – the patients who are receiving or receiving and MAO during the last 14 days – digestive tract erosive cankers (in an aggravation phase) – the profound renal and/or liver failure – alcoholism – closed-angle glaucoma – a prostate hyperplasia – a hyperoxaluria – children’s age up to 15 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 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 – with hypnotic drugs or tranquilizers – strengthening of the sedative effet increases – enhance anticholinergic effects of iMAO – ethanol – 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. – holestiramin reduces paracetamol absorption speed that can lead to decrease in analgetic effect – warfarin together with paracetamol enhances effect of warfarin and increases risk of bleeding – at reception by paracetamol with chloramphenicol, concentration in plasma of the last – Metoclopramidum increases and domperidon increase paracetamol absorption speed. 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. In a type of existence in composition of drug of chlorphenaminum of a maleate it is necessary to apply carefully MaksiGrippin in such diseases as epilepsy, the increased intraocular pressure, including glaucoma, a prostatauxe, heavy hypertensia or cardiovascular diseases, bronchitis, a bronchietasia, a liver failure, a renal failure. Elderly people test neurologic anticholinergic effects and paradoxical excitement more often. 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. High doses of vitamin C can give false negative testimonies in the analysis a calla on the occult blood. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. It is necessary to show care at control of vehicles and mechanisms and also potentially dangerous types of activity which are accompanied by need for the increased concentration of attention and speed of psychomotor reactions 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). An acute renal failure with acute tubular necrosis, accompanied with pain in lumbar department, a gemutriya and a prorteinuriya can develop even in the absence of serious damage of a liver. Also it was reported about cases of disturbance of a warm rhythm and pancreatitis. Also chlorphenaminum overdose manifestations are possible: dizziness, excitement, a sleep disorder, a depression, spasms, toxic psychosis, an apnoea, dystonic reactions and cardiovascular collapse, including arrhythmia. High doses of ascorbic acid can cause diarrhea and formation of oxalic stones in kidneys. The increased use of ascorbic acid during the long period can lead to increase in renal clearance. The dosage more than 600 mg has diuretic effect. Treatment: to stop administration of drug, to make gastric lavage. 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. At acceptance of the symptomatic and supporting measures, it is necessary to pay special attention to warm, respiratory, renal and hepatic functions and also water salt to balance. At oral overdose, treatment by activated carbon should be considered in the absence of contraindications to its use and provided that the overdose happened recently (treatment is most effective within the first hour after oral administration of drug). As soon as possible to begin treatment of hypotension and arrhythmia. Form of release and packing of the Tablet sparkling. On 10 tablets place in a plastic case or on 6 tablets place in planimetric bezjyacheykovy packing from the printing aluminum foil varnished. On 1 case or 5 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not over 25 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 Product of JV .z Pharm. the lake of the lake, Podstochisko 30, 07-300, Ostruv Mazovetska, Poland the Holder of the registration certificate of LLC VALEANT, Russia, Moscow the Address of the organization, the claim (offer) in the territory of the Republic of Kazakhstan accepting from consumers on quality of medicine and responsible for post-registration observation of safety of medicine of Valeant LLP Kazakhstan, 050059, Almaty, Al-Farabi Avenue, 17, Business center “Nurly-Tau”, block 4B, office 1104 Phone number + 7 727 3 111 516, +7 727 329 00 45, fax +7 727 3 111 517 E-mail:
To Develop office.kz@valeant.com
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