Grippomix powder for solution for oral administration (lemon) in bags 10g №10

Name:
Grippomix por.d/prik.p-ra d/pr.in.(lemon) in pack.10g in pack No. 10
Description:
White or almost white powder with a yellowish or gray tint with a lemon smell (Grippomix lemon). Soft lumps are allowed. The main active ingredient Paracetamol in combination with other drugs (excluding psychotropic drugs) Release form Powder for solution for oral administration. Dosage 10 g Pharmacological properties The pharmacological activity of the drug is due to the complex action of its components – paracetamol, rimantadine hydrochloride, ascorbic acid, cetirizine dihydrochloride and calcium carbonate. The drug has an antiviral, antipyretic, anti-inflammatory, analgesic, antihistamine effect. Paracetamol has antipyretic, analgesic and some anti-inflammatory effects, reduces pain associated with colds, sore throat, headache, muscle and joint pain, and reduces high temperature. It blocks cyclooxygenase of the first and second types mainly in the central nervous system. Due to the absence of a blocking effect on the synthesis of prostaglandins in peripheral tissues, it does not affect the water-salt metabolism (retention of Na + and water) and the mucous membrane of the gastrointestinal tract. Rimantadine hydrochloride is an antiviral agent derived from adamantane. It is active against various strains of the influenza A virus, Herpes simplex type I and II viruses, tick-borne encephalitis viruses (Central European and Russian spring-summer from the group of arboviruses of the Flaviviridae family). Rimantadine has an inhibitory effect at an early stage of the replication cycle, possibly inhibiting the transcription of the viral genome. The results of genetic studies suggest that the viral protein of the indicated virion M2 gene plays an important role in the susceptibility of the influenza A virus to rimantadine. Rimantadine inhibits replication in cell culture of isolates of each of the three antigenic subtypes of influenza A virus, i.e. H1N1, H2N2 and H3N3 isolated from human cells. Rimantadine is inactive or almost inactive against influenza B virus. The quantitative relationship between susceptibility in cell culture of influenza A virus to rimantadine and the clinical effect has not been established. Susceptibility test results, expressed as the drug concentration required to inhibit viral replication by 50% or more in cell culture, vary greatly (19 nM to 93 µM) depending on the test protocol used, inoculum size, influenza A virus strains isolated and the cell type used. RESISTANCE: Rimantadine-resistant influenza A virus isolates resulting from treatment have been isolated in vivo cell culture. Rimantadine-resistant strains of influenza A virus have emerged among recently isolated strains under experimental conditions where rimantadine has been used. It has been shown that resistant viruses can be transmitted and are the cause of the typical flu. Substitution of any of the five amino acids in the M2 domain membrane results in rimantadine resistance. The most common substitutions causing resistance include influenza A (H1N1) and A (H3N2) and S31N. Other less common substitutions that cause resistance include A30F, V27A and L26F. Resistance to rimantadine has been found in isolated strains of pandemic seasonal influenza in individuals who have not received rimantadine. Swine influenza A (H1N1) (S-OIV) viruses that were resistant to rimantadine have been shown to contain the S31N substitution. CROSS-RESISTANCE: Cross-resistance has been observed among adamantanes, rimantadine and amantadine. Resistance to rimantadine occurs through cross-resistance to amantadine and vice versa. Amino acid substitutions that cause resistance to rimantadine include (most commonly) M2 S31N, as well as the less common V27, V30A, L26F, and A30T changes. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and reduces vascular permeability. Has antioxidant properties. Maintains the colloidal state of the intercellular substance and normal capillary permeability (inhibits hyaluronidase). Due to the activation of respiratory enzymes in the liver, it enhances its detoxification and protein-forming functions, increases the synthesis of prothrombin. Regulates immunological reactions (activates the synthesis of antibodies, the C3-component of complement, interferon), promotes phagocytosis, increases the body’s resistance to infections. It inhibits the release and accelerates the degradation of histamine, inhibits the formation of prostaglandins and other mediators of inflammation and allergic reactions. Cetirizine dihydrochloride is a blocker of peripheral histamine H1 receptors, an antihistamine antiallergic agent, a metabolite of hydroxyzine. In pharmacologically active doses, it does not have a significant sedative effect. It inhibits the histamine-mediated early phase of the allergic reaction, prevents various physiological and pathophysiological effects of histamine, such as expansion and increased capillary permeability (development of edema, urticaria, redness), stimulation of sensitive nerve endings (itching, pain) and contraction of smooth muscles of the respiratory and gastrointestinal organs tract. In the late stage of an allergic reaction, cetirizine dihydrochloride inhibits the release of histamine and the migration of eosinophils and other cells, thus attenuating the late allergic reaction. Reduces the expression of adhesion molecules such as ICAM-1 and VCAM-1, which are markers of allergic inflammation. Suppresses the action of other mediators and inducers of histamine secretion, such as PAF (platelet-activating factor) and substance P. Significantly reduces the hyperreactivity of the bronchial tree that occurs in response to the release of histamine in patients with bronchial asthma. These effects are not accompanied by a central action. Calcium carbonate prevents the development of increased permeability and fragility of blood vessels, promotes normal blood clotting, participates in the transmission of nerve impulses, contractions of skeletal and smooth muscles, and in the regulation of cardiac activity. Indications for use Treatment of influenza and acute respiratory viral infections (or colds), accompanied by fever. Dosage and administration Inside. The contents of the sachet are dissolved in 1 cup of boiled hot water. Used hot. Children over 12 years old and adults – 1 powder 3 times a day while maintaining a febrile syndrome for 3-5 days. Use during pregnancy and lactation The use of the drug is contraindicated. Influence on the ability to drive vehicles and work with mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions (contains rimantadine). Precautions The drug is not intended for prophylaxis. Treatment should begin no later than 24-48 hours from the onset of the first symptoms of the disease. Duration of application – no more than 5 days. With prolonged use (over 7 days), exacerbation of chronic concomitant diseases is possible. In elderly patients with arterial hypertension, the risk of developing hemorrhagic stroke is increased (due to rimantadine, which is part of the drug). Before using the drug for influenza, accompanied by an increase in temperature up to 38.5 ° C, it is recommended to consult a doctor about the advisability of taking the drug. Associated with the presence of paracetamol: Use with caution in patients with renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, glucose-6-phosphate dehydrogenase deficiency, alcoholic liver damage, alcoholism, in old age. Patients with impaired renal and hepatic function, people who abuse alcohol should consult a doctor before using the drug. Do not exceed the indicated doses. Do not take medicines with other medicines containing paracetamol. If the recommended dose is exceeded, paracetamol can have a damaging effect on the liver. Associated with the presence of rimantadine: Use with caution in hypertension, epilepsy (including history), cerebral atherosclerosis, liver failure, diseases of the gastrointestinal tract, in elderly patients. The emergence of drug-resistant viruses is possible. Exacerbation of chronic concomitant diseases is possible. Elderly patients with arterial hypertension have an increased risk of hemorrhagic stroke. With indications of a history of epilepsy and ongoing anticonvulsant therapy, the risk of developing a seizure increases. Associated with cetirizine: Use with caution in patients with hepatic impairment, epilepsy, or a tendency to convulsions. Patients who have predisposing factors for urinary retention (spinal cord injury, prostatic hyperplasia) should be cautious because cetirizine may increase the risk of urinary problems. Ascorbic acid related: Use with caution in patients with hyperoxaluria, urolithiasis, renal failure, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, glucose-6-phosphate dehydrogenase deficiency, sickle cell anemia, advanced malignant disease, pregnancy. Interaction with other drugs During treatment with GRIPPOMIX, simultaneous intake of alcoholic beverages is unacceptable! Associated with the presence of paracetamol: Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, the onset of end-stage renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding, single doses do not have a significant effect. Inducers of microsomal oxidation enzymes in the liver (barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine, diphenin, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in case of overdose. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Ethanol contributes to the development of acute pancreatitis. The drug may reduce the activity of uricosuric drugs. Associated with the presence of rimantadine: Pharmacodynamic: rimantadine reduces the effectiveness of antiepileptic drugs. Pharmacokinetic: adsorbents, astringents and enveloping agents reduce the absorption of rimantadine. Paracetamol and acetylsalicylic acid reduce the maximum concentration of rimantadine by 11% and 10%, respectively. Cimetidine reduces the clearance of rimantadine by 18%. Urine acidifying agents (ammonium chloride, ascorbic acid, etc.) reduce the effectiveness of rimantadine, due to the excretion of the latter by the kidneys. Urine alkalizing agents (acetazolamide, diacarb, sodium bicarbonate, etc.) enhance the effect of rimantadine, due to a decrease in its excretion by the kidneys. Associated with the presence of cetirizine: When used simultaneously with pseudoephedrine, cimetidine, ketoconazole, erythromycin or azithromycin, no effect on the pharmacokinetics of cetirizine was detected. No pharmacokinetic interactions were observed. In vitro tests have shown that cetirizine does not affect the protein-binding properties of warfarin. With simultaneous use with azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine, no clinically significant adverse interactions were detected, no changes were noted on the electrocardiogram. With the simultaneous use of cetirizine (20 mg / day) with theophylline (400 mg / day), a slight but stable increase in the area under the curve of concentration and time per day was revealed, cetirizine by 19%, theophylline – 11%. However, when initially treated with cetirizine, there was no significant effect on theophylline pharmacokinetics. After a single dose of 10 mg of cetirizine, the effect of alcohol (0.8 ‰) does not increase significantly; a notable interaction is noted with diazepam 5 mg in 1 of 16 psychometric tests. It is recommended to take drugs separately – glipizide in the morning and cetirizine-containing drug in the evening. Eating does not affect the completeness of absorption, although its rate decreases by 1 hour. With simultaneous course treatment with ritonavir (600 mg 2 times a day), the duration of action of cetirizine at a dose of 10 mg / day increases by 40%, the effect of ritonavir decreases by 11%. A three-day “washout” period is recommended before the appointment of allergological tests. Associated with the presence of ascorbic acid: Increases the concentration in the blood of benzylpenicillin and tetracyclines; at a dose of 1 g / day, increases the bioavailability of ethinylestradiol. Improves absorption in the intestines of iron preparations (converts ferric iron to ferrous); May increase iron excretion when used concomitantly with deferoxamine. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drinks reduce the absorption and absorption of ascorbic acid. With simultaneous use with ASA, the excretion of ascorbic acid in the urine increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of salicylates with short-acting sulfonamides, slows down the excretion of acids by the kidneys, increases the concentration of oral contraceptives in the blood. Increases the overall clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body. Preparations of the quinoline series (fluoroquinolones, etc.), calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the reserves of ascorbic acid. With simultaneous use reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, the interaction of disulfiram-ethanol can be disrupted. In high doses, it increases the renal excretion of mexiletin. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotics (phenothiazine derivatives), tubular reabsorption of amphetamine and tricyclic antidepressants. Contraindications Hypersensitivity to any of the active or excipients; pregnancy and lactation; phenylketonuria (due to the presence of aspartame); Associated with the presence of rimantadine and paracetamol: acute and chronic kidney disease, acute liver disease, thyrotoxicosis. Associated with the presence of cetirizine: terminal stage renal insufficiency (creatinine clearance <10 ml/min). fructose or glucose-galactose malabsorption. The composition of the drug includes aspartame, which is a source of phenylalanine and is contraindicated in patients with phenylketonuria. Patients with diabetes should take into account that the medicinal product contains 9.1 g of sugar in each package. Composition Each package contains: active substances: paracetamol - 325 mg, rimantadine hydrochloride - 75 mg, ascorbic acid - 125 mg, cetirizine dihydrochloride - 2.5 mg, calcium carbonate 70 with sorbitol - 89.3 mg, which corresponds to 25 mg of calcium. excipients: aspartame, anhydrous citric acid, flavor (lemon), sugar. OverdoseOverdose associated with the presence of paracetamol: If the recommended dose is exceeded, there is a risk of delayed serious liver damage. Liver damage in adults is possible when taking 10 g or more of paracetamol. Taking 5 g or more of paracetamol can lead to liver damage in patients with the following risk factors: prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. those with glutathione deficiency (malnutrition, cystic fibrosis, HIV infection, starving, malnourished patients). Symptoms of acute paracetamol poisoning in the first 24 hours: nausea, vomiting, stomach pain, sweating, pallor of the skin. Liver damage may become apparent 12 to 48 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, bleeding, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis may present with severe low back pain, hematuria, proteinuria, and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis were also noted. Treatment: Overdose requires immediate medical attention. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose or risk of organ damage. Treatment with activated charcoal is applicable if an overdose of paracetamol has been taken within 1 hour. Plasma concentrations of paracetamol should be assessed 4 hours and later after taking the drug (early determination of the concentration is unreliable). Treatment with N-acetylcysteine can be carried out within approximately 24 hours after taking paracetamol, but the maximum protective effect is obtained when it is used for 8 hours after taking it. The effectiveness of the antidote drops sharply after this time. If necessary, N-acetylcysteine is administered intravenously to the patient according to the established list of doses. In the absence of vomiting, oral methionine can be used as an appropriate alternative in remote areas outside the hospital. Overdose associated with the presence of rimantadine: Symptoms: agitation, hallucinations, arrhythmias. In some cases, when the recommended dose is exceeded, there is observed: tearing of the eyes and pain in the eyes, increased urination, fever, constipation, sweating, inflammation of the oral mucosa, dry skin. Treatment: gastric lavage, symptomatic therapy. In case of poisoning, it is necessary to maintain vital functions. In the event of symptoms from the central nervous system, intravenous administration of physostigmine is effective; adults - 1.2 mg, children 0.5 mg, with repetition if necessary, but not more than 2 mg / h. Rimantadine is partially excreted by hemodialysis. Overdose associated with the presence of cetirizine: With a single dose of the drug at a dose of 50 mg, the following symptoms were observed: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, weakness, anxiety, sedation, drowsiness, stupor, tachycardia , hand tremor, urinary retention. Treatment: immediately after taking the drug - gastric lavage or stimulation of vomiting. It is recommended to take activated charcoal, conduct symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is not effective. Overdose associated with the presence of ascorbic acid: When taking more than 1 g per day, heartburn, diarrhea, difficulty urinating or staining urine red, hemolysis (in patients with glucose-6-phosphate dehydrogenase deficiency) are possible. If side effects occur, stop taking the drug and consult a doctor. Side effects Possible side effects are listed below by body systems and frequency of occurrence: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely ( ≥1/10000, <1/1000), very rarely (<1/10000), the frequency is unknown (due to insufficient data). Associated with the presence of paracetamol: From the immune system: anaphylaxis, skin hypersensitivity reactions, including skin rash, angioedema, Stevens-Johnson syndrome / toxic epidermal necrolysis. From the blood system: anemia, methemoglobinemia, thrombocytopenia, agranulocytosis. From the respiratory system: bronchospasm in patients sensitive to aspirin and other NSAIDs. Hepatobiliary disorders: abnormal liver function. Associated with the presence of rimantadine: From the side of the cardiovascular system: tachycardia, heart failure, heart block (cardiac arrhythmias), palpitations, arterial hypertension, cerebrovascular accident, loss of consciousness. From the nervous system: insomnia, dizziness, headache, irritability, fatigue, impaired concentration, movement disorders, drowsiness, depressed mood, euphoria, hyperkinesia, tremor, hallucinations, confusion, convulsions. From the senses: tinnitus, change or loss of smell. From the respiratory system: shortness of breath, bronchospasm, cough. From the gastrointestinal tract: nausea, vomiting, loss of appetite, dryness of the oral mucosa, abdominal pain, diarrhea, dyspepsia. From the skin and subcutaneous tissue: rash. Other: fatigue. Associated with the presence of cetirizine: From the immune system: rarely - hypersensitivity reactions, very rarely - anaphylactic shock. Metabolic and nutritional disorders: frequency unknown - increased appetite. From the nervous system: infrequently - paresthesia, rarely - convulsions, very rarely - taste perversion, dyskinesia, dystonia, fainting, tremor, frequency unknown - deafness, amnesia, memory impairment. Mental disorders: infrequently - agitation, rarely - aggression, confusion, depression, hallucinations, sleep disturbance, very rarely - tick, frequency unknown - suicidal thoughts. On the part of the organ of vision: very rarely - disturbance of accommodation, blurred vision, nystagmus, frequency unknown - vasculitis. On the part of the organ of hearing and balance: the frequency is unknown - vertigo. From the digestive system: infrequently - diarrhea. From the side of the cardiovascular system: rarely - tachycardia. From the urinary system: very rarely - dysuria, enuresis, the frequency is unknown - urinary retention. From the blood and lymphatic system: very rarely - thrombocytopenia. On the part of the skin: infrequently - rash, itching, rarely - urticaria, very rarely - angioedema, persistent erythema. On the part of laboratory parameters: rarely - changes in liver function tests (increased levels of transaminases, alkaline phosphatase, ?-glutamate transferase and bilirubin), weight gain. General disorders: infrequently - asthenia, malaise, rarely - peripheral edema. Associated with the presence of ascorbic acid: From the side of the central nervous system: headache, fatigue, with prolonged use of large doses - increased excitability of the central nervous system, sleep disturbances. From the digestive system: irritation of the gastrointestinal mucosa, nausea, vomiting, diarrhea, stomach cramps. From the endocrine system: inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria). From the urinary system: when used in high doses - hyperoxalaturia and the formation of urinary stones from calcium oxalate. From the side of the cardiovascular system: thrombosis, when used in high doses - increased blood pressure, the development of microangiopathies, myocardial dystrophy. Allergic reactions: skin rash, rarely - anaphylactic shock. Laboratory indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia. Others: hypervitaminosis, sensation of heat, with prolonged use of large doses - sodium (Na +) and fluid retention, impaired metabolism of zinc (Zn +), copper (Cu +). Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life - 2 years. Do not use after the expiration date indicated on the package. Buy Grippomix powder for oral solution (lemon) in bags 10g №10 powder for solution for oral administration (lemon) in bags 10g №10