Properties
What is it?
Trade name ANTIFLU Dosage form Soluble powder Description White, slightly yellowish loose powder with crystalline particles, with a faint lemon odor. Composition Active ingredients: (per 1 sachet): Acetaminophen 650mg, Phenylephrine hydrochloride 10mg, Chlorpheniramine maleate 4mg. Excipients: Ascorbic acid, Sugar (powdered sugar), Sugar (sucrose), Citric acid, Silicon dioxide, Colloidal silicon dioxide, Lemon flavoring, Trisodium citrate, Starch (corn starch), Titanium dioxide, Tricalcium phosphate, D&C Yellow No. 10 (E104), FD&C Yellow No. 6 (E110). Pharmacotherapeutic group Preparation for use in cold-related diseases. ATC code: N02BE51 Pharmacological properties Acetaminophen (paracetamol) has analgesic, antipyretic, and weak anti-inflammatory effects. It reduces headache, muscle and joint pain, as well as sore throat. Phenylephrine hydrochloride has a vasoconstrictive effect, reduces swelling and hyperemia of the nasal and nasopharyngeal mucosa, and facilitates nasal breathing. Chlorpheniramine maleate has an antihistamine effect: it reduces swelling of the nasal mucosa, nasopharynx, and upper respiratory tract, and reduces eye itching. Indications For the symptomatic treatment of acute respiratory diseases of the upper respiratory tract (hyperthermia, headache, joint and muscle pain, nasal congestion, runny nose, tearing) and influenza. Dosage and administration For adults: Dissolve one sachet in a glass of hot water and consume hot. If necessary, repeat every 4 hours, but not more than 4 doses per 24 hours. Sugar and honey can be added to taste. Side effects Allergic reactions: skin rash, itching, urticaria, toxic epidermal necrolysis (Lyell's syndrome), polymorpho-bullous erythema (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, angioneurotic edema (Quincke's edema), anaphylactic shock. CNS: dizziness, increased excitability (especially in children), sleep disturbances, drowsiness, decreased psychomotor reaction speed, feeling of fatigue. Hematopoietic system: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, hemolytic anemia, methemoglobinemia, pancytopenia. Gastrointestinal system: nausea, vomiting, abdominal pain, dry mouth, diarrhea. Liver and biliary tract: liver dysfunction (increased liver enzyme activity), hepatitis, as well as dose-dependent liver failure, liver necrosis. Prolonged unjustified use can lead to liver fibrosis, liver cirrhosis. Respiratory organs: bronchospasm or exacerbation of bronchial asthma, including in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Cardiovascular system: palpitations, increased blood pressure. Urinary system: urinary retention, prolonged intake of high doses can lead to nephrotoxic effects. Other: mydriasis, paralysis of accommodation, increased intraocular pressure. Contraindications Hypersensitivity to individual components of the preparation. Portal hypertension, alcoholism, renal failure, severe liver and kidney dysfunction, angle-closure glaucoma, prostatic hypertrophy, sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, glucose-6-phosphate dehydrogenase deficiency. Age under 18 years. Simultaneous administration of the preparation is not allowed with monooxygenase inhibitors, hypnotics, tranquilizers, and preparations containing paracetamol. Use with caution: arterial hypertension, severe cardiovascular diseases, diabetes mellitus, bronchial asthma, chronic obstructive pulmonary diseases, thyrotoxicosis, pheochromocytoma, severe liver and kidney diseases, difficulty urinating with benign prostatic hyperplasia, blood diseases, congenital hyperbilirubinemia (Gilbert's, Dubin-Johnson, and Rotor syndromes), viral hepatitis, hyperoxaluria. Overdose In case of overdose, seek immediate medical attention. Paracetamol. Manifests with daily intake of more than 10-15g. Symptoms: paleness of the skin, diarrhea, loss of appetite, nausea and vomiting, discomfort in the abdominal cavity and/or abdominal pain, increased sweating. The clinical picture of paracetamol overdose develops 6-14 hours after intake. Symptoms of chronic overdose appear 2-4 days after taking increased doses of the preparation. In case of severe poisoning, liver failure develops, including hepatic encephalopathy, coma, and death. Hypokalemia and metabolic acidosis (including lactic acidosis) can develop with acute and/or chronic overdose. Frequent clinical manifestations after 3-5 days include: jaundice, fever, halitosis, hemorrhagic diathesis, hypoglycemia, liver failure. Acute liver failure with acute tubular necrosis, diagnosed by lumbar pain, hematuria, and proteinuria, can develop independently of severe liver damage. The overdose threshold may be low in patients taking certain medications, alcohol, or who are severely depleted. Treatment: gastric lavage, activated charcoal within the first 6 hours, administration of SH group donors, methionine (precursor of glutathione synthesis) 8-9 hours after overdose, and N-acetylcysteine 12 hours after overdose. Chlorpheniramine. Symptoms: dizziness, excitability, sleep disturbances. Treatment: symptomatic. Phenylephrine. Symptoms: excitability, headache, dizziness, in severe cases, hallucinations, confusion, seizures, increased blood pressure, and arrhythmia may develop. Treatment: symptomatic, use of alpha-adrenoblockers such as phentolamine for severe arterial hypertension. Ascorbic acid. High doses of ascorbic acid (over 3000 mg) can cause temporary ostiomyolitic diarrhea and gastrointestinal disturbances such as nausea and discomfort in the stomach area. Treatment: symptomatic, forced diuresis. Special instructions and precautions During treatment, alcohol, hypnotics, and anxiolytics (tranquilizers) should be prohibited. Even small amounts of alcohol taken with paracetamol increase the potential risk of liver toxicity. Reports of serious skin reactions are very rare. If redness, rash, blistering, or peeling of the skin occurs, paracetamol treatment should be discontinued and a doctor should be consulted. The risk of liver damage is increased in patients with alcoholic steatohepatitis. Alters laboratory test results for quantitative determination of glucose and plasma urea nitrogen. During long-term treatment, it is necessary to monitor peripheral blood and liver functional parameters. Do not take with other medications containing paracetamol. If hyperthermia lasts longer than 3 days, and pain syndrome lasts longer than 5 days, a doctor's consultation is necessary. Pregnancy and lactation It is not recommended to take the preparation during pregnancy and lactation. Effect on ability to drive and operate machinery During treatment, it is advisable to avoid driving vehicles, operating machinery, and other potentially dangerous activities. Interactions with other medicinal products It is recommended to refrain from taking monoamine oxidase inhibitors, sedatives, and ethanol with the preparation. The risk of developing hepatotoxicity by paracetamol increases when taken with barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine, and other inducers of liver microsomal enzymes. Ethanol enhances the sedative effect of chlorpheniramine. Antidepressants, antiparkinsonian, and phenothiazine antipsychotic drugs increase the risk of side effects (urinary retention, dry oral mucosa, constipation). Glucocorticosteroids increase the risk of glaucoma development. Paracetamol reduces the effectiveness of uricosuric drugs and increases the effectiveness of indirect anticoagulants. Chlorpheniramine with monoamine oxidase inhibitors, e.g., furazolidone, can cause hypertensive crisis, excitability, hyperpyrexia. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine; simultaneous administration with halothane increases the risk of ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine. Ascorbic acid increases the absorption of penicillin and iron, reduces the clinical effect of heparin and indirect anticoagulants, increases the risk of crystalluria when taking salicylates and short-acting sulfonamides, slows down the excretion of acids from the kidneys, increases the excretion of drugs with alkaline reactions (including alkaloids), and reduces the concentration of oral contraceptives in the blood. Simultaneous administration with chloramphenicol may increase the half-life from blood plasma and enhance toxic effects. Paracetamol (or its metabolites) interacts with the enzyme involved in the synthesis of vitamin K-dependent clotting factors. Its interaction with paracetamol and warfarin or coumarin derivatives can lead to an increase in the overall normalized ratio and the risk of bleeding. Patients taking oral anticoagulants should not take paracetamol long-term without medical supervision. Antagonists of tropisetron and granisetron, type 3 5-hydroxytryptamine may completely inhibit the analgesic effect of paracetamol due to pharmacodynamic interaction. Paracetamol should not be taken with zidovudine without a doctor's consultation, as there is an increased risk of reduced white blood cell count (neutropenia). Storage conditions At a temperature not exceeding +25 0 C, out of reach of children. Shelf life 3 years. Do not use after the expiry date indicated on the packaging. Form of release 5 sachets are placed in a cardboard box with a leaflet. Dispensing conditions Over-the-counter Applicant / Manufacturer Name, Address Bayer Consumer Care AG Peter Merian-Strasse 84, 4052 Basel Switzerland Contract Pharmacal Corporation, 135 Adams Avenue, Hauppauge, New York, 11788 USA