Active substanceParacetamol + Phenylephrine + ChlorphenamineParacetamol + Phenylephrine + Chlorphenamine
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  • Dosage form: & nbspPowder for solution for oral administration
    Composition:

    For one sachet:

    Active substances: paracetamol (acetaminophen) 650 mg,

    phenylephrine hydrochloride 10 mg,

    chlorpheniramine maleate 4 mg,

    ascorbic acid 85 mg.

    Excipients: sugar powder 3840 mg, sucrose 11565.38 mg, flavoring lemon 125 mg, citric acid 340 mg, silicon dioxide colloid 170 mg, silicon dioxide 173.4 mg, sodium citrate dihydrate 34 mg, titanium dioxide 1 mg, calcium phosphate 1 mg, dye FD&C yellow No. 6 (sunset yellow) 0.05 mg, dye FD&C yellow No. 10 (quinoline yellow) 0.17 mg, corn starch 1 mg.

    Description:

    A white or almost white mixture of powder and microgranules with inclusions of crystalline particles, with a specific odor.

    Description of the solution after dissolution: opaque solution of light yellow color with a faint smell of lemon.

    Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic agent + alpha-adrenomimetic + H1-histamine receptor blocker + vitamin)
    ATX: & nbsp

    N.02.B.E   Anilides

    N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Combined drug. Paracetamol has analgesic and antipyretic effect.

    Phenylephrine hydrochloride - alpha-adrenomimetic - has a vasoconstrictive effect, reduces swelling and hyperemia of the nasal mucosa and accessory sinuses. Chlorpheniramine maleate - blocker H1-gistaminovyh receptors - has anti-allergic effect, reduces the severity of local exudative manifestations, eliminates tearing, itching in the eyes and nose.

    Ascorbic acid (vitamin C) replenishes the increased need for vitamin C for colds and flu, especially in the initial stages of the disease. Increases the body's resistance to infections, improves the tolerability of paracetamol.

    Indications:

    Symptomatic treatment of ARVI, including influenza and "colds", accompanied by fever, chills, headache and muscle pain, runny nose and stuffiness of the nose, sore throat, body aches and sneezing.

    Contraindications:

    Hypersensitivity to individual components of the drug. Portal hypertension, alcoholism, renal failure, severe liver and kidney dysfunction, angle-closure glaucoma, prostatic hypertrophy, sugar deficiency / isomaltase, fructose intolerance, glucose-galactose malabsorption, glucose-6-phosphate dehydrogenase deficiency. Children under 18 years. The drug should not be taken concurrently with drugs that are monoamine oxidase inhibitors, hypnotics, tranquilizers and other drugs containing paracetamol.

    Carefully:

    With caution apply when: arterial hypertension, severe cardiovascular diseases, diabetes, bronchial asthma, chronic obstructive pulmonary disease, thyrotoxicosis, pheochromocytoma, severe liver or kidney problems, difficulty urinating with prostatic adenoma, blood disorders, congenital hyperbilirubinemia (Gilbert syndromes , Dubin-Johnson and Rother), viral hepatitis, hyperoxaturia.

    Pregnancy and lactation:Not recommended for use during pregnancy and during breastfeeding.
    Dosing and Administration:

    Inside. Adults appoint: 1 packet every 4 hours, but not more than 4 sachets a day. Before taking the contents of 1 sachet it is necessary to dissolve in a glass of hot water.

    Duration of treatment is no more than 3 days. In the absence of sufficient therapeutic effect, the presence of a high temperature, which is kept on the background of treatment for more than 3 days, as well as the appearance of new symptoms - it is urgent to see a doctor.

    Side effects:

    Allergic reactions: skin rash, itching, urticaria, toxic epidermal necrolysis (Lyell syndrome), erythema polymorphin-biliary (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, angioedema (Quincke's edema), anaphylactic shock.

    From the central nervous system: dizziness, increased excitability (especially in children), sleep disturbance, drowsiness, decreased speed of psychomotor reactions, a feeling of fatigue.

    On the part of the hematopoiesis system: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis; hemolytic anemia, methemoglobinemia, pancytopenia.

    From the digestive system: nausea, vomiting, pain in the stomach, dry mouth. diarrhea.

    Disturbances from the liver and bile ducts: liver damage (increased activity of "liver" enzymes), hepatitis, as well as dose-dependent hepatic insufficiency, liver necrosis. Prolonged unjustified use can lead to liver fibrosis, liver cirrhosis.

    Disturbances from the respiratory organs: bronchospasm or exacerbation of bronchial asthma, including in patients susceptible to acetylsalicylic acid or other NSAIDs.

    From the side of the cardiovascular system: a feeling of heartbeat, increased blood pressure.

    From the urinary system: urinary retention, with prolonged use of high doses of nephrotoxic action.

    Other: mydriasis, paresis of accommodation, increased intraocular pressure.

    Overdose:

    If an overdose occurs, seek medical help immediately.

    Paracetamol. It appears after taking more than 10-15 g of the latter. Symptoms: pallor of the skin, diarrhea, decreased appetite, nausea and vomiting, discomfort in the abdominal cavity and / or abdominal pain, increased sweating.The clinical picture of acute paracetamol overdose develops within 6-14 hours after paracetamol administration. Symptoms of chronic overdose appear after 2-4 days after increasing the dose of the drug. In case of severe poisoning, severe hepatic insufficiency may develop, including hepatic encephalopathy, coma, and death. Hypokalemia and metabolic acidosis (including lactic acidosis) can also develop in conditions of acute and / or chronic overdose. Frequent clinical manifestations after 3-5 days are jaundice, fever, liver odor from the mouth. hemorrhagic diathesis, hypoglycemia, hepatic insufficiency. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without a serious impairment of liver function. The overdose threshold can be reduced in patients taking certain drugs or alcohol, or who are seriously depleted. Treatment: gastric lavage, Activated carbon in the first 6 hours, the introduction of donors of SH-groups and precursors of the synthesis of glutathione-methionine after 8-9 hours after an overdose and N-acetylcysteine ​​after 12 hours.

    Chlorfeniramine. Symptoms: dizziness, agitation, sleep disturbances.Treatment: symptomatic.

    Phenylephrine. Symptoms: agitation, headache, dizziness, in severe cases, may develop hallucinations, confusion, seizures, increased blood pressure and arrhythmia. Treatment: symptomatic, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine.

    Ascorbic acid: high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disruptions to the gastrointestinal tract, such as nausea, discomfort in the stomach. Treatment: symptomatic, forced diuresis.

    Interaction:

    It is recommended to refrain from taking the drug when taking monoamine oxidase inhibitors, sedatives, ethanol. The risk of hepatotoxic effects of paracetamol increases with the simultaneous use of barbiturates, phenytoin, carbamazepine. rifampicin, zidovudine and other inducers of microsomal enzymes of the liver. Ethanol strengthens the sedative effect of chlorpheniramine. Antidepressants, antiparkinsonian and phenothiazine antipsychotic drugs increase the risk of side effects (urinary retention, dryness of the oral mucosa, constipation).Glucocorticosteroids increase the risk of developing glaucoma. Paracetamol reduces the effectiveness of uricosuric medicines and improves the effectiveness of indirect anticoagulants. Chlorpheniramine concurrently with monoamine oxidase inhibitors, furazolidone can lead to hypertensive crisis, excitation, hyperpyrexia. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, the simultaneous administration of 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 drugs of the penicillin and iron group, reduces the clinical effect of heparin and indirect anticoagulants, increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids) , reduces the concentration of oral contraceptives in the blood.

    With simultaneous application with chloramphenicol, it is possible to increase the half-life period from plasma and increase the toxic effect.

    Paracetamol (or its metabolites) interacts with enzymes involved in vitamin K-dependent synthesis of coagulation factor. Interaction between paracetamol and warfarin or coumarin-derivatives may result in increased international normalized ratio (INR) and an increased risk of bleeding. Patients taking oral anticoagulants should not take long paracetamol without medical supervision.

    Tropisetron and granisetron antagonists, 5-hydroxytryptamine type 3 can completely inhibit the analgesic effect of paracetamol through pharmacodynamic interaction.

    Paracetamol should not be taken with zidovudine without a doctor's recommendation because of the increased tendency to decrease the number of leukocytes (neutronization).

    Special instructions:

    During treatment should refrain from taking alcohol, sleeping pills and anxiolytic (tranquilizers) medicines. Moderate alcohol use and concomitant use of paracetamol potentially increases the risk of toxicity toliver. Very rare cases of serious skin reactions have been reported. In case of skin redness, rashes, blisters or scaling, stop using paracetamol and consult a doctor immediately.

    The risk of liver damage increases in patients with alcoholic hepatosis.

    Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma. In the case of long-term treatment, it is necessary to monitor the parameters of peripheral blood and the functional state of the liver. Do not take with other medicines containing paracetamol. With hyperthermia lasting more than 3 days, and pain syndrome for more than 5 days, a doctor's consultation is required.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, one should refrain from driving vehicles and performing actions requiring concentration of attention or psychomotor reactions.
    Form release / dosage:

    Powder for solution for oral administration.

    Packaging:For 17 grams in bags of laminated foil (paper / polyethylene / foil / polyethylene). For 5 bags together with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012271 / 01
    Date of registration:06.08.2010 / 15.09.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.09.2017
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