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Dosage form: & nbspfilm-coated tablets
Composition:

1 tablet contains

Active substances:

paracetamol * (acetaminophen) 325 mg

chlorpheniramine maleate 2 mg

phenylephrine hydrochloride 5 mg

Excipients: cellulose microcrystalline 45.9 mg, sodium croscarmellose 9 mg, silicon dioxide colloid 3 mg, stearic acid 11 mg, magnesium stearate 2 mg, dye Yellow No. 10 (quinoline yellow) 0.9 mg.

Sheath: hypromellose 2.29 mg, mineral oil 0.41 mg, macrogol 0.41 mg, magnesium silicate 3.0 mg.

* Paracetamol in the form of granules DC 90% - 361.1 mg (paracetamol 325.0 mg, pregelatinized starch 21.31 mg, povidone K-30 2.17 mg, stearic acid 7.22 mg, sodium carboxymethyl starch 5.42 mg) .

Description:The tablets are yellow capsular-shaped, covered with a transparent film shell with an engraving "AntiFlu" on one side.
Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic means + alpha-adrenomimetic + H1-histamine receptor blocker)
ATX: & nbsp
  • 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.

    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 impairment of liver and kidney function, angle-closure glaucoma, prostatic hypertrophy, deficiency of glucose-6-phosphate dehydrogenase. The drug should not be taken concurrently with drugs that are monoamine oxidase inhibitors, hypnotics, tranquilizers and other drugs containing paracetamol. Do not use in children under 6 years.
    Carefully:

    Use with caution in: arterial hypertension, severe cardiovascular disease, diabetes, bronchial asthma, chronic obstructive pulmonary disease,thyrotoxicosis, pheochromocytoma, severe liver or kidney disease, difficulty urinating with prostate adenoma, blood diseases, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rother syndrome), viral hepatitis, hyperoxaturia.

    Pregnancy and lactation:Not recommended for use during pregnancy and during breastfeeding.
    Dosing and Administration:
    Inside. Adults and children over 12 years of age take 1-2 tablets every 4 hours, but not more than 8 tablets per day.

    Single doses for children depend on the weight of the child and are calculated by the content of paracetamol: 10-15 mg per 1 kg of body weight, which for a child from 6 to 12 years corresponds to 1 tablet 2 times a day, with an interval between meals of at least 6 hours. DurationThe 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),polymorphon-bullous erythema (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, angioedema, 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, stomach pain, dry mouth, hepatotoxic effect, diarrhea.

    From the liver and biliary tract: liver damage (increased activity of "liver" enzymes), hepatitis, as well as dose-dependent hepatic insufficiency, liver necrosis (including fatal). Prolonged unjustified use can lead to liver fibrosis, liver cirrhosis, including fatal.

    On the part of the respiratory system: 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 risingdose 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 to 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.

    Chlorpheniramine. 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.

    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 liver enzymes. Ethanol increases the sedative effect of chlorphenamine. 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. Chlorpheniramine maleate simultaneously 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.

    With simultaneous application with chloramphenicol, it is possible to increase the period of its half-elimination from the blood 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 indirect 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 together with zidovudine without the recommendation of a doctor because of the increasing tendency to decrease the number of white blood cells (neutropenia).
    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:Tablets, film-coated 325 mg + 5 mg + 2 mg.
    Packaging:

    For 12 tablets in a blister of PVC / Al foil. The blister is divided by perforation into two equal parts. 1 blister together with instructions for use are placed 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. He use at expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012271 / 02
    Date of registration:06.08.2010 / 28.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp07.09.2017
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