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Dosage form: & nbspPills.
Composition:

1 tablet contains:

active substances: Acetylsalicylic acid - 240 mg, paracetamol - 180 mg, caffeine (in terms of monohydrate) - 30 mg;

Excipients: cocoa powder 22.5 mg, citric acid monohydrate 5.0 mg, potato starch 64.2 mg, talc 4.9 mg, calcium stearate 2.8 mg, polysorbate 80 mg 0.6 mg.

Description:

Tablets of light brown color with impregnations, flat-cylindrical form with a risk and a facet, with a smell of cocoa.

Pharmacotherapeutic group:Analgesic combined (NSAIDs + analgesic non-narcotic remedy + psychostimulant)
ATX: & nbsp
  • Acetylsalicylic acid in combination with psycholeptics
  • Pharmacodynamics:

    Combined drug.

    Acetylsalicylic acid has antipyretic and anti-inflammatory effect, relieves pain, especially caused by the inflammatory process, and also moderately inhibits platelet aggregation and thrombosis, improves microcirculation in the inflammatory focus.

    Paracetamol has an analgesic, antipyretic and weak anti-inflammatory effect, which is related to its effect on the center of thermoregulation in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins (Pg) in peripheral tissues.
    Caffeine increases the reflex, excitability of the spinal cord,stimulate the respiratory and vasomotor centers, dilates blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, fatigue. In this combination caffeine in a small dose practically does not have a stimulating effect on the central nervous system, but it contributes to the regulation of the tone of the vessels of the brain.

    Pharmacokinetics:
    Indications:

    Pain syndrome of mild and moderate severity (of various origins): headache, migraine, toothache, neuralgia, myalgia, arthralgia, algodismenorea. Feverish syndrome: with acute respiratory infections, including influenza.

    Contraindications:

    - hypersensitivity to the components of the drug;

    - erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

    - gastrointestinal bleeding (including anamnesis);

    - complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (including in anamnesis);

    - severe violations of the liver and / or kidney function;

    - hemorrhagic diathesis, hypocoagulation, hemophilia, hypoprothrombinemia;

    - pregnancy (I and III trimesters);

    - the period of breastfeeding;

    - surgical interventions, accompanied by heavy bleeding; ,

    - deficiency of glucose-6-phosphate dehydrogenase;

    - glaucoma;

    - severe arterial hypertension;

    - portal hypertension;

    - severe course of ischemic heart disease;

    - avitaminosis K;

    - children under 15 years of age (risk of developing Reye's syndrome in children with hyperthermia in the presence of a viral disease);

    increased excitability, sleep disturbance.
    Carefully:

    Renal failure of mild to moderate degree, liver disease, alcoholism, epilepsy and propensity to convulsive seizures, elderly age, gout, pregnancy (II trimester).

    Pregnancy and lactation:

    Application in pregnancy and during breastfeeding

    In pregnancy (I and III trimesters) and during breastfeeding, the drug is contraindicated. In the second trimester of pregnancy, the drug should be used with caution, correlating the perceived benefit to the mother and the potential risk to the fetus.

    Dosing and Administration:

    Inside (during or after a meal), 1 tablet every 4 hours, with pain - 1-2 tablets; the average daily dose of 3-4 tablets, the maximum daily dose - 8 tablets. The use of the drug is not more than 7-10 days. To reduce the irritant effect on the gastrointestinal tract, you should drink the tablet with milk or alkaline mineral water.

    Side effects:

    Side reactions typical of acetylsalicylic acid paracetamol and caffeine can be observed: anorexia, nausea, vomiting, gastralgia (decreased platelet aggregation), erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, allergic reactions, bronchospasm, multiforme exudative erythema including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), renal failure, hepatic insufficiency, dizziness, tachycardia, increased arterial pressure and I.

    With prolonged use, dizziness, headache, visual disturbances, tinnitus, reduced platelet aggregation, hypocoagulation, hemorrhagic syndrome (nosebleeds, bleeding gums, purpura, etc.) are possible,kidney damage with papillary necrosis; deafness, Reye's syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

    Overdose:

    Do not exceed the recommended dose and duration of use!

    Symptoms:
    - with light intoxication: nausea, vomiting, stomach pain, dizziness, ringing in the ears;
    - with severe intoxication: inhibition, drowsiness, collapse, convulsions, shortness of breath, anuria, bleeding.
    Treatment: gastric lavage with activated charcoal, symptomatic therapy, depending on the state of metabolism - the introduction of sodium bicarbonate, sodium citrate or sodium lactate, which increases the excretion of acetylsalicylic acid due to alkalinization of urine.

    Interaction:

    Enhances the effect of heparin, indirect anticoagulants, reserpine, steroid hormones and hypoglycemic drugs.

    Simultaneous use with other non-steroidal anti-inflammatory drugs, methotrexate increases the risk of side effects.

    - Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs means, as well as anti-arthritis drugs that promote the excretion of uric acid.

    Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other stimulants of microsomal oxidation contribute to the formation of toxic metabolites of paracetamol that affect liver function.

    Metoclopramide accelerates the absorption of paracetamol.

    Under the influence of paracetamol, the half-life (T1 / 2) of chloramphenicol increases five-fold. At repeated reception paracetamol can enhance the effect of anticoagulants (derivatives of dicumarin).

    Caffeine accelerates the absorption of ergotamine.

    With the simultaneous administration of the drug and alcohol-containing liquids, the risk of toxic damage to the liver increases.

    Special instructions:

    Acetylsalicylic acid slows blood clotting. If the patient is to undergo surgery, the doctor should be warned about taking the drug.

    With continued use of the drug, control of peripheral blood and the functional state of the liver is necessary.

    Patients with hypersensitivity or asthmatic reactions to salicylic acid and its derivatives, including acetylsalicylic acid,can be administered only with special precautions (in emergency services).

    In patients with a predisposition to accumulation of uric acid, taking the drug may trigger a gout attack.

    During admission, you should refrain from drinking alcohol (increased risk of gastrointestinal bleeding and toxic damage to the liver).

    Acetylsalicylic acid has a teratogenic effect; when applied in the first trimester leads to a developmental defect - splitting of the upper palate; in the third trimester - to inhibition of labor (inhibition of synthesis Pg), to the closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the small circle of blood circulation. Excreted in breast milk, which increases the risk of bleeding in the child due to violation function of platelets.

    Children under 15 years of age should not be prescribed medications containing acetylsalicylic acid, since in the case of a viral infection they are capable of increase the risk of developing Reye's syndrome. Symptoms of Reye's syndrome are prolonged vomiting, acute encephalopathy, enlargement of the liver.

    Effect on the ability to drive transp. cf. and fur:

    There is no data on the impact on the management of vehicles and on the maintenance of machines and mechanisms that require concentration.

    Form release / dosage:

    Pills.

    Packaging:For 6 or 10 tablets in a contiguous, non-jawed package or 10 tablets per contour cell package.
    2 contour squares with instructions for use in a pack of cardboard.
    By 600 (10 tablets) or 900 (6 tablets) contour non-jammed packages or 1000 (10 tablets each).
    contour mesh packages together with an equal number of instructions for use are placed in a cardboard box.
    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:4 years.
    After expiration date the drug should not be used.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-005236/09
    Date of registration:30.06.2009 / 13.02.2015
    The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.03.2016
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