Active substanceAcetylsalicylic acid + Caffeine + ParacetamolAcetylsalicylic acid + Caffeine + Paracetamol
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    Names of the substance

    Amount, mg

    Active substances

    Acetylsalicylic acid

    250,00

    Caffeine

    65,00

    Paracetamol

    250,00

    Excipients

    Sodium carboxymethyl starch

    24,00

    Starch

    22,8

    Povidone K-30

    7,4

    Stearic acid

    8,00

    Microcrystalline cellulose

    16,00

    Casing of the tablet

    Opadry II White:

    hypromellose

    6,0

    macrogol

    0,3

    maltodextrose

    0,2

    Titanium dioxide

    0,02

    Description:White, round, film-coated tablets with embossing "FR9" on one side. In the break, the tablets are white.
    Pharmacotherapeutic group:An analgesic agent combined (non-steroidal anti-inflammatory drug + analgesic non-narcotic agent + psychostimulating agent)
    ATX: & nbsp

    N.02.B.A.51   Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Migrenol® Extra is a combined preparation. Paracetamol has analgesic, antipyretic and extremely weak anti-inflammatory effect, which is associated with its influence on the center of thermoregulation in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues.

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

    Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, dilates the blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation, reduces drowsiness, fatigue, increases mental and physical performance. 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 normalization of the vascular tone of the brain and the acceleration of blood flow.

    Pharmacokinetics:

    Paracetamol it is easily absorbed in the gastrointestinal tract (GIT), the maximum concentrations in the blood plasma are detected in the interval from 30 minutes to 2 hours after ingestion. Paracetamol metabolized in the liver and excreted by the kidneys, mainly in the form of glucuronides and sulfate conjugates. Less than 5% of paracetamol is excreted unchanged. The duration of the half-life period varies from 1 to 4 hours. The connection with plasma proteins is negligible at usual therapeutic doses, however, it increases with increasing dose. Hydroxylated metabolite, formed in small amounts in the liver under the influence of mixed oxidases and usually rendered harmless by binding to glutathione, can accumulate in case of an overdose of paracetamol and cause liver damage.

    Acetylsalicylic acid quickly and completely absorbed, undergoes rapid hydrolysis in the gastrointestinal tract, liver and blood to the formation of salicylates, which undergo further metabolism, mainly in the liver.

    Caffeine completely and quickly absorbed. The maximum concentrations are observed in the interval from 5 to 90 minutes after administration on an empty stomach. In adults, completely occurs through hepatic metabolism. There is a pronounced variability in the individual values ​​of elimination in adults. The mean half-life (T1/2) from the blood plasma is 4.9 hours in the range of 1.9-12.2 hours. Caffeine is distributed in all liquid media of the body. Communication of caffeine with plasma proteins is 35%. Caffeine almost completely metabolized by oxidation, demethylation and acetylation and excreted by the kidneys. The main metabolites are: 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine.

    Indications:

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

    Contraindications:

    Hypersensitivity to any of the components of the drug; erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation); gastrointestinal bleeding; bronchial asthma; urticaria or acute rhinitis, triggered by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; gantryhypertension; Vitamin K vitamin deficiency; kidney failure; pregnancy; the period of breastfeeding; deficiency of glucose-6-phosphate dehydrogenase; severe arterial hypertension; severe course of ischemic heart disease; glaucoma; increased excitability; sleep disorders; surgical interventions accompanied by bleeding; with febrile syndrome - children under 18 years of age, with pain syndrome - children under 15 years (the risk of developing Reye syndrome in children with hyperthermia in the background of viral diseases).

    Carefully:

    Gout, liver disease.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    The drug is taken orally during or after a meal.

    To relieve the pain syndrome, adults and children over 15 years old - 1 tablet every 4-6 hours, adults with febrile syndrome - 2 tablets every 6 hours.

    The average daily dose is 3-4 tablets, the maximum daily dose of 8 tablets. The course of treatment is not more than 7-10 days.

    The drug should not be taken more than 5 days as an analgesic drug and more than 3 days - antipyretic (without appointment and supervision of a doctor).

    Side effects:

    Allergic reactions: skin rash, itching, angioedema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm.

    From the gastrointestinal tract: gastralgia, nausea, vomiting, hepatotoxicity, erosive-ulcerative lesions of the gastrointestinal tract.

    From the cardiovascular system: tachycardia, increased blood pressure.

    From the sense organs: impaired vision, tinnitus, deafness.

    From the central nervous system: dizziness, headache.

    From the urinary system: nephrotoxicity, renal damage with papillary necrosis.

    From the coagulation system of the blood: anemia, decreased platelet aggregation, thrombocytopenia, hypocoagulation, hemorrhagic syndrome (new bleeding, bleeding gums, purpura, etc.).

    Reye's syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

    Overdose:

    Symptoms, caused by the presence of paracetamol: during the first 24 hours the pallor of the skin, nausea, vomiting, anorexia, abdominal pain,disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose, renal failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

    Symptoms due to the presence of acetylsalicylic acid: with the lungs intoxication - nausea, vomiting, dizziness, tinnitus, impaired vision, severe headache; with severe intoxication - hyperventilation of the lungs of the central genesis (dyspnea, choking, cyanosis, cold sticky sweat, respiratory paralysis), respiratory acidosis. The greatest risk of developing chronic intoxication is noted in children and the elderly with more than 100 mg / kg / day for several days.

    Symptoms due to the presence of caffeine: gastralgia, agitation, anxiety, agitation, motor anxiety, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity,tremor or muscle twitching; nausea and vomiting, sometimes with blood; ringing in the ears, epileptic seizures (with acute overdose - tonic-clonic).

    Treatment: constant monitoring of the acid-base state and electrolyte balance. Depending on the state of metabolism - the introduction of sodium bicarbonate, sodium citrate or sodium lactate. Increasing alkalinity increases the excretion of acetylsalicylic acid due to alkalinization of urine. Gastric lavage in the first 4 hours, provocation of vomiting, intake of activated carbon, laxative drugs, administration of donators SH-groups and precursors of the synthesis of glutathione methionine for 8-9 hours after an overdose and acetylcysteine ​​- for 8 hours.

    Interaction:

    Acetylsalicylic acid. Strengthens the action 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, hypotensive drugs,as well as anti-arthritis drugs that promote the excretion of uric acid.

    Paracetamol. 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 T1 / 2 Chloramphenicol increased by 5 times. Upon repeated admission, paracetamol can enhance the effect of anticoagulants (coumarin derivatives). Simultaneous reception of paracetamol and ethanol increases the risk of hepatotoxic effects.

    Caffeine. Accelerates the absorption of ergotamine, reduces the absorption of calcium preparations in the digestive tract, reduces the effect of narcotic and hypnotics.

    Special instructions:

    If symptoms persist after taking the drug, worsening or new symptoms occur, immediately consult a doctor.

    When taking the drug in the recommended dose, the body receives the same amount of caffeine as is contained in one cup of coffee,so you should reduce the consumption of caffeine-containing products when treated with this drug in order to avoid the development of nervous excitement, irritability, insomnia and rapid heartbeat against the background of an overdose of caffeine. If you suspect an overdose, you should immediately seek medical help, even if you have no symptoms. It should be refrained from drinking alcohol when taking the drug in connection with an increased risk of liver damage and gastrointestinal bleeding.

    With continued use of the drug, control of peripheral blood and the functional state of the liver is necessary. Because the acetylsalicylic acid slows the clotting of the blood, the patient, if he is to undergo surgery, must warn the doctor in advance about taking the drug.

    Acetylsalicylic acid in low doses reduces the excretion of uric acid. In patients with a corresponding predisposition, this can in some cases provoke a gout attack.

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

    It was not reported on the effect of the drug on the ability to drive vehicles and service mechanisms.

    Form release / dosage:

    Film-coated tablets.

    Packaging:

    For 8 tablets in a blister of PVC / aluminum foil. For 1 or 2 blisters together with instructions for use in a cardboard bundle.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use the product after the expiration date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002201
    Date of registration:23.08.2013
    Expiration Date:23.08.2018
    The owner of the registration certificate: Foor Ventures Enterprise, Inc. Foor Ventures Enterprise, Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspMASKOVI COMPANY LTDMASKOVI COMPANY LTD
    Information update date: & nbsp24.04.2018
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