Active substanceParacetamol + Phenylephrine + Ascorbic acidParacetamol + Phenylephrine + Ascorbic acid
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  • Dosage form: & nbspPowder for solution for oral administration [lemon]
    Composition:

    Composition per 1 sachet:

    Active substances:

    paracetamol 1000 mg,

    ascorbic acid 40 mg,

    phenylephrine hydrochloride 10 mg.

    Excipients: sucrose 3725 mg, citric acid 680 mg, sodium citrate 430 mg, corn starch 200 mg, flavoring lemon 200 mg, sodium cyclamate 79 mg, sodium saccharinate 54 mg, dye curcumin (E 100) 7 mg, silicon dioxide colloid 2 mg.

    Description:Light yellow, loose, heterogeneous powder with lemon scent. The powder dissolves in hot water with the formation of a cloudy yellowish-green solution without surface foam and solid inclusions, with the smell of lemon.
    Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic agent + alpha-adrenomimetic + vitamin)
    ATX: & nbsp

    N.02.B.E   Anilides

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

    Pharmacodynamics:

    Coldrex® MaxGrip is a combined preparation. Paracetamol has analgesic and antipyretic effect. The drug contains the maximum single dose of paracetamol, permitted for over-the-counter use. Phenylephrine - vasoconstrictor, relieves nasal congestion (narrows the vessels of the nasal mucosa and paranasal sinuses) and facilitates breathing. Ascorbic acid (vitamin C) replenishes the increased need for vitamin C for colds and flu.

    The active ingredients of Coldrex® MaxGripp do not cause drowsiness.

    Pharmacokinetics:

    Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract; distribution in body fluids is relatively even. Metabolized mainly in the liver with the formation of several metabolites. The half-life with a therapeutic dose is 2-3 hours.

    The majority of the drug is excreted after conjugation in the liver. In unchanged form, not more than 3% of the received dose of paracetamol is released.

    Ascorbic acid is well absorbed from the gastrointestinal tract, the connection with plasma proteins is 25%, the distribution in the tissues of the body is wide. Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged.

    Ascorbic acid, taken in excessive amounts, is quickly excreted unchanged in urine.

    Phenylephrine is poorly absorbed from the gastrointestinal tract and is metabolized by the "primary passage" in the intestine and liver under the action of monoamine oxidase. When taking phenylephrine inside the bioavailability of the drug is limited. It is excreted in urine almost completely in the form of a sulfuric acid conjugate.

    Indications:

    Elimination of the symptoms of "colds" and flu:

    - high temperature,

    - headache,

    - chills,

    - pain in the joints and muscles,

    - nasal congestion,

    - sore throat,

    - pain in the sinuses of the nose.

    Contraindications:- hypersensitivity to paracetamol, phenylephrine, ascorbic acid (vitamin C) or any other ingredient in the preparation;
    - pregnancy or lactation;
    severe liver or kidney disease;
    - diseases of the blood system;
    - increased function thyroid glands (thyrotoxicosis);
    - arterial hypertension;
    - heart disease (pronounced stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmia);
    - hyperplasia of the prostate;
    - an angle-closure glaucoma;
    - simultaneous admission tricyclic antidepressants, beta-adrenoblockers, MAO inhibitors and up to 14 days after their cancellation;
    - diabetes mellitus and diseases associated with a hereditary violation of sugars absorption - each packet contains 4 g of sugar;
    - genetic absence of glucose-6-phosphate dehydrogenase;
    - age to 18 years;
    - deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, t. the composition of the drug includes sucrose.
    Carefully:In benign hyperbilirubinemia, pheochromocytoma, vasospastic diseases (Raynaud's syndrome), diseases of the cardiovascular system, simultaneous admission with other antihypertensive drugs.
    Pregnancy and lactation:The drug is contraindicated during pregnancy and during breastfeeding.
    Dosing and Administration:

    Put the contents of one sachet in a mug and pour half a mug of hot water. Stir until dissolved. Add cold water, if necessary, and sugar to taste.

    Adults:

    One packet every 4-6 hours.

    Do not take more than 4 sachets in 24 hours.

    Do not take the drug more than 4 hours later.

    The drug is not recommended for more than 5 days without consulting a doctor.

    If symptoms persist, consult a physician.

    DO NOT EXCEED THE INDICATED DOSE.

    Side effects:Side effects are classified according to organ systems and frequency. Frequency of collateral effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely (greater or is equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less 1/10 000).
    In recommended doses, the drug is usually OK is transferred.
    Paracetamol rarely has a side effect.
    From the hematopoiesis:
    Very rarely: thrombocytopenia, leukopenia, agranulocytosis.
    Allergic reactions:
    Very rarely: anaphylactic shock, cutaneous rash, hives, angioedema, Stevens-Johnson syndrome.
    From the respiratory system:
    Very rarely: bronchospasm in patients, sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
    From the liver and bile ducts:
    Very rarely: a violation of the liver.
    From the urinary system:
    with prolonged use with excess of the recommended dose, nephrotoxic effect can be observed.
    Phenylephrine
    From the nervous system:
    Very rarely: nervousness, headache, dizziness, insomnia.
    From the cardiovascular system:
    Very rarely: increased blood pressure, tachycardia, palpitation.
    From the digestive system:
    Very rarely: nausea, vomiting.
    From the sense organs:
    Very rarely: mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.
    From the skin and subcutaneous fabrics:
    Very rarely: allergic reactions (skin rash, hives, allergic dermatitis).
    From the urinary system:
    Very rarely: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.
    Ascorbic acid
    The incidence of side effects has not been established.
    Allergic reactions: skin rash, skin hyperemia.
    On the part of the digestive system: irritation of the mucous membrane of the gastrointestinal tract.
    From the hematopoiesis: thrombocytosis, hyperprotrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.
    When taking ascorbic acid more than 600 mg / day, moderate pollakiuria is possible.
    In case of side effects immediately stop taking the medication and consult a doctor as soon as possible.
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.
    Overdose:

    The drug should be taken only in recommended doses. When excess of the recommended dose immediately contact medical care, even if You feel good, because there is a risk of deferred serious damage to the liver.

    Overdose is due, as typically, paracetamol.

    Liver failure in adults possible when taking 10 or more grams of paracetamol. Receiving 5 and more gram of paracetamol can lead to liver damage in patients with the followingrisk factors:

    - long-term treatment with carbamazepine, phenobarbital, phenytoin, primidonom, rifampicin, drugs Hypericum perforatum, or other drugs, stimulating liver enzymes;

    - regular use of alcohol in excess quantities;

    - deficiency of glutathione (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

    Symptoms (due to paracetamol):

    Within 24 hours are possible: pallor of the skin, anorexia, nausea, vomiting, abdominal pain. During 12-48 hours, signs of a liver function disorder may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. In case of severe poisoning, severe hepatic insufficiency may develop hepatic encephalopathy, coma and death.

    Sharp renal Insufficiency with acute necrosis of the tubules, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without a serious impairment of liver function. There are reports of cardiac arrhythmias and pancreatitis in case of an overdose of paracetamol.

    When first signs overdose should immediately call a doctor, even if there are no distinct symptoms of poisoning. In the early period, the symptomatology can be limited only by nausea and vomiting and may not reflect the severity of the overdose or the risk of injury to the internal organs.

    Treatment: within the first hour after an alleged overdose it is advisable appointment activated carbon inside. Four or more hours after anticipated overdose is necessary determination of the concentration of paracetamol in the plasma (an earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine ​​can be carried out up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary acetylcysteine can be administered intravenously. In the absence of vomiting an alternative option (in the absence of the possibility of rapid receipt of inpatient care) is the appointment of methionine inside. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

    Symptoms (due to phenylephrine): irritability, headache, dizziness, insomnia, increased arterial pressure, nausea, vomiting, increased excitability, reflex bradycardia. AT severe cases of overdose possible the development of hallucinations, confusion, convulsions, arrhythmias.

    An overdose of phenylephrine can cause symptoms similar to the side effect (see the "Side effect" section).

    Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine.

    Symptoms (due to ascorbic acid): at application of more than 1000 mg - headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hypercalic gastritis, gastrointestinal mucosal damage, suppression of the function of the insulin pancreas apparatus (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to glomerular renal apparatus, decreased capillary permeability (possibly worsening trophism of tissues, increased blood pressure, hypercoagulation, development of microangiopathies ).

    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.Manifestations of an overdose of ascorbic acid can be categorized as those that are caused by severe liver damage as a result of an overdose of paracetamol.

    Treatment: symptomatic, forced diuresis.

    Interaction:Paracetamol when taken for a long time increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants.
    Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses and simultaneous administration with paracetamol.
    Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Paracetamol reduces the effectiveness of diuretic drugs. Metoclopramide and domperidone increase, and colestraminereduces the rate of absorption of paracetamol.
    Paracetamol increases the effects of MAO inhibitors, sedatives, ethanol.
    Phenylephrine when taken with MAO inhibitors may lead to an increase blood pressure.
    Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders. Simultaneous application of phenylephrine from sympathomimetic amines can increase the risk of side effects from the cardiovascular system. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, may increase the risk of side effects cardiovascular system.
    The simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.
    Antidepressants, antiparkinsonics, antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.Simultaneous use of glucocorticosteroids with phenylephrine increases the risk of developing glaucoma.
    When used simultaneously with digoxin and cardiac glycosides, there may be an increased risk of heart rhythm disturbances or heart attack.
    Ascorbic acid increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short acts, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.
    Ethanol promotes the development of acute pancreatitis. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
    Special instructions:The drug should not be taken concomitantly with other paracetamol-containing means, as well as other non-narcotic and analgesics, NSAIDs (metamizol sodium, acetylsalicylic acid, ibuprofen etc.), barbiturates, antiepileptic medicinal drugs and rifampicin, chloramphenicol, sympathomimetics (such as decongestants, drugs, suppressing appetite, amphetamine-like psychostimulants), with other drugs to relieve the symptoms of "colds" and flu.
    When performing tests for the determination of uric acid and blood glucose level, tell your doctor about the use of the drug "Coldrex"® MaxGrip, "since the drug may distort the results laboratory tests assessing the concentration of glucose and urinary acid.
    Before taking "Coldrex"® MaxGripp " is needed doctor's consultation in case of:
    - reception metoclopramide, domperidone (used to eliminate nausea and vomiting) or colstrum used to reduce cholesterol in the blood;
    - taking medications to reduce blood clotting (eg, warfaria);
    - compliance with a diet with a lower sodium content - each the sachet contains 0,12 g of sodium
    - (including sepsis) in patients with glutathione deficiency, as the risk of metabolic acidosis may increase in the presence of paracetamol (see also the section on overdose), the signs of which are violation of the frequency and depth of breathing accompanied by a feeling of shortage of air ( shortness of breath), nausea, vomiting, loss of appetite.If you find symptoms in your body, you should immediately consult a doctor.
    TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT COMBINE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TAKE PERSONS, CHRONICALLY CONSUMER ALCOHOL.
    Effect on the ability to drive transp. cf. and fur:Does not render (at reception in recommended doses). When dizziness occurs, it is not recommended to drive vehicles or operate machinery.
    Form release / dosage:

    Powder for solution for ingestion (lemon).

    Packaging:

    By 6.427 g of powder in multi-layer bags (paper / aluminum foil / polyethylene). For 5 or 10 bags together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014920 / 01
    Date of registration:15.05.2009
    The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom
    Information update date: & nbsp27.09.2015
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