Active substanceParacetamol + Phenylephrine + Ascorbic acidParacetamol + Phenylephrine + Ascorbic acid
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  • Dosage form: & nbspPowder for solution for oral administration (for children)
    Composition:

    Active substances: paracetamol 300 mg, phenylephrine hydrochloride 5 mg, ascorbic acid 20 mg.

    Excipients: sodium saccharinate - 21.5 mg, sodium cyclamate - 31.5 mg, citric acid - 340.0 mg, sodium citrate - 215.0 mg, corn starch - 100.0 mg, sucrose - 1862.5 mg, flavoring lemon 610399 E - 100.0 mg, dye curcumin E 100 - 3.5 mg, silicon dioxide colloid -1.0 mg.

    Description:

    From white to pale yellow, a heterogeneous powder with the smell of lemon.

    When the contents of the sachet are dissolved in 125 ml of hot water, a cloudy solution is formed from yellow to yellow-green, without a foam on the surface, with the smell of lemon; there may be a slight precipitate.

    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® Junior is a combined preparation.

    Paracetamol has an analgesic and antipyretic effect, phenylephrine reduces the swelling of the mucous membranes of the sinuses of the nose, thereby facilitating breathing, ascorbic acid (Vitamin C) compensates for the increased need for vitamin C with colds and flu.

    Indications:It is used in children 6-12 years to relieve symptoms of colds and flu, such as fever, headache, chills, pain in joints and muscles, feeling of nasal congestion, pain in the sinuses and throat.
    Contraindications:
    Hypersensitivity to the paracetamol, phenylephrine, ascorbic - acid and other ingredients in the drug, the genetic absence of glucose-6-phosphate dehydrogenase deficiency sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption, since preparation contains sucrose, blood disease, severe liver or kidney disease, thyrotoxicosis, diabetes, hypertension, heart disease (expressed aortic stenosis, acute myocardial infarction, tachyarrhythmia); angle-closure glaucoma, concomitant use of tricyclic antidepressants, beta-blockers, MAO inhibitors, and within 14 days after their cancellation, up to age 6 years.
    Carefully:In benign hyperbilirubinemia, pheochromocytoma, peripheral vascular disease (Raynaud's syndrome).
    Dosing and Administration:

    The contents of 1 sachet pour into a mug, pour about 125 ml of hot water, stir until dissolved. If necessary, add cold water and sugar.

    Children from 6 to 12 years: 1 sachet every 4 hours. Do not take more than 4 sachets in 24 hours. Do not give the drug to children under 6 without consulting a doctor.

    The drug is not recommended for more than five days without consulting a doctor. If symptoms persist, consult a physician.

    Do not exceed the indicated dose. In case of an overdose, immediately seek medical help, even if the child feels well, because there is a risk of delayed severe liver damage.

    Side effects:

    Side effects are classified according to organ systems and frequency. The frequency of side 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 than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less than 1/10 000).

    In recommended doses, the drug is usually transferred to the chorone. Paracetamol rarely has a side effect. With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects can be observed.

    From the hematopoiesis:

    Very rarely: ttyumboshshsheniya.

    Allergic reactions:

    Rarely: skin rash, hives, allergic dermatitis.

    Very rarely: anaphylaxis, hypersensitivity reactions including skin rash, angioedema, Stevens-Johnson syndrome.

    From the respiratory system:

    Very rarely: bronchospasm in patients susceptible to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).

    From the digestive system:

    Very rarely: nausea. vomiting, impaired liver function.

    From the central nervous system:

    Very rarely: dizziness, headache, insomnia.

    From the sense organs:

    Rarely: mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.

    From the cardiovascular system:

    Rarely: tachycardia, palpitations, increased blood pressure.

    From the urinary system:

    Very rarely: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.

    In case of any undesired reactions, consult a physician.

    Overdose:

    PREPARATION SHOULD BE ACCEPTED ONLY IN RECOMMENDED DOSES.

    If you suspect an overdose, even if you feel well, you should stop using the drug and immediately seek medical help.

    Symptoms (due to paracetamol): within 24 hours: pallor of the skin, decreased appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of impaired liver function may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. In case of severe poisoning, severe hepatic insufficiency may develop, including hepatic encephalopathy, coma, and death. 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.

    There are reports of cardiac arrhythmias and pancreatitis in case of an overdose of paracetamol.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 the proposed overdose, it is advisable to assign activated carbon inside. Four or more hours after the alleged overdose, a determination of the paracetamol concentration in the plasma is required (an earlier determination of the paracetamol concentration 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. In case of necessity 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 phenylephin): irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, it is possible to develop hallucinations, confusion, convulsions, arrhythmias.

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

    Symptoms (due to ascorbic acid): high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and impairment of the gastrointestinal tract, such as nausea, discomfort in the stomach. Manifestations of an overdose can be categorized as those 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.

    Irregular intake of single doses does not have a significant effect.

    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 decreases the effectiveness of diuretic drugs. Metoclopramide and domperidone increase, and colestramine reduces 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 in blood pressure. Phenylephrine reduces the effectiveness of beta-adrenoblockers and antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders.

    Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, simultaneous administration 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, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Simultaneous administration of glucocorticosteroids with phenylephrine increases the risk of glaucoma.

    The simultaneous use of digoxin and cardiac glycosides increases the risk of cardiac rhythm and heart attack.

    Ascorbic acid with simultaneous use with iron preparations, thanks to its restorative. properties, converts trivalent iron into bivalent iron, which improves its absorption. With simultaneous application ascorbic acid increases the excretion of iron in patients receiving deferoxamine. When used simultaneously with barbiturates, primidone, excretion of ascorbic acid with urine increases. Ascorbic acid in high doses can reduce the pH of urine, which, when used at the same time, reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.With simultaneous application acetylsalicylic acid reduces absorption of ascorbic acid by about a third. With simultaneous use with warfarin, the effects of warfarin may be reduced. With simultaneous use with tetracycline, the excretion of ascorbic acid with urine increases.

    Special instructions:

    The drug should not be taken concurrently with other paracetamol-containing drugs, as well as other non-narcotic analgesics, NSAIDs (metamizol sodium, acetylsalicylic acid, ibuprofen etc.), drugs for cold symptoms, sympathomimetics, such as decongestants, with appetite regulating drugs, amphetamine-like stimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol. Before taking the drug, you need to consult a doctor if: taking metoclopramide, domperidone (used to eliminate nausea and vomiting), or colestyramine, used to lower blood cholesterol; taking medications to reduce blood clotting (for example, warfarin); compliance with the hyponatric diet (each packet contains 0.06 g of sodium).

    To avoid toxic damage to the liver, the drug should not be combined with ethanol-containing drugs.

    When performing tests for the determination of uric acid and blood glucose level, tell your doctor about the use of the drug "Coldrex® Junior", because the drug can distort the results of laboratory tests assessing the concentration of glucose and uric acid.

    Active substances "Coldrex® Junior" do not cause drowsiness. In case of dizziness, it is necessary to refrain from driving vehicles or other potentially dangerous activities requiring increased concentration of attention and quickness of the psychomotor reaction.

    Form release / dosage:Powder for solution for oral administration (for children).
    Packaging:For 3 grams in bags of laminate (FFP). 10 bags together with 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 expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-000826/08
    Date of registration:18.02.2008 / 19.04.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom
    Information update date: & nbsp31.01.2018
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