Active substanceParacetamol + Phenylephrine + Ascorbic acidParacetamol + Phenylephrine + Ascorbic acid
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  • Dosage form: & nbspPpowder for solution for oral administration [black currant]
    Composition:

    One package contains:

    active ingredients: paracetamol 650 mg, ascorbic acid 50 mg, phenylephrine hydrochloride 10 mg;

    auxiliary components: sugar powder 2518 mg, fine milling sucrose 650 mg, citric acid anhydrous 500 mg, sodium citrate 500 mg, enocyanin * 150 mg, black currant currants 75 mg, black currant flavor 50 mg, aspartame 27 mg, sodium saccharinate 20 mg.

    * Anthocyanin E163 dye.

    Description:

    Powder of light purple color, with a smell of black currant.

    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:

    The mechanism of action of paracetamol is due to the inhibition of the synthesis of prostaglandins in the central nervous system (CNS).

    Paracetamol has an analgesic and antipyretic effect.

    Phenylephrine hydrochloride is mainly a postsynaptic alpha receptor with a low affinity for cardioselective beta receptors,in normal doses has a minimal stimulating effect on the central nervous system. Phenylephrine hydrochloride narrows the vessels of the nose, reduces the swelling of the nasal mucosa, facilitating the runny nose and stuffiness of the nose.

    Ascorbic acid (vitamin C) replenishes the increased need for vitamin C for "colds" and flu, especially in the initial stages of the disease. Normalizes the permeability of capillaries, has an antioxidant effect. Increases the body's resistance to infectious diseases.

    The effect of the drug is noted 15-20 minutes after administration and lasts for 4-6 hours.

    Pharmacokinetics:

    Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract (GIT). Rapidly spread to all tissues of the body. The half-life (T1/2) - about 2 hours. It is excreted by the kidneys, mainly in the form of metabolites - glucuronides and sulfate compounds.

    Phenylephrine hydrochloride is absorbed from the gastrointestinal tract, but has a reduced bioavailability for oral administration due to irregular absorption, the effect of "first passage" through the liver and metabolism with the participation of monoamine oxidase (MAO) inhibitors in the intestine.When ingested, it retains its activity as a nasal anticongestant.

    Ascorbic acid is rapidly absorbed from the intestine, the half-life is about 16 days. It is excreted by the kidneys in the unaltered form and in the form of metabolites.

    Indications:

    ForI relief of symptoms of acute respiratory diseases ("colds") and influenza:

    - increased body temperature, chills,

    - headache,

    - nasal congestion, runny nose,

    - pain in the throat and nasal sinuses.

    Contraindications:

    - Hypersensitivity to paracetamol and other components that make up the drug;

    - aboutsimultaneous reception of other drugs containing paracetamol;

    - aboutsimultaneous reception of beta adrenoblockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their cancellation);

    - tischemic heart disease or cardiovascular disease: arterial hypertension, severe coronary artery atherosclerosis, severe aortic stenosis, acute myocardial infarction, tachyarrhythmia;

    - ghyperthyroidism;

    - thepatic liver failure or liver disease in the active phase;

    - Pacute insufficiency of severe severity (creatinine clearance <30 ml / min);

    - fenylketonuria;

    - Mr.fructose intolerance, glucose-galactose malabsorption, insufficiency of sucrose-isomaltase;

    - dEthnic age up to 12 years;

    - bVariability, the period of breastfeeding.

    Carefully:

    In the presence of conditions specified in this section, before using the drug should consult a doctor.

    Allergic reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized pustular exanthema; bronchial asthma, chronic obstructive pulmonary disease, hepatitis, liver function disorders caused by alcohol, hyperbilirubinemia; renal failure (creatinine clearance less than 30-60 ml / min), hyperoxalaturia, diabetes mellitus, angle-closure glaucoma and prostatic hyperplasia; Raynaud's disease; pheochromocytoma; deficiency of glucose-6-phosphate dehydrogenase; diseases of the blood system.

    Pregnancy and lactation:

    The drug is contraindicated during pregnancy and during breastfeeding.

    Dosing and Administration:

    Read the instructions carefully before taking the drug.

    For oral administration. Only for short-term use.

    The contents of one packet correspond to a single dose. For the preparation of a hot drink, dissolve the contents of the packet in one glass of hot water (but not boiling water). Stir until dissolved. Drink a freshly prepared hot or warm drink.

    Adults - 1 package, with an interval between meals of at least 4 hours. The maximum daily dose is 4 packages.

    Children over 12 years - 1 package, with an interval between meals at least 6 hours. The maximum daily dose is 3 packs.

    Do not exceed the indicated dose.

    The course of treatment is no more than 5 days.

    If the symptoms persist or worsen during the course of 5 days, stop treatment and consult a doctor.

    Side effects:

    The incidence of adverse reactions associated with paracetamol, phenylephrine hydrochloride and ascorbic acid was estimated on the basis of the following criteria: very frequent (≥1/10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100), rare (≥1 / 10000, <1/1000), very rare (<1/10000) and the frequency is unknown (there is no data for estimating the hour).

    Violations of the blood and lymphatic system

    The frequency is unknown: thrombocytopenia, agranulocytosis.

    Disturbances from the nervous system

    The frequency is unknown: headache, dizziness, insomnia, increased excitability.

    Disturbances on the part of the organ of sight

    The frequency is unknown: mydriasis, increased intraocular pressure (in most cases, patients with closed-angle glaucoma).

    Disorders from the cardiovascular system

    The frequency is unknown: a feeling of palpitation, increased blood pressure, tachycardia.

    Disorders from the rut and subcutaneous tissues

    Frequency unknown: Stevens-Johnson Syndrome, toxic epidermal necrosis (Lyell's Syndrome), acute generalized exanthematous pustulosis, skin rash, hives, angioedema.

    Disorders from the gastrointestinal tract

    The frequency is unknown: nausea, vomiting, dry mouth.

    Ondestruction from the liver and biliary tract

    Frequency unknown: impaired liver function.

    Disorders from the kidneys and urinary tract

    The frequency is unknown: retention of urine, dysuria.

    With prolonged use with exceeding the recommended dose, nephrotoxic effect can be observed.

    Overdose:

    Symptoms: symptoms of paracetamol overdose during the first 24 bolt: pallor of the skin, nausea, vomiting, anorexia and abdominal pain. Damage to the liver can occur 12-48 hours after admission, so you need to see a doctor even if you have no symptoms. Possible disturbance of glucose metabolism and metabolic acidosis. In severe poisoning, liver failure may progress with complications such as encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Acute renal failure with acute tubular necrosis (defined by pain in the lower back, hematuria and proteinuria) can develop even in the absence of severe liver damage. There are reports of heart rhythm disturbances and pancreatitis.

    An overdose of phenylephrine hydrochloride can also cause nausea and vomiting. In addition, the symptoms include nervousness, headache, dizziness, insomnia, hypertension, reflex bradycardia, mydriasis, acute closed-angle glaucoma (most likely in patients with closed-angle glaucoma), tachycardia, palpitations, allergic reactions (eg, rash,urticaria, allergic dermatitis), dysuria and urinary retention (most likely in patients with obstruction of the bladder outlet, for example prostatic hypertrophy). Features of severe overdose of phenylephrine hydrochloride include hemodynamic changes and cardiovascular insufficiency with respiratory depression, hallucinations, seizures and arrhythmias. However, in the case of this combined preparation containing paracetamol, phenylephrine hydrochloride and ascorbic acid, an overdose will rather cause symptoms of liver toxicity associated with paracetamol than toxicity symptoms associated with phenylephrine or 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.

    Treatment: symptomatic. You need immediate treatment with an overdose of paracetamol. Despite the lack of significant early symptoms, patients should be rushed to the hospital for immediate medical examination.Symptoms may be limited to the top note or vomiting and do not correspond to the severity of the overdose or the risk of organ damage. Damage to the liver can occur 12-48 hours after paracetamol enters the interior, so it is necessary to consult a doctor even if there are no symptoms.

    Treatment with activated charcoal and gastric lavage should be considered if an excessive dose has been taken less than 1 hour ago. The concentration of paracetamol in plasma should be measured after 4 hours or more after administration (earlier concentrations are unreliable).

    Treatment N-acetylcysteine ​​can be carried out up to 24 hours after taking paracetamol, however the maximum protective effect is achieved about 8 hours after taking the drug. The effectiveness of the antidote gradually decreases after this time. If necessary, enter intravenously N-acetylcysteine ​​according to the established scheme of use. Outside the hospital, if there is no vomiting, you can apply methionine inside. Patients who have been treated with serious hepatic dysfunction 24 hours after taking the drug, should be referred to a specialist for poisoning.

    In hypertensive effects of phenylephrine hydrochloride overdose, intravenous alpha-receptor blockers, such as phentolamine, can be used.

    Additional information about specific patient groups

    The increased risk of liver damage with paracetamol overdose is most likely in:

    - Patients receiving long-term treatment with enzyme-inducing agents (such as, carbamazepine, phenobarbitone, phenytoin, primidon, rifampicin and St. John's wort pitted);

    - patients who consume alcohol in quantities higher than those recommended;

    - patients with glutathione depletion (eg, patients with eating disorders, cystic fibrosis, HIV infection, cachexia, starvation).

    Interaction:

    - Monoamine oxidase inhibitors (MAO inhibitors): when joint intake of sympathomimetic amines, such as phenylephrine hydrochloride, and MAO inhibitors, an increase in blood pressure is possible.

    - Cardiac glycosides: simultaneous application of cardiac glycosides (e.g., digoxin) and phenylephrine hydrochloride may increase the risk of arrhythmia and myocardial infarction.

    - Tricyclic antidepressants: simultaneous use of tricyclic antidepressants (for example, amitriptyline) and phenylephrine hydrochloride may increase the risk of cardiovascular side effects.

    - Sympathomimetics: simultaneous use of phenylephrine hydrochloride and other sympathomimetic amines can lead to increased blood pressure and other side effects from the cardiovascular system. Phenylephrine hydrochloride may reduce the effectiveness of beta-blockers and other antihypertensive agents.

    - Anticoagulants: The anticoagulant effect of warfarin and other coumarins can be enhanced by a prolonged daily intake of paracetamol with an increased risk of bleeding.

    - Antiemetic means: metoclopramine and domperidone can increase the rate of absorption of paracetamol.

    - Kolestyramine: colestramine can reduce the rate of absorption of paracetamol.

    - Glucocorticosteroids: increased risk of glaucoma.

    - Urikozuric preparations: The simultaneous use of uricosuric drugs and paracetamol can reduce the effectiveness of uricosuric drugs.

    - Inductors of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, diphenyl, carbamazepine, zidovudine, flumecinol): increase in the production of hydroxylated active metabolites of paracetamol, which allows the development of severe intoxication with small overdoses.

    - Inhibitors of microsomal oxidation (cimetidine): reducing the risk of hepatotoxic action.

    - Sedative medicines: paracetamol enhances the effects of sedatives.

    - Ethanol: Paracetamol enhances the effects of ethanol.

    - Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives: increased risk of urinary retention, dry mouth, constipation.

    - Phenylephrine: phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders.

    - Halothane: simultaneous application of halothane and phenylephrine increases the risk of ventricular arrhythmia.

    Ascorbic acid increases the absorption of drugs of the penicillin and iron group, reduces the clinical effect of heparin and indirect anticoagulants, increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids) , reduces the concentration of oral contraceptives in the blood.

    Special instructions:

    It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms.

    At the first appearance of skin rashes, lesions of the mucous membrane or any other signs of hypersensitivity, it is necessary to stop taking the drug and consult a doctor.

    It is necessary to refrain from drinking alcohol during the application of the drug.

    During treatment should refrain from taking sleeping pills and anxiolytic drugs (tranquilizers).

    The drug should not be used concurrently with other drugs containing paracetamol.

    The drug distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the blood plasma.

    Each packet contains 3.2 g of sugar.

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

    Patients who report dizziness, drowsiness, blockage, or visual impairment should avoid driving vehicles or controlling mechanisms when taking medications containing paracetamol.

    Form release / dosage:

    Powder for solution for oral administration [blackcurrant].

    Packaging:

    5.2 g of powder are placed in hermetically sealed three-layer bags of aluminum foil, polyethylene and paper.

    For 5 or 10 bags in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C, in a dry place.

    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-001925/08
    Date of registration:18.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Rekitt Benckiser Chelskar (United Kingdom) LimitedRekitt Benckiser Chelskar (United Kingdom) Limited United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom
    Information update date: & nbsp05.03.2018
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