Vicks Anti-Influenza Complex Powder for oral solution lemon sachets, 10pcs

Composition

Auxiliary substances:

sucrose – 2000 mg,

citric acid 330 mg,

citric acid 330 mg,

sodium cyclamate – 200 mg,

sodium citrate – 500 mg,

aspartame – 6 mg,

ascorbic acid 100 mg,

potassium Acesulfame,17 mg,

lemon flavor 8476 – 50 mg,

flavoring lemon juice – 120 mg,

menthol flavor,100 mg,

quinoline yellow dye – 1 mg.

Pharmacological action

A combined drug, the action of which is determined by the composition of its components. Paracetamol has analgesic and antipyretic effects. Guaifenesin has a mucolytic effect, facilitates the removal of sputum from the bronchi and promotes the transition of an unproductive cough to a productive one. Phenylephrine is a sympathomimetic, has a pronounced alpha-adrenergic activity, narrows the vessels of the nasal mucosa, eliminates swelling and hyperemia of the nasal mucosa. Pharmacokinetics Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. After oral use, Cmax of paracetamol in plasma is reached in 10-60 minutes. It is metabolized in the liver and excreted in the urine, mainly in the form of glucuronides and sulfate compounds. T 1/2 is 1-3 h. Guaifenesin is rapidly absorbed from the gastrointestinal tract (25-30 minutes after oral use). T 1/2-1 h. It is metabolized in the liver by oxidation to β-(2-methoxy-phenoxy)-lactic acid, which is excreted in sputum and kidneys as inactive metabolites. Phenylephrine has irregular absorption from the gastrointestinal tract and at the first stage of metabolism is exposed to monoamine oxidase in the intestine and liver, so oral use of phenylephrine reduces its bioavailability. It is excreted in the urine in the form of sulfate compounds. Cmax in plasma is reached in 1-2 hours, T 1/2 is 2-3 hours.

Indications

Symptoms of colds and flu (headache, sore throat, pain in the body and limbs, nasal congestion, cough with difficult discharge of viscous sputum, fever).

Contraindications

Impaired liver function; severe chronic renal failure; arterial hypertension; hyperthyroidism; diabetes mellitus; phenylketonuria; IHD (acute myocardial infarction, coronary artery atherosclerosis); aortic stenosis; tachyarrhythmia; acute gastric and duodenal ulcer; prostatic hyperplasia; angle-closure glaucoma; porphyria; pheochromocytoma; age up to 12 years of age; pregnancy, lactation period; concomitant use of beta-blockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their withdrawal); concomitant use of other sympathomimetic drugs; concomitant use of other drugs containing paracetamol; sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption syndrome; hypersensitivity to guaifenesin, paracetamol, phenylephrine or other components of the drug. With caution: glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemia (Gilbert’s, Dubin-Johnson’s, Rotor’s syndromes), hyperoxaluria, bronchial asthma, COPD, mild to moderate renal failure, dehydration, hypovolemia, anorexia, bulimia and cachexia (insufficient supply of glutathione in the liver), viral hepatitis, alcoholic liver damage, alcoholism, Raynaud’s syndrome; concomitant use of cardiac glycosides, beta-blockers, methyldopa and other antihypertensive agents, elderly.

Side effects

The frequency of adverse reactions is estimated as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (Paracetamol-allergic reactions: rarely-urticaria, anaphylaxis, bronchospasm, angioedema. From the skin and subcutaneous tissue: rarely-skin rash, frequency unknown-Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis. Nervous system disorders: rarely – dizziness. From the side of the visual organ: rarely-paresis of accommodation, increased intraocular pressure, mydriasis. From the hematopoietic system: rarely-aplastic anemia, methemoglobinemia; very rarely-pathological changes in the blood, such as thrombocytopenia, agranulocytosis, hemolytic anemia, neutropenia, leukopenia, pancytopenia. From the cardiovascular system: rarely-increased blood pressure. From the digestive system: rarely-nausea, vomiting, dry mouth, hepatotoxic effect. From the urinary system: rarely-urinary retention, nephrotoxicity (papillary necrosis); frequency unknown-interstitial nephritis. Phenylephrine from the cardiovascular system: rarely-tachycardia, arterial hypertension, accompanied by headache, vomiting and rapid heartbeat. From the nervous system: rarely-insomnia, nervousness, tremor, anxiety, agitation, confusion, irritability and headache. From the digestive system: often – anorexia, nausea and vomiting. Allergic reactions: rarely-skin rash, urticaria, anaphylaxis and bronchospasm. Guaifenesin from the nervous system: rarely-headache, dizziness and drowsiness. From the digestive system: rarely-gastrointestinal discomfort, nausea, vomiting and diarrhea.

Interaction

Paracetamol reducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which causes the possibility of severe intoxication with a minor overdose. Long-term use of barbiturates reduces the effectiveness of paracetamol. Concomitant use with ethanol increases the risk of acute pancreatitis. Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxic effects. When used together with NSAIDs, including salicylates, the nephrotoxic effect of paracetamol increases. Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity. Metoclopramide and domperidone may increase the rate of absorption of paracetamol. Colestyramine may reduce the rate of absorption of paracetamol. Isoniazid reduces the clearance of paracetamol by suppressing its metabolic transformation in the liver, which may lead to an increase in the pharmacological effects of paracetamol and/or its toxicity. Probenecid reduces the clearance of paracetamol by almost 2 times due to inhibition of paracetamol conjugation with glucuronic acid. When used concomitantly with probenecid, a reduction in the dose of paracetamol should be considered. Regular use of paracetamol may lead to a possible decrease in zidovudine metabolism (increased risk of neutropenia). Paracetamol may reduce the bioavailability of lamotrigine with a possible reduction in the severity of its effect due to the possible induction of lamotrigine metabolic transformation in the liver. Paracetamol enhances the effect of indirect anticoagulants, which increases the risk of bleeding and reduces the activity of uricosuric drugs. Phenylephrine reduces the hypotensive effect of diuretics and antihypertensive drugs (including methyldopa, mecamylamine, guanadrel. guanethidine). Phenothiazines, alpha-blockers (phentolamine), furosemide and other diuretics reduce the hypertensive effect. MAO inhibitors (including furazolidone, procarbazine, selegiline), oxytocin, ergot alkaloids, tricyclic antidepressants, methylphenidate, and adrenostimulants enhance the pressor effect and arrhythmogenicity of phenylephrine. Beta-blockers reduce pacing activity, while reserpine may cause hypertension (due to depletion of catecholamine stores in the adrenergic endings, sensitivity to adrenomimetics increases). Inhaled anesthetics (including chloroform, enflurane, halothane, isoflurane, and methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias, as they dramatically increase the sensitivity of the myocardium to sympathomimetics. Ergometrine, ergotamine, methylergometrine, oxytocin, doxapram increase the severity of the vasoconstrictor effect. Reduces the antianginal effect of nitrates, which in turn can reduce the pressor effect of sympathomimetics and the risk of arterial hypotension (simultaneous use is allowed depending on the achievement of the necessary therapeutic effect). Thyroid hormones increase (mutually) the effect and the associated risk of coronary insufficiency (especially in coronary atherosclerosis). Concomitant use of phenylephrine and other sympathomimetic amines may lead to increased blood pressure and other cardiovascular side effects. Concomitant use of cardiac glycosides (e. g. digoxin) and phenylephrine may increase the risk of arrhythmia and myocardial infarction. Guaifenesincodeine makes it difficult to remove the liquid sputum. It is compatible with bronchodilators, antimicrobial drugs, and cardiac glycosides.

How to take it, course of use and dosage

Adults and children over 12 years of age: 1 sachet. If necessary, repeat the dose every 4-6 hours, but no more than 4 doses (sachets) per day. The maximum daily dose is 4 sachets.The maximum duration of use of the drug without consulting a doctor is no more than 5 days. Dissolve the contents of one sachet in hot, but not boiling water (250 ml). Allow to cool to an acceptable temperature. Have a drink.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. Do not use the drug simultaneously with other cough, cold remedies or drugs with decongestive action. Concomitant use of the drug with other paracetamol-containing medicinal products should be avoided, as this may cause an overdose of paracetamol. In patients with alcoholic liver disease, the negative effects of overdose are more pronounced. When using the drug for more than 5 days, peripheral blood parameters and the functional state of the liver should be monitored. The drug distorts the results of laboratory tests of glucose and uric acid in blood plasma. During treatment, it is recommended to take a sufficient amount of fluids. Possible staining of urine in pink. Guaifenesin, which is part of the drug, can give false positive results when determining 5-hydroxyindoleacetic and vanillinmindalic acids in the urine due to the effect of guaifenesin metabolites on color (guaifenesin should be discontinued 48 hours before urine collection for these tests). The drug contains sodium, which should be taken into account in patients who follow a diet with a reduced sodium intake. The drug contains aspartame, which is a source of phenylalanine, which can be toxic for patients with phenylketonuria. During the use of the drug, it is necessary to refrain from taking alcohol and medications containing ethanol. Effects on the ability to drive motor vehicles and operate mechanisms When driving vehicles and engaging in other potentially dangerous activities, it is necessary to take into account that the drug can cause side effects such as dizziness and confusion.

Form of production

Powder for preparation of an oral solution

Active ingredient

Paracetamol, Phenylephrine

Dosage form

oral solution