Description
Release form
Powder for preparation of oral solution
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 coronary heart disease (acute myocardial infarction, atherosclerosis of the coronary artery disease of the ulcer and hypertrophic ulcer burden, lactation, concomitant use of beta-blockers, tricyclic antide ressantov, MAO inhibitors (including 14 days after withdrawal) simultaneous reception of other sympathomimetic drugs simultaneous reception of other formulations containing paracetamol deficit sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption syndrome hypersensitivity to guaifenesin, paracetamol, phenylephrine or other components of the drug.
Precautions: glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes), hyperoxaluria, bronchial asthma, COPD, mild and moderate renal failure, dehydration, hypovolemia, anorexia cachexia (insufficient supply of glutathione in the liver), viral hepatitis, alcoholic liver damage, alcoholism, Raynaud’s syndrome simultaneous use of cardiac glycosides, beta-blockers, methyldopa and other antihypertensive cf units, old age.
Special instructions
It is recommended that you take the drug as soon as possible and in the minimum effective dose necessary to eliminate the symptoms.
The drug should not be used concurrently with other cough, cold, or decongestant drugs.
The simultaneous use of the drug with other paracetamol-containing drugs should be avoided, as this may cause an overdose of paracetamol.
In patients with alcoholic liver disease, the negative effects of an overdose are more pronounced.
When using the drug for more than 5 days, peripheral blood counts and the functional state of the liver should be monitored.
The drug distorts the results of laboratory studies of glucose and uric acid in blood plasma.
A sufficient amount of fluid is recommended during treatment.
Possibly staining urine pink.
Guaifenesin, which is part of the drug, can give false-positive results in the determination of 5-hydroxyindoleacetic and vanillinindindic acids in urine due to the influence 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 by patients on a low sodium diet.
The drug contains aspartame, which is a source of phenylalanine, which may be toxic to patients with phenylketonuria.
During the use of the drug, it is necessary to refrain from taking alcohol and drugs containing ethanol.
Influence on driving ability and driving mechanisms
When driving vehicles and engaging in other potentially hazardous activities, it must be taken into account that the drug can cause side effects such as dizziness and confusion.
Composition
1 pack.
paracetamol 500 mg
guaifenesin 200 mg
phenylephrine hydrochloride 10 mg
Excipients: sucrose – 2000 mg, citric acid – 330 mg, tartaric acid – 330 mg, sodium cyclamate – 200 mg, sodium citrate – 500 mg, aspartame – 6 mg ascorbic acid 100 mg potassium acesulfame 17 mg lemon flavoring 8476 – 50 mg, lemon juice flavoring – 120 mg, menthol flavoring – 100 mg, quinoline yellow dye – 1 mg.
Dosing and Administration
Adults and children 12 years of age and older: 1 sachet.
If necessary, repeat the dose every 4-6 hours, but not more than 4 doses (sachets) per day.
The maximum daily dose is 4 sachets.
The maximum duration 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.
Side effects
The frequency of adverse reactions is estimated as follows: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (cannot be estimated from the available data). Paracetamol Allergic reactions: rarely – urticaria, anaphylaxis, bronchospasm, angioedema. From the skin and subcutaneous tissue: rarely – skin rash, unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis. From the nervous system: rarely – dizziness. From the side of the organ of vision: rarely – paresis of accommodation, increased intraocular pressure, mydriasis. From the hemopoietic 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 is 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, agitated state, 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. Drug interaction Paracetamol Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication with a slight overdose. Prolonged 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 hepatotoxicity. When used together with NSAIDs, incl. 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 absorption rate of paracetamol. Colestyramine may decrease the absorption rate of paracetamol. Isoniazid reduces the clearance of paracetamol by inhibiting its metabolic transformation in the liver, which can lead to an increase in the pharmacological effects of paracetamol and / or its toxicity. Probenecid causes a decrease in clearance of paracetamol by almost 2 times due to inhibition of conjugation of paracetamol with glucuronic acid. With simultaneous use 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 decrease the bioavailability of lamotrigine with a possible decrease in the severity of its effect due to the possible induction of the metabolic transformation of lamotrigine 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, guanadrell. 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, adrenostimulants enhance the pressor effect and arrhythmogenicity of phenylephrine. Beta-blockers reduce pacemaking activity, arterial hypertension is possible against the background of reserpine (due to depletion of catecholamines in the adrenergic endings, sensitivity to adrenergic agonists increases). Inhalation anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias, since they sharply 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 desired therapeutic effect). Thyroid hormones increase (mutually) the effect and the associated risk of coronary insufficiency (especially with coronary atherosclerosis). The simultaneous use of phenylephrine and other sympathomimetic amines can lead to increased blood pressure and other side effects from the cardiovascular system. Concomitant use of cardiac glycosides (eg, digoxin) and phenylephrine may increase the risk of arrhythmias and myocardial infarction. Guaifenesin Codeine makes it difficult to drain liquefied sputum. Compatible with bronchodilators, antimicrobials, cardiac glycosides. Active ingredient Paracetamol, Phenylephrine pharmacy package without lekarstvennaja form Solution for pryema inside
