Composition, form of production and packaging
? Powder for solution for ingestion from white to light yellow with a pink tinge, with a characteristic odor. The aqueous solution of the preparation (the contents of 1 packet in 200 ml of hot boiled water) should have a pink color.
1 pack.
paracetamol 0.5 g
ascorbic acid 0.3 g
phenylephrine hydrochloride 0.01 g
Auxiliary substances: "Malina 909" flavoring 0.05 g, kollidone 30 0.002 g, sodium saccharinate 0.05 g, refined sugar 4.088 g.
5 g - Packages heat-sealing (5) - packs cardboard.
5 g - Packages heat-sealing (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Combined drug.
Paracetamol has antipyretic and analgesic effect.
Phenylephrine has a vasoconstrictive effect and reduces the swelling of the mucous membrane of the nasopharynx, facilitating breathing.
Ascorbic acid replenishes the increased need for vitamin C for colds and flu.
INDICATIONS
Elimination of cold and flu symptoms:
- fever;
- headache;
- pain in the joints and muscles;
- pain in the sinuses of the nose and in the throat;
- chills and stuffiness of the nose.
DOSING MODE
Inside. The contents of 1 sachet poured into a mug, pour hot boiled water (200 ml), stir until completely dissolved and add cold boiled water or sugar at will.
Adults:
Take 1 packet every 4-6 hours, but not 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 as an anesthetic and 3 days as an antipyretic agent without consulting a doctor. If symptoms persist, consult a physician.
Do not exceed the indicated dose.
In case of an overdose, seek medical assistance immediately, even if you are feeling well, as there is a risk of delayed signs of serious liver damage.
SIDE EFFECT
Paracetamol: allergic reactions are possible (skin rash, hives, angioedema); rarely - thrombocytopenia, leukopenia, agranulocytosis.
Phenylephrine can cause nausea, headache, a slight increase in blood pressure and, in rare cases, a heartbeat that occurs after drug withdrawal.
Ascorbic acid: irritation of the mucous membrane of the gastrointestinal tract; thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria, moderate pollakiuria.
With prolonged use at doses much higher than recommended, the probability of impaired liver and kidney function increases.
In case of adverse reactions, consult a doctor.
CONTRAINDICATIONS
- hypersensitivity to any component of the drug;
- marked violations of the liver or kidney;
- hyperthyroidism (thyrotoxicosis);
- heart disease (pronounced stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmias);
- arterial hypertension;
- simultaneous reception of tricyclic antidepressants, beta-blockers, monoamine oxidase (MAO) inhibitors, including. in the period up to 14 days after cancellation;
- taking other paracystamol-containing drugs, ascorbic acid and drugs to relieve the symptoms of "colds", flu and nasal congestion;
- hyperplasia of the prostate;
- an angle-closure glaucoma;
- Children's age (up to 18 years);
- rare hereditary diseases, such as sugar / isomaltase deficiency, fructose intolerance, or glucose-galactose malabsorption.
With caution: in the genetic absence of glucose-6-phosphate dehydrogenase, benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, hepatic and renal function disorders, alcoholic liver damage, alcoholism, hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, oxalose , nephrolithiasis, diabetes mellitus; in old age, during pregnancy and lactation.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and lactation is possible only according to the doctor's prescription.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in the violation of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in the violation of liver function.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
APPLICATION IN ELDERLY PATIENTS
With caution in old age.
SPECIAL INSTRUCTIONS
To avoid toxic damage to the liver, paracetamol should not be combined with the intake of alcoholic beverages, and should also be taken to persons prone to chronic alcohol consumption.
Distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the plasma.
High doses of ascorbic acid increase the excretion of oxalates,. promoting the formation of kidney stones. In newborns, whose mothers took high doses of ascorbic acid, and in adults who took high doses, "ricochet" scurvy may be observed. In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenals and arterial pressure.
With prolonged use of large doses, oppression of the insulin function of the pancreas is possible, so during treatment it must be regularly monitored.
In patients with elevated iron levels in the body, ascorbic acid should be used in minimal doses.
Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood and urine glucose, bilirubin, liver transaminases and lactate dehydrogenase activity).
1 packet contains 4 g of sugar, which corresponds to 0.4 XE.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Overdose is caused, as a rule, by paracetamol.
During the first 24 hours after administration, pale skin, anorexia, nausea, vomiting, abdominal pain, hepatonecrosis, increased activity of "liver" transaminases, an increase in prothrombin time are possible; disturbance of glucose metabolism, metabolic acidosis. In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults is manifested when taking 10 g or more. If you suspect a poisoning, you should immediately seek medical help.
Treatment: gastric lavage, followed by the appointment of activated charcoal; symptomatic therapy. A specific antidote for paracetamol poisoning is acetylcysteine.
DRUG INTERACTION
Paracetamol
Reduces the effectiveness of uricosuric medicines (LS). The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Inducers of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.
Long-term use of barbiturates reduces the effectiveness of paracetamol.
Ethanol promotes the development of acute pancreatitis.
Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects.
Prolonged sharing of paracetamol and other NSAIDs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Phenylephrine
Reduces the hypotensive effect of diuretics and hypotensive drugs (including methyldopy, mekamilamin, guanadrel, guanetidine).
Phenotiazines, alpha-adrenoblockers (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-adrenoblockers reduce cardiostimulating activity, against the background of reserpine, arterial hypertension is possible (due to depletion of catecholamine stores in adrenergic endings, sensitivity to adrenomimetics increases).
Inhalational anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias, as sharply increase the sensitivity of the myocardium to sympathomimetics.
Ergometrin, 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).
Ascorbic acid
Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives).
Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous use with deferoxamine. Reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce absorption and absorption.
With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.
LS quinoline, calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the stores of ascorbic acid.
With simultaneous use reduces the chronotropic effect of isoprenaline.
With prolonged use or use in high doses, it can interfere with the interaction of disulfiram and ethanol.
In high doses increases the excretion of mexiletine by the kidneys.
Barbiturates and primidon increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C, in a dry place. Keep out of the reach of children. Shelf life - 2 years.
