Maxikold - instructions for use, dose, side effects, contraindications

Excipients: silicon dioxide colloid (aerosil) - 0.017 g, sodium saccharinate dihydrate - 0.08 g, lemon acid (citric / acid anhydrous) 0.30 g, sodium citrate (sodium citrate anhydrous) 0.30 g, ethyl cellulose EC 22 0.0004 g, dye quinoline yellow (dye quinoline yellow water-soluble E-104) [for orange, lemon] 0.0001 g or dye azorubin (acidic red 2C) [for crimson] 0.0001 g, flavor orange or lemon or raspberry 0.05 g, lactose monohydrate - up to 5,00 g.

Description:

Crystalline powder of orange light yellow color with a specific smell. It is allowed to have crystals of white color and easily crumbling lumps. The powder is dissolved in 250 ml of hot water to form an opalescent solution of light yellow color with a characteristic orange odor.

Crystalline powder of lemon light yellow color with a specific smell.It is allowed to have crystals of white color and easily crumbling lumps. The powder is dissolved in 250 ml of hot water to form an opalescent solution of light yellow color with xa characteristic smell of lemon.

Crystalline powder of crimson pink color with a specific smell. It is allowed to have crystals of white color and easily crumbling lumps. The powder is dissolved in 250 ml hot water with the formation of opalescent solution of pink color with a characteristic smell of raspberry.

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:

Combined product, the effect of which is due to its constituent componentmi.

Paracetamol has an analgesic and antipyretic effect.

The drug blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the absence of a significant anti-inflammatory effect.The drug does not adversely affect the water-salt metabolism and mucosa of the gastrointestinal tract.

Phenylephrine - has a vasoconstrictive effect due to stimulation of alphaa1- adrenoreceptors, thus reducing the edema and flushing of the mucous membrane of the nasal cavity, facilitating breathing through the nose and facilitating the clearance of nasal passages and paranasal sinuses.

Ascorbic acid (vitamin C) - is involved in the regulation of oxidation-reduction processes, carbohydrate metabolism, in immune reactions, increases the body's resistance to infections, replenishes vitamin C deficiency with "cold" diseases.

Indications:

Infectious and inflammatory diseases (acute respiratory infections, influenza), accompanied by high body temperature, chills, headache, joint and muscle pains, nasal congestion and pains in the throat and sinuses of the nose.

Contraindications:Hypersensitivity to the components of the drug; expressed renal and hepatic insufficiency, arterial hypertension, prostatic hyperplasia, angle-closure glaucoma, hyperthyroidism (thyrotoxicosis); heart disease (incl.coronarosclerosis, hypertrophic obstructive cardiomyopathy); hypertensive crisis; pheochromocytoma, simultaneous administration of monoamine oxidase inhibitors, incl. within 14 days after their cancellation; simultaneous reception of tricyclic antidepressants, beta-blockers, other paracetamol-containing drugs; hereditary diseases (lactose intolerance, lactase deficiency or glucose-galactose malabsorption), children under 12 years of age.

Carefully:Viral hepatitis, alcoholic liver damage, alcoholism, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), hypertension in the small circulation, hypovolemia, severe stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmia; ventricular arrhythmia, atrial fibrillation; metabolic acidosis, hypercapnia, hypoxia; occlusive diseases of blood vessels (including in the anamnesis), deficiency of glucose-6-phosphate dehydrogenase, diabetes mellitus, hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, renal stone disease, advanced age, pregnancy, lactation.

Dosing and Administration:

Inside: the contents of one packet pour into a glass, pour hot water, stir until completely dissolved and eat hot.

Adults: one sachet every 4-6 hours. Do not take more than 4 sachets in 24 hours. Do not take the drug more than 4 hours later.

Children over 12 years of age: one sachet every 6 hours. Do not take more than 3 sachets in 24 hours.

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 please contact your doctor.

DO NOT EXCEED THE INDICATED DOSE. In case of an overdose, seek medical help immediately, even if you are feeling well, as there is a risk of delayed signs of severe liver damage.

Side effects:

Paracetamol: allergic reactions are possible (skin rash, itching, hives, angioedema); nausea, vomiting, abdominal pain; rarely - thrombocytopenia, leukopenia, agranulocytosis.

Phenylephrine can cause nausea, headache, a slight increase or decrease in blood pressure and,in rare cases, angina, dyspnoea, tachycardia, bradycardia, ventricular arrhythmia (especially when used in high doses), irritability, motor anxiety, allergic reactions.

Ascorbic acid: allergic reactions are possible, irritation of the mucosa of the gastrointestinal tract; thrombocytosis, hyperprotrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

With prolonged use in doses much higher than recommended, the probability of impaired liver and kidney function increases

In case of appearance of undesirable reactions, it is necessary to consult a doctor.

Overdose:

Overdose is caused, as a rule, by paracetamol. If you suspect an overdose, seek medical help immediately.

Symptoms within the first 24 hours after admission - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. 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 of adults is manifested when taking 10 g or more.

Treatment: gastric lavage, followed by the appointment of activated charcoal; symptomatic therapy, the introduction of specific antidotes - SH-groups and precursors of the synthesis of glutathione - methionine for 8-9 hours after an overdose and acetylcysteine for 8 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after taking.

Interaction:

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

Long-term use of barbiturateseffectiveness of paracetamol.

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects of paracetamol and enhance the pressor effect and the arrhythmogenic effect of phenylephrine.

When taken together with a non-steroidal anti-inflammatory drugagents and salicylates The nephrotoxic effect of paracetamol increases.

Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.

Simultaneous use with ethanol increases the risk of acute pancreatitis. Paracetamol enhances the effect of anticoagulants of indirect action and reduces the effectiveness of uricosuric drugs. Paracetamol enhances the effects of monoamine oxidase inhibitors, sedatives, alcohol.

Phenylephrine reduces the hypotensive effect of nitrates, diuretics and hypotensive drugs (including methyldopy, mekamilamin, guanadrel, guanetidine). Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives - the risk of urinary retention, dry mouth, constipation against the background of the use of phenylephrine.Glucocorticosteroids - the risk of developing glaucoma with the simultaneous use of phenylephrine. Guanethidine increases alpha-adrenomimetic, and tricyclic antidepressants - the sympathomimetic effect of phenylephrine.

Ergometrine, ergotamine, methylergomethrin, oxytocin, doxapram increase the severity of the vasoconstrictor effect of phenylephrine. Inhalation anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmias. Thyroid hormones increase (mutually) the effect of phenylephrine and the associated risk of coronary insufficiency (especially in coronary atherosclerosislerosis).

Beta-adrenoblockers reduce the cardiostimulating activity of phenylephrine, against the background of taking reserpine, the occurrence of hypertension is possible:

Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; reduces the therapeutic effect of antipsychotics (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. Ascorbic acid reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid reduces absorption of ascorbic acid.

Special instructions:

It should avoid simultaneous application of the drug with other paracetamol-containing drugs and agents to relieve the symptoms of "colds", flu and nasal congestion.

When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood and the functional state of the liver.

Paracetamol distorts the results of laboratory studies of glucose and uric acid in the blood plasma.

Before taking the drug, nA doctor's consultation is necessarytea of simultaneous receptionToclopramide, domperidone, colestyramine, anticoagulants (warfarin).

The use of the drug during pregnancy and during breastfeeding is possible only according to the doctor's prescription.

TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT COMBINE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TAKE FACES, STRONG TO CHRONIC ALCOHOL CONSUMPTION.

Effect on the ability to drive transp. cf. and fur:The components of the drug do not affect the ability to drive vehicles, as well as employment in other potentially hazardous activities requiring increased attention and speed of mental and motor reactions.

Form release / dosage:Powder for the preparation of the solution for ingestion [orange, lemon, raspberry].

Packaging:

For 5 grams in heat-sealed bags of composite material.

5,10 or 50 bags together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001317

Date of registration:28.06.2010 / 25.05.2015

Expiration Date:Unlimited

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp30.03.2018

Illustrated instructions

Instructions

Maxcold® (Maxicold®)