Maxicold^® (Tablets, Powder) Instructions for Use

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Phenylephrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the "common cold" (non-narcotic analgesic agent + alpha-adrenomimetic + vitamin)

Pharmacological Action

A combined drug that has antipyretic and analgesic effects, intended to relieve the symptoms of the "common cold" and influenza. The action of the drug is due to the properties of its constituent components.

Paracetamol is a non-narcotic analgesic that has antipyretic and analgesic effects due to the blockade of cyclooxygenase in the central nervous system and its effect on the centers of pain and thermoregulation. It reduces headache and muscle pain, as well as fever.

Phenylephrine is an alpha₁-adrenergic stimulant that has little effect on the beta-adrenergic receptors of the heart; it is not a catecholamine. It causes constriction of arterioles, thereby reducing edema and hyperemia of the nasal mucosa and facilitating nasal breathing.

Ascorbic acid increases the body’s resistance to infections and replenishes the increased need for vitamin C during colds and influenza.

Pharmacokinetics

Paracetamol is well absorbed in the intestine, T_max – 0.5-2 hours; plasma protein binding – 15%. It is metabolized in the liver to form both active and inactive metabolites. T_1/2 – 1-4 hours. It is predominantly excreted by the kidneys in the form of metabolites – glucuronides and sulfates, 3% is excreted unchanged.

Phenylephrine after oral administration, phenylephrine is poorly absorbed from the gastrointestinal tract. It is metabolized with the participation of monoamine oxidase (MAO) in the intestinal wall and during the "first pass" through the liver. The bioavailability of phenylephrine is low.

Ascorbic acid is absorbed in the gastrointestinal tract (mainly in the jejunum). T_max after oral administration is 4 hours. It easily penetrates into leukocytes, platelets, and then into all tissues; the highest concentration is achieved in glandular organs, leukocytes, liver, and the lens of the eye; it crosses the placenta. It is metabolized mainly in the liver to dehydroascorbic acid and then to oxaloacetic acid and ascorbate-2-sulfate. It is excreted by the kidneys, through the intestines, with sweat, breast milk in unchanged form and in the form of metabolites.

Indications

• Symptomatic treatment of infectious and inflammatory diseases (including influenza and other acute respiratory viral infections (ARVI)), accompanied by elevated body temperature, chills, nasal congestion, headache, bone and muscle pain, sore throat, and sinus pain.

ICD codes

Dosage Regimen

Tablets

Orally, before meals or 1-2 hours after meals, with plenty of liquid.

Adults and children over 12 years of age (body weight over 40 kg): 1-2 tablets every 4-6 hours. The frequency of administration should not exceed 4 times/day with an interval of at least 4 hours.

Children aged 9 to 12 years (body weight over 30 kg) 1 tablet every 4-6 hours. The frequency of administration should not exceed 4 times/day with an interval of at least 4 hours.

The drug is not recommended for use for more than 5 days as an analgesic and 3 days as an antipyretic without consulting a doctor. If symptoms persist, you should consult a doctor.

Do not exceed the indicated dose.

Powder

Pour the contents of 1 sachet into a cup, add hot water, stir until completely dissolved and drink hot.

Adults are prescribed 1 sachet every 4-6 hours. Do not take more than 4 sachets within 24 hours. The drug should not be taken more frequently than every 4 hours.

Children over 12 years of age are prescribed 1 sachet every 6 hours. Do not take more than 3 sachets within 24 hours.

The patient should be warned that the drug is not recommended for use for more than 5 days as an analgesic and 3 days as an antipyretic. The need for longer use of the drug is determined by the doctor individually.

If symptoms persist during the specified periods of use, the patient should consult a doctor.

Adverse Reactions

Allergic reactions are possible (skin rash, skin hyperemia, urticaria, angioedema).

Paracetamol blood formation disorders (anemia, thrombocytopenia, methemoglobinemia).

Phenylephrine headache, nausea or vomiting; angina pectoris, bradycardia, shortness of breath, increase or decrease in blood pressure, palpitations, tachycardia, ventricular arrhythmia (especially when used in high doses), irritability, motor restlessness, allergic reactions.

Ascorbic acid can cause irritation of the gastrointestinal mucosa, with long-term use of large doses – nausea, vomiting, diarrhea, hyperacid gastritis, ulceration of the gastrointestinal mucosa; decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies). The occurrence of thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis, hypokalemia, glucosuria, and suppression of the function of the insular apparatus of the pancreas is also possible.

With long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired renal function (moderate pollakiuria, hyperoxaluria, nephrolithiasis, damage to the glomerular apparatus of the kidneys), increased excitability of the central nervous system, headache, and insomnia increases.

If adverse reactions occur, consult a doctor.

Contraindications

• Severe renal/hepatic insufficiency;
• Hyperthyroidism (including thyrotoxicosis);
• Heart diseases (severe aortic stenosis, acute myocardial infarction, tachyarrhythmias);
• Arterial hypertension;
• Simultaneous use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors, including within 14 days after their discontinuation;
• Simultaneous use of other paracetamol-containing products and remedies for relieving symptoms of the "common cold", influenza, and nasal congestion;
• Prostatic hyperplasia;
• Closed-angle glaucoma;
• Childhood (up to 9 years, as well as children weighing less than 30 kg);
• Hypersensitivity to any component of the drug.

With caution in case of glucose-6-phosphate dehydrogenase deficiency, in benign hyperbilirubinemia, during pregnancy and breastfeeding, in old age.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

To avoid toxic liver damage, the drug should not be combined with the intake of alcoholic beverages, and should not be taken by persons with chronic alcoholism.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Contraindicated in children under 9 years of age, as well as those weighing less than 30 kg.

Geriatric Use

Use with caution in elderly persons.

Special Precautions

Consultation with a doctor is necessary before taking the drug in case of concomitant use of metoclopramide, domperidone, cholestyramine (since metoclopramide and domperidone increase, and cholestyramine reduces the absorption rate of paracetamol), anticoagulants (since concomitant use of paracetamol in high doses enhances the effect of anticoagulant drugs).

Taking the drug distorts the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.

If the drug is used for more than 5-7 days, peripheral blood counts and the functional state of the liver should be monitored.

The use of the drug during pregnancy is possible only as prescribed by a doctor.

To avoid toxic liver damage, the drug should not be combined with the intake of alcoholic beverages, and should not be taken by persons with chronic alcoholism.

Effect on the ability to drive vehicles and mechanisms

The drug does not have a negative effect on the performance of potentially hazardous activities that require special attention and quick reactions.

Overdose

In case of overdose, seek medical help immediately, even if you feel well, as there is a risk of delayed signs of serious liver damage.

In case of overdose, symptoms are usually due to the effects of high doses of paracetamol.

Symptoms within the first 24 hours after ingestion – pallor of the skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after 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 in adults manifests when taking 10 g or more.

Treatment: administration of SH-group donors and precursors of glutathione synthesis – methionine within 8-9 hours after overdose and acetylcysteine – within 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its ingestion.

Drug Interactions

The drug enhances the effects of monoamine oxidase inhibitors, sedatives, and ethanol.

The risk of developing the hepatotoxic effect of paracetamol increases with the simultaneous use of ethanol, hepatotoxic drugs, inducers of microsomal oxidation enzymes in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, etc.).

Concomitant use of paracetamol in high doses enhances the effect of anticoagulant drugs (by reducing the synthesis of procoagulant factors in the liver). Paracetamol reduces the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Metoclopramide and domperidone increase, and cholestyramine reduces the absorption rate of paracetamol. Inhibitors of microsomal oxidation enzymes (including cimetidine) reduce the risk of hepatotoxic action of paracetamol.

Simultaneous use of ethanol and paracetamol contributes to the development of acute pancreatitis. Long-term combined use of paracetamol and non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, and the onset of end-stage 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 enhance the manifestations of the hematotoxicity of paracetamol.

Phenylephrine reduces the hypotensive effect of diuretics and antihypertensive drugs (including methyldopa, mecamylamine, guanadrel, guanethidine), and reduces the antianginal effect of nitrates.

Phenothiazines, alpha-blockers (phentolamine), furosemide and other diuretics reduce the hypertensive effect of pheniramine. Monoamine oxidase inhibitors (including furazolidone, procarbazine, selegiline), oxytocin, ergot alkaloids, tricyclic antidepressants, methylphenidate, adrenergic stimulants enhance the vasoconstrictor effect and arrhythmogenicity of phenylephrine; against the background of reserpine, arterial hypertension is possible. Ergonovine, ergotamine, methylergometrine, oxytocin, doxapram increase the severity of the vasoconstrictor effect of pheniramine.

Inhalational anesthetics (including chloroform, enflurane, halothane, isoflurane, methoxyflurane) increase the risk of severe atrial and ventricular arrhythmia. Thyroid hormones mutually enhance the effect of phenylephrine and the associated risk of coronary insufficiency (especially with coronary atherosclerosis).

Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood, reduces the effectiveness of heparin and indirect anticoagulants, increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body, reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

When used simultaneously with acetylsalicylic acid, the urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Acetylsalicylic acid, oral contraceptives, fresh juices, and alkaline drinks reduce the absorption and assimilation of ascorbic acid.

Ascorbic acid improves the absorption of iron preparations in the intestine; increases the risk of crystalluria during treatment with salicylates and short-acting sulfonamides, slows down the renal excretion of acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood, and reduces the chronotropic effect of isoprenaline. With long-term use or use in high doses, it may interfere with the interaction of disulfiram and ethanol; in high doses, it increases the renal excretion of mexiletine.

Drugs of the quinoline series, calcium chloride, salicylates, glucocorticoids with long-term use deplete the reserves of ascorbic acid. Barbiturates and primidone increase the excretion of ascorbic acid in the urine.

Storage Conditions

In a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 2 years.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.