Koldakt Hot Drink 325 mg + 10 mg + 20 mg 5 pcs. sachet powder for solution preparation for oral use orange flavor

Symptomatic therapy for infectious-inflammatory diseases: ARVI, including influenza and "cold," accompanied by high fever, chills, headache, sore throat, runny nose, nasal congestion, sneezing, and muscle pain.

Orally.
Do not exceed the recommended dose.
Use the lowest dose necessary to achieve the effect for the shortest duration of treatment.
Adults (including the elderly) and children 12 years and older:
One packet every 4-6 hours as needed, but no more than 4 doses within 24 hours. Dissolve one packet in a glass of hot, but not boiling water. Take while hot. The medication can be taken at any time of day, but the best effect is achieved when taken before bedtime, at night. If symptoms do not improve within 3 days of starting the medication, consult a doctor.
Patients should not take the medication for more than 5 days.

1 sachet contains:
Active ingredients: paracetamol - 325.0 mg, pheniramine maleate - 20.0 mg, phenylephrine hydrochloride - 10.0 mg.
Excipients: anhydrous citric acid, flavoring agent "Orange" *, sucrose.
*Composition of flavoring agent "Orange": flavorings (aromatic products, natural aromatic substances), maltodextrin, gum arabic (E414), triacetin (E1518).

Powder for the preparation of a solution for oral administration
A white or almost white powder with an orange scent. The presence of soft lumps is permissible.
Powder for the preparation of a solution for oral administration
When dissolving the contents of the sachet in 200 ml of hot (85±5) °C water, a colorless or slightly yellowish transparent or opalescent solution with a characteristic orange scent is formed.

Increased sensitivity to individual components of the drug; simultaneous use of tricyclic antidepressants, beta-blockers, or other sympathomimetic drugs (such as decongestants, appetite suppressants, and amphetamine-like substances); simultaneous or within the previous 2 weeks use of monoamine oxidase inhibitors (MAO); portal hypertension; alcoholism; diabetes mellitus; sucrose/isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption; pregnancy; breastfeeding; children under 12 years of age; severe cardiovascular diseases; hypertension; hyperthyroidism; angle-closure glaucoma; pheochromocytoma.

With caution
In cases of severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood disorders, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert's, Dubin-Johnson, and Rotor syndromes), chronic malnutrition (caloric deficiency) and dehydration, pyloroduodenal obstruction, stenosing ulcer of the stomach and/or duodenum, epilepsy, with simultaneous use of digoxin and cardiac glycosides, ergot alkaloids (such as ergotamine and methysergide), as well as drugs that may negatively affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine, and other inducers of liver microsomal enzymes).

Use during pregnancy and breastfeeding
Pregnancy
There is insufficient data on the use of this drug in pregnant women. Data from reproductive toxicity studies in animals are insufficient.
The use of the drug during pregnancy is not recommended.
Breastfeeding
The use of the drug during breastfeeding is not recommended.
Paracetamol
Paracetamol is excreted in breast milk, but in clinically insignificant amounts when used at recommended doses.
Pheniramine
There are no animal studies or clinical data on the use of pheniramine during breastfeeding.
Phenylephrine
Phenylephrine may be excreted in breast milk.

To avoid toxic liver damage, the use of this medication should not be combined with alcoholic beverages. Contains paracetamol; do not use with any other medications containing paracetamol.
Concurrent use with other medications containing paracetamol may lead to overdose.
Paracetamol overdose can cause liver failure, which may necessitate a liver transplant or result in death.
Cases of liver dysfunction/liver failure have been reported in patients with low glutathione levels, such as severely malnourished patients suffering from anorexia, with low body mass index, patients with severe chronic alcohol dependence, or sepsis.
Concurrent use with decongestants and antihistamines should be avoided.
Patients with the following conditions should consult a doctor before taking this medication:
• Liver or kidney dysfunction. Coexisting liver disease increases the risk of paracetamol-related liver damage;
• Conditions associated with decreased glutathione levels, as the use of paracetamol may increase the risk of metabolic acidosis.
Use with caution in elderly patients, who are more susceptible to adverse effects. Avoid use in elderly patients with altered consciousness.
Patients should consult a doctor if:
• Bronchial asthma, emphysema, or chronic bronchitis is present;
• Symptoms persist for more than 5 days or are accompanied by severe fever lasting for 3 days, rash, or persistent headache.
These may be signs of more serious disorders.
1 sachet of the medication contains:
• 9.4 g of sucrose, which should be considered by patients with diabetes.
Do not use the medication from damaged sachets.

Effects on the ability to drive vehicles and operate machinery
The medication may cause drowsiness, dizziness, blurred vision, impaired cognitive function, and coordination disturbances, which may significantly affect the ability to drive vehicles and operate machinery. These adverse effects may be further enhanced by the consumption of alcoholic beverages or other sedatives.

Adverse reactions listed below are categorized according to the affected organs and systems and their frequency of occurrence.
Frequency of occurrence is defined as follows: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1000 and < 1/100); rare (≥ 1/10000 and < 1/1000); very rare (< 1/10000, including isolated cases). Frequency categories were formed based on post-marketing surveillance.Disorders of the blood and lymphatic system Very rare: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. Frequency unknown: hemolytic anemia.Disorders of the immune system Rare: hypersensitivity reactions (rash, dyspnea, anaphylactic shock), angioedema and skin rash, urticaria, allergic dermatitis. Frequency unknown: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.Mental disorders Rare: increased excitability, sleep disturbances. Frequency unknown: hallucinations, confusion.Nervous system disorders Common: drowsiness. Rare: dizziness, headache. Frequency unknown: anticholinergic symptoms, impaired coordination, tremor, memory or attention loss (more common in elderly patients), balance disturbances (more common in elderly patients), dizziness (more common in elderly patients), sedation (more pronounced at the beginning of treatment), drowsiness (more pronounced at the beginning of treatment).Eye disorders Rare: mydriasis, accommodation paresis, intraocular pressure disturbances, acute angle-closure glaucoma (most likely to occur in individuals with angle-closure glaucoma).Heart disorders Rare: tachycardia, palpitations.Vascular disorders Rare: increased blood pressure. Frequency unknown: orthostatic hypotension.Gastrointestinal disorders Common: nausea, vomiting. Rare: dry mouth, constipation, abdominal pain, diarrhea.Liver and biliary tract disorders Rare: increased liver enzyme activity.Skin and subcutaneous tissue disorders Rare: eczema, rash, itching, erythema, purpura.Kidney and urinary tract disorders Rare: difficulty urinating (most commonly occurs in patients with bladder outlet obstruction, for example, due to prostatic hyperplasia), dysuria.General disorders and administration site conditions Rare: malaise. Frequency unknown: dryness of mucous membranes.If any of the effects listed in the instructions worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.Symptoms caused by paracetamol (manifest after intake of more than 10-15 g) In severe cases of paracetamol overdose, hepatotoxic effects may occur, including the potential for liver necrosis. Overdose may also lead to liver failure, which can result in liver transplantation or death. Clinical signs of liver damage typically develop within 24-48 hours and peak at 4-6 days. Acute pancreatitis has been observed, usually with impaired liver function and toxic effects on the liver. The severity of overdose depends on the dose; therefore, simultaneous intake of paracetamol-containing medications is prohibited. There is a pronounced risk of poisoning, especially in elderly patients, children, patients with liver diseases, in cases of chronic alcoholism, in patients with chronic malnutrition (caloric intake deficiency), and in patients taking inducers of microsomal oxidation in the liver. Symptoms of paracetamol overdose in the first 24 hours: pallor of the skin, nausea, vomiting, loss of appetite, seizures. Abdominal pain may be the first sign of liver damage and may not manifest for 24-48 hours, and sometimes may appear later, at 4-6 days, on average 72-96 hours after taking the medication. Metabolic disturbances in glucose metabolism and metabolic acidosis may also occur. Even in the absence of liver damage, acute liver failure and acute tubular necrosis may develop. Cases of cardiac arrhythmia and the development of pancreatitis have been reported. Treatment In case of exceeding the recommended dose, seek medical attention immediately, even if you feel well, as there is a risk of delayed severe liver damage. Administration of acetylcysteine intravenously or orally as an antidote, gastric lavage, and oral methionine may have a positive effect for at least 48 hours after overdose. Activated charcoal is recommended, along with monitoring of breathing and circulation. In case of seizures, diazepam may be prescribed. Symptoms caused by diphenhydramine and phenylephrine (combined due to the mutual potentiation of the parasympatholytic effect of diphenhydramine and the sympathomimetic effect of phenylephrine in case of drug overdose) Symptoms of overdose include drowsiness, which is subsequently accompanied by agitation (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disturbances, coma, seizures (especially in children), behavioral changes, increased or decreased blood pressure, bradycardia. In cases of diphenhydramine overdose, cases of atropine-like "psychosis" have been reported. In severe cases, confusion, hallucinations, seizures, and arrhythmias may develop. There is no specific antidote. Standard supportive measures are required, including the administration of activated charcoal, saline laxatives, and measures to support cardiac and respiratory functions. Psychostimulants (methylphenidate) should not be administered due to the risk of seizures. In cases of hypotension, vasopressor agents may be used. In case of elevated blood pressure, intravenous administration of alpha-adrenergic blockers (e.g., phenoxybenzamine) may be necessary, as phenylephrine is a selective agonist of alpha1-adrenergic receptors; therefore, the hypertensive effect in phenylephrine overdose should be treated by blocking alpha-adrenergic receptors. In case of seizures, use diazepam.Effects of Paracetamol Enhances the effects of MAO inhibitors, sedatives, and ethanol. The risk of hepatotoxicity from paracetamol increases with the simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine, and other inducers of liver microsomal enzymes. The properties of warfarin as an anticoagulant and other coumarins may be enhanced with prolonged regular use of paracetamol, increasing the risk of bleeding. A single dose of paracetamol does not have this effect. Metoclopramide increases the absorption rate of paracetamol and raises the plasma concentration of paracetamol to its maximum. Similarly, domperidone may increase the absorption rate of paracetamol. When chloramphenicol and paracetamol are used together, the half-life of chloramphenicol may be prolonged. Paracetamol may reduce the bioavailability of lamotrigine, potentially decreasing its effectiveness due to the induction of its hepatic metabolism. The absorption of paracetamol may be reduced when taken simultaneously with cholestyramine; however, this can be avoided by taking cholestyramine one hour after paracetamol. Regular use of paracetamol alongside zidovudine may cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. In patients taking probenecid concurrently, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol may be enhanced with chronic or excessive alcohol consumption. Paracetamol may affect the results of uric acid tests using the precipitating reagent phosphotungstic acid.Effects of Pheniramine May enhance the effects of other substances on the central nervous system (e.g., MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, benzodiazepines, tranquilizers, and narcotics). Pheniramine may inhibit the action of anticoagulants. Pheniramine has anticholinergic activity and may enhance the anticholinergic effects of other drugs (other antihistamines, Parkinson's disease medications, and phenothiazine neuroleptics).Effects of Phenylephrine The drug is contraindicated in patients who are taking or have taken MAO inhibitors within the last two weeks. Phenylephrine may enhance the effects of MAO inhibitors and cause an increase in blood pressure. Concurrent use of phenylephrine with other sympathomimetic amines (e.g., decongestants, appetite suppressants, and amphetamine-like substances) or tricyclic antidepressants (e.g., amitriptyline) may increase the risk of cardiovascular side effects. Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive medications (e.g., debresyl, guanethidine, reserpine, methyldopa). The risk of increased blood pressure and other cardiovascular side effects may be heightened. Concurrent use of phenylephrine with digoxin and cardiac glycosides may increase the risk of arrhythmia or myocardial infarction. Concurrent use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.

Pharmacological properties
A combined agent whose action is determined by its components provides antipyretic, analgesic, and vasoconstrictive effects, alleviating symptoms of "cold."
It constricts the blood vessels of the nose, reducing swelling of the mucous membrane of the nasal cavity and nasopharynx.

Pharmacodynamics
Paracetamol
Paracetamol exerts analgesic and antipyretic effects by inhibiting the synthesis of prostaglandins primarily in the central nervous system. It does not affect platelet function and homeostasis.
Pheniramine maleate
Pheniramine maleate is an antihistamine - an H1 receptor blocker. It alleviates common allergic symptoms associated with respiratory tract disturbances. It has a moderate sedative effect and also exhibits antimuscarinic activity.
Phenylephrine hydrochloride
Phenylephrine is a sympathomimetic agent that, when taken orally, exerts a moderate vasoconstrictive effect (due to stimulation of alpha1-adrenergic receptors), reducing swelling and hyperemia of the mucous membrane of the nasal cavity.

Pharmacodynamic effects
Paracetamol
The absence of peripheral prostaglandin synthesis suppression gives the drug significant pharmacological properties, such as the preservation of protective prostaglandins in the gastrointestinal tract. Therefore, paracetamol is particularly suitable for patients with a history of diseases or those concurrently receiving medications where suppression of peripheral prostaglandin synthesis would be undesirable (for example, patients with a history of gastrointestinal bleeding or elderly patients).
Phenylephrine hydrochloride
Phenylephrine hydrochloride has decongestant activity, reducing swelling and edema of the nasal mucosa.

Paracetamol
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract.
After oral administration, the maximum concentration of paracetamol in plasma is reached within 10-60 minutes.
Paracetamol is distributed in most body tissues, crosses the placenta, and is present in breast milk. At therapeutic concentrations, plasma protein binding is minimal, increasing with higher concentrations.
It undergoes primary metabolism in the liver and is primarily excreted in urine as glucuronide and sulfate conjugates. Less than 5% of the administered dose is excreted as unchanged paracetamol. The half-life is 1-3 hours.

Pheniramine maleate
The maximum concentration of pheniramine in plasma is reached approximately 1-2.5 hours after administration. The half-life of pheniramine is 16-19 hours. 70-83% of the administered dose is excreted from the body in urine as metabolites or in unchanged form.

Phenylephrine hydrochloride
Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract and undergoes presystemic metabolism by monoamine oxidases in the intestine and liver. Thus, phenylephrine hydrochloride has reduced bioavailability when taken orally. It is excreted in urine almost entirely as sulfate conjugates. Maximum plasma concentrations are reached within 45 minutes to 2 hours. The half-life is 2-3 hours.

Koldakt Hot Drink 0.325+0.01+0.02 Powder for Solution Preparation is a combined medicinal product whose action is determined by its components, providing antipyretic, analgesic, and vasoconstrictive effects, alleviating symptoms of "cold."

It constricts nasal blood vessels, reducing swelling of the mucous membrane of the nasal cavity and nasopharynx.

Indications: symptomatic therapy for infectious-inflammatory diseases: ARVI, including influenza and "cold," accompanied by high fever, chills, headache, sore throat, runny nose, nasal congestion, sneezing, and muscle pain.

Adults (including the elderly) and children aged 12 years and older.

Dosage: One packet every 4-6 hours as needed, but no more than 4 doses within 24 hours. Dissolve one packet in a glass of hot, but not boiling water. Take while hot. The product can be taken at any time of day, but the best effect is achieved when taken before bedtime, at night.

To avoid toxic liver damage, do not combine the use of this product with alcoholic beverages. Contains paracetamol; do not use with any other products containing paracetamol. It is recommended to consult a doctor before use.