Coldrex HotRem Menthol and Honey Lemon for cold and flu, 5 sachets

Composition

Composition for one sachet 5 g: Active ingredients: paracetamol 750 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 60 mg. Auxiliary substances: citric acid 600.0 mg, sodium saccharinate 10.0 mg, sodium citrate 500.0 mg, lemon flavor PHS-163671 100.0 mg, honey flavor PFW PHS-050860 75.0 mg, honey flavor Felton F7624P 125.0 mg, caramel color 626 50.0 mg, corn starch 200.0 mg, aspartame 50.0 mg, sucrose 2468.50 mg

Pharmacological action

A combined drug, the action of which is due to the components included in its composition. Paracetamol is an analgesic and antipyretic agent. The mechanism of its action presumably consists in suppressing the synthesis of prostaglandins, mainly in the central nervous system. It does not affect platelet function and hemostasis. Paracetamol practically does not affect the synthesis of prostaglandins in peripheral tissues, it does not change water and electrolyte metabolism and does not damage the gastrointestinal mucosa. Phenylephrine hydrochloride is a sympathomimetic agent whose action is aimed at stimulating adrenoreceptors (mainly alpha-adrenoreceptors), which leads to a decrease in swelling of the nasal mucosa and facilitates nasal breathing. Ascorbic acid (vitamin C) makes up for the increased need for vitamin C in “cold” diseases and flu, especially in the initial stages of the disease. The components included in the preparation do not cause drowsiness and do not interfere with concentration.

Clinical pharmacology

Absorption and DISTRIBUTIONPARACETAMOL: absorption of paracetamol from the gastrointestinal tract is high. The time to reach Cmax in plasma is 0.5-2 hours; Cmax in plasma is 5-20 mcg / ml. Binding to plasma proteins is 15%. Penetrates through the BBB. Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract. Cmax in plasma is reached in the range from 45 minutes to 2 hours. Ascorbic acid is rapidly absorbed from the gastrointestinal tract and distributed throughout the body. Binding to plasma proteins is 25%. Metabolism Paracetamol is mainly metabolized in the liver (90-95%) in three main ways: 80% react by conjugation with glucuronic acid and sulfates to form inactive metabolites; 17% undergo hydroxylation to form 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in drug metabolism. Phenylephrine hydrochloride undergoes primary metabolism with the participation of MAO in the intestine and liver. Thus, the bioavailability of phenylephrine decreases with oral use. Excretion Paracetamol is excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, about 3% is excreted unchanged. T1 / 2 is 1-4 hours. In elderly patients, clearance of the drug decreases and T1 / 2 increases, but no dose adjustment is required. Phenylephrine hydrochloride is excreted by the kidneys almost completely in the form of sulfate conjugates. The elimination period is 2-3 hours. When used in doses exceeding the body’s needs for ascorbic acid, ascorbic acid is excreted by the kidneys in the form of metabolites.

Indications

In adults (including elderly patients) and children over 12 years of age to eliminate the symptoms of” cold ” and flu, including: : increased body temperature; headache;chills;joint and muscle pain;sinus pain;nasal congestion;sore throat.

Use during pregnancy and lactation

The drug should be used with caution during pregnancy and lactation. Pregnancypre Paration should not be used during pregnancy without first consulting a doctor. In experimental studies conducted on animals and in clinical studies in humans, there was no risk of using paracetamol during pregnancy or negative effects on fetal development. There are no sufficient data on the effect of drugs containing phenylephrine on the course of pregnancy. Breast-feeding Periodthe drug should not be used during breastfeeding without first consulting a doctor. Paracetamol penetrates the placental barrier and is excreted in breast milk. In clinical studies in humans, no negative effects on the child’s body were found during breastfeeding. Phenylephrine can be excreted in breast milk.

Contraindications

-Hypersensitivity to any component of the drug; – severe liver and kidney dysfunction; – hyperthyroidism (including thyrotoxicosis);- diabetes mellitus and sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (because the drug contains sucrose);- heart diseases (severe aortic stenosis, acute myocardial infarction, tachyarrhythmias);- arterial hypertension; – concomitant use of tricyclic antidepressants, beta-blockers, monoamine oxidase (MAO) inhibitors, including up to 14 days after their withdrawal; – concomitant use of other paracetamol-containing medications and medications to relieve the symptoms of “colds”, flu and nasal congestion;prostatic hyperplasia; – angle-closure glaucoma; – age up to 12 years. With caution: – with a deficiency of glucose-6-phosphate dehydrogenase, with benign hyperbilirubinemia; with liver or kidney diseases; – with increased blood pressure, heart diseases, obliterating vascular diseases (Raynaud’s syndrome), glaucoma (excluding angle-closure glaucoma), pheochromocytoma. If you have one of these diseases, be sure to consult your doctor before taking the drug.

Side effects

At the recommended doses, the drug is usually well tolerated. The following adverse reactions were detected spontaneously during post-marketing use of the drug. Adverse reactions are classified according to body systems and frequency of development. Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (≥1/100 000 andParacetamol Paracetamol rarely has a side effect. From the blood and lymphatic system: very rarely – thrombocytopenia, leukopenia, agranulocytosis. Immune system disorders: very rare-anaphylactic shock, hypersensitivity skin reactions, including skin rash, urticaria, angioedema (Quincke’s edema), Stevens-Johnson syndrome; frequency unknown – toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis. From the respiratory system: very rarely – bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other NSAIDs. From the liver and biliary tract: very rarely-impaired liver function; frequency unknown-increased activity of liver enzymes. From the urinary system: with prolonged use of the drug in doses exceeding the recommended one, the probability of nephrotoxic action increases. Phenylephrine from the nervous system: very rarely – nervousness, irritability, headache, dizziness, insomnia. From the cardiovascular system: very rarely – increased blood pressure, tachycardia, palpitation. From the digestive system: very rarely-nausea, vomiting. From the side of the organ of vision: very rarely – mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma. From the immune system: very rarely – allergic reactions (skin rash, urticaria, allergic dermatitis). Hypersensitivity reactions, including cross-sensitivity reactions to other sympathomimetics. From the urinary system: very rarely – dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy. If any of the listed adverse reactions occur, the patient should immediately stop taking the drug and consult a doctor as soon as possible. If any of the above adverse reactions get worse, or the patient has noticed other adverse reactions, they should inform their doctor.

Interaction

Paracetamol, when taken for a long time, increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic use of a single dose of the drug does not significantly affect the effect of indirect anticoagulants. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone, and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses and concomitant use with paracetamol. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects. Paracetamol reduces the effectiveness of diuretic medications. Paracetamol reduces the effectiveness of uricosuric drugs. Metoclopramide and domperidone increase, and colestyramine reduces the rate of absorption of paracetamol. Paracetamol enhances the effects of MAO inhibitors, sedatives, and ethanol. Phenylephrine, when taken with MAO inhibitors, can lead to an increase in blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and other antihypertensive drugs, increases the risk of hypertension and cardiovascular disorders. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, the simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia.Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, increases the alpha-adrenostimulating activity of phenylephrine. Antidepressants, antiparkinsonian drugs, antipsychotics, and phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation. Concomitant use of glucocorticosteroids with phenylephrine increases the risk of glaucoma. Concomitant use of digoxin and other cardiac glycosides increases the risk of cardiac arrhythmia and heart attack. Concomitant use of phenylephrine with sympamimetic amines may increase the risk of side effects from the cardiovascular system. Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Ethanol contributes to the development of acute pancreatitis. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

How to take, course of use and dosage

For oral use. Do not exceed the specified dose. Use the lowest dose necessary to achieve the effect. The minimum interval between taking Coldrex® HotRem Menthol and honey lemon should be 4 hours. Put the contents of one sachet in a mug and pour half a mug of hot water. Stir until dissolved. Add cold water, if necessary, and sugar to taste. Adults (including the elderly) and children over 12 years of age: single dose-1 sachet. Repeated use of the drug is possible no earlier than in 4-6 hours and no more than 4 times / day. The maximum daily dose should not exceed 4 sachets. The maximum duration of use of the drug without consulting a doctor is no more than 5 days. It is not recommended to take the drug as an antipyretic for more than 3 days without consulting a doctor. Do not take concomitantly with other paracetamol-containing products, decongestants, and cold and flu relief products, as well as with ethanol-containing products and beverages. If the symptoms of the disease persist while taking the drug, you should consult a doctor. If you exceed the recommended dose of the drug, you should immediately seek medical help, even if you feel well. An overdose of paracetamol can cause liver failure. Before using Coldrex® HotRem Menthol and honey lemon, patients with impaired renal function should first consult a doctor. Limitations associated with the use of drugs containing such a combination of active substances in patients with impaired renal function are mainly associated with the content of paracetamol in the drug. Before using Coldrex® HotRem Menthol and honey lemon, patients with impaired liver function should first consult a doctor. Limitations associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the content of paracetamol in the drug.

Overdose

THE DRUG SHOULD BE TAKEN ONLY IN THE RECOMMENDED DOSES. If an overdose is suspected, even if you feel well, you should stop using the drug and immediately seek medical help, because there is a risk of delayed serious liver damage. Symptoms (due to paracetamol): within 24 hours: pallor of the skin, decreased appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of impaired liver function may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after simultaneous use of more than 10 g of paracetamol: increased activity of “hepatic” transaminases, the clinical picture of liver damage is manifested in 1-6 days. In the case of severe poisoning, severe liver failure can develop up to hepatic encephalopathy, coma, and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe liver dysfunction. Cases of cardiac arrhythmia and pancreatitis have been reported with paracetamol overdose. In the early period, symptoms may be limited only to nausea and vomiting and may not reflect the severity of overdose or the risk of internal organ damage. Treatment: within the first hour after the suspected overdose, it is advisable to prescribe activated charcoal inside. Four or more hours after the suspected overdose, it is necessary to determine the concentration of paracetamol in plasma (an earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine can be carried out up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine can be administered intravenously. In the absence of vomiting, an alternative option (if it is not possible to quickly receive inpatient care) is to prescribe methionine orally. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases. Symptoms (due to phenylephrine): irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, seizures, and arrhythmias may develop. An overdose of phenylephrine may cause symptoms similar to side effects (see section “Side effects”). Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine. Symptoms (caused by ascorbic acid): high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disorders of the gastrointestinal tract, such as nausea, stomach discomfort. Symptoms of overdose can be classified as those caused by severe liver damage, as a result of an overdose of paracetamol. Treatment: symptomatic, forced diuresis.

Description

Powder for the preparation of a solution for oral use from almost white to light brown, loose, heterogeneous, with the smell of honey, lemon and menthol; the prepared solution is brownish-orange, cloudy, without surface foam, with a pronounced smell of honey, lemon and menthol; the solution may contain a small amount of sediment.

Special instructions

The drug should not be taken simultaneously with other paracetamol-containing drugs, as well as other non-narcotic analgesics, NSAIDs (metamizole sodium, acetylsalicylic acid, ibuprofen, etc. ), drugs to eliminate the symptoms of the “cold”, sympathomimetics, such as decongestants, with drugs that regulate appetite, amphetamine-like psychostimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol. To avoid toxic liver damage, the drug should not be combined with ethanol-containing drugs. When performing uric acid and blood glucose tests, inform your doctor about the use of Coldrex HotRem, as the drug may distort the results of laboratory tests that assess the concentration of glucose and uric acid. For patients with phenylketonuria, the drug is not recommended, because it contains aspartame, which is a source of phenylalanine. Before taking the drug” Coldrex HotRem”, you should consult your doctor if you are taking:- warfarin or other indirect anticoagulants for blood thinning; – medications to control blood pressure, such as beta-blockers; – digoxin or other cardiac glycosides for the treatment of heart failure;- appetite-reducing drugs or psychostimulants;- medications for the treatment of depression (tricyclic antidepressants-amitriptyline);- metoclopramide, domperidone (used to treat nausea and vomiting), or colestyramine, used to lower blood cholesterol levels;- if necessary, follow a hyponatremic diet (each sachet contains 0.12 g of sodium). Influence on the ability to drive vehicles and engage in other activities that require concentration of attention and speed of psychomotor reactions:It does not work (when taken in the recommended doses). If dizziness occurs, it is not recommended to drive vehicles or work with mechanisms.

Form of production

6 g of powder in bags made of paper /PE/Al. /EMAA (copolymer of ethylene and methacrylic acid).5 sachets together with the instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Paracetamol, Phenylephrine, Ascorbic acid

Dosage form

oral solution