Coldrex HotRem for cold and flu, honey and lemon, 5g, 10 sachets

Product description

Coldrex HotRem is a combined drug, the action of which is due to the active components included in the composition:

• Paracetamol has analgesic and antipyretic effects.
• Phenylephrine is a vasoconstrictor, relieves nasal congestion (narrows the vessels of the nasal mucosa and paranasal sinuses) and facilitates breathing.
• Ascorbic acid (vitamin C ) makes up for the need for vitamin C for colds and flu.

The active ingredients of Coldrex HotRem do not cause drowsiness. ** Instructions for medical use, RU N016305 / 01

Composition

of Phenylephrine; Paracetamol; Ascorbic acid

Pharmacological action

A combined remedy, the action of which is determined by the components that make up 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. Paracetamol has an extremely small effect on the synthesis of prostaglandins in peripheral tissues, it does not change water and electrolyte metabolism and does not damage the mucous membrane of the gastrointestinal tract. This property of paracetamol makes the drug particularly suitable for patients with a history of gastrointestinal diseases (for example, patients with a history of gastrointestinal bleeding or elderly patients) or patients taking concomitant medication, in which suppression of peripheral prostaglandin synthesis may be undesirable. 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 “colds” 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

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, the distribution in body fluids is relatively uniform. It is mainly metabolized in the liver with the formation of several metabolites. T1 / 2 when taking a therapeutic dose is 2-3 hours. The main amount of the drug is excreted after conjugation in the liver. No more than 3% of the received dose of paracetamol is released unchanged. Phenylephrine is poorly absorbed from the gastrointestinal tract and undergoes metabolism at the first passage in the intestines and liver under the influence of MAO. When taking phenylephrine orally, the bioavailability of the drug is limited. It is excreted in the urine almost completely as a conjugate of sulfuric acid. Ascorbic acid is well absorbed from the gastrointestinal tract, binding to plasma proteins – 25%. The distribution in the body’s tissues is wide. It is metabolized in the liver, excreted in the urine as oxalate and unchanged. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Indications

To eliminate the symptoms of acute respiratory infections and flu, including: – increased body temperature;- headache;— chills;— joint and muscle pain— – nasal congestion;- sore throat and sinuses.

Use during pregnancy and lactation

Pregnancypre Paration should not be used during pregnancy without first consulting your doctor!Animal and human studies have not shown any risk of paracetamol use 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-feedingthe product should not be used during breastfeeding without first consulting a doctor!Paracetamol passes through the placental barrier and into breast milk. In studies conducted on humans, no negative effects on the child’s body during breastfeeding were found. Phenylephrine can pass into breast milk.

Recommendations for use

If you have any of these diseases / conditions / risk factors, be sure to consult your doctor before taking this medicine. :

• Benign hyperbilirubinemia.
• Liver and kidney function disorders of mild to moderate severity.
• Alcoholic liver disease.
• Cardiovascular diseases, including high blood pressure, vascular obliterating diseases (Raynaud’s syndrome).
• Pheochromocytoma.
• The presence of severe infections, including sepsis, as taking the drug may increase the risk of metabolic acidosis.
• Patients with glutathione deficiency (in particular, in extremely emaciated patients suffering from anorexia, chronic alcoholism, or patients with a low body mass index).
• Simultaneous use of antihypertensive agents.
• Pregnancy and breast-feeding period.

Contraindications

-Severe liver function disorders— – severe renal function disorders— – hyperthyroidism (including thyrotoxicosis);— diabetes mellitus;- sucrose/isomaltase deficiency, fructose intolerance, glucose/galactose malabsorption syndrome, because the drug contains sucrose;- heart diseases (severe aortic stenosis, acute myocardial infarction, tachyarrhythmias);— arterial hypertension; – concomitant use of tricyclic antidepressants, beta-blockers, MAO inhibitors and a period of up to 14 days after their withdrawal— – concomitant use of other paracetamol-containing drugs and drugs to relieve the symptoms of colds, flu and nasal congestion;- benign prostatic hyperplasia;- angle-closure glaucoma— – children under 12 years of age;- hypersensitivity to the components of the drug

Side effects

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 andAt the recommended doses, the drug is usually well tolerated. Paracetamol rarely has a side effect. From the hematopoietic system: very rarely – thrombocytopenia, leukopenia, agranulocytosis. Allergic reactions: very rare – anaphylactic shock, skin rash, urticaria, angioedema, Stevens-Johnson syndrome. From the respiratory system: very rarely – bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs. From the liver and biliary tract: very rarely – impaired liver function. With prolonged use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur. Phenylephrine from the nervous system: often – increased excitability, headache, dizziness, insomnia; very rarely-irritability, nervous tension. From the cardiovascular system: often-increased blood pressure; rarely-tachycardia, palpitation. From the digestive system: often – nausea, vomiting. From the sensory organs: rarely-mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma. Allergic reactions: rarely-skin rash, urticaria, allergic dermatitis. From the urinary system: rarely-dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy. Ascorbic acidthe frequency of side effects has not been established. Allergic reactions: skin rash, hyperemia of the skin. From the digestive system: irritation of the gastrointestinal mucosa. From the hematopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis. Other: hypokalemia. Moderate pollakiuria is possible if ascorbic acid is taken more than 600 mg / day. In case of side effects, the patient should immediately stop taking the drug and consult a doctor as soon as possible. If any of the above side effects get worse, or any other side effects occur, the patient should inform the 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. 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 antihypertensive drugs, increases the risk of hypertension and cardiovascular disorders. Concomitant use of phenylephrine with sympathomimetic amines may increase the risk of side effects from the cardiovascular system. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine and may increase the risk of side effects from the cardiovascular system. Concomitant 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 corticosteroids with phenylephrine increases the risk of glaucoma. When used concomitantly with digoxin and cardiac glycosides, there may be an increased risk of developing cardiac arrhythmias or a heart attack. 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 indicated dose!Apply the lowest dose necessary to achieve the effect!The minimum interval between doses of Coldrex ® HotRem should be at least 4 hours. Pour the contents of 1 sachet into a mug, pour hot water, stir until dissolved. If necessary, add cold water and sugar. Adults (including the elderly) and children over 12 years of age: Inside, a 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 should be no more than 5 days. 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.

Overdose

In the event of an overdose of Coldrex® HotRem (even if you feel well), the risk of delayed signs of serious liver damage should be considered. Symptoms due to paracetamol: within 24 hours – pallor of the skin, nausea, vomiting, anorexia, abdominal pain; within 12-48 hours, signs of impaired liver function, signs of impaired glucose metabolism and metabolic acidosis may appear. 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. After 4 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). A specific antidote for paracetamol poisoning is acetylcysteine. 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 there is no possibility of rapid inpatient care) is the appointment of methionine inside. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out jointly with specialists of the toxicology center or specialized department of liver diseases. Symptoms caused by phenylephrine: possible 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. Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine. Ascorbic acid-related symptoms: High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disorders, such as nausea and stomach discomfort. Symptoms of ascorbic acid overdose can be classified as those that are caused by severe liver damage as a result of an overdose of paracetamol. Treatment: symptomatic, forced diuresis. At the first sign of overdose, you should immediately seek medical help, even if there are no clear symptoms of poisoning.

Description

Powder for the preparation of a solution for oral use (lemon-honey) is heterogeneous, from grayish-white with a beige tint to light brown with white, light brown and dark brown inclusions; the prepared solution is from light yellow to light brown with insoluble white inclusions and a characteristic smell of lemon and honey.

Special instructions

The patient should be informed that if the symptoms of the disease persist after 5 days of using the drug, you should stop taking it and consult your doctor. The drug should be taken only in the recommended doses. The patient should stop taking the drug and immediately consult a doctor if the following side effects occur::

• allergic reactions: itching or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat or face;
• rash or flaking of the skin, sores on the oral mucosa;
• bruising or bleeding;
• loss of vision. This may be due to increased intraocular pressure. Very rarely, but most likely, this side effect is observed in patients with glaucoma;
• a feeling of a strong heartbeat or an increase in heart rate or cardiac arrhythmias;
• difficulty urinating. More often, this side effect is observed in patients with prostatic hypertrophy.

Do not take the drug if you have previously experienced respiratory disorders when taking acetylsalicylic acid or other NSAIDs. The drug should not be taken simultaneously with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsants, rifampicin and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other means to relieve cold symptoms, etc. the flu. When performing uric acid and blood glucose tests, the patient should inform the 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. Before taking Coldrex ® HotRem (lemon), you should consult a doctor if::

• receiving metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine used to reduce the concentration of cholesterol in the blood;
• receiving drugs to reduce blood clotting (e. g. warfarin);
• diet low in sodium – each bag contains 0.12 g of sodium;
• serious infectious disease (including sepsis) in patients with deficiency of glutathione, because on the background of paracetamol may increase the risk of metabolic acidosis, the signs of which are a violation of the frequency and depth of breathing, accompanied by a feeling of shortness of breath (shortness of breath), nausea, vomiting, loss of appetite. If the patient finds these symptoms, you should immediately consult a doctor.

Patients with phenylketonuria should not take Coldrex® HotRem (lemon honey) because it contains aspartame, which is a source of phenylalanine. Before taking Coldrex ® HotRem (lemon honey), you should consult a doctor in the following cases::

• the use of warfarin or other indirect anticoagulants;
• medications for control of blood pressure, for example beta-blockers;
• receiving digoxin or other cardiac glycosides for the treatment of heart failure;
• receiving drugs to reduce appetite or psychostimulants;
• taking drugs in the treatment of depression (tricyclic antidepressants – amitriptyline);
• receiving metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine used
• to reduce the level of cholesterol in the blood;
• compliance with hyponatraemia diet (each bag contains 0.12 g of sodium).

In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who use alcohol chronically. Influence on the ability to drive vehicles and mechanisms When taken in the recommended doses, the drug does not affect the ability to drive vehicles and mechanisms, as well as engage in other potentially dangerous activities that require concentration of attention and speed of psychomotor reactions. If dizziness occurs, it is not recommended to drive vehicles or work with mechanisms.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Paracetamol, Phenylephrine, Ascorbic acid

Dosage form

solution for oral use

Purpose

For adults, Children over 12 years of age, Pregnant women as prescribed by a doctor, Nursing mothers

Indications

Swelling of the nasal mucosa, Runny nose, Myalgia, Flu, Cold, Joint pain, Sore throat, Fever, Headache, Acute respiratory viral infections