Coldrex MaxGrippe for colds and flu, lemon flavour, 6g, 10 sachets

Product description

Coldrex Maxgripp 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 Maxgripp do not cause drowsiness. ** Instructions for medical use, RU N014920 / 01

Composition

Paracetamol; Ascorbic acid; Phenylephrine Hydrochloride

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 fully absorbed from the gastrointestinal tract and is metabolized during the” first pass” in the intestines and liver under the action 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

Elimination of cold and flu symptoms:

• fever;
• headache;
• chills;
• joint and muscle pain;
• nasal congestion;
• sore throat;
• sinus pain.

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. The maximum daily dose of ascorbic acid during pregnancy is 2000 mg, which is significantly higher than the maximum daily dose of the drug, so taking the drug in pregnant women is presumably not associated with the risk of side effects from ascorbic acid. 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. The maximum daily dose of ascorbic acid during breastfeeding is 2000 mg, which significantly exceeds the maximum daily dose of the drug, so taking the drug in women during breastfeeding is not associated with the occurrence of side effects from ascorbic acid.

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.
• Acute hepatitis.
• Alcoholic liver disease.
• Difficulty urinating.
• Pyloroduodenal obstruction.
• Stenosing ulcer of the stomach and / or duodenum.
• Bronchial asthma.
• 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.

Contraindications

• Hypersensitivity to the ingredients of the drug.
• Pregnancy and lactation.
• Severe liver or kidney disease.
• Diseases of the blood system.
• Increased thyroid function (thyrotoxis).
• Arterial hypertension.
• Heart diseases: severe aortic stenosis, acute myocardial infarction, tachyarrhythmias.
• Prostatic hyperplasia.
• Angle-closure glaucoma.
• Concomitant use of tricyclic antidepressants, beta-blockers, Mao inhibitors and up to 14 days after their withdrawal.
• Diabetes mellitus and diseases associated with hereditary malabsorption of sugar – each sachet contains 4 g of sugar.
• Genetic absence of glucose-6-phosphate dehydrogenase.
• Under 18 years of age.

With caution:

• Benign hyperbilirubinemia.

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. From the urinary system: with prolonged use in excess of the recommended dose, nephrotoxic effects may occur. Phenylephrine from the nervous system: very rarely – nervousness, headache, dizziness, insomnia. From the cardiovascular system: very rarely – increased blood pressure, tachycardia, palpitation. From the digestive system: very rarely-nausea, vomiting. Sensory disorders: very rare – mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma. Allergic reactions: very rare – skin rash, urticaria, allergic dermatitis. From the urinary system: very 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!Minimum interval between doses of Coldrex® Maxgrip should be 4 hours. Place 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: 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 is 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 case of an overdose of Coldrex® MAXGRIP (even if you feel well) should be considered for the risk of delayed signs of serious liver damage. Overdose is usually caused by paracetamol. Liver damage in adults is possible when taking ≥ 10 g of paracetamol. Taking ≥ 5 g of paracetamol may cause liver damage in patients with the following risk factors::-long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs that stimulate liver enzymes; – regular excessive alcohol consumption; – glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion). Symptoms (due to paracetamol): paleness of the skin, nausea, vomiting, anorexia, abdominal pain may occur within 24 hours; signs of impaired liver function, signs of impaired glucose metabolism, and metabolic acidosis may occur within 12-48 hours. 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. <br>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. <br>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). The antidote 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. At the first sign of overdose, you should immediately seek medical help, even if there are no clear symptoms of poisoning. Symptoms caused by 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. Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine. Symptoms caused by ascorbic acid: when using more than 1 g – headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the gastrointestinal mucosa, inhibition of the function of the insular pancreatic apparatus (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration trophic tissues, increased blood pressure, hypercoagulation, development of microangiopathies). Ascorbic acid in high doses (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disorders, such as nausea, 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. “

Description

Powder for the preparation of a solution for oral use (lemon) is light yellow in color, with the smell of lemon; the prepared solution is cloudy, yellowish-green in color, with the smell of lemon, without surface foam and solid inclusions.

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 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® Maxgripp, because the drug may distort the results of laboratory tests that assess the concentration of glucose and uric acid. Before taking Coldrex® Maxgripp needs a doctor’s consultation in case of:-taking metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine, used to reduce the concentration of cholesterol in the blood; – taking medications to reduce blood clotting (for example, warfarin);- following a low-sodium diet – each sachet contains 0.12 g of sodium;- severe infectious diseases (including sepsis) in patients with glutathione deficiency, because while taking paracetamol, the risk of metabolic acidosis may increase, the signs of which are a violation of the frequency and depth of breathing, accompanied by a feeling of lack of air (shortness of breath), nausea, vomiting, loss of appetite. If the patient finds these symptoms, you should immediately consult a doctor. 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.

Form of production

Coldrex Maxgripp. Powder for the solution.

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

Indications

Swelling of the nasal mucosa, SARS, Flu, Sore throat, Fever, Joint Pain, Myalgia, Headache, Runny nose, Cold