Coldrex maxgripp instructions for use ultrasound scanner. Coldrex maxgripp: instructions for use

Release form:

Powder for preparing a solution for oral administration (lemon) 6.427 g - multilayer sachets (5, 10) - cardboard packs.

Compound:

One sachet of lemon powder for oral solution contains

Active substances: paracetamol 1 g, phenylephrine hydrochloride 10 mg, ascorbic acid 40 mg

Excipients: sucrose, citric acid, sodium citrate, corn starch, lemon flavor, sodium cyclamate, sodium saccharinate, curcumin dye (E100), colloidal silicon dioxide.

Description:

Powder for preparing a solution for oral administration (lemon) is light yellow in color, free-flowing, heterogeneous, with the smell of lemon; the powder dissolves in hot water to form a cloudy yellowish-green solution without surface foam and solid inclusions, with the smell of lemon.

Pharmacotherapeutic group:

• Non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Pharmacological properties:

Pharmacodynamics

Combined drug for symptomatic treatment colds and other infectious and inflammatory diseases.

Paracetamol has an antipyretic and analgesic effect. The content of paracetamol in the drug corresponds to the maximum single dose allowed for over-the-counter use.

Phenylephrine is a vasoconstrictor, relieves nasal congestion (constricts blood vessels in the nasal mucosa and paranasal sinuses) and facilitates breathing.

Ascorbic acid replenishes the increased need for vitamin C during colds and flu.

Active components The drug does not cause drowsiness.

Pharmacokinetics

Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract, distribution in body fluids is relatively even.

Metabolized primarily 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 excreted unchanged.

Ascorbic acid is well absorbed from the gastrointestinal tract, binding to plasma proteins is 25%. Distribution in body tissues is wide.

Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged.

Ascorbic acid, taken in excessive quantities, is quickly excreted unchanged in the urine.

Phenylephrine is poorly absorbed from the gastrointestinal tract and undergoes first-pass metabolism in the intestine and liver under the influence of MAO. When phenylephrine is taken orally, the bioavailability of the drug is limited.

It is excreted almost entirely in the urine as a sulfuric acid conjugate.

Indications for use:

Relieving cold and flu symptoms:

Increased body temperature;

Headache;

Pain in joints and muscles,

Nasal congestion;

Sore throat;

Pain in the sinuses.

Refers to diseases:

• Flu
• Cough
• ARVI
• acute respiratory infections

Contraindications:

The drug should not be used if any of the conditions listed below are present:

Severe liver diseases;

Severe kidney disease;

Diseases of the hematopoietic system;

Thyrotoxicosis;

Arterial hypertension;

Heart diseases (severe stenosis of the aortic mouth, acute myocardial infarction, tachyarrhythmias);

Benign hyperplasia prostate gland;

Angle-closure glaucoma;

Diabetes mellitus;

Hereditary lactase deficiency (each sachet contains 4 g of sugar);

Genetic absence of glucose-6-phosphate dehydrogenase;

Simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors and a period of up to 14 days after their discontinuation;

Pregnancy;

Lactation (breastfeeding);

Children's and adolescence up to 18 years old;

Hypersensitivity to the components of the drug.

With caution: The drug should be used for benign hyperbilirubinemia.

Directions for use and dosage:

The contents of 1 sachet should be poured into a half-filled mug. hot water, stir until completely dissolved and add cold water or sugar as desired.

The maximum duration of use of the drug is 5 days.

Side effect:

Side effects caused by paracetamol included in the drug.

Allergic reactions: Sometimes - skin rash, urticaria, angioedema.

rarely - thrombocytopenia, leukopenia, agranulocytosis.

Side effects caused by phenylephrine included in the drug.

From the cardiovascular system: increased blood pressure; rarely - palpitations.

From the side of the central nervous system: headache, dizziness, insomnia.

From the outside digestive system: vomiting, diarrhea.

Side effects caused by ascorbic acid included in the drug.

Allergic reactions: skin rash, skin hyperemia.

From the hematopoietic system: thrombocytosis, erythropenia, neutrophilic leukocytosis.

From the urinary system: upon admission ascorbic acid more than 600 mg/day - moderate pollakiuria.

Others: irritation of the gastrointestinal mucosa, hyperprothrombinemia, hypokalemia.

Overdose:

In case of an overdose of Coldrex ® MaxGripp (even with feeling good) the risk of delayed signs of serious liver damage should be considered.

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 preparations, or other drugs,
stimulating liver enzymes;

Regular consumption of alcohol in excess quantities;

Possibly having glutathione deficiency (those with malnutrition, cystic fibrosis, HIV infection, starving, malnourished).

Symptoms: pallor is possible within 24 hours skin, nausea, vomiting, anorexia, abdominal pain; within 12-48 hours, signs of liver dysfunction, signs of impaired glucose metabolism and metabolic acidosis may appear. In case of severe poisoning, severe liver failure 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. There are reports of cases of cardiac arrhythmia and pancreatitis with an overdose of paracetamol.

At the first signs of an overdose, you should urgently seek help. medical care, even in the absence of clear symptoms of poisoning. IN early period symptoms may be limited to nausea and vomiting only and may not reflect the severity of the overdose or the risk of damage to internal organs.

Symptoms of phenylephrine overdose: may be accompanied by the following symptoms: irritability, headache, increased blood pressure, reflex bradycardia, nausea and vomiting.

Symptoms of ascorbic acid overdose (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 apparatus of the pancreas (hyperglycemia, glugocosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

Treatment: within the first hour after the expected overdose, it is advisable to prescribe activated carbon inside. 4 or more hours after the suspected overdose, it is necessary to determine the concentration of paracetamol in plasma (more than early definition paracetamol concentration may be unreliable). The antidote is acetylcysteine. Treatment with acetylcysteine ​​can be carried out up to 24 hours after taking paracetamol, however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After this, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine ​​can be administered intravenously. In the absence of vomiting, alternative option(if it is not possible to quickly receive inpatient care) is the administration of methionine orally. Treatment of patients with pronounced violation liver function 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized department liver diseases.

Use during pregnancy and breastfeeding:

Coldrex ® MaxGrip with lemon flavor is contraindicated for use during pregnancy.

If it is necessary to use it during lactation, the issue of stopping it should be decided. breastfeeding.

Interaction with other drugs:

Paracetamol, when taken for a long time, enhances the effect indirect anticoagulants(warfarin and other coumarins), which increases the risk of bleeding.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses and simultaneous administration with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretics.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.

Paracetamol enhances the effects of MAO inhibitors, sedatives, 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.

Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine; simultaneous administration of halothane with phenylephrine increases the risk of developing ventricular arrhythmia.

Phenylephrine reduces hypotensive effect guanethidine, which, in turn, enhances the alpha-adrenergic stimulating activity of phenylephrine.

Antidepressants, antiparkinsonian drugs, antipsychotics, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.

The simultaneous administration of GCS with phenylephrine increases the risk of developing glaucoma.

Special instructions and precautions:

The patient should be informed that if symptoms of the disease persist after 5 days of using the drug, they should stop taking it and consult a doctor.

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 medicines, rifampicin and chloramphenicol.

Coldrex ® MaxGrip should be taken with caution simultaneously with metoclopramide, domperidone, cholestyramine, and indirect anticoagulants (warfarin).

Patients taking the drug Coldrex ® MaxGrip should refrain from drinking alcohol. It is not recommended to prescribe the drug for chronic alcoholism.

Patients on a low-sodium diet should be aware that 1 sachet of Coldrex ® MaxGrip contains 0.12 g of sodium.

When conducting tests to determine the level uric acid and blood glucose levels, you should warn your doctor about the use of Coldrex ® MaxGrip, since the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid.

Storage conditions:

Abbott Nutrition Ltd SMITHKLINE BEECHAM CONSUMER HEALTHCARE/SEARLPHARMA GlaxoSmithKline GmbH & Co. KG/Heumann Pharma GmbH GlaxoSmithKline Consumer Healthcare GlaxoSmithKline Consumer Healthcare/SmithKline Beecham SmithKlein Beecham S.A. SmithKline Beecham S.A./GlaxoSmithKline Consumer He

Country of origin

Spain

Product group

Medicines for colds and flu

Acute respiratory infections and “cold” symptoms are eliminated (non-narcotic analgesic + alpha-adrenergic agonist + vitamin).

Release forms

• 6.427 g - multilayer bags (10) - cardboard packs, pack of 5 bags

Description of the dosage form

• powder Powder for the preparation of solution for oral administration (lemon)

Pharmacological action

Combined drug for the symptomatic treatment of colds and other infectious and inflammatory diseases. Paracetamol has an antipyretic and analgesic effect. The content of paracetamol in the drug corresponds to the maximum single dose allowed for over-the-counter use. Phenylephrine is a vasoconstrictor, relieves nasal congestion (constricts the vessels of the nasal mucosa and paranasal sinuses) and facilitates breathing. Ascorbic acid replenishes the increased need for vitamin C during colds and flu. The active components of the drug do not cause drowsiness.

Pharmacokinetics

Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract, distribution in body fluids is relatively even. Metabolized predominantly 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 excreted unchanged. Ascorbic acid is well absorbed from the gastrointestinal tract, binding to plasma proteins is 25%. Distribution in body tissues is wide. Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged. Ascorbic acid, taken in excessive quantities, is quickly excreted unchanged in the urine. Phenylephrine is poorly absorbed from the gastrointestinal tract and undergoes first-pass metabolism in the intestines and liver under the influence of MAO. When phenylephrine is taken orally, the bioavailability of the drug is limited. It is excreted almost entirely in the urine as a sulfuric acid conjugate.

Special conditions

The patient should be informed that if symptoms of the disease persist after 5 days of using the drug, they should stop taking it and consult a doctor. The drug should be taken only in 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. Coldrex® MaxGrip should be taken with caution simultaneously with metoclopramide, domperidone, cholestyramine, and indirect anticoagulants (warfarin). Patients taking Coldrex® MaxGrip should avoid drinking alcohol. It is not recommended to prescribe the drug for chronic alcoholism. Patients on a low-sodium diet should be aware that 1 sachet of Coldrex® MaxGrip contains 0.12 g of sodium. When conducting tests to determine the level of uric acid and blood glucose levels, you should warn your doctor about the use of Coldrex® MaxGrip, since the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid.

Compound

• 1 pack contains paracetamol 1 g phenylephrine hydrochloride 10 mg ascorbic acid 40 mg Excipients: sucrose, citric acid, sodium citrate, corn starch, lemon flavor, sodium cyclamate, sodium saccharinate, curcumin dye (E100), colloidal silicon dioxide paracetamol 1 g phenylephrine hydrochloride 10 mg ascorbic acid 40 mg Excipients: sucrose, citric acid, sodium citrate, corn starch, lemon flavor, sodium cyclamate, sodium saccharinate, curcumin dye (E100), colloidal silicon dioxide. paracetamol 1 g phenylephrine hydrochloride 10 mg ascorbic acid 40 mg Excipients: sucrose, citric acid, sodium citrate, corn starch, lemon flavor, sodium cyclamate, sodium saccharinate, curcumin dye (E100), colloidal silicon dioxide.

Coldrex MaxGripp indications for use

• Elimination of cold and flu symptoms: - elevated body temperature; - headache; - chills; - pain in joints and muscles, - nasal congestion; - sore throat; - pain in the sinuses.

Coldrex MaxGrip contraindications

• severe liver diseases; - severe kidney diseases; - diseases of the hematopoietic system; - thyrotoxicosis; - arterial hypertension; - heart disease (severe aortic stenosis, acute myocardial infarction, tachyarrhythmias); - benign prostatic hyperplasia; - angle-closure glaucoma; - diabetes mellitus ;- hereditary lactase deficiency (each sachet contains 4 g of sugar); - genetic absence of glucose-6-phosphate dehydrogenase; - simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors and a period of up to 14 days after their withdrawal; - pregnancy; - lactation (breastfeeding); - childhood and adolescence up to 18 years; - hypersensitivity to the components of the drug. The drug should be used with caution in cases of benign hyperbilirubinemia.

Coldrex MaxGrip side effects

• Side effects caused by paracetamol included in the drug. Allergic reactions: sometimes - skin rash, urticaria, angioedema. From the hematopoietic system: rarely - thrombocytopenia, leukopenia, agranulocytosis. At long-term use if the recommended dose is exceeded, hepatotoxic and nephrotoxic effects may be observed. Side effects caused by phenylephrine included in the drug. From the cardiovascular system: increased blood pressure; rarely - palpitations. From the central nervous system: headache, dizziness, insomnia. From the digestive system: vomiting, diarrhea. Side effects caused by ascorbic acid included in the drug. Allergic reactions: skin rash, skin hyperemia. From the hematopoietic system: thrombocytosis, erythropenia, neutrophilic leukocytosis. From the urinary system: when taking ascorbic acid more than 600 mg/day - moderate pollakiuria. Other: irritation of the gastrointestinal mucosa, hyperprothrombinemia, hypokalemia.

Drug interactions

Paracetamol, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses and concomitant use with paracetamol. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxicity. Paracetamol reduces the effectiveness of diuretics. Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol. Paracetamol enhances the effects of MAO inhibitors, sedatives, 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. Tricyclic antidepressants

Overdose

In case of overdose of Coldrex® MaxGripp, the risk of delayed signs of serious liver damage should be taken into account. Overdose is usually caused by paracetamol. Is liver damage possible in adults when taken? 10 g paracetamol

Storage conditions

• store in a dry place
• keep away from children

Information provided

Manufacturer: Wrafton Laboratories Limited (Rafton Laboratories Limited,) UK

ATC code: N02B

Farm group:

Release form: Solid dosage forms. Powder for oral use.

General characteristics. Compound:

Active ingredients: paracetamol 1000 mg, phenylephrine hydrochloride 10 mg and ascorbic acid (vitamin C) 40 mg: excipients: sugar, citric acid, sodium citrate, corn starch, sodium cyclamate, sodium saccharin, colloidal silica anhydrous, lemon flavor and natural curcumin (E 100).

Pharmacological properties:

Coldrex MaxGrip with lemon flavor - combination drug. Paracetamol has an analgesic and antipyretic effect. The drug contains its maximum single dose permitted for over-the-counter use. Phenylephrine hydrochloride is a vasoconstrictor that relieves nasal congestion (constricts the vessels of the nasal mucosa and paranasal sinuses) and makes breathing easier. Ascorbic acid (vitamin C) replenishes the increased need for vitamin C during colds and flu, especially in initial stages diseases.

The active ingredients of Coldrex MaxGrip with lemon flavor do not cause drowsiness.

Indications for use:

Coldrex MaxGripp with lemon flavor provides relief from the symptoms of colds and flu: fever, joint and muscle pain, nasal congestion, pain in the sinuses and throat.

Directions for use and dosage:

Place the contents of one sachet in a mug and fill with hot water. Stir until dissolved. Add cold water if necessary and sugar to taste.

Adults: one sachet every 4-6 hours. Do not take more than 4 sachets within 24 hours. Do not take the drug more often than every 4 hours.

Do not give this medicine to children under 18 years of age unless directed by a doctor.

Do not exceed the indicated dose. If you exceed the recommended dose, seek immediate medical attention, even if you feel well, as there is a risk of delayed serious liver damage.

The specific antidote for paracetamol poisoning is acetylcysteine.

Features of application:

Before taking Coldrex MaxGrip with lemon flavor, consult your doctor:

• If you are taking metoclopramide, domperidone (used for nausea and vomiting), or cholestyramine, used to lower blood cholesterol
• If you are taking medications to reduce blood clotting (such as warfarin)
• If you are on a low sodium diet - each packet contains 0.12 g sodium

To avoid toxic liver damage, paracetamol should not be combined with alcoholic drinks, and also taken by people who chronically drink alcohol.

Side effects:

Paracetamol rarely causes side effects. Sometimes possible allergic reactions: , angioedema. Rarely - blood picture disturbances (thrombocytopenia,). With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur.

The risk of developing hepatotoxicity increases with simultaneous use of barbiturates, diphenine, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.

Phenylephrine may cause nausea, headache, slight increase blood pressure and extremely rarely palpitations. These effects disappear with discontinuation of the drug.

If an unusual reaction occurs, consult a doctor

Interaction with other drugs:

Enhances the effects of MAO inhibitors, sedatives, ethanol.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.

Glucocorticosteroids increase the risk of developing glaucoma.

Paracetamol reduces the effectiveness of diuretics.

Tricyclic antidepressants enhance the symptomatic effect; simultaneous administration of halothane increases the risk of developing ventricular arrhythmia. Reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenergic stimulating activity of phenylephrine.

Contraindications:

The drug should not be taken simultaneously with other paracetamol-containing drugs, or together with other drugs to relieve symptoms or relieve nasal congestion. Do not give this medicine to children under 18 years of age.

Do not take Coldrex MaxGrip lemon flavored:

• At hypersensitivity to paracetamol, phenyephrine hydrochloride, ascorbic acid (vitamin C) or any other ingredient listed above
• If you are pregnant or breastfeeding
• If you have serious illness liver or kidneys
• If you suffer from diseases of the blood system
• With increased function thyroid gland(thyrotoxicosis), diabetes mellitus, or heart disease
• If you have prostate adenoma
• If you have
• The drug should not be taken simultaneously with tricyclic antidepressants, beta-blockers, MAO inhibitors and for up to 14 days after their discontinuation
• For diseases associated with hereditary malabsorption of sugar - each sachet contains 4 g of sugar
• With a genetic absence of glucose-6-phosphate dehydrogenase

Overdose:

The drug should be used only in recommended doses.

Overdose is usually caused by paracetamol. Possible: pallor of the skin, nausea, hepatonecrosis; increased activity of “liver” transminases, increased prothrombin time. In case of overdose, consult a doctor immediately. Treatment: followed by the administration of activated carbon; symptomatic therapy.

Storage conditions:

Shelf life - 3 years. Do not use after the expiration date stated on the package.

Vacation conditions:

Over the counter

Package:

5 or 10 sachets per cardboard box along with instructions for use. Each sachet contains 6.4 g of powder.

Ingredients for 1 sachet:

Ingredients	Amount, mg
Active substances:
Paracetamol
Ascorbic acid
Phenylephrine hydrochloride
Excipients:
Sucrose
Citric acid
Sodium citrate
Corn starch
Lemon flavor
Sodium cyclamate
Sodium saccharinate
Curcumin dye (E100)
Silicon dioxide colloidal

Description of the dosage form

Light yellow powder with a lemon scent.

Description of the prepared solution:

A cloudy solution of yellowish-green color with the smell of lemon without surface foam and solid inclusions.

Pharmacodynamics

A combined product whose effect is determined by its constituent components.

Paracetamol is an analgesic and antipyretic agent. Its mechanism of action is believed to be the suppression of prostaglandin synthesis, primarily in the central nervous system.

Paracetamol has an extremely small effect on the synthesis of prostaglandins in peripheral tissues; it does not change water-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 medications in which suppression of peripheral prostaglandin synthesis may be undesirable.

Phenylephrine hydrochloride- a sympathomimetic agent, the action of which is aimed at stimulating adrenergic receptors (mainly a-adrenergic receptors), which leads to a reduction in swelling of the nasal mucosa and easier nasal breathing.

Ascorbic acid(vitamin C) replenishes the increased need for vitamin C during colds and flu, especially in the initial stages of the disease. The components included in the drug do not cause drowsiness and do not interfere with concentration.

Pharmacokinetics

Suction and distribution

Paracetamol is quickly and almost completely absorbed into gastrointestinal tract. Plasma protein binding is minimal when used at therapeutic concentrations.

Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract.

Ascorbic acid is quickly absorbed in the gastrointestinal tract and distributed throughout the body. The connection with blood plasma proteins is 25%.

Metabolism

Paracetamol is metabolized primarily in the liver.

Phenylephrine hydrochloride undergoes primary metabolism by monoamine oxidases in the intestine and liver. Thus, when administered orally, the bioavailability of phenylephrine is reduced.

Removal

Paracetamol is excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, less than 5% of the dose taken is excreted unchanged.

Phenylephrine hydrochloride is excreted almost entirely by the kidneys in the form of sulfate conjugates.

When used in doses exceeding the body's needs for ascorbic acid, ascorbic acid is excreted by the kidneys in the form of metabolites.

Coldrex MaxGrip: Indications

Coldrex ® MaxGripp is used in adults as a remedy for the symptoms of colds and flu, including:

· elevated temperature;

· headache;

pain in joints and muscles;

Pain in the sinuses and nasal congestion;

· sore throat.

Coldrex MaxGrip: Contraindications

· hypersensitivity to paracetamol, phenylephrine, ascorbic acid (vitamin C) or any other component of the drug;

· severe liver and kidney dysfunction;

· arterial hypertension;

· hyperfunction of the thyroid gland (including with thyrotoxicosis);

diseases of the blood system;

· heart diseases (with severe stenosis of the aortic mouth, acute myocardial infarction, tachyarrhythmia);

prostatic hyperplasia;

· diabetes mellitus and diseases associated with hereditary malabsorption of sugar - each sachet contains about 4 g of sugar;

· genetic absence of glucose-6-phosphate dehydrogenase;

· sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, because the drug contains sucrose;

· angle-closure glaucoma;

diseases accompanied by portal hypertension;

· simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors, including up to 14 days after their discontinuation;

· simultaneous use of other paracetamol-containing drugs, decongestants, non-narcotic analgesics, non-steroidal anti-inflammatory drugs, medicines to relieve symptoms of colds, flu and nasal congestion, drugs that regulate appetite, amphetamine-like psychostimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol (see section “Interaction with other drugs”);

· simultaneous intake of ethanol-containing drinks and medications;

· chronic alcoholism;

· under 18 years of age;

· pregnancy and during breastfeeding.

With caution

If you have one of the following diseases/conditions/risk factors, be sure to consult your doctor before taking the drug:

· Benign hyperbilirubinemia.

· Mild to moderate liver and kidney dysfunction.

· Acute hepatitis.

· Alcohol disease liver.

· Difficulty urinating.

· Pyloroduodenal obstruction.

· Stenosing ulcer of the stomach and/or duodenum.

· Bronchial asthma.

· Cardiovascular diseases including high blood pressure, obliterating diseases vessels (Raynaud's syndrome).

· Pheochromocytoma.

· The presence of severe infections, including sepsis, because taking the drug may increase the risk of metabolic acidosis.

· Patients with glutathione deficiency (in particular, extremely malnourished patients suffering from anorexia, chronic alcoholism or patients with a low body mass index).

· Concomitant use of antihypertensive drugs.

Use during pregnancy and breastfeeding

Pregnancy

The drug should not be used during pregnancy without first consulting a doctor!

Animal and human studies have not shown any risk from the use of paracetamol during pregnancy or negative impact on intrauterine development of the fetus.

There are no sufficient data on the effect of drugs containing phenylephrine on the course of pregnancy.

Maximum daily dose ascorbic acid during pregnancy is 2000 mg, which significantly exceeds 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.

Breastfeeding period

The drug should not be used during breastfeeding without first consulting a doctor!

Paracetamol penetrates the placental barrier and into breast milk. Studies conducted on humans have not shown any negative effects on the baby's body during breastfeeding.

Phenylephrine may 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 side effects from ascorbic acid.

Directions for use and doses

For oral administration.

Do not exceed the indicated dose!

The smallest dose necessary to achieve the effect should be used!

The minimum interval between doses of Coldrex ® MaxGrip should be 4 hours.

Place the contents of one sachet in a mug and pour half of the mug hot water. Stir until dissolved. Add cold water if necessary and sugar to taste.

Adults: Orally, single dose - 1 sachet. Repeated use of the drug is possible no earlier than after 4-6 hours and no more than 4 times a 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 simultaneously with other paracetamol-containing products, decongestants and cold and flu relief products, as well as ethanol-containing products and drinks.

If symptoms of the disease persist while taking the drug, you should consult a doctor.

Special patient groups

Patients with impaired renal function:

Before using the drug Coldrex ® MaxGripp, patients with impaired renal function should first consult with their doctor. Restrictions associated with the use of drugs containing this combination active substances, in patients with impaired renal function, are mainly associated with the paracetamol content of the drug.

Patients with impaired liver function:

Before using the drug Coldrex ® MaxGripp, patients with impaired liver function should first consult a doctor. Restrictions associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the paracetamol content of the drug.

Coldrex MaxGrip: Side effects

The following adverse reactions were detected spontaneously during post-registration use of the drug.

Adverse reactions are classified according to body systems and according to the frequency of development. The frequency of adverse reactions is determined as follows: very often (≥1/10), often (≥1/100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000), очень редко (<10 000), частота неизвестна (частота не может быть оценена, исходя из имеющихся данных).

Paracetamol rarely has side effects.

Paracetamol

Very rare: thrombocytopenia, leukopenia, agranulocytosis.

Very rare: anaphylactic shock, skin hypersensitivity reactions including skin rash, urticaria, angioedema (Quincke's edema), Stevens-Johnson syndrome,

Frequency unknown: toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis.

Respiratory system disorders, organs of the chest and mediastinum:

Very rare: bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other non-steroidal anti-inflammatory drugs.

Disorders of the liver and biliary tract:

Very rare: liver dysfunction.

Frequency unknown: increased activity of liver enzymes.

Urinary system disorders:

With long-term use of the drug in doses exceeding the recommended one, the likelihood of nephrotoxicity increases.

Phenylephrine

Nervous system disorders:

Very rare: nervousness, irritability, headache, dizziness, insomnia.

Cardiovascular system disorders:

Very rare: increased blood pressure, tachycardia, palpitations.

Gastrointestinal disorders:

Very rarely: nausea, vomiting.

Visual disorders:

Very rare: mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

Immune system disorders:

Very rare: allergic reactions (skin rash, urticaria, allergic dermatitis).

Urinary system disorders:

Very rare: dysuria, urinary retention in patients with bladder outlet obstruction due to prostatic hypertrophy.

Ascorbic acid

The frequency of side effects has not been established.

Immune system disorders:

Allergic reactions (skin rash, skin hyperemia).

Digestive system disorders:

Irritation of the mucous membrane of the gastrointestinal tract.

Blood and lymphatic system disorders:

Thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

When taking ascorbic acid more than 600 mg/day, moderate pollakiuria is possible.

If any of the listed adverse reactions occur, immediately stop taking the drug and consult a doctor as soon as possible.

If any of the adverse reactions indicated in the instructions worsen, or you notice other adverse reactions not listed in the instructions, tell your doctor.

Overdose

If you suspect an overdose, even if you feel well, you must stop using the drug and consult a doctor immediately, because there is a risk of delayed serious liver damage.

Overdose is usually caused by paracetamol.

Symptoms (due to paracetamol)

An overdose of paracetamol may cause liver failure, which may lead to the need for liver transplantation or death.

Within 24 hours it is possible: pale skin, anorexia, nausea, vomiting, abdominal pain. Signs of liver dysfunction may appear within 12-48 hours. Signs of impaired glucose metabolism and metabolic acidosis (including lactic acidosis) may appear. Toxic effects in adults are possible after taking more than 10 g of paracetamol. In cases of severe poisoning, severe liver failure may develop, including hepatic encephalopathy, the need for a liver transplant, 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 impairment of liver function. There have been reports of cases of cardiac arrhythmia, hypokalemia and pancreatitis following an overdose of paracetamol.

Taking 5 g or more 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 preparations, or other drugs that stimulate liver enzymes;

Regular consumption of alcohol in excess quantities;

Glutathione deficiency (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

At the first signs of an overdose, you should immediately consult a doctor, even in the absence of clear symptoms of poisoning.In the early period, symptoms may be limited to nausea and vomiting only and may not reflect the severity of overdose or the risk of organ damage.

Treatment: during the first hour after the expected overdose, it is advisable to administer activated carbon orally. Four or more hours after the expected overdose, it is necessary to determine the concentration of paracetamol in the blood plasma (earlier determination of the concentration of paracetamol may be unreliable). Treatment with acetylcysteine ​​can be carried out up to 24 hours after taking paracetamol, however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After this, 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 obtain hospital care) is to prescribe methionine orally. Treatment of patients with severe liver dysfunction 24 hours after taking paracetamol should be carried out in conjunction with specialists from a poison control center or specialized liver disease department.

Symptoms (due to phenylephrine)

Symptoms of a phenylephrine overdose are similar to those of side effects. In addition: irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, convulsions, and arrhythmias may develop. It should be borne in mind that the appearance of clinically significant symptoms of phenylephrine overdose when taking the drug is always associated with severe liver damage due to an overdose of paracetamol.

Treatment: symptomatic therapy, for severe arterial hypertension, the use of alpha-blockers such as phentolamine.

Symptoms (due to ascorbic acid)

When using 1000 mg or more ascorbic acid, 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 apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis may occur. (from calcium oxalate), damage to the glomerular apparatus of the kidneys, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea and stomach discomfort. It should be borne in mind that the appearance of clinically significant symptoms of an overdose of ascorbic acid when taking the drug is always associated with severe liver damage due to an overdose of paracetamol.

Treatment: symptomatic, forced diuresis.

Interaction

Paracetamol, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Occasional administration of a single dose of the drug does not have a significant effect on the effect of indirect anticoagulants.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses and concomitant use with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretics.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.

Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol.

The simultaneous use of paracetamol and alcoholic beverages increases the risk of developing liver damage and acute pancreatitis.

Phenylephrine when taken with MAO inhibitors can lead to increased blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and other antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa), increases the risk of developing hypertension and disorders of the cardiovascular system. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine and may increase the risk of side effects from the cardiovascular system; simultaneous use of halothane with phenylephrine increases the risk of developing ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenergic stimulating activity of phenylephrine.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.

Concomitant use of glucocorticosteroids with phenylephrine increases the risk of developing glaucoma.

Concomitant use of digoxin and other cardiac glycosides increases the risk of heart rhythm disturbances and heart attack.

Concomitant use of phenylephrine with sympathomimetic amines may increase the risk of adverse cardiovascular effects.

Ascorbic acid increases the risk of developing crystalluria during treatment with salicylates and short-acting sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), and reduces the concentration of oral contraceptives in the blood.

Ethanol contributes to the development of acute pancreatitis.

Myelotoxic drugs enhance the hematotoxicity of the drug.

Special instructions

There is no sufficient data on the effect of the drug on fertility.

If there is no improvement in your condition while taking the drug, you should consult a doctor.

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 “colds” and flu, sympathomimetics (decongestants, drugs that regulate appetite , amphetamine-like psychostimulants), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

TO AVOID TOXIC DAMAGE TO THE LIVER, THE DRUG SHOULD NOT BE COMBINED WITH ETHANOL-CONTAINING DRUGS AND DRINKS, AND SHOULD NOT BE TAKEN BY PEOPLE PROMOTED TO CHRONIC ALCOHOL CONSUMPTION.

Concomitant liver disease increases the risk of further liver damage while taking the drug. When taking the drug in patients with non-alcoholic cirrhosis of the liver, there is a high risk of overdose.

When performing tests to determine uric acid and blood glucose levels, tell your doctor about the use of Coldrex ® MaxGrip, as the drug may distort the results of laboratory tests that assess the concentration of glucose and uric acid.

Patients with glutathione deficiency due to an eating disorder, cystic fibrosis, HIV infection, fasting, malnutrition are susceptible to overdose, so precautions must be taken and it is recommended to consult a doctor before taking the drug. Cases of liver failure/impaired liver function have been reported with a small overdose of paracetamol (5 g or more) in patients with low glutathione levels, in particular in extremely malnourished patients suffering from anorexia, chronic alcoholism or patients with a low body mass index.

Use of the drug in patients with low levels of glutathione, for example, with sepsis, may increase the risk of developing metabolic acidosis, accompanied by symptoms of rapid, difficult breathing (feeling short of air, shortness of breath), nausea, vomiting, loss of appetite. If these symptoms occur simultaneously, you should immediately consult a doctor.

Coldrex MaxGripp- a combined drug with antipyretic, analgesic, sympathomimetic and immunostimulating effects. The drug contains three active ingredients - paracetamol, phenylephrine hydrochloride and ascorbic acid. The mechanism of action and therapeutic effects of the drug are determined by the pharmacological properties of the active components included in its composition:
Paracetamol is a drug from the group of non-narcotic analgesics. The mechanism of action of the drug is associated with its ability to inhibit the activity of the enzyme cyclooxygenase and reduce the synthesis of prostaglandins from arachidonic acid. The analgesic effect of the drug is due to a decrease in the amount of prostaglandins in the tissues of the central nervous system. The antipyretic effect of paracetamol is due to the direct effect of the drug on the thermoregulation center in the hypothalamus.
The anti-inflammatory effect of the drug is insignificant.
Phenylephrine hydrochloride is a sympathomimetic drug. Phenylephrine reduces swelling of the nasal mucosa, eliminates rhinorrhea, and facilitates nasal breathing.
Ascorbic acid (vitamin C) - has an immunostimulating effect, increases the nonspecific immune response, increases the phagocytic activity of macrophages. In addition, ascorbic acid has a pronounced antioxidant effect.
The pharmacokinetics of the drug has not been studied.

Indications for use

Preparation Coldrex MaxGripp used for symptomatic treatment of patients suffering from acute respiratory diseases and influenza, which are accompanied by fever, rhinorrhea, sore throat and muscle pain.

Directions for use

Preparation Coldrex MaxGripp intended for the preparation of a solution for oral use. Before use, the contents of the sachet should be completely dissolved in a glass of hot drinking water. The drug is taken regardless of meals. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient.
Adults and children over 12 years of age are usually prescribed 1 sachet of the drug 1-4 times a day. The interval between doses of the drug should be at least 4 hours. The maximum daily dose of the drug is 4 sachets.
The duration of the course of treatment should not exceed 5 days, unless the attending physician prescribes otherwise.
If within 3 days after starting drug therapy the elevated body temperature does not decrease or a repeated increase in body temperature is observed, you should consult your doctor.

Side effects

The drug is usually well tolerated by patients; in isolated cases, the development of such side effects was noted when using the drug Coldrex MaxGripp:
From the gastrointestinal tract and liver: nausea, vomiting, dry mouth, diarrhea, increased activity of liver enzymes.
From the cardiovascular system and hematopoietic system: increased blood pressure, heart rhythm disturbances, thrombocytopenia, neutropenia, leukopenia, anemia, pancytopenia, agranulocytosis.
From the central nervous system: headache, disturbance of sleep and wakefulness, loss of consciousness.
From the urinary system: oliguria, renal colic, nephrotoxic effect.
Allergic reactions: skin rash, itching, urticaria, Quincke's edema.

Contraindications

:
Increased individual sensitivity to the components of the drug; severe form of liver and/or kidney failure, arterial hypertension, diseases of the cardiovascular system.
Preparation Coldrex MaxGripp Contraindicated in patients suffering from hyperthyroidism, diabetes mellitus, as well as in patients taking beta-blockers, monoamine oxidase inhibitors or tricyclic antidepressants. The drug can be taken no earlier than 2 weeks after stopping taking drugs from the monoamine oxidase inhibitor group. The drug is not prescribed to women during pregnancy, as well as to children under the age of 12 years. The drug should be prescribed with caution to patients suffering from angina pectoris, liver disease, impaired renal function, as well as to patients over the age of 65 years.

Pregnancy

:
The use of the drug is contraindicated Coldrex MaxGripp during pregnancy. If it is necessary to use the drug during lactation, you should consult with your doctor and decide whether to interrupt breastfeeding.

Interaction with other drugs

Preparation Coldrex MaxGripp incompatible with other drugs used for the symptomatic treatment of acute respiratory diseases, drugs containing paracetamol, and ethyl alcohol. When the drug is used in combination with anticoagulants, there is an increase in the therapeutic effect of the latter and an increase in the risk of bleeding. Cholestyramine, when used simultaneously, reduces the absorption of paracetamol, while domperidone and metoclopramide increase it. Monoamine oxidase inhibitors, when used simultaneously with the drug, increase the risk of developing arterial hypertension. Phenylephrine hydrochloride, when used in combination, weakens the therapeutic effect of beta-blockers and antihypertensive drugs.

Overdose

:
In case of drug overdose Coldrex MaxGripp Patients experience the development of nausea, vomiting, headache, pallor of the skin, and arterial hypertension. With a further increase in the dose, the development of liver failure is possible; when using more than 10 sachets of the drug at the same time, the development of encephalopathy, metabolic acidosis and coma is possible.
In case of an overdose of the drug, hospitalization is indicated; if less than 2 hours have passed after taking the drug, gastric lavage is performed. In addition, in case of overdose, symptomatic therapy is indicated. In case of paracetamol poisoning, methionine is prescribed orally and acetylcysteine ​​intravenously.

Storage conditions

Preparation Coldrex MaxGripp It is recommended to store in a dry place away from direct sunlight at a temperature of 15 to 25 degrees Celsius. Shelf life - 3 years.

Release form

Powder for the preparation of a solution for oral use, 6.4 g in sachets, 5 or 10 sachets in a carton.

Compound

:
1 sachet of the drug Coldrex MaxGripp contains:
Paracetamol - 1000 mg;
Ascorbic acid (vitamin C) - 40 mg;
Phenylephrine hydrochloride - 10 mg;
Excipients, including sucrose.