Efferalgan from what these pills. Effervescent tablets "Efferalgan": instructions for use, description and reviews

Efferalgan is an antipyretic and pain-relieving drug.

Release form and composition of Efferalgan

Efferalgan is available in the form of children's syrup, rectal suppositories, effervescent tablets, the main active ingredient of which is paracetamol.

Auxiliary substances of Efferalgan are:

in syrup - sugar syrup, macrogol 6000, sodium saccharinate, potassium sorbate, citric acid, purified water, caramel-vanilla flavor;

in rectal suppositories- semi-synthetic glycerides;

in effervescent tablets - anhydrous sodium carbonate, anhydrous citric acid, sodium bicarbonate, soluble saccharin, sorbitol; povidone, sodium benzoate, docusate

Pharmacological action of Efferalgan

Efferalgan has analgesic and antipyretic effects.

Paracetamol, contained in Efferalgan, blocks COX-1 and COX-2 in the central nervous system, while affecting the centers of thermoregulation and pain. Cellular peroxidases in inflamed tissues neutralize the action of paracetamol, which is the reason why the drug has no anti-inflammatory effect.

The drug does not have a negative effect on the mucosa of the gastrointestinal tract and water-salt metabolism, due to the fact that there is no blocking effect on the synthesis of PG in peripheral tissues.

Indications for the use of Efferalgan

According to the instructions, Efferalgan is used:

in the form of syrup - for children aged 1 month-12 years (weight 4-32 kg);

in the form of suppositories 80 mg - for children aged 3 months-5 years (weight 6-8 kg);

in the form of suppositories 150 mg - for children aged 6 months-3 years (weight 10-14 kg);

in the form of suppositories 300 mg - for children aged 5-10 years (weight 20-30 kg)

in the following cases:

as an analgesic for moderate and mild pain (dental, headache, neuralgia, muscle pain, burns and injuries);

as an antipyretic for influenza, acute respiratory diseases, post-vaccination reactions, childhood infections, other infectious and inflammatory diseases that occur with fever.

Contraindications to the use of Efferalgan

According to the instructions, Efferalgan in the form of suppositories and syrup is contraindicated:

• in the presence of severe disorders in the work of the kidneys and liver;
• with a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
• with high sensitivity of the patient's body to paracetamol;
• with blood diseases;
• at the age of up to one month (syrup), up to three months (suppositories 80 mg);
• if there is bleeding or inflammation in the rectum (suppositories).

Suppositories and syrup are used carefully when:

• disorders in the work of the kidneys. The break between doses of drugs should be at least 8 hours;
• disorders in the work of the kidneys or liver with Gilbert's syndrome;
• diarrhea.

Efferalgan effervescent tablets are contraindicated:

• with high sensitivity to paracetamol or other components included in the drug;
• with a deficiency of glucose-6-phosphate dehydrogenase;
• with alcoholism;
• during the first and third trimesters of pregnancy and during lactation;
• under the age of 15 years (weight - not less than 50 kg).

Efferalgan effervescent tablets are used with caution in:

• liver or kidney failure;
• alcoholic liver damage;
• congenital hyperbilirubinemia;
• viral hepatitis;

as well as in old age.

Method of application and dosage

Efferalgan syrup is taken orally. It can be diluted with water, juice, milk, or consumed without dilution.

A single dose of syrup is determined by the weight of the child at the rate of 10-15 mg per kg of weight. The syrup is taken 3-4 times a day. In this case, the daily dose of the drug should be no more than 60 mg per kg of body weight. The break between doses of the remedy is 4-6 hours.

Efferalgan suppositories are intended for rectal administration.

The candle must be released from the packaging and after emptying the intestines, enter into the anus.

A single dose of Efferalgan suppositories is determined by the weight of the child at the rate of 10-15 mg per kg of weight. Suppositories are administered 3-4 times a day. In this case, the daily dose of Efferalgan should not be more than 60 mg per kg of weight, and the interval between the administration of suppositories is 4-6 hours.

Dosage of suppositories:

3-5 months (weight 6-8 kg) - 1 suppository 80 mg;

6 months-3 years (weight 10-14 kg) - 1 suppository 150 mg;

5–10 years (weight 20–30 kg) - 1 suppository 300 mg.

Effervescent tablets are taken orally, dissolved in 200 ml of water. As a rule, the drug is taken 2-3 times a day, 1-2 tablets, the interval is not less than 4 hours.

As analgesic the drug in any form can be used up to 5 days, as an antipyretic - up to 3 days.

Side effects of Efferalgan

According to reviews, Efferalgan in all forms can cause side effects in the form of: nausea, vomiting, irritation of the rectal mucosa, allergic reactions(skin rash, urticaria, itching, angioedema), tenesmus, thrombocytopenia, anemia, leukopenia, methemoglobinemia, neutropenia.

When used for a long time in high doses, nephro- and hepatotoxic effects may occur.

The syrup may cause: diarrhea, changes in the prothrombin index, abdominal pain, decreased blood pressure, anaphylactic shock.

According to reviews, Efferalgan in the form of effervescent tablets is well tolerated at doses recommended by the instructions. When used for a long time and in high doses, control of the peripheral blood picture is required.

Overdose

According to reviews of Efferalgan, an overdose of syrup and suppositories is manifested by: nausea, vomiting, epigastric pain, anorexia, sweating, pallor of the skin on the first day after ingestion.

140 mg of paracetamol per kg of weight in children leads to the destruction of liver cells and irreversible hepatonecrosis, metabolic acidosis, liver failure, encephalopathy, which can cause coma and death.

Treatment of an overdose is to stop taking the drug and hospitalization.

An overdose of effervescent tablets is manifested by: pale skin, nausea, vomiting, anorexia, hepatonecrosis.

In adults, the toxic effect develops after ingestion of more than 10-15 g of paracetamol.

For the treatment of an overdose in the first 6 hours, it is indicated: gastric lavage, donors of SH-groups and methionine.

Interaction with other drugs

When using Efferalgan simultaneously with:

• tricyclic antidepressants, barbiturates, flumecinol, anticonvulsants, phenylbutazone, ethanol, rifampicin - the risk of hepatotoxic action increases;
• salicylates - increases the risk of nephrotoxic action;
• chloramphenicol - increases the toxicity of chloramphenicol;
• probenecid - reduced clearance of paracetamol;
• anticoagulants of indirect action - their effect is enhanced;
• uricosuric drugs - their effect decreases;

Taking paracetamol can distort the results of tests for the content of uric acid and glucose in the blood.

Efferalgan storage conditions

The drug must be stored in places with limited access children at a temperature not exceeding 30 °.

Please read this leaflet carefully before taking/using this product.
This medicine is available without a prescription. To achieve optimal results, it should be used strictly following all the recommendations outlined in the instructions.
Save the instructions, they may be needed again.
If you have any questions, please contact your doctor.

INSTRUCTIONS FOR THE MEDICAL USE OF THE MEDICINE EFFERALGAN® (EFFERALGAN®)

REGISTRATION NUMBER: P N011549/01-081215
TRADENAME: EFFERALGAN® (EFFERALGAN®)
INTERNATIONAL NON-PROPRIETARY NAME: paracetamol (paracetamol)
PHARMACEUTICAL FORM: effervescent tablets

DESCRIPTION
Round, flat with beveled edges and a notch on one side of the tablet white color. When dissolved in water, intensive release of gas bubbles is observed.

COMPOUND
1 effervescent tablet contains:
paracetamol 500 mg.
anhydrous citric acid 1114.00 mg, sodium bicarbonate 942.00 mg, anhydrous sodium carbonate 332.00 mg, sorbitol 300.00 mg, sodium saccharinate 7.00 mg, docusate sodium 0.227 mg, povidone 1.287 mg, sodium benzoate 60.606 mg.

PHARMACOTHERAPEUTIC GROUP: analgesic non-narcotic agent.
ATX CODE

PHARMACOLOGICAL PROPERTIES

Paracetamol (a derivative of para-aminophenol) has analgesic, antipyretic and weak anti-inflammatory effects.
The exact mechanism of the analgesic and antipyretic action of paracetamol has not been established. Apparently, it includes the central and peripheral components.
The drug blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains practically complete absence it has an anti-inflammatory effect. The drug does not adversely affect the water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa due to the lack of influence on the synthesis of prostaglandins in peripheral tissues.
Pharmacokinetics
Absorption
When taken orally, paracetamol is absorbed quickly and completely. Cmax (maximum plasma concentration of paracetamol) is reached 10-60 minutes after ingestion.
Distribution
Paracetamol is rapidly distributed in all tissues. The concentration in blood, saliva and plasma is the same. Plasma protein binding is negligible.
Metabolism
Paracetamol is mainly metabolized in the liver. There are two main metabolic pathways with the formation of glucuronides and sulfates. The latter is mainly used if the accepted dose of paracetamol exceeds the therapeutic one.
A small amount of paracetamol is metabolized by the cytochrome P450 isoenzyme to form the intermediate N-acetylbenzoquinoneimine, which under normal conditions undergoes rapid detoxification with glutathione and is excreted in the urine after binding to cysteine ​​and mercaptopurine acid. However, with massive intoxication, the content of this toxic metabolite increases.
breeding
It is carried out mainly with urine. 90% of the dose of paracetamol is excreted by the kidneys within 24 hours, mainly in the form of glucuronide (60 to 80%) and sulfate (20 to 30%). Less than 5% is excreted unchanged. The half-life is about 2 hours.
Pharmacokinetics in special groups of patients
At severe violations renal function (creatinine clearance less than 30 ml / min), the excretion of paracetamol and its metabolites is delayed.

INDICATIONS FOR USE

Moderate or mild pain syndrome (headache, toothache, migraine pain, neuralgia, muscle pain, lower back pain, pain from injuries and burns, sore throat, painful menstruation);
- Increased body temperature with colds and other infectious and inflammatory diseases.

CONTRAINDICATIONS

Hypersensitivity to paracetamol, propacetamol hydrochloride (prodrug of paracetamol) or any other component of the drug;
- Severe liver failure or decompensated liver disease in the acute stage.
- Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
- Pregnancy (I and III trimester) and lactation.
- Childhood up to 12 years old.

CAREFULLY

Severe renal failure (clearance, creatinine

METHOD OF APPLICATION AND DOSES

inside. Dissolve the tablet in a glass of water (200 ml). Do not chew or swallow tablets. Usually used 1-2 tablets 2-3 times a day at intervals of at least 4 hours.
The maximum single dose is 2 tablets (1 g), the maximum daily dose is 8 tablets (4 g), which corresponds to a single dose of 10-15 mg/kg of body weight, for a maximum daily dose of 75 mg/kg of body weight.
As a rule, it is not necessary to exceed the recommended daily dose of paracetamol of 3 g. The daily dose may be increased to the maximum (4 g) only in case of severe pain.
In case of impaired renal function, the time interval between doses of the drug should be at least 8 hours with a creatinine clearance of less than 10 ml / min, at least 6 hours with a creatinine clearance of 10-50 ml / min.
In patients with chronic or compensated active liver diseases, especially those accompanied by liver failure, in patients with chronic alcoholism, chronic insufficiency nutrition (insufficient supply of glutathione in the liver), dehydration or body weight less than 50 kg, the daily dose should not exceed 3 g, i.e. 6 tablets.
The drug should be used with caution in children and patients weighing less than 50 kg to eliminate the risk of exceeding the recommended dose.
The dosing regimen in children over 12 years of age and weighing more than 43 kg is the same as in adults, while the interval should preferably be 6 hours (strictly at least 4 hours).
The duration of admission without consulting a doctor is no more than 5 days when prescribed as an anesthetic and 3 days as an antipyretic.

SIDE EFFECTS

When using the drug, the following side effects were noted (frequency not established):
Allergic reactions: hypersensitivity reactions, pruritus, rash on the skin and mucous membranes (erythema or urticaria), Quincke's edema, exudative erythema multiforme (including Steven-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, acute generalized exanthematous pustulosis .
From the central and peripheral nervous system: (when taking high doses) dizziness, psychomotor agitation and disorientation in space and time.
From the side of the digestive system: nausea, diarrhea, epigastric pain, increased activity of "liver" enzymes, as a rule, without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the side of the hematopoietic organs: anemia (cyanosis), sulphohemagglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia(especially in patients with deficiency of glucose-6-phosphate dehydrogenase), thrombocytopenia, neutropenia, leukopenia.
Others: decrease in blood pressure (as a symptom of anaphylaxis), changes in prothrombin time and international normalized ratio (INR).

OVERDOSE

In case of overdose, intoxication is possible, especially in children, patients with liver diseases (caused by chronic alcoholism), in patients with malnutrition, as well as in patients taking enzyme inducers, which may develop fulminant hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases - sometimes fatal.
The clinical picture of acute overdose develops within 24 hours after taking paracetamol.
gastrointestinal disorders (nausea, vomiting, loss of appetite, discomfort in abdominal cavity and/or abdominal pain), pallor skin, sweating, malaise. With a simultaneous administration of 7.5 g or more to adults or more than 140 mg / kg to children, cytolysis of hepatocytes occurs with complete and irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after the administration of paracetamol, there is an increase in the activity of "liver" transaminases, lactate dehydrogenase, bilirubin concentration and a decrease in prothrombin concentration.
Clinical symptoms of liver damage appear 1-2 days after an overdose of the drug and reach a maximum at 3-4 days.

immediate hospitalization;
Determination of the quantitative content of paracetamol in blood plasma before starting treatment in as much as possible early dates after an overdose;
Gastric lavage;
The introduction of donators of SH-groups and precursors of the synthesis of glutathione - methionine and acetylcysteine ​​- within 8 hours after an overdose. The need for additional therapeutic measures (further administration of methionine; intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration;
symptomatic treatment;
Liver tests should be performed at the start of treatment and every 24 hours thereafter. In most cases, the activity of hepatic transaminases is normalized within 1-2 weeks. In very severe cases, a liver transplant may be required.

INTERACTION WITH OTHER DRUGS

Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity. Patients taking phenytoin should avoid frequent use of paracetamol, especially at high doses.
Probenecid almost doubles the clearance of paracetamol by inhibiting the process of its conjugation with glucuronic acid. With simultaneous administration, consideration should be given to reducing the dose of paracetamol.
Caution should be exercised with the simultaneous use of paracetamol and inducers of microsomal liver enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, anticoagulants, zidovudine, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants).
Long-term simultaneous use of barbiturates reduces the effectiveness of paracetamol.
Salicylamide may increase the half-life of paracetamol.
INR should be monitored during and after the end of the simultaneous use of paracetamol (especially in high doses and / or for a long time) and coumarins (for example, warfarin), since paracetamol when taken at a dose of 4 g / day for at least 4- x days may enhance the effect of indirect anticoagulants and increase the risk of bleeding. If necessary, adjust the dose of anticoagulants.

SPECIAL INSTRUCTIONS

In order to avoid overdose, the content of paracetamol in other drugs that the patient takes simultaneously with Efferalgan® should be taken into account. Taking paracetamol in doses higher than recommended can cause severe liver damage.
With ongoing febrile syndrome against the background of the use of paracetamol for more than 3 days, and pain syndrome for more than 5 days, a doctor's consultation is required.
Taking the drug Efferalgan® may distort the performance laboratory research in the quantitative determination of glucose and uric acid in plasma.
To avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption.
The risk of developing liver damage increases in patients with alcoholic hepatosis.
With prolonged use of the drug, it is necessary to control the pattern of peripheral blood and the functional state of the liver.
Paracetamol can cause serious skin reactions such as Steven-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, which can be fatal. At the first manifestation of a rash or other hypersensitivity reactions, the use of the drug should be discontinued.
Also, the use of paracetamol should be discontinued if acute viral hepatitis is detected in a patient.
Efferalgan® contains 412.4 mg of sodium per tablet, which should be taken into account by patients on a strict low-salt diet.
Since the drug contains sorbitol, it should not be used in case of sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Influence on the ability to drive vehicles and work with mechanisms.

The impact on the ability to drive vehicles and work with mechanisms has not been studied.
If the patient experiences dizziness, psychomotor agitation and disorientation in space and time, he is not recommended to drive a car and other mechanisms during drug treatment.

RELEASE FORM
Effervescent tablets 500 mg.
4 tablets in a strip (aluminum foil/polyethylene). 4 strips together with instructions for use in a cardboard box.

STORAGE CONDITIONS
Store in a dry place at a temperature of 15-30 °C.
Keep out of the reach of children!

BEST BEFORE DATE
3 years.
Do not use after the expiration date.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
Without recipe.

LEGAL ENTITY IN WHICH NAME THE REGISTRATION CERTIFICATE IS ISSUED
UPSA SAS, France
3, rue Joseph Monnier, 92500 Rueil-Malmaison, France

Efferalgan is a non-steroidal anti-inflammatory drug with antipyretic and analgesic effects. Active substance- paracetamol.

The mechanism of action of the drug is associated with the inhibition of the activity of cyclooxygenase, as a result of which the production of prostaglandins from arachidonic acid decreases.

As a result of a decrease in the number of prostaglandins, a decrease in the generation and conduction of pain impulses is noted. The antipyretic effect of Efferalgan is carried out due to a direct effect on the thermoregulatory center in the hypothalamus.

It does not adversely affect the water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa due to the lack of influence on the synthesis of prostaglandins in peripheral tissues.

Indications for use

What helps Efferalgan? According to the instructions, the drug is prescribed in the following cases:

• as an antipyretic for acute respiratory infections, influenza, childhood infections, post-vaccination reactions and other conditions accompanied by fever;
• as an anesthetic for pain syndrome of mild or moderate intensity, incl. headache and toothache, muscle pain, neuralgia, pain from injuries and burns.

Instructions for use Efferalgan, dosage

The drug is taken orally with a large amount of liquid, 1-2 hours after a meal (taken immediately after a meal leads to a delay in the onset of action).

Standard dosages of Efferalgan according to the instructions for adults and adolescents over 12 years old (body weight over 40 kg):

• single dose - 1 tablet Efferalgan 500 mg;
• the maximum single dose is 1 g;
• frequency of appointment - up to 4 times a day with an interval of 6 hours;
• the maximum daily dose is 4 g;
• the maximum duration of treatment is 5-7 days.

In patients with impaired liver or kidney function, with Gilbert's syndrome, in elderly patients, the daily dose should be reduced and the interval between doses increased.

Instructions for use of Efferalgan for children - the maximum daily dose:

• up to 6 months (up to 7 kg) - 350 mg,
• up to 1 year (up to 10 kg) - 500 mg,
• up to 3 years (up to 15 kg) - 750 mg,
• up to 6 years (up to 22 kg) - 1 g,
• up to 9 years (up to 30 kg) - 1.5 g,
• up to 12 years (up to 40 kg) - 2 g.

Candles Efferalgan

They are administered rectally.

Adults - 500 mg 1-4 times a day, the maximum single dose is 1 g and the maximum daily dose is 4 g.

• Children 12-15 years old - 250-300 mg 3-4 times a day;
• 8-12 years - 250-300 mg 3 times a day;
• 6-8 years - 250-300 mg 2-3 times a day;
• 4-6 years - 150 mg 3-4 times a day;
• 2-4 years - 150 mg 2-3 times a day;
• 1-2 years - 80 mg 3-4 times a day;
• from 6 months to 1 year - 80 mg 2-3 times a day;
• from 3 months to 6 months - 80 mg 2 times a day.

The maximum duration of treatment without consulting a doctor is 3 days (when taken as an antipyretic drug) and 5 days (as an analgesic).

Side effects

The instruction warns of the possibility of developing the following side effects when prescribing Efferalgan:

• From the side digestive system: possible - diarrhea, abdominal pain, nausea, vomiting, tenesmus; with prolonged use in high doses, a hepatotoxic effect is possible.
• Allergic reactions: possible - skin rash, itching, urticaria, angioedema, anaphylactic shock, lowering blood pressure (as a symptom of anaphylaxis).
• From the hematopoietic system: rarely - anemia, thrombocytopenia, leukopenia, neutropenia.
• Others: decrease or increase in the prothrombin index;
• With prolonged use in high doses, a nephrotoxic effect is possible.

Contraindications

Efferalgan is contraindicated in the following cases:

• Blood diseases.
• Heavy functional disorders kidneys, liver.
• Recent bleeding or inflammation in the rectum (contraindication due to the method of administration - for suppositories).
• Lack of the enzyme glucose-6-phosphate dehydrogenase.
• Children's age up to 3 months (for suppositories of 80 mg), up to 1 month (for syrup).
• Hypersensitivity to paracetamol.
• Contraindications to taking Efferalgan in the form of effervescent tablets are:
• Lack of glucose-6-phosphate dehydrogenase.
• Alcoholism.
• Children's age up to 15 years (body weight - not less than 50 kg).
• Pregnancy period (I and III trimesters) and breastfeeding(lactation).
• Increased individual sensitivity to paracetamol or other auxiliary components of the drug.

The drug is prescribed with extreme caution: with liver and / or kidney failure, viral hepatitis, congenital hyperbilirubinemia (Rotor, Dubinin-Johnson and Gilbert syndromes), alcoholic liver damage, as well as elderly patients.

Efferalgan is taken with extreme caution in benign hyperbilirubinemia (including Gilbert's syndrome), liver and kidney failure, alcoholic liver damage, viral hepatitis, alcoholism, old age, pregnancy, glucose-6-phosphate dehydrogenase deficiency.

Overdose

A single dose of 150 mg/kg of body weight to a child can cause impaired glucose metabolism, hepatocellular insufficiency, metabolic acidosis, hypoglycemia, hemorrhage, coma, encephalopathy, and death.

With prolonged use of high doses, aplastic pancytopenia, anemia, agranulocytosis, leukopenia, neutropenia, thrombocytopenia, psychomotor agitation, dizziness, disorientation, nephrotoxicity, hepatonecrosis may develop.

In case of overdose, you should immediately consult a doctor. Recommended gastric lavage, the introduction of N-acetylcysteine ​​(or methionine) for 10 hours, symptomatic therapy.

Efferalgan analogues, price in pharmacies

If necessary, you can replace Efferalgan with an analogue according to active substance are the drugs:

ATX code:

• Aldolor,
• Acetaminophen,
• Daperone,
• panadol,
• Paracetamol.

When choosing analogues, it is important to understand that the instructions for use of Efferalgan, the price and reviews of drugs of similar action do not apply. It is important to consult a doctor and not to make an independent replacement of the drug.

Price in Russian pharmacies: Efferalgan suppositories (candles) 80 mg 12 pcs. - from 85 to 103 rubles, syrup for children 90 ml - from 82 to 99 rubles, according to 593 pharmacies.

Store out of direct sunlight, at a temperature not exceeding 30°C. Keep away from children. Shelf life - 3 years. Terms of dispensing from pharmacies - without a prescription.

Interaction with other drugs

When taking 4 g / day or more for more than 3 days, there is a risk of increased anticoagulant action, an increased risk of bleeding.

The rate of absorption of paracetamol increases metoclopramide, domperidone, and reduces - cholestyramine.

Barbiturates reduce the antipyretic effect of the drug.

Anticonvulsants (phenytoin, carbamazepine, barbiturates) may increase paracetamol liver toxicity.

The use of paracetamol in high doses simultaneously with rifampicin, isoniazid increases the risk of hepatotoxic syndrome.

Paracetamol reduces the effectiveness of diuretics.

Do not use with alcoholic beverages.

Compound

Active ingredient: paracetamol;

1 ml of oral solution contains 30 mg of paracetamol;

Excipients: macrogol 6000, sucrose solution, sodium saccharin, potassium sorbate, citric acid, caramel-vanilla flavor, purified water.

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Dosage form

Oral solution.

Basic physical and chemical properties: slightly viscous solution of brown color with a caramel-vanilla smell.

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Pharmacological group

Analgesics and antipyretics. Paracetamol

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Pharmacological properties

Pharmacological.

It has an analgesic, antipyretic and weak anti-inflammatory effect. The mechanism of action is due to the inhibition of prostaglandin synthesis and the predominant effect on the thermoregulatory center in the hypothalamus.

Pharmacokinetics.

Paracetamol after oral administration is rapidly and completely absorbed in the digestive tract. The maximum concentration of paracetamol in the blood plasma is reached 30-60 minutes after ingestion. Paracetamol is metabolized in the liver to form inactive compounds with glucuronic acid and sulfates.

It is excreted mainly in the urine. 90% of the dose of paracetamol is excreted by the kidneys within 24 hours, mainly in the form of glucuronic and sulfate conjugates. Less than 5% is excreted unchanged. The half-life is approximately 2:00.

Indications

Symptomatic treatment of diseases accompanied by mild to moderate pain and / or fever.

Contraindications

Hypersensitivity to paracetamol or other components of the drug.

Severe renal and / or liver dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia, leukopenia.

Special Security Measures

Do not use in children along with other products containing paracetamol.

When treating with paracetamol at a dose of 60 mg / kg / day, the simultaneous use of another antipyretic is justified only if paracetamol is ineffective. Do not exceed recommended doses.

The drug contains sucrose, which should be taken into account in patients with fructose intolerance, malabsorption of glucose-galactose and / or sucrose-isomaltose. If the signs of the disease do not begin to disappear within 3 days of treatment, or vice versa, the state of health has worsened, you should consult a doctor.

Interaction with other medicinal products and other forms of interaction

When taking the maximum doses of paracetamol (4 g / day) for at least 4 days, there is a risk of increasing the effect of oral anticoagulant and an increased risk of bleeding. The INR (International Normalized Ratio) should be monitored at regular intervals. If necessary, the dose of anticoagulant should be adjusted during treatment with paracetamol.

The rate of absorption of paracetamol may increase when interacting with metoclopramide and domperidone and decrease with cholestyramine. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, may increase the toxic effects of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With the simultaneous use of paracetamol with hepatotoxic agents, the hepatotoxic effect of the drug on the liver increases. The simultaneous use of high doses of paracetamol with isoniazid, rifampicin increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics. Do not use simultaneously with alcohol.

High concentrations of paracetamol can affect laboratory results for determining blood glucose by the oxidase-peroxidase method, uric acid when using the phosphotungstic acid method.

Application features

In patients with severe infections, such as sepsis, which are accompanied by a decrease in glutathione levels when taking paracetamol, the risk of metabolic acidosis is increased.

Symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.

Use with caution at body weight up to 50 kg, with chronic malnutrition (low reserves of glutathione in the liver), dehydration, mild to moderate liver failure.

Treatment should be discontinued if acute viral hepatitis is detected.

Use during pregnancy or lactation.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

The drug is intended for use in pediatric practice.

Dosage and administration

Eferalgan is intended for children weighing 4 to 32 kg (from 1 month to 12 years).

A single dose of paracetamol is 15 mg/kg of body weight. The daily dose of paracetamol should not exceed 60 mg/kg of body weight per day. The interval between doses of the drug should be at least 6:00. In severe renal failure (creatinine clearance less than 10 ml / min), the interval between doses should be at least 8:00.

Table 1 shows data on the use of the drug:

Table 1

Before using the drug, the child must be weighed to prevent overdose and avoid the toxic effects of the drug.

The measuring spoon is marked with divisions corresponding to a mass of 4-6-8-10-12-14-16 kg.

Additional divisions correspond to the intermediate body weight: 3-5-7-9-11-13-15 kg.

The drug can be used undiluted or diluted in a small amount of liquid (eg water, milk, fruit juice).

Fill the measuring spoon according to the child's body weight and adjust the liquid level depending on the divisions.

• 4 to 16 kg: Use measuring spoon with graduations according to the child's body weight, or use the graduation that is closest to the child's body weight.

For example, from 4 kg to 5 kg: fill the measuring spoon up to the 4 kg mark. If necessary, the drug can be repeated after 6:00.

• From 16 to 32 kg: first fill the measuring spoon, and then bring to the required amount, filling the measuring spoon suddenly, until the child's body weight is obtained.

For example, from 18 to 19 kg: first fill the measuring spoon to the 10 kg mark, and then, suddenly, fill it to the 8 kg mark. If necessary, the drug can be repeated after 6:00.

If pain syndrome or fever persists or increases within 3 days from the start of treatment, the advisability of further use of the drug should be reconsidered.

The drug is used for children weighing 4 to 32 kg (from 1 month to 12 years).

Overdose

To avoid overdose, you should check that others medicines did not contain paracetamol.

There is a risk of serious poisoning in the elderly, in young children, in patients with liver damage, in chronic alcoholism, in patients with chronic malnutrition. This can lead to death.

In children weighing less than 37 kg, the total dose of paracetamol should not exceed 80 mg/kg/day.

In children weighing between 38 kg and 50 kg, the total dose of paracetamol should not exceed 3 g/day.

In adults and children weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g / day.

When taken once at a dose of 10 g for an adult and 150 mg / kg of body weight, it can lead to hepatocellular insufficiency, impaired glucose metabolism, metabolic acidosis, hemorrhages, hypoglycemia, encephalopathy, coma and death. At the same time, the level of hepatic transaminase, lactate dehydrogenase and bilirubin increases, and the level of prothrombin decreases within 12-48 hours. Acute renal failure with acute tubular necrosis may present with severe pain in the lumbar region, hematuria, proteinuria and develop even in the absence of severe liver damage. Cardiac arrhythmia and pancreatitis were also noted. With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic organs. When taking large doses from the side of the central nervous system - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity ( renal colic, interstitial nephritis, papillary necrosis) From the digestive system - hepatonecrosis. In patients with risk factors (long-term use of carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. malnutrition, AIDS, starvation, cystic fibrosis, cachexia) the use of 5 g or more of paracetamol can lead to liver damage. Liver damage may occur 12-48 hours after an overdose. In case of an overdose, the patient should be immediately taken to the hospital, even if there are no early symptoms overdose. Symptoms of overdose appear within the first 24 hours: nausea, vomiting, loss of appetite, pallor, abdominal pain, or may not reflect the severity of the overdose or the risk of injury. urgent measures.