Efferalgan pills effervescent 500mg, 16pcs

Composition

>

of 1 tab. contains:

Active ingredients:

paracetamol-500 mg

Auxiliary substances:

citric acid anhydrous,

sodium carbonate anhydrous,

sodium bicarbonate,

sorbitol,

soluble saccharin,

sodium docusate,

povidone,

sodium benzoate.

Pharmacological action

Paracetamol has analgesic, antipyretic and extremely weak anti-inflammatory effect, which is associated with its effect on the center of thermoregulation in the hypothalamus and its weak ability to inhibit prostaglandin synthesis in peripheral tissues.

The drug does not have a negative effect on 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

• as an antipyretic agent for acute respiratory infections and other infectious and inflammatory diseases accompanied by an increase in body temperature;
• as an analgesic agent for pain syndrome of mild or moderate intensity: arthralgia, myalgia, neuralgia, migraine, tooth and headache, algodismenorrhea, pain from injuries and burns.

Use during pregnancy and lactation

It is contraindicated to use the drug in the first and third trimesters of pregnancy and during lactation (breastfeeding).

Contraindications

• severe liver failure or decompensated liver diseases in the acute stage;
• sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• children under 12 years of age.
• hypersensitivity to paracetamol, propacetamol hydrochloride (a prodrug of paracetamol) or any other component of the drug.

With caution:  severe renal insufficiency (CC

Side effects

When using the drug, the following side effects were noted (frequency is not established).

Allergic reactions:  hypersensitivity reactions, pruritus of the skin, rash on the skin and mucous membranes (erythema or urticaria), angioedema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock, acute generalized exanthematous pustulosis.

Respiratory system disorders:  bronchospasm.

Nervous system disorders (when taking high doses): dizziness, psychomotor agitation, and disorientation in space and time.

From the digestive system:  nausea, diarrhea, epigastric pain, increased activity of liver enzymes, usually without jaundice, hepatonecrosis (dose-dependent effect), hepatitis, tenesmus, liver failure.

From the side of the kidneys and urinary tract:  increased creatinine.

From the endocrine system:  hypoglycemia, up to hypoglycemic coma.

From the hematopoietic system:  anemia (cyanosis), sulfohemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia, neutropenia, leukopenia.

Other services:  reduced blood pressure (as a symptom of anaphylaxis), changes in prothrombin time and international normalized ratio (INR).

Interaction

Inducers of microsomal liver enzymes or potentially hepatotoxic substances (for example, ethanol, rifampicin, isoniazid, sleeping pills and antiepileptic drugs, including phenobarbital, phenytoin and carbamazepine) increase the toxicity of paracetamol and can lead to liver damage even at non-toxic doses of paracetamol, so liver function should be monitored.

Phenytoin reduces the effectiveness of paracetamol and increases the risk of hepatotoxicity, therefore, patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses.

Paracetamol reduces the effectiveness of uricosuric drugs.

Paracetamol may increase the risk of increasing the concentration of chloramphenicol and, as a result, may increase the risk of developing neutropenia, and therefore hematological parameters should be monitored. Simultaneous use of these two drugs is possible only after consulting a doctor.

Probenecid reduces the clearance of paracetamol by almost 2 times, which requires a reduction in the dose of paracetamol.

Repeated use of paracetamol for more than 4 days increases the anticoagulant effect. The international normalized ratio (INR) should be monitored during and after the end of concomitant use of paracetamol (especially in high doses and/or for a long time) and coumarin derivatives. If necessary, adjust the dose of anticoagulants. Irregular use of paracetamol does not significantly affect the effect of anticoagulants.

Propanthelin and other drugs that slow gastric evacuation reduce the rate of absorption of paracetamol, which may delay or reduce the onset of the effect.

Metoclopramide and domperidone increase the rate of absorption of paracetamol and, accordingly, the onset of analgesic and antipyretic effects.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol contributes to the development of acute pancreatitis.

Long-term concomitant use of paracetamol and other NSAIDs increases the risk of analgesic nephropathy and renal failure.

Concomitant long-term use of high-dose paracetamol and salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the plasma concentration of paracetamol by 50% – the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Salicylamide may increase the T_1/2 of paracetamol.

How to take, course of use and dosage

The drug is taken orally. The tablet should be dissolved in a glass of water (200 ml). Do not chew or swallow pills.

Usually apply 1-2 tablets. 2-3 times / 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, the maximum daily dose is 75 mg/kg of body weight.

As a rule, it is not necessary to exceed the recommended daily dose of paracetamol equal to 3 g. The daily dose can be increased to the maximum (4 g) only in case of severe pain.

If renal function is impaired, 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 hepatic insufficiency, in patients with chronic alcoholism, chronic malnutrition (insufficient supply of glutathione in the liver), Gilbert’s syndrome (hereditary hyperbilirubinemia), dehydration, or a body weight of less than 50 kg, the dose of the drug should be reduced or the interval between doses increased. The daily dose should not exceed 2 g, i. e. 4 tablets.

The drug should be used with caution in children and patients weighing less than 50 kg to avoid the risk of exceeding the recommended dose.

The dosage regimen for children over 12 years of age and weighing more than 43 kg is the same as for adults, and 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 analgesic and 3 days as an antipyretic.

Overdose

Overdose can lead to intoxication, especially in children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking enzyme inducers, which can develop lightning-fast hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases – sometimes with a fatal outcome. The clinical picture of acute overdose develops within 24 hours after taking paracetamol.

Symptoms:

gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and / or abdominal pain), pallor of the skin, sweating, malaise. With simultaneous use 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 paracetamol use, there is an increase in the activity of hepatic 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 on 3-4 days.

Treatment:

immediate hospitalization; determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after overdose; gastric lavage; use of SH-group donors and glutathione synthesis precursors – methionine and acetylcysteine – within 8 hours after overdose.The need for additional therapeutic measures (further use of methionine, intravenous use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its use; symptomatic treatment; liver tests should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of hepatic transaminases normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required.

Special instructions

To avoid overdose, the content of paracetamol in other medications that the patient takes simultaneously with Efferalgan®should be taken into account. Taking paracetamol in doses higher than recommended may cause severe liver damage.

If the fever syndrome continues for more than 3 days with the use of paracetamol, and the pain syndrome lasts for more than 5 days, a doctor’s consultation is required.

The use of Efferalgan® may distort the results of laboratory tests in the quantitative determination of glucose and uric acid in plasma.

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 are prone to chronic alcohol consumption.

The risk of developing liver damage increases in patients with alcoholic hepatosis. In patients with nutritional deficiencies (low liver glutathione supply), paracetamol should be used with caution, reducing the daily dose and/or increasing the interval between doses.

With prolonged use of the drug, it is necessary to monitor the picture of peripheral blood and the functional state of the liver.

Paracetamol can cause serious skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, which can be fatal. At the first appearance of rash or other hypersensitivity reactions, the drug should be discontinued.

The use of paracetamol should be discontinued if acute viral hepatitis is detected in the patient.

Efferalgan ® contains 412.4 mg of sodium per 1 tablet, which should be considered by patients who follow a strict low-salt diet.

Since the drug contains sorbitol, it should not be used for sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Influence on the ability to drive motor vehicles and manage mechanisms

When using paracetamol in the recommended dose range, the effect on the concentration of attention and the speed of psychomotor reactions was not established. If the patient experiences dizziness, psychomotor agitation and disorientation in space and time, it is not recommended to drive a car or other mechanisms during treatment with the drug.

Form of production

Tablets are effervescent white, round, flat, with beveled edges and a notch on one side; when dissolved in water, there is an intense release of gas bubbles.

Storage conditions

Keep out of reach of children at a temperature not exceeding 30°C.

Shelf

life is 3 years.

Active ingredient

Paracetamol

Dosage form

soluble tablets

Purpose

Children over 15 years of age, For adults, Pregnant Women only in the second trimester as prescribed by a doctor

Indications

Colds, Burns, Infectious Diseases, Sciatica, Osteoarthritis, Arthritis, Sciatica, Migraines, Otitis Media, Neuritis, Osteoarthritis, Flu, Myositis