Efferalgan^® with vitamin C (Tablets) Instructions for Use

Marketing Authorization Holder

Bristol-Myers Squibb (France)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Dosage Form

Efferalgan® with vitamin C

Effervescent tablets 330 mg+200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white in color, flat, with beveled edges and a score mark; dissolution in water is accompanied by the release of gas bubbles.

Excipients: potassium bicarbonate, sodium bicarbonate, sorbitol, anhydrous citric acid, sodium benzoate, docusate sodium, povidone.

10 pcs. – polypropylene tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Non-narcotic analgesic agent (non-narcotic analgesic + vitamin)

Pharmacological Action

Combination analgesic-antipyretic.

Paracetamol has analgesic and antipyretic effects. It inhibits COX-1 and COX-2 primarily in the CNS, affecting the centers of pain and thermoregulation.

Ascorbic acid (vitamin C) is involved in the regulation of redox processes, reduces vascular permeability, and increases the body’s resistance to infections.

Pharmacokinetics

Pharmacokinetic data for the drug Efferalgan^® with vitamin C are not provided.

Indications

• Colds (including acute respiratory infections, influenza) and other infectious and inflammatory diseases accompanied by elevated body temperature;
• Pain syndrome of mild or moderate intensity: headache, toothache, neuralgia, muscle pain, pain from injuries and burns, dysmenorrhea.

ICD codes

Dosage Regimen

Adults and children over 15 years of age (with a body weight of 50 kg or more) are prescribed 2-3 tablets 2-3 times/day. The maximum single dose is 3 tablets (990 mg of paracetamol). The maximum daily dose is 12 tablets (3960 mg of paracetamol).

The duration of treatment is no more than 3 days when prescribed as an antipyretic, and no more than 5 days when prescribed as an analgesic.

Children aged 8 years and older, depending on body weight, the drug is prescribed at a rate of 10-15 mg of paracetamol per 1 kg of body weight 3-4 times a day. The maximum daily dose in terms of Paracetamol is 60 mg/kg.

The correlation between age and body weight is approximate. The maximum duration of treatment for children is 3 days. If longer therapy is necessary, medical supervision is required.

The interval between doses of the drug is at least 4 hours.

In patients with impaired liver or kidney function, with Gilbert’s syndrome, and in elderly patients, the daily dose should be reduced, and the interval between doses of the drug should be at least 8 hours.

Dissolve the tablet in a glass of water (200 ml) and drink.

Adverse Reactions

Allergic reactions skin itching, rash on the skin and mucous membranes (usually erythematous or urticarial), angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

From the central and peripheral nervous system usually when taken in high doses – dizziness, psychomotor agitation, disorientation.

From the digestive system nausea, epigastric pain, increased activity of liver transaminases, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

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

From the hematopoietic system anemia (cyanosis), sulfhemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency); with long-term use in high doses – aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

From the urinary system when taken in high doses – nephrotoxicity (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).

Contraindications

• Children under 8 years of age;
• Hypersensitivity to the components of the drug.

With caution the drug should be used in cases of renal and/or hepatic insufficiency, benign hyperbilirubinemia (Gilbert’s syndrome), viral hepatitis, alcoholic liver disease, chronic alcoholism, glucose-6-phosphate dehydrogenase deficiency, during pregnancy, during lactation, and in elderly patients.

Use in Pregnancy and Lactation

The drug should be used with caution during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

The drug should be used with caution in hepatic insufficiency.

Use in Renal Impairment

The drug should be used with caution in renal insufficiency.

Pediatric Use

The drug is used in children over 8 years of age.

Geriatric Use

The drug should be used with caution in elderly patients.

Special Precautions

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

The risk of liver damage increases when the drug is used in patients with alcoholic hepatosis.

The drug distorts the indicators of laboratory tests during the quantitative determination of glucose and uric acid in plasma.

During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure.

With long-term use of ascorbic acid in high doses, suppression of the function of the insular apparatus of the pancreas is possible.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

Prescribing drugs containing ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may exacerbate the course of the process.

Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity, LDH).

If it is necessary to prescribe the drug to patients on a salt-restricted diet, it should be taken into account that 1 tablet contains 330 mg of sodium.

The drug contains sorbitol, so it should not be used in cases of fructose intolerance, low absorption of glucose and galactose, or isomaltase deficiency.

Overdose

The clinical picture of acute overdose develops within 6-14 hours after taking paracetamol. Symptoms of chronic overdose appear 2-4 days after increasing the dose of the drug.

Symptoms in acute overdose, disturbances from the digestive system are observed – diarrhea, loss of appetite, nausea and vomiting, abdominal discomfort and/or abdominal pain; increased sweating.

In chronic overdose, a hepatotoxic effect develops, characterized by general symptoms (pain, weakness, adynamia, increased sweating) and specific ones characterizing liver damage. As a result, hepatonecrosis can develop. The hepatotoxic effect of paracetamol can be complicated by the development of hepatic encephalopathy (thinking disorders, depression of higher nervous activity, agitation and stupor). Seizures, respiratory depression, coma, cerebral edema, coagulation disorders, development of DIC syndrome, hypoglycemia, metabolic acidosis, arrhythmia, and collapse are possible. Rarely – fulminant development of liver failure, which can be complicated by renal failure (tubular necrosis).

Treatment administration of SH-group donors and precursors of glutathione synthesis – methionine 8-9 hours after overdose and N-acetylcysteine – after 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its intake.

Drug Interactions

The drug reduces the effectiveness of uricosuric drugs.

Concomitant use of paracetamol in high doses enhances the effect of anticoagulants (by reducing the synthesis of procoagulant factors in the liver).

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications even with a slight overdose.

With long-term use of barbiturates, the effectiveness of paracetamol decreases.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic action of paracetamol.

Long-term combined use of paracetamol and other NSAIDs increases the risk of analgesic nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.

With simultaneous long-term use of paracetamol in high doses and salicylates, the risk of developing kidney or bladder cancer increases.

Diflunisal increases the plasma concentration of paracetamol by 50%, with a risk of hepatotoxicity.

Ascorbic acid increases the absorption of penicillin and iron, reduces the effect of heparin and indirect anticoagulants, and increases the risk of crystalluria during treatment with salicylates.

The absorption of ascorbic acid is reduced when used simultaneously with oral contraceptives.

Ascorbic acid slows down the renal excretion of acids and reduces the reabsorption of drugs with an alkaline reaction (including alkaloids).

Ascorbic acid in combination with deferoxamine increases the toxic effect of iron on tissues (especially on the heart, causing the development of heart failure); prescription of drugs containing ascorbic acid is carried out after determining the concentration of deferoxamine and determining iron excretion, no earlier than 1-2 hours after the deferoxamine infusion.

Ethanol contributes to the development of acute pancreatitis.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.