EG 20CPR 500MG

PARACETAMOL AND ITS SALTS

active ingredients

EG 500 mg tablets Each tablet contains 500 mg of paracetamol. EG 1000 mg tablets Each tablet contains 1000 mg of paracetamol. Excipient with known effects: sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium carboxytylaride (type A), Povidone (K-30), pregelatinized corn starch, stearic acid.

Therapeutic indications

Syntomatic treatment of mild to moderate pain and fever states.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population The doses depend on body weight and age; a single dose may vary from 10 to 15 mg/kg body weight up to a maximum of 60 mg/kg total daily dose. The specific dose range depends on the symptoms and the maximum daily dose. However, it should not be less than 4 hours.PARACETAMAGE EG 500 mg tablets

Body weight (age)	Single dose (paracetamol dose)	Maximum daily dose (24 hours)(paracetal dose corresponding)
33 kg - 43 kg (Children aged 11 to 12 years)	500 mg	2,000 mg
44 kg - 65 kg (adults and teenagers from 12 years of age)	500 mg	3,000 mg
> 65 kg	500 - 1,000 mg	3,000 mg

PARACETAMOLO EG 1000 mg tablets (The 1000 mg tablet can be divided into two equal half)

Body weight (age)	Single dose	Maximum daily dose (24 hours)
33 kg - 43 kg (Children aged 11 to 12 years)	500 mg	2,000 mg
44 kg - 65 kg (adults and teenagers from 12 years of age)	500 mg	3,000 mg
> 65 kg	1000 - 500 mg	3,000 mg

You should not exceed a maximum daily dose of 3000 mg paracetamol. Do not use PARACETAMOLO EG for a period of more than three days without medical control. Special groups of patients Senior population No dosage reduction is required in the case of elderly patients. Promoted liver or kidney function In patients with hepatic or renal impairment or suffering from Gilbert's syndrome, the dose must be reduced or prolonged interval of administration. Patients with compromised kidney function Promoted kidney function A reduction in dose in patients with kidney failure is required.

Glomerular Filtration	Dose
10-50 ml/min	500 mg every 6 hours
	500 mg every 8 hours

Pediatric population For 500 mg tablets: Children and teenagers with low body weight The use of PARACETAMOLO EG is not recommended in children under 11 years or weighing less than 33 kg: the dosing concentration is not suitable for this age group. However, appropriate concentrations and/or formulations are available for this age group. For 1000 mg tablets (divisible): Children and teenagers with low body weight The use of PARACETAMOLO EG is not recommended in children under 11 years or weighing less than 33 kg: the dosing concentration is not suitable for this age group. However, appropriate concentrations and/or formulations are available for this age group. Method of administration Oral use. Dip the tablet with a glass of water.

Conservation

This medicine does not require special conditions of conservation.

Warnings

Do not exceed the recommended dose. Consult your doctor if you experience high fever or signs of a secondary infection or if symptoms persist for more than 3 days. As a rule, medications containing paracetamol should only be taken for a few days without the advice of a doctor or dentist and not at high doses. Patients need to be aware of the need to not simultaneously take other paracetamol-based products. Paracetamol should be taken with caution in case of dehydration and chronic malnutrition. Precaution is required in the administration of paracetamol to patients with severe liver or kidney failure or severe haemolytic anemia. Paracetamol should be given with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure, acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. The risk of overdose is greater in patients with non cirrhotic alcoholic hepatopathy. A reduction in dose is required in patients who abuse alcohol. In these cases the daily dose should not exceed 2 grams. It must be used caution when the paracetamol is used in combination with CYP3A4 inductors or substances that induce liver enzymes, such as rifampin, cymetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. Following incorrect use, prolonged use of high dose analgesics, a non-treated headache with high doses of this product may occur. As a rule, the usual intake of analgesics, in particular a combination of more analgesic substances, may lead to permanent kidney damage with the risk of kidney failure (nephropathy from analgesics). We do not recommend the frequent and prolonged use. Intake of several daily doses in a single administration can severely damage the liver, although there is no unconsciousness. However, it is necessary to contact the doctor immediately. Prolonged use may be harmful unless the treatment is supervised by a doctor. In children treated with 60 mg/kg/die paracetamol, the combination with another antipyretic is not justified if not in case of ineffective treatment. The sudden interruption of analgesics taken incorrectly, for prolonged periods and at high doses may cause headaches, fatigue, muscle pain, nervousness and autonomic symptoms. These suspension symptoms resolve within a few days. In the meantime, you avoid taking other analgesics, which should not be recovered without medical control. Children under 11 years of age: Unconscious without medical advice. In children treated with 60 mg/kg/die paracetamol, the combination with another antipyretic is not justified if not in case of ineffective treatment. Excipient This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘without sodium’.

Interactions

The anticoagulant effect of warfarin and other cumarinics can be enhanced by prolonged and regular daily use of paracetamol with increased risk of bleeding. The interaction is dose-dependent but can already occur at daily doses of 1.5-2 g. Occasional administrations do not give rise to any significant effect. Concurrent use of paracetamol and AZT (zidovudine) increases the tendency to a reduction in the leukocytes count (neutropenia). This medicine, therefore, should not be taken in association with AZT (zidovudine) without consulting a doctor. Concurrent intake of medicines that increase the rate of gastric emptying (e.g. metoclopramide) entail an increase in absorption speed and onset of the effects of paracetamol. Concurrent intake of medicines that slow gastric emptying can reduce the absorption rate of paracetamol, delaying the therapeutic effect. The absorption rate of the paracetamol can be increased by metoclopramide and domperidone and reduced by cholesteramine. Intake of choleramine and paracetamol must be at least an hour. The probenecid reduces the clearance of the paracetamol by about 50%. It is therefore necessary to halve the dose of paracetamol during the concomitant treatment. The risk of paracetamol toxicity has increased in the case of alcoholism. Enzymatic inductors such as rifampin, some antiepileptic drugs, St. John's herb may lead to a reduction in plasma concentrations of paracetamol, whose effectiveness is consequently reduced. It is also believed that the risk of liver damage is greater in patients treated simultaneously with enzymatic inductors and paracetamol at the highest therapeutic dose. Paracetamol can affect plasma concentrations of chloramphenicol. In the process of treatment with chloramphenicol by injective we recommend the monitoring of plasma concentrations. You should pay attention when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). Effects on laboratory tests Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidaseperoxidase).

Effects

Very common (≥1/10)

Common (≥1/100 -

Not common (≥1/1.000 -

Rare (≥1/10.000 -

Very rare (

Notable (frequency cannot be defined on the basis of available data)

Within each frequency class, unwanted effects are reported in decreasing order of gravity. Diseases of the emolinfopoietic system. Rare: anemia, non-emolytic and midollar depression; depression of the marrow, thrombocytopenia. Heart disease. Rare: edema. Vascular diseases. Rare: edema. Gastrointestinal disease. Rare: exocrine pancreatic conditions, acute and chronic pancreatis. Hemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice. Pathologies of skin and subcutaneous tissue. Rare: itching, rash, sweating, purple, angioedema, hives. Very rare cases of severe skin reactions have been reported. Kidney and urinary pathologies. Rare: nephropathy, nephropathic diseases and kidney tubular diseases. Paracetamol has been widely used and rare are reports of adverse reactions, generally associated with overdose. Nephrotoxic effects are not common and have not been reported in association with the use of therapeutic doses, except in case of prolonged administration. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is a risk of intoxication, especially in elderly patients, in small children, in patients with liver disease, in case of chronic alcoholism, in patients with chronic malnutrition. In these cases overdose can be fatal. It is possible the appearance of liver damage in adult patients who have taken 10 g or more paracetamol. Ingestion of 5 g or more paracetamol by patients with risk factors (see below) can cause liver damage. It is believed that excessive amounts of a toxic metabolite (usually properly detoxified by glutathione, when normal doses of paracetamol are ingested) bind irreversibly to liver tissue. Risk factors If the patient a. is in long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampin, St. John's herb or other drugs that induce liver enzymes or b. regularly consumes excess ethanol to the recommended quantities or c. is probably lacking in glutathione, for example in the case of disorders of food behaviour, cystic fibrosis, HIV infection, inedia, cachessia. Synonyms Symptoms of paracetamol overdose that generally appear within the first 24 hours include: pallor, nausea, vomiting, anorexia and abdominal pain. Hepatic damage can occur 12-48 hours after ingestion. It can also occur abnormality of glucose metabolism and metabolic acidosis. In severe poisoning cases, liver failure can progress in encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Even in the absence of severe liver damage, a severe kidney failure with acute tubular necrosis may arise, particularly likely if accompanied by lumbar pain, hematuria and proteinuria. Heart arrhythmia and pancreatitis were reported. Treatment In case of paracetamol overdose, it is essential to immediately treat the patient. Even in the absence of significant initial symptoms, the patient should be urgently taken to the hospital. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. The treatment should be carried out according to the current guidelines, see the overdose section in the BNF. The treatment with activated charcoal can be taken into account if it has not been more than an hour after taking the overdose of paracetamol. It should be measured the plasma concentration of paracetamol not before 4 hours from its ingestion (plasmic concentrations measured in previous times are not reliable). Patient can be treated with N-acetylcysteine within 24 hours of ingestion of paracetamol; however, the maximum protective effect is achieved within 8 hours of the ingestion of the paracetamol itself. After this time, the effectiveness of the antidote decreases rapidly. If necessary, in line with the established therapeutic scheme, we should administer Nacetilcisteina patient intravenously. Where vomiting is not a problem, the administration of oral methionin may be an appropriate alternative in a zone far from the hospital. It is appropriate to discuss the treatment of patients with severe liver failure and who have taken the paracetamol for more than 24 hours with an Antiveleni Center or with a hepathology department. Dialysis can reduce plasma concentrations of paracetamol.

Pregnancy

A large amount of data on pregnant women indicates neither malformative toxicity nor fetus/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose possible for the shortest time possible and with the lowest frequency possible.

Food

After oral administration the paracetamol is excreted in breast milk in small quantities. No side effects were reported on the breast-feeding baby. It is possible to administer therapeutic doses of the medicinal product during feeding.

Source: Farmadati