Paracetamolo eg 500 mg - 20 tablets for pain and fever

Product Description

Tablets to relieve pain and reduce fever.

Indications

Paracetamol Eg 500 mg is a medicine used for the symptomatic treatment of mild to moderate pain and/or fever (analgesic and antipyretic).

Composition

Active ingredients: Each tablet contains 500 mg of paracetamol.
Excipients: Sodium starch glycolate (type A) Povidone (K-30) Pregelatinized corn starch Stearic acid

Directions for use and Dosage

The doses depend on body weight and age; a single dose can be used as a single dose. 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.
It should not, however, be less than 4 hours.

A maximum daily dose of paracetamol of 3,000 mg should not be exceeded.
Do not use PARACETAMOLO EG for more than three days without medical supervision.
Special patient groups
Elderly population
No dosage reduction is necessary in elderly patients.
Reduced liver or kidney function
In patients with liver or kidney failure or with Gilbert's syndrome, the dose should be reduced or the administration interval prolonged.
Patients with reduced renal function
A dose reduction is necessary in patients with renal failure.

Children and adolescents with a low body weight
The use of Paracetamol Eg is not recommended in children under 11 years of age or weighing less than 33 kg: the dosage 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. Swallow the tablet with a glass of water.

Warnings

Do not exceed the recommended dose.
Consult your doctor if you experience high fever or signs of a secondary infection or if the symptoms persist for more than 24 hours. 3 days.
Medications containing paracetamol should normally only be taken for a few days without the advice of a doctor or dentist and not in high doses.
Patients should be made aware of the need not to take other paracetamol-containing products at the same time.
Paracetamol should be taken with caution in cases of dehydration and chronic malnutrition.
Caution is required when administering paracetamol to patients with severe hepatic or renal insufficiency or severe haemolytic anaemia.
Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.
The risk of overdose is greater in patients with non-cirrhotic alcoholic liver disease.
/>A dose reduction is necessary in patients who abuse alcohol.
In these cases, the daily dose should not exceed 2 grams.
Caution should be exercised when paracetamol is used in combination with CYP3A4 inducers or substances that induce liver enzymes, such as (for example, rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine).
Following incorrect, prolonged use of high-dose analgesics, headache may occur that cannot be treated with high doses of this product.
As a general rule, the habitual intake of analgesics, especially a combination of several analgesic substances, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy).
Frequent and prolonged use is therefore not recommended.
Taking multiple analgesics at once may cause severe kidney damage. Daily doses in a single administration can seriously damage the liver, although this does not result in unconsciousness.
However, it is necessary to consult a doctor immediately.
Prolonged use may be harmful unless the treatment is supervised by a doctor.
In children treated with 60 mg/kg/day of paracetamol, the combination with another antipyretic is not justified unless the treatment is ineffective.
Abrupt discontinuation of analgesics taken incorrectly, for prolonged periods and at high doses can cause serious liver damage. cause headache, tiredness, muscle pain, nervousness and autonomic symptoms.
These withdrawal symptoms resolve within a few days.
In the meantime, avoid taking other analgesics, which should not be restarted without medical supervision.
Paediatric population
Children under 11 years of age: Not recommended without medical advice.
In children treated with 60 mg/kg/day of paracetamol, the combination with another antipyretic is not justified unless the treatment is ineffective.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed.

Interactions

The anticoagulant effect of warfarin and other coumarins may be impaired. be potentiated by prolonged and regular daily use of paracetamol with increased risk of bleeding.
The interaction is dose-dependent but can may occur already at daily doses of 1.5–2 g.
Occasional administration does not result in any significant effect.
The concomitant use of paracetamol and AZT (zidovudine) increases the tendency to a reduction in the leukocyte count (neutropenia).
This medicine should therefore not be taken in combination with AZT (zidovudine) without consulting a doctor.
Concomitant use of medicines that increase the rate of gastric emptying (e.g. metoclopramide) leads to an increase in the rate of absorption and the onset of the effects of paracetamol.
Concomitant use of medicines that slow gastric emptying can reduce the rate of absorption of paracetamol, delaying its therapeutic effect.
The rate of absorption of paracetamol may be increased. be increased by metoclopramide and domperidone and reduced by cholestyramine.
The intake of cholestyramine and paracetamol should be separated by at least one hour.
Probenecid reduces the clearance of paracetamol by approximately 50%.
It is therefore necessary to halve the dose of paracetamol during concomitant treatment.
The risk of paracetamol toxicity is increased in case of alcoholism.
Enzyme inducers such as rifampicin, some antiepileptic drugs, St. John's wort can cause a reduction in plasma concentrations of paracetamol, the efficacy of which is consequently reduced.
It is also believed that the risk of liver damage is greater in patients treated simultaneously with enzyme inducers and paracetamol at the maximum therapeutic dose.
Paracetamol can influence plasma concentrations of chloramphenicol.
During treatment with injected chloramphenicol, monitoring of plasma concentrations is recommended.
Effects on laboratory tests
The administration of paracetamol may interfere with the determination of uric acid levels (using the phosphotungstic acid method) and blood glucose levels (using the glucose-oxidase-peroxidase method).

Undesirable effects

• Very common (>1/10).
• Common (>1/100 –<1/10).
• Uncommon (>1/1,000 – <1/100).
• Rare (>1/10,000 – <1/1,000).
• Very rare (<1/10,000)
• Not known (frequency cannot be estimated from the available data).

Within Within each frequency grouping, adverse reactions are reported in decreasing order of seriousness.
Blood and lymphatic system disorders
Rare: Anaemia, non-haemolytic and bone marrow depression; Bone marrow depression, thrombocytopenia.
Cardiac disorders
Rare: Oedema
Vascular disorders
Rare: Oedema
Gastrointestinal disorders
Rare: Exocrine pancreatic conditions, acute and chronic pancreatitis.
Haemorrhage, abdominal pain, diarrhoea, nausea, vomiting, hepatic failure, hepatic necrosis, jaundice.
Skin and subcutaneous tissue disorders
Rare: Pruritus, rash, sweating, purpura, angioedema, urticaria.
Very rare cases of serious skin reactions have been reported.
Renal and urinary disorders
Rare: Nephropathy, nephropathic disease and renal tubular disease.
Paracetamol has been widely used in the treatment of The use of this medicinal product is widespread and reports of adverse reactions are rare, generally associated with overdose.
Nephrotoxic effects are uncommon and have not been reported in association with the use of therapeutic doses, except in cases of prolonged administration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Overdose

There is a risk of intoxication, especially in elderly patients, young children, patients with liver disease, in cases of chronic alcoholism, and in patients suffering from chronic malnutrition.
In these cases, overdose may be fatal. be fatal.
Liver damage may occur in adult patients who have taken 10 g or more of paracetamol.
Ingestion of 5 g or more of paracetamol by patients with risk factors (see below) may cause liver damage. cause liver damage.
It is believed that excessive amounts of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.
Risk Factors
If the patient

• is on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes or
• regularly consumes ethanol in excess of recommended amounts or
• is likely to be glutathione deficient, for example in cases of eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. 

Symptoms
Symptoms of paracetamol overdose that generally appear within Symptoms within the first 24 hours include: pallor, nausea, vomiting, anorexia, and abdominal pain.
Liver damage may occur 12–48 hours after ingestion.
Abnormalities in glucose metabolism and metabolic acidosis may also occur.
In cases of severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, cerebral edema, and death.
Even in the absence of severe liver damage, liver failure may occur. Severe renal failure with acute tubular necrosis may develop, particularly if accompanied by back pain, hematuria, and proteinuria.
Cardiac arrhythmia and pancreatitis have been reported.
Treatment
In the event of paracetamol overdose, it is essential to treat the patient immediately.
Even in the absence of significant initial symptoms, the patient should be taken to hospital urgently.
Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.
Treatment should be carried out according to current guidelines; see overdose section in the BNF.
Treatment with activated charcoal may be considered if no more than 1 month has elapsed. within one hour of taking a paracetamol overdose.
Plasma paracetamol concentrations should be measured no earlier than 4 hours after ingestion (plasma concentrations measured earlier are unreliable).
The patient can be treated with N-acetylcysteine ​​within 24 hours of paracetamol ingestion; however, the maximum protective effect is achieved within 8 hours of paracetamol ingestion.
After this time, the effectiveness of the antidote rapidly decreases.
If necessary, in line with the established therapeutic regimen, the patient should be administered N-acetylcysteine ​​intravenously.
Where vomiting is not a problem, oral methionine administration may be effective. represent an adequate alternative in an area remote from the hospital.
It is advisable to discuss the treatment of patients with severe liver failure and who have been taking paracetamol for more than 24 hours with a Poison Control Center or a hepatology department.
Dialysis may reduce plasma concentrations of paracetamol.

Pregnancy and breastfeeding

Pregnancy
A large amount of data on pregnant women indicates no malformative or feto/neonatal toxicity.
Paracetamol can be used during pregnancy if clinically needed, however it should be used at the lowest effective dose for the shortest possible duration and as frequently as possible. possible low.
Breastfeeding
After oral administration, paracetamol is excreted in breast milk in small quantities.
No adverse effects on the breast-fed child have been reported.
Therapeutic doses of the medicine can be administered during breastfeeding.

Format

Pack of 20 tablets