Paracetamol Eg 500mg 20 Tablets

NAME
PARACETAMOL EG TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics.

ACTIVE PRINCIPLES
Paracetamol.

EXCIPIENTS
Sodium carboxymethyl starch (type A); povidone (K-30); pregelatinised maize starch; stearic acid.

INDICATIONS
Symptomatic treatment of mild to moderate pain and febrile states.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients.

DOSAGE
Doses depend on body weight and age; a single dose can vary from 10 to 15 mg / kg body weight up to a maximum of 60 mg / kg of total daily dose. The specific dose range depends on the symptoms and the maximum daily dose. However, it must not be less than 4 hours. >> 500 mg tablets. Body weight (age) 33 kg - 43 kg (Children aged between 11 and 12 years): 500 mg single dose; 2,000 mg maximum daily dose. Body weight (age) 44 kg - 65 kg (adults and adolescents from 12 years of age): 500 mg single dose; 3,000 mg maximum daily dose. Body weight (age)> 65 kg: 500-1,000 mg single dose; 3,000 mg maximum daily dose. >> Tablets 1000 mg. (The 1000 mg tablet can be divided into equal halves). Body weight (age) 33 kg - 43 kg (Children aged between 11 and 12 years): 500 mg single dose; 2,000 mg maximum daily dose. Body weight (age) 44 kg - 65 kg (adults and adolescents from 12 years of age): 500 mg single dose; 3,000 mg maximum daily dose. Body weight (age)> 65 kg: 1,000 - 500 mg single dose; 3,000mg maximum daily dose. A maximum daily dose of paracetamol of 3000 mg should not be exceeded. Do not use acetaminophen for longer than three days. Elderly population: no dosage reduction is necessary in the case of elderly patients. Impaired hepatic or renal function: in patients with hepatic or renal insufficiency or with Gilbert's syndrome, the dose should be reduced over the prolonged dosing interval. Patients with impaired renal function: a dose reduction is required in patients with renal insufficiency. Glomerular filtration 10-50 ml / min: 500 mg every 6 hours. Glomerular filtration <10 ml / min: 500 mg every 8 hours >> For 500 mg tablets. Children and adolescents with low body weight: the use of paracetamol is not recommended in children under 11 years or weighing less than 33 kg: the dosage strength 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 adolescents with low body weight: the use of paracetamol is not recommended in children under 11 years or weighing less than 33 kg: the dosage strength 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.

STORAGE
This medicinal product does not require any special storage conditions.

WARNINGS
Do not exceed the recommended dose. Normally, medicines containing paracetamol should only be taken for a few days without the advice of a doctor or dentist and not in high doses. Patients need to be aware of the need not to take other paracetamol-based products at the same time. Paracetamol should be taken with caution in case of dehydration and chronic malnutrition. Caution is required when administering paracetamol to patients with severe hepatic or renal insufficiency or severe haemolytic anemia. 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 impair liver function, glucose-6-phosphate dehydrogenase deficiency. , haemolytic anemia. The risk of overdose is greater in patients with non-cirrhotic alcoholic liver disease. A dose reduction is required in patients who abuse alcohol. In these cases the daily dose should not exceed 2 grams. Caution should be used when paracetamol is used in combination with inducers of CYP3A4 or substances that induce liver enzymes, such as (e.g. rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). in high doses a headache may occur which cannot be treated with high doses of this product. Usually the habitual intake of analgesics, in particular of 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. The assumption of more 'daily doses in a single administration can seriously damage the liver, even if in this case no state of unconsciousness occurs. However, it is necessary to seek immediate medical attention. Prolonged use may be harmful, unless treatment is supervised by a physician. In children treated with 60 mg / kg / day of paracetamol, the combination with another antipyretic is not 'justified except in case of ineffectiveness of the treatment. The abrupt discontinuation of analgesics taken incorrectly, for prolonged periods and at high doses can 'cause headache, fatigue, muscle aches, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. In the meantime, avoid taking other analgesics, which should not be repeated without medical supervision. Children under 11 years of age: not recommended without medical advice. In children older than 11 years treated with 60 mg / kg / day of paracetamol, the combination with another antipyretic is not justified except in case of ineffectiveness of the treatment.

INTERACTIONS
The anticoagulant effect of warfarin and other coumarins can be enhanced by prolonged and regular daily use of paracetamol with an increased risk of bleeding. The interaction is dose-dependent but can already occur at daily doses of 1.5-2 g. Occasional administrations have no significant effect. Concomitant use of paracetamol and AZT (zidovudine) increases the tendency for a decrease in white blood cell count (neutropenia). Therefore, this medicine should not be taken in combination with AZT (zidovudine) without consulting a doctor. Concomitant use of drugs that increase the rate of gastric emptying (eg metoclopramide) lead to an increase in the rate of absorption and in the onset of the effects of paracetamol. The concomitant intake of drugs that slow down gastric emptying can reduce the paracetamol absorption rate, delaying its therapeutic effect. The absorption rate of paracetamol can be increased by metoclopramide and domperidone and reduced by cholestyramine. The intake of cholestyramine and paracetamol should be spaced at least one hour apart. 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 effectiveness of which is consequently decreased. It is also believed that the risk of liver injury is greater in patients treated concomitantly with enzyme inducers and paracetamol at the maximum therapeutic dose. Paracetamol can affect plasma concentrations of chloramphenicol. Monitoring of plasma concentrations is recommended during treatment with injected chloramphenicol. Effects on laboratory tests: the administration of paracetamol can interfere with the determination of uric acid (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method).

SIDE EFFECTS
Frequency of adverse reactions: 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. Disorders of the blood and lymphatic system. Rare: anemia, non-haemolytic and bone marrow depression; bone marrow depression, thrombycytopenia. Cardiac pathologies. Rare: edema. Vascular pathologies. Rare: edema. Gastrointestinal disorders. Rare: exocrine pancreatic conditions, acute and chronic pancreatitis. Haemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, necrosiepathic, jaundice. Skin and subcutaneous tissue disorders. Rare: pruritus, rash, sweating, purpura, angioedema, urticaria. Very rare cases of severe skin reactions have been reported. Renal and urinary disorders. Rare: nephropathies, nephropathic diseases and renal tubular diseases. Paracetamol has been widely used and there are rare reports of adverse reactions, generally associated with overdose. Nephrotoxic effects are uncommon and have not been reported in association with the use of therapeutic doses, except in the case of prolonged administration. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Epidemiological data from the oral use of therapeutic doses of paracetamol indicate no adverse effects on pregnancy or on the health of the fetus / newborn. Prospective data on pregnancies exposed to excessive doses did not show an increased risk of malformations. Reproduction studies following oral administration did not reveal any malformation or foetotoxic effects. Consequently, in normal conditions of use, paracetamol can 'be used for the duration of pregnancy, after a risk-benefit assessment. During pregnancy, paracetamol should not be taken for prolonged periods, in high doses or in combination with other medicines, as the safety of use in these cases has not been established. After oral administration, paracetamol is excreted in breast milk in small quantities. No undesirable effects affecting the breastfed infant have been reported. Therapeutic doses of the drug can be administered during breastfeeding.