PARACETAMOL PEN * 20CPR 500MG

PARACETAMOL PEN * 20CPR 500MG

Therapeutic indications

Symptomatic treatment of mild and moderate pain and febrile affections.

Dosage and method of use

Doses depend on body weight and age; a single dose ranges from 10 to 15 mg / kg of body weight to a maximum of 60 mg / kg per total daily dose. The specific interval between doses depends on the symptoms and the maximum daily dose. However, it must not be less than 4 hours. Paracetamol Think 500mg tablets

(the 1000 mg tablet can be divided into equal halves).

The maximum daily dose of paracetamol should not exceed 3000 mg. Do not administer Paracetamol Pensa for more than 3 consecutive days without consulting your doctor. Special populations.Elderly patients: There is no need to reduce the dosage in elderly patients. Impaired hepatic or renal function: In patients with impaired hepatic or renal function or with Gilbert's syndrome, the dose should be reduced or the dosing interval prolonged. Patients with impaired renal function.Impaired renal function. In patients with renal insufficiency, the dose should be reduced:

Paracetamol Pensa is not recommended for children under 11 years of age or with a body weight of less than 33 kg, as this dosage is not suitable for this age group However, there are appropriate dosages and / or formulations available for this age group. of age. For 1000 mg tablets (divisible): Children and adolescents with low body weight:Paracetamol Pensa is not recommended for children under 11 years of age or with a body weight of less than 33 kg, as this dosage is not suitable for this age group However, there are appropriate dosages and / or formulations available for this age group. of age. Method of administration: Oral use. Swallow the tablets with a glass of water.

Contraindications

Hypersensitivity to paracetamol or to any of the excipients.

Side effects

Very common (≥1 / 10); Common (≥1 / 100 and Blood and lymphatic system disorders. Rare: anemia, bone marrow non-haemolysis and depression, thrombocytopenia.Cardiac pathologies.Vascular disorders: Rare: edema.Gastrointestinal disorders.Rare conditions of exocrine pancreas, acute and chronic pancreatitis. Hemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, hepatic necrosis, jaundice.Skin and subcutaneous tissue disorders. Rare: pruritus, rash, sweating, purpura, angioedema, urticariaRenal and urinary disorders.Rare: nephropathies, nephropathies and tubular diseases. Paracetamol has been widely used; reports of adverse reactions are rare, and are generally associated with overdose. Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses except after prolonged administration.

Special warnings

Do not exceed the indicated dose. If febrile illnesses or signs of secondary infections occur or if symptoms persist for more than 3 days, a doctor should be consulted. In general, medicines that contain acetaminophen should only be taken for a few days without the advice of a doctor or dentist and not in high dosages. Children under 11 years: not recommended without medical advice. Patients should be advised not to take other paracetamol-containing medicinal products at the same time. Paracetamol should be used with caution in case of chronic dehydration and malnutrition. Caution is recommended when administering paracetamol to patients with severe renal or hepatic impairment or severe haemolytic anemia. The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. In patients who abuse alcohol the dose should be reduced. In this case, the daily dose should not exceed 2 grams. Caution should be exercised when paracetamol is used in combination with inducers of CYP3A4 or substances that induce liver enzymes, such as rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine. Following long-term, high-dose administration, and incorrect use of analgesics, headaches may occur which may not be treated with higher doses of the drug. In general, the habitual intake of analgesics, in particular a combination of several analgesic substances, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). Prolonged or frequent use is not recommended. Taking several daily doses in a single administration can severely damage the liver; in this case a state of unconsciousness does not occur. However, medical attention should be sought immediately. Prolonged use if not under medical supervision can be harmful. In children treated with 60mg / kg of paracetamol per day, the combination with another antipyretic is not justified except in case of ineffectiveness. Abrupt discontinuation after long-term, high-dose, or incorrect use of analgesics can cause headaches, fatigue, muscle aches, nervousness, and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until this time, further analgesic intake should be avoided and should not be resumed without medical advice.

Pregnancy and breastfeeding

Pregnancy:Epidemiological data from the use of oral 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. Oral reproductive studies did not reveal any malformation or foetotoxic effects. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency.Feeding time:After oral use, paracetamol is excreted in breast milk in small quantities. No undesirable effects on infants have been reported. Therapeutic doses of this medicine can be used during breastfeeding.

Expiration and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

The anticoagulant effect of warfarin and other coumarins can be enhanced by regular and prolonged daily use of paracetamol, with an increased risk of bleeding. The interaction is dose-dependent, but can occur as early as 1.5-2g daily. Occasional doses do not have a significant effect. Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. This medicinal product should therefore be administered in combination with AZT only on medical advice. Concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of the effects of paracetamol. Concomitant use of medicinal products that slow gastric emptying may delay the absorption and onset of effects of paracetamol. The absorption rate of paracetamol can be increased by metoclopramide or domperidone, and the absorption reduced by cholestyramine. The intake of cholestyramine and paracetamol must be separated by at least one hour. Probenecid reduces the clearance of paracetamol by almost 50%. Consequently, the dose of paracetamol can be halved during concomitant treatment. Alcohol abuse increases the risk of paracetamol intoxication. Enzyme-inducing drugs such as rifampicin, some antiepileptic drugs or St. John's wort can result in reduced plasma concentrations and reduce the efficacy of paracetamol. Furthermore, the risk of liver damage is expected to be increased in patients treated concomitantly with enzyme inducers and with the maximum therapeutic dose of paracetamol. Paracetamol can affect plasma concentrations of chloramphenicol. Monitoring of plasma concentrations is advised during treatment with injectable chloramphenicol.Effects on laboratory tests: Taking paracetamol may affect uric acid tests using phosphotungstic acid and blood glucose tests using glucose-oxidase-peroxidase.

Overdose

There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition. In these cases, overdose can be fatal. Liver damage is possible in adults who have taken 10g or more of acetaminophen. Ingesting 5g or more of acetaminophen can cause liver damage if the patient has risk factors (see below). Excessive amounts of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of acetaminophen are ingested) are believed to bind irreversibly to liver tissue.Risk factors: If the patient a. You are on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other drugs that induce liver enzymes. or b. Regularly consume excess ethanol or c. is likely to have a glutathione depletion, p. ex. nutritional disorders, cystic fibrosis, HIV infection, starvation, cachexia.Symptoms: Symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, anorexia and abdominal pain. Liver damage can become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, hemorrhage, hypoglycemia, brain edema, and death. Acute renal failure with acute tubular necrosis, strongly indicated by lower back pain, hematuria, and proteinuria, can develop in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.TherapyPrompt treatment is essential in the treatment of acetaminophen overdose. Despite the lack of significant early symptoms, patients need to be rushed to hospital for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Therapy should be in accordance with recognized treatment guidelines (see the overdose section of the BNF). If the overdose has occurred within 1 hour, treatment with activated charcoal should be considered. Plasma concentrations of paracetamol should be measured 4 hours or more after ingestion (earlier concentrations are not reliable). The treatment with N-acetylcysteine can be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours after ingestion. The effectiveness of the antidote decreases abruptly after this time. If necessary, the patient should be administered intravenous N-acetylcysteine, in accordance with the established posology. If vomiting is not a problem, oral administration of methionine may be a viable alternative for remote areas away from the hospital. Treatment of patients presenting with severe hepatic dysfunction within 24 hours of ingestion should be discussed with a poison center or hepatology unit. Dialysis can reduce the plasma concentration of paracetamol.

Active principles

Paracetamol Think500 mg tablets: Each tablet contains 500 mg of paracetamol. Paracetamol Think1000 mg tablets:Each tablet contains 1000 mg of paracetamol. For the full list of excipients, see section 6.1.

Excipients

Sodium starch glycolate Type A; Povidone (K-30); Pregelatinised maize starch; Stearic acid.