PEN 20CPR 500MG

PARACETAM COMPRESITION

active ingredients

Paracetamus Think 500 mg tablets: Each tablet contains 500 mg of paracetamol. Paracetamus Think 1000 mg tablets: Each tablet contains 1000 mg of paracetamol. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium starch type A; Povidone (K-30); Pregelatinized corn starch; Stearic acid.

Therapeutic indications

Symptomatic treatment of mild and moderate pain and fever.

Contraindications

Hypersensitivity to paracetamol or any of the excipients.

Population

The doses depend on body weight and age; a single dose varies from 10 to 15 mg/kg 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 should not be less than 4 hours. Paracetamus Think 500mg tablets

Body weight (age)	Single dose (paracetamol equivalent dose)	Max. daily dose (24 h) (paracetamol equivalent dose)
33 kg - 43 kg (children from 11 to 12 years)	500 mg	2000 mg
44 kg - 65 kg (adults and teenagers over 12 years)	500 mg	3000 mg
> 65 kg	500 - 1000 mg	3000 mg

Paracetamus Think 1000mg tablets (the 1000 mg tablet can be divided into two equal half).

Body weight (age)	Single dose	Max. daily dose (24 h)
33 kg - 43 kg (children from 11 to 12 years)	500 mg	2000 mg
44 kg - 65 kg (adults and teenagers over 12 years)	500 mg	3000 mg
> 65 kg	1000 - 500 mg	3000 mg

The maximum daily dose of paracetamol should not exceed 3000 mg. Do not administer Paracetamol Think for more than 3 consecutive days without consulting your doctor. Special popularity. Senior Patients: It is not necessary to reduce the dosage in elderly patients. Epatic or renal function compromised: In patients with impaired liver or kidney function or Gilbert syndrome, the dose must be reduced or the extended dose range. Patients with compromised kidney function. Promoted kidney function. In patients with kidney failure, the dose must be reduced:

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

For 500 mg tablets: Children and teenagers with reduced body weight: Think Paracetamol is not recommended in children under 11 years or with a body weight less than 33 kg, as such dosage is not suitable for this age group. However, there are appropriate dosages and/or formulations available for this age group. For tablets of 1000 mg (divisible): Children and teenagers with reduced body weight: Think Paracetamol is not recommended in children under 11 years or with a body weight less than 33 kg, as such dosage is not suitable for this age group. However, there are appropriate dosages and/or formulations available for this age group. Method of administration: Oral use. Eating the tablets with a glass of water.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Do not exceed the dose indicated. If fever or signs of secondary infections occur or if symptoms persist for more than 3 days, a doctor must be consulted. In general, medicines containing paracetamol should only be taken for a few days without the advice of a doctor or dentist and not to high dosages. Children under 11 years: it is not recommended without medical advice. Patients should be informed that they do not take other medications containing paracetamol at the same time. Paracetamol should be used with caution in case of chronic dehydration and malnutrition. It is recommended caution in administering paracetamol in patients with severe renal or hepatic impairment or severe haemolytic anemia. Overdose risks are greater in patients with non-cirrhotic liver disease. In patients with alcohol abuse, the dose must be reduced. In this case, the daily dose should not exceed 2 grams. It should be precautionary when paracetamol is used in combination with CYP3A4 inductors or substances that induce liver enzymes, such as rifampin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine. As a result of long-term administration, at a high dose, to incorrect use of analgesics, headaches may occur which may not be treated with higher doses of medicine. In general, the usual intake of analgesics, in particular a combination of more analgesic substances, can lead to permanent kidney damage with the risk of kidney failure (nephropathy from analgesics). Prolonged or frequent use is not recommended. Taking more daily doses in one administration can severely damage the liver; in this case there is no state of loss of consciousness. However, medical assistance must be immediately requested. Prolonged use if not under medical control can be harmful. In children treated with 60mg/kg paracetamol per day, the combination with another antipyretic is not justified if not in case of ineffectiveness. A sudden interruption after long-term use, at high dosage, or incorrect analgesics may cause headaches, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until now, the further intake of analgesics must be avoided and should not be resumed without medical advice.

Interactions

The anticoagulant effect of warfarin and other cumarinics can be increased by a regular and prolonged daily use of paracetamol, with an increased risk of bleeding. The interaction is dose-dependent, but can already occur at daily doses of 1.5-2g. Occasional doses have no significant effect. Concurrent administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. This medicine must therefore be administered in association with AZT only on medical advice. Concurrent intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates absorption and onset of the effects of paracetamol. Concurrent intake of medicines that slow gastric emptying may delay the absorption and onset of the effects of paracetamol. Paracetamol absorption speed can be increased by metoclopramide or domperidone, and reduced absorption by cholesteramine. Taking cholesteramine and paracetamol must be separated from at least an hour. Probenecid reduces the clearance of the paracetamol almost 50%. Therefore, the dose of paracetamol can be halved during the concomitant treatment. Alcohol abuse increases the risk of paracetamol poisoning. Enzymatic inductors such as rifampin, some antiepileptic drugs or the Herba of San Giovanni can give rise to reduced plasma concentrations and reduce the effectiveness of paracetamol. In addition, the risk of liver damage is expected to be greater in patients treated simultaneously with enzymatic inductors and with the maximum therapeutic dose of paracetamol. Paracetamol can affect plasma concentrations of chloramphenicol. During treatment with injectable chloramphenicol it is recommended to monitor plasma concentrations. Effects on laboratory tests: Paracetaminol intake may affect tests for uric acid using phosphotungstic acid and blood glucose analysis using glucose-oxidase-peroxidase.

Effects

Very common (≥1/10); Common (≥1/100 and pathologies of the emolinfopoietic system. Rares: anemia, non-emolysis and depression of the marrow, thrombocytopenia. Heart disease. Vascular pathologies: Rare: edema. Gastrointestinal disease. Rare conditions of exocrine pancreas, acute and chronic pancreatis. Hemorrhage, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice. Pathologies of skin and subcutaneous tissue. Rare: itching, rashes, sweating, porpura, angioedema, hives Kidney and urinary pathologies. Rare: nephropathy, nephropathy and tubular pathologies. Paracetamol has been widely used; adverse reactions are rare, and are generally associated with overdose. Nephrotoxic effects are not common and have not been reported in combination with therapeutic doses, if not after prolonged administration.

Overdosing

There is a risk of poisoning, especially in elderly people, in small children, in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition. In these cases overdose can be fatal. The liver damage is possible in adults who have taken 10g or more paracetamol. Ingestion of 5g or more paracetamol can cause liver damage if the patient has risk factors (see below). 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 is. It is in long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampin, St. John's herb or other drugs that induce liver enzymes. o b. Consuma regularly ethanol in excessive quantities or c. is likely to have a depletion of glutathione, e.g. nutritional disorders, cystic fibrosis, HIV infection, inedia, caching. Synonyms: The symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. The liver damage can become apparent from 12 to 48 hours after ingestion. There may be abnormalities of glucose metabolism and metabolic acidosis. In severe poisoning, liver failure can progress in encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Acute kidney failure with acute tubular necrosis, strongly indicated by lumbar pain, hematuria and proteinuria, can develop in the absence of severe liver damage. Heart arrhythmias and pancreatitis were reported. Therapy Immediate treatment is essential in paracetamol overdose therapy. Despite the lack of significant early symptoms, patients must be urgently conducted in the hospital for immediate medical care. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. The therapy should be in accordance with the guidelines recognised on treatment (see the overdose section of the BNF). If the overdose occurred within 1 hour, an active carbon treatment should be considered. Plasma concentrations of paracetamol should be measured after 4 hours or more by ingestion (precocious concentrations are not reliable). 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 sharply after that time. If necessary the patient should be administered N-acetylcysteine intravenously, in accordance with the established dosage. If vomiting is not a problem, oral administration of methionine may be a valid alternative to remote areas, far from the hospital. Patient therapy with severe liver dysfunction after 24 hours of ingestion must be discussed with an antivileno center or a hepathology unit. Dialysis can reduce the plasma concentration of paracetamol.

Pregnancy: Epidemiological data concerning the use of oral therapeutic doses of paracetamol do not indicate undesirable effects on pregnancy or health of fetus/newborn. Perspective data on pregnancies exposed to excessive doses showed no increase in the risk of malformation. Oral reproductive studies have not shown any malformation or fetotoxic effects. 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 for as short as possible and with the lowest frequency possible. Nursing: After oral use, the paracetamol is excreted in breast milk in small quantities. No side effects have been reported. During breastfeeding, therapeutic doses of this medicine may be used.

Source: Farmadati