Acamol

/ Teva

Adults and children aged 12 years and over: 1-2 tablets/caplets every 4-6 hours, as needed. Do not exceed a dosage of 8 tablets/caplets in any 24 hours.
Children aged 9-12 years: ½ -1 tablet/caplet every 4-6 hours, as needed. Do not exceed a dosage of 4 tablets/caplets in a day (2 grams a day).
Children aged 6-9 years: ½ tablet/caplet every 4-6 hours, as needed. Do not exceed a dosage of 3 tablets/ caplets in a day (1.5 grams a day).
Do not give a tablet/caplet to children under 6 years of age.
Do not exceed the recommended dose. Patient should refer to a doctor if the fever persists for more than 3 days or if the symptoms do not pass within 5 days, despite use of the medicine.

Relief of pain and fever of different etiologies such as headache, toothache, colds, influenza, rheumatic pain and dysmenorrhea.

Known hypersensitivity to paracetamol or to any other ingredient of the preparation.

Prolonged or frequent use is discouraged. Patients should be advised not to take other Paracetamol containing products , including cold and cough medicines concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur. However, medical assistance should be sought immediately. Caution is advised if skin side effects have been developed in the past as a result of taking products containing paracetamol, products containing paracetamol should not be used, so that severe skin effects will not recur. Prolonged use except under medical supervision may be harmful. Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Caution is advised in the administration of Paracetamol to patients with moderate and severe renal insufficiency, mild to moderate hepatic insufficiency (including Gilbert’s syndrome), severe hepatic insufficiency (child-pugh>9), acute hepatitis, concomitant treatment with medicinal products affecting hepatic functions, glucose-6 phosphatedehydrogenase deficiency, hemolytic anemia, alcohol abuse dehydration and chronic malnutrition.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2 grams in such case. Alcohol should not be used during the treatment with Paracetamol.
Caution is advised in asthmatic patients sensitive to aspirin because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested.
Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis.
In the case of high fever, or signs of secondary infection or persistence of symptoms a doctor should be consulted. Immediate medical advice should be sought in the event of overdosage even if the patient feels well because of the risk of irreversible liver damage.
If symptoms persist consult your doctor.
Keep out of the sight and reach of children.

Adverse reactions of paracetamol are rare and usually mild.
Hepatotoxicity: Hepatotoxicity has occurred in patients receiving high or excessive doses within therapeutic doses. Certain patients may be more susceptible to paracetamol hepatotoxicity, e.g., chronic alcoholics, patients with liver disease, or those who are malnourished or taking other drugs that induce hepatic enzymes. Because of the risk of hepatotoxicity, patients should be cautioned against the inadvertent administration of excessive doses of paracetamol by using multiple paracetamol-containing product at once, such as cough and cold remedies, analgesics or arthritic formulations, antipyretics or products for relief of menstrual symptoms or muscle spasm. Administration of paracetamol to children may be especially prone to error due to the many concentrations and strengths of products available. To avoid dosing errors, all product labels should be checked carefully to ensure calculation of the amount of paracetamol to be given.
Hematologic: Neutropenia and thrombocytopenia purpura have been reported and rarely agranulocytosis.
Hypersensitivity: Reactions including skin eruptions, laryngeal edema, bronchospasm, and/or anaphylaxis have occurred rarely. Dose-dependent cross-sensitivity to paracetamol may occur in aspirin-sensitive asthmatics. Low initial doses of paracetamol (less than 1000 mg) are recommended in these patients, with monitoring for about 3 hours following initial doses.
Renal: Nephropathy, including papillary renal failure has been reported following consumption of large amounts of paracetamol. Renal tubular necrosis has been associated occasionally with hepatic injury produced by paracetamol overdose.

Hepatotoxic substances may increase the possibility of Paracetamol accumulation and overdose. The risk of hepatotoxicity of paracetamol may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.
Probenecid causes an almost 2-fold reduction in clearance of Paracetamol by inhibiting its conjugation with glucuronic acid. A reduction of the Paracetamol dose should be considered for concomitant treatment with probenecid.
Salicylamide may prolong the elimination t1/2 of Paracetamol.
Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and Domperidone: The speed of absorption of paracetamol may be increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Concomitant use of Paracetamol (4 g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values. In this case, increased monitoring of INR values should be done during the duration of the combination and after its discontinuation. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Isoniazid: Reduction of paracetamol clearance, with possible potentiation of its action and/or toxicity, by inhibiting its metabolism in the liver.
Lamotrigine: Decrease in the bioavailability of lamotrigine, with possible reduction of its effect, due to possible induction of its metabolism in the liver.
Interference with laboratory tests: Paracetamol may affect uric acid tests by wolframatop phosphoric acid, and blood sugar tests by glucose-oxydaseperoxydase.
Flucloxacillin: Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, due to pyroglutamic acidosis especially in patients with risks factors.

Pregnancy:A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.
Lactation:Following oral administration, Paracetamol is excreted into breast milk in small quantities. To date, no adverse reactions or undesirable effects are known in association with lactation. Therapeutic doses of Paracetamol can be administered during breast-feeding.

Manifestations: Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. In massive overdose, paracetamol may cause hepatic toxicity. In adults and adolescents, hepatic toxicity has been rarely reported following ingestion of acute overdose of less than 7.5 –10 g. Fatalities are infrequent (less than 3-4% of untreated cases) and have been rarely reported with overdoses of less than 15 g. Early symptoms following a potentially hepatotoxic overdose may include nausea, vomiting, stomach pain, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hours post-ingestion. Serious toxicity or fatalities are extremely infrequent in children, possibly due to differences in the way they metabolize paracetamol. An acute overdose of less than 150 mg/kg bodyweight in children has not been associated with hepatic toxicity.
Treatment:
Adults and Adolescents: Regardless of the quantity of paracetamol reported or assumed to have been ingested, N-acetylcysteine should be administered immediately, if 24 hours or less have elapsed from the time of ingestion. An initial dose of 150 mg N-acetylcysteine/kg body weight is infused I.V. in 200 ml of 5% Dextrose Injection over 15 minutes. This is followed by I.V infusion of 50 mg N-acetylcysteine/kg body weight in 500 ml of 5% Dextrose Injection over the next 4 hours, and 100 mg N-acetylcysteine/kg body weight in 1 liter of 5% Dextrose Injection over the next 16 hours (providing a total dose of 300 mg/kg body weight of Nacetylcysteine over 20 hours). In addition to N-acetylcysteine administration, it is recommended that the stomach be emptied promptly by lavage, or by induction of emesis with syrup of ipecac. A serum paracetamol assay should be obtained as early as possible, but not less than 4 hours following ingestion. If plasma level falls above the lower treatment line on the paracetamol overdose nomogram, acetylcysteine therapy should be continued. Liver function tests should be performed initially, and repeated at 24-hour intervals.
Children: Induce emesis using syrup of ipecac. A serum paracetamol assay should be obtained as soon as possible, but not less than 4 hours following ingestion. If more than 150 mg/kg body weight or an unknown amount was ingested, plasma paracetamol level should be obtained. The plasma paracetamol level should be obtained as soon as possible, but no sooner than 4 hours following ingestion. If plasma level falls above the lower treatment line on the paracetamol overdose nomogram, the acetylcysteine therapy should be initiated and continued for a full course of therapy. If a paracetamol assay is not available and the paracetamol ingestion exceeds 150 mg/kg body weight, N-acetylcysteine therapy should be initiated and continued for a full course. The dosage and administration of N-acetylcysteine in children is the same as recommended for adults and adolescents. However, the quantity of I.V. fluid used in children should be modified, taking into account both age and weight.