PARACETAMAGE DOC 20CPR 500MG

PARACETAM DOC GENERICI 500 MG COMPRESENT

active ingredients

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

Excellent

Pregelatinized corn starch, stearic acid, povidone.

Therapeutic indications

Generic PARACETAMOLO DOC 500 mg tablets is indicated for the symptomatic treatment of mild to moderate pain and fever.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • severe kidney failure. • alcohol abuse.

Population

Posology. For children it is essential to respect the defined dosage according to their body weight. Approximate ages according to body weight are indicated as information. Under three months, in case of jaundice, the single dose should be reduced by mouth. In adults the maximum oral posology is 3000 mg of paracetamol per day (see paragraph 4.9). The doctor must assess the need for treatments for over 3 consecutive days. The Posological scheme of PARACETAMOLO DOC Generic 500 mg tablets in relation to body weight: • Children weighing between 21 and 25 kg (approximately between 6 and 10 years): 1⁄2 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours. Mode of administration. Just for oral use. Intake of foods and drinks with paracetamol does not affect the effectiveness of the medicinal product. Special popularity. Hepatic or kidney failure: In patients with hepatic or kidney failure or Gilbert syndrome, the dose must be reduced or the time interval between administrations must be extended. Patients with kidney failure: In patients with severe kidney failure (clearance of creatinine Chronic Alcoholism: Chronic consumption of alcohol can lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses must be at least 8 hours. The dose of 2 g paracetamol should not be exceeded per day. Senior Patients: In the elderly, dose adjustment is not required. Renal insufficiency: In case of kidney failure the dose must be reduced:

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

Proven liver function: In patients with impaired liver function or Gilbert syndrome, the dose must be reduced or the interval between individual administrations must be extended. The effective daily dose should not exceed 60 mg/kg/die (up to a maximum of 3 g/die) in the following cases: • adults weighing less than 50 kg • mild to moderate liver failure, Gilbert syndrome (non-hemolytic hereditary) • dehydration • chronic malnutrition • chronic alcoholism.

Conservation

No special precaution for conservation.

Warnings

To avoid the risk of overdose, it is necessary to check that any other medications taken in conjunction do not contain paracetamol. Paracetamol must be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh >9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, severe haemolysis, chronic alcohol abuse

Interactions

The intake of probenecid inhibits the binding of the paracetamol to glucuronic acid, resulting in a reduction of the clearance of the paracetamol approximately twice. In patients taking probenecid at the same time, the dose of paracetamol should be reduced. Paracetamol metabolism has increased in patients taking medications that induce enzymes, such as rifampin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe hepatotoxicity unforeseen in patients taking enzyme-inducing medicines. Concurrent administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, the co-administration of this drug along with the AZT should only take place on medical advice. Concurrent intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates absorption and onset of paracetamol action. Concurrent intake of drugs that slow gastric emptying can delay absorption and onset of paracetamol action. Cholesteramine reduces the absorption of paracetamol and, therefore, cannot be administered before it is spent an hour from the administration of paracetamol Repeated intake of paracetamol for periods over a week increases the effect of anticoagulants, especially warfarina. Therefore, the administration of long-term paracetamol in patients treated with anticoagulants should only take place under the supervision of the doctor. The occasional intake of paracetamol has no significant effects on the tendency to bleeding. Effects on laboratory tests Paracetamol may interfere with the determinations of the urcemia that use phosphotungstic acid and glycemia that use the glucose-oxidase-peroxidase reaction. Propenenecid causes a reduction of almost twice of paracetamol clearance by inhibiting conjugation with glucuronic acid. A reduction of the paracetamol should be taken into consideration in case of treatment with probenecid. Paracetamol increases the plasma levels of acetylsalicylic acid and chloramphenicol.

Effects

The frequency is established according to the following convention: very common (≥ 1/10); common (from ≥ 1/100 to ≤1/10); not common (from ≥ 1/1.000 to ≥ 1/100); rare (from ≥ 1/10.000 to ≤1/1.000); very rare (≤1/10.000), including isolated cases; Note: Frequency cannot be defined on the basis of the available data. Within each frequency class, unwanted effects are reported in decreasing order of gravity.

Frequency	System	Synonyms
Raro >1/10.000 -	Emolinfopoietic system pathologies	Piastrinic alterations, stem cell pathologies, non-hemolytic anemia, midolla depression
	Immune system disorders	Allergies (excluding angioedema)
	Psychiatric disorders	Depression not otherwise specified, confusion, hallucinations
	Diseases of the nervous system	Tremor not otherwise specified, cephalea not otherwise specified
	Pathologies of the eye	Changed vision
	Heart disease	Edema
	Gastrointestinal diseases	Hemorrhage not otherwise specified, abdominal pain not otherwise specified, diarrhea not otherwise specified, nausea, vomiting, acute and chronic pancreatititis, esocrine pancreas disease
	Hepatobiliary diseases	Abnormal liver function, liver failure, liver necrosis, jaundice.
	Pathologies of skin and subcutaneous tissue	Prurito, skin rash, sweating, purple, angioedema, hives.
	Systemic pathologies and conditions for administration	Capogiro (excluding vertigo), malaise, pyrexia, sedation, pharmacological interaction not otherwise specified.
	Traumatism, poisoning and procedure complications	Overdosing and poisoning
Very rare (	Hepatobiliary diseases	Hepatotoxicity
	Systemic pathologies and conditions for administration	Reaction of hypersensitivity (which requires the interruption of treatment).
	Emolinfopoietic system pathologies	Trombocytopenia Leucopenia Neutropenia Hemolytic anemia
	Disorders of metabolism and nutrition	Hypoglycemia
	Kidney and urinary pathologies	Sterile feather (torbidden urine) and kidney side effects

Notable: some cases of epidermal necrolysis, Stevens-Johnson syndrome, multiform erythema, larynx edema, anaphylactic shock, bronchospasm*, anemia, alteration of liver and hepatitis function, alteration to the kidneys ( severe kidney failure, interstitial nephrite, hematuria, anuresis), gastrointestinal effects. * Paracetamol have been reported cases of bronchospasm, but these are more likely in asthmatic subjects sensitive to aspirin or other NSAIDs. Very rare cases of severe skin reactions have been reported. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the Italian Pharmaco Agency, Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is a risk of poisoning, especially in elderly people, in small children, in patients with hepatopathy, in case of chronic alcoholism and in patients with chronic malnutrition. Overdose can be fatal in these cases. Symptoms generally appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, i.e. the administration of 10 g paracetamol or more in a single dose in adults or the administration of 150 mg/kg body weight in a single dose in children, causes the necrosis of liver cells that can induce a complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy that can lead to coma and death. At the same time, the increase in the levels of hepatic transaminasis (AST, ALT), hydrogenase lactate and bilirubin, together with the increase in protrombine levels that may appear 12 to 48 hours after administration. Emergency procedure: Immediate recovery in hospital Blood samples withdrawal to determine the initial plasma concentration of paracetamol Gastric lavender EV (or oral if possible) of the N-acetylcystein antidote as soon as possible and before 10 hours have passed since overdosage Implement symptomatic treatment.

Pregnancy:

Epidemiological data derived from the use of oral therapeutic doses of paracetamol does not indicate any undesirable effect on pregnancy or health of the fetus or the newborn. Prospect data on overdose pregnancies did not show an increase in the risk of malformation. Reproductive studies with oral administration showed no malformation or fetotoxic effect. A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. Therefore, 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 and after performing a risk assessment and benefits. During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other drugs since safety of use in these cases is not established.

Nursing:

After oral intake, the paracetamol is excreted in breast milk in small quantities. No side effects were reported in breast-feededed babies. During breastfeeding, therapeutic doses of this medicine may be used.

Source: Farmadati