ZEN 30CPR 500MG

PARACETAM ZENTIVA SRL COMPRESENT

active ingredients

Paracetamol Zentiva S.r.l. 500 mg tablets: each tablet contains 500 mg of paracetamol. Paracetamol Zentiva S.r.l.. 1000 mg tablets: each tablet contains 1,000 mg of paracetamol. For the full list of excipients, see paragraph 6.1.

Excellent

Pregelatinized starch, Corn starch, Talco (E 553), Stearic Acid (E 570), Povidone (E 1201), Potassium Sorbate (E 202).

Therapeutic indications

Short-term symptom treatment of mild to moderate pain and/or fever. Paracetamol Zentiva S.r.l. 500 mg is intended for adults, adolescents and children weighing more than 21 kg (aged or older than 6 years). Paracetamol Zentiva S.r.l. 1000 mg is intended for adults and adolescents weighing more than 60 kg (aged or older than 15 years).

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Severe liver failure. - Acute hepatitis.

Population

Population The lowest effective dose should be used for as little time as possible. The maximum daily dose should not be exceeded. Paracetamol is dosed according to body weight and age, usually 10 - 15 mg/kg body weight in single dose, up to a maximum daily dose of 60 mg/kg body weight. For dosage based on body weight and age see tables. Paracetamol Zentiva S.r.l.500 mg tablets Paracetamol Zentiva S.r.l. 500 mg tablets is not intended for children under 6 years of age with body weight less than 21 kg.

Age	Body weight	Single dose	Maximum daily dose	Posological interval
6 - 8 years	21 - 24 kg	250 mg	1,25 g	at least 4 - 6 hours
9 - 10 years	25 - 32 kg	250 mg	1.5 g
10 - 12 years	> 33 kg	500 mg	2 g
12 - 15 years	34 – 60 kg	500 mg	3	at least 4 - 6 hours
> 15 years	34 – 60 kg	500 mg	3	at least 4 - 6 hours
	> 60 kg	500 - 1000 mg	3 g

* Only after consulting a doctor, the maximum daily dose in patients with body weight > 60 kg can be increased to 4 g of paracetamol. Paracetamol Zentiva S.r.l. 1000 mg tablets Paracetamol Zentiva S.r.l. 1000 mg tablets is not intended for children and adolescents under the age of 15 and weighing less than 60 kg.

Age	Body weight	Single dose	Maximum daily dose	Posological interval
> 15 years	> 60 kg	1000 mg mg	3 g	at least 4 - 6 hours

* Only after consulting a doctor, the maximum daily dose in patients with body weight > 60 kg can be increased to 4 g of paracetamol. Renal insufficiency Paracetamol should be used with caution in patients with kidney failure because a reduced dose is required and/or a prolonged interval of administration (see paragraph 4.4). The maximum single dose should not exceed 500 mg. - It is recommended a 6-hour posological interval with a glomerular filtration speed of 50 ± 10 ml/min. - An 8-hour posological interval with a glomerular filtration speed of less than 10 ml/min is recommended. Epathetic insufficiency Paracetamol should be used with caution in patients with mild to moderate liver failure or Gilbert syndrome since the dose should be reduced or the interval between administrations should be extended (see paragraph 4.4). In these patients, the daily dose should not exceed 60 mg/kg (maximum 2 g/day). The use of this medicine is contraindicated in patients with severe liver failure (see paragraph 4.3). Seniors The experience indicated that the normal dose of paracetamol for adults is generally appropriate. However, in elderly persons fragile and still or in elderly patients with kidney or liver failure, a reduction in the amount or frequency of administration may be appropriate (see paragraph 4.4). Method of administration For oral use. Tablets should be swallowed with a sufficient amount of liquid.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Patients should be advised not to use other medications containing paracetamol at the same time. Cases of hepatotoxicity induced by paracetamol, including fatal cases, were reported in patients taking paracetamol at doses included in the therapeutic interval. These cases have been reported in patients with one or more risk factors for hepatotoxicity included low body weight (

Interactions

Paracetamol absorption speed can be increased by metoclopramide or domperidone. However, it is not necessary to avoid concomitant use. Colestramine reduces the absorption of paracetamol. Paracetamol should be administered at least 1 hour before or 4-6 hours after cholesteramine. Long-term co-administration with acetylsalicylic acid or other NSAIDs can cause kidney damage. The anticoagulant effect of warfarin or other cumarinic products can be increased along with an increase in the risk of bleeding with regular daily long-term intake of paracetamol. Occasional use has no significant effects. Hepatotoxic substances can increase the potential accumulation and overdose of paracetamol. Paracetamol may affect pharmacokinetics of chloramphenicol. Therefore, an analysis of chloramphenicol in plasma is recommended in case of combined treatment with chloramphenicol by injection. The probenecid reduces the clearance of the paracetamol by almost 50%. Therefore, the dose of paracetamol can be halved during the concomitant treatment. Inductors of microsomal enzymes (e.g. rifamp, phenobarbital, phenytoin, carbamazepine, St. John's herb) reduce the bioavailability of paracetamol through an increase in glucuronidation and the risk of liver toxicity increases. Such combinations should be avoided. Concurrent use of paracetamol and zidovudine can lead to increased neutropenia risk. Concurrent use of paracetamol and isoniazide can lead to increased risk of hepatotoxicity. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).

Effects

Paracetamol administration can cause the following side effects (classified in groups according to MedDRA terminology with frequency indication as follows: very common (≥1/10); common (from: ≥1/100 to: MedDRA Classification for systems and organs Frequency Undesirable effects Emolinfopoietic system pathologies Very rare Trombocytopenia Immune system disorders Rare Reaction of skin hypersensitivity incl. rash and angioedema Very rare Anafilas Respiratory, chest and mediastinic pathologies Very rare Broncospasm Hepatobiliary diseases Very rare Abnormal liver function Pathologies of skin and subcutaneous tissue Very rare Cases of severe skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), generalized acute exantematic pustolosis * In patients with acetylsalicylic acid or other NSAIDs. 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 workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of paracetamol overdose, immediate medical care is required, even if there are no overdose symptoms. Synonyms Overdose with relatively low doses of paracetamol can cause severe damage to the liver and sometimes acute renal necrosis. Nausea, vomiting, lethargy, anorexia, pallor and sweating may occur within 24 hours or patients may be asymptomatic. Abdominal pain can be the first symptom of liver damage and manifests within 1 to 2 days. Overdose of paracetamol can cause 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, there is an increase in hepatic transaminasis levels (AST, ALT), dihydrogenase lactate and bilirubin along with prolonged protrombine time that may appear from 12 to 48 hours after administration. Prolongation of protrombine time is one of the indicators of compromised liver function and therefore recommends monitoring. Complications of liver failure include brain edema, bleeding, hypoglycemia, hypotension, infections and kidney failure. Epathetic damage is possible in patients who have taken a higher amount of paracetamol than recommended. It is believed that excessive amounts of toxic metabolite are irreversibly linked to liver tissue. Some patients may be more at risk of liver damage due to paracetamol toxicity. Risk factors include: - Patients with liver disease. - Old people. - Small children. - Patients in long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampin, St. John's herb or other drugs that induce liver enzymes. - Patients who regularly consume excess alcohol compared to recommended quantities. - Patients with glutathione depletion, e.g. food disorders, cystic fibrosis, HIV infection, inedia, cachesia. Acute kidney failure can occur without severe liver failure. Other manifestations of intoxication are myocardial damage, heart arrhythmias and pancreatitis. Management Restoration is required. The blood sampling must be performed to determine the initial plasma concentration of paracetamol. In case of a single acute overdose, the plasma concentration of paracetamol must be measured 4 hours after ingestion. Induction of vomiting, gastric lavender, especially if the paracetamol has been ingested less than 4 hours before, then administration of methionine (2.5 g by mouth) must be prepared, also support measures are appropriate. The administration of activated carbon to reduce gastrointestinal absorption is controversial. The N-acetylcysteine specific antidote should be administered as soon as possible, within 8 ± 15 hours of poisoning, but beneficial effects were observed also with the subsequent administration of acetylcysteine. Acetylcysteine should be administered in accordance with national therapeutic guidelines, it is usually administered to adults, adolescents and children EV in glucosate solution at 5%, the initial dose must be 150 mg/kg body weight within 15 minutes. Moreover, 50 mg/kg in infusion of glucosate solution at 5% for a period of 4 hours, and then 100 mg/kg up to 16^a rev. 20^a now from the beginning of therapy. Acetylcysteine can also be administered orally within 10 hours of ingestion of a toxic dose of paracetamol at the dose of 70 − 140 mg/kg 3 times a day. Hemodialysis or hemoperfusion is in place in case of very serious intoxication. A symptomatic treatment must be implemented.

Pregnancy

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 the womb show unconclusive 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.

Food

Paracetamol passes into breast milk but is unlikely to affect the child at therapeutic doses. It is not necessary to stop breastfeeding during short-term treatment with the recommended doses of this medicine.

Fertility

Clinical data is not available.

Source: Farmadati