Description
Short-term symptomatic treatment of mild to moderate pain and/or fever. Paracetamol Zentiva Srl 500 mg is intended for adults, adolescents and children weighing more than 21 kg (aged 6 years and over). Paracetamol Zentiva Srl 1000 mg is intended for adults and adolescents weighing more than 60 kg (aged 15 years and over).
Active Ingredients
Paracetamol Zentiva Srl 500 mg tablets: each tablet contains 500 mg of paracetamol. Paracetamol Zentiva Srl. 1000 mg tablets: each tablet contains 1000 mg of paracetamol. For the full list of excipients, see section 6.1.
Excipients
Pregelatinized starch, Maize starch, Talc (E 553), Stearic acid (E 570), Povidone (E 1201), Potassium sorbate (E 202).
Dosage
Dosage The lowest effective dose should be used for the shortest possible duration. The maximum daily dose should not be exceeded. Paracetamol is dosed according to body weight and age, usually 10 - 15 mg/kg body weight as a single dose, up to a maximum daily dose of 60 mg/kg body weight. For dosage according to body weight and age see tables. Paracetamol Zentiva Srl500 mg tablets Paracetamol Zentiva Srl 500 mg tablets is not intended for children under 6 years of age with a body weight of less than 21 kg.
| Age | Body weight | Single dose | Maximum daily dose | Dosage range |
| 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 g | at least 4 - 6 hours |
| > 15 years | 34 ‒ 60 kg | 500 mg | 3 g | 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 Srl 1000 mg tablets Paracetamol Zentiva Srl 1000 mg tablets is not intended for children and adolescents under 15 years of age and weighing less than 60 kg.
| Age | Body weight | Single dose | Maximum daily dose | Dosage range |
| > 15 years | > 60 kg | 1000 mg | 3 g* | at least 4 - 6 hours |
* Only after consulting a doctor, the maximum daily dose in patients with body weight > 60 kg may be increased to 4 g paracetamol. Renal impairment Paracetamol should be used with caution in patients with renal impairment as a reduced dose and/or prolonged dosing interval is required (see section 4.4). The maximum single dose should not exceed 500 mg. - A dosing interval of 6 hours is recommended with a glomerular filtration rate of 50 ± 10 ml/min. - A dosing interval of 8 hours is recommended with a glomerular filtration rate of less than 10 ml/min. Hepatic impairment Paracetamol should be used with caution in patients with mild to moderate hepatic impairment or Gilbert's syndrome as the dose should be reduced or the dosing interval extended (see section 4.4). In these patients, the daily dose should not exceed 60 mg/kg (maximum 2 g/day). The use of this medicinal product is contraindicated in patients with severe hepatic impairment (see section 4.3). Elderly Experience has shown that the normal adult dosage of paracetamol is generally appropriate. However, in frail and immobile elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the quantity or frequency of administration may be appropriate (see section 4.4). Method of administration For oral use. The tablets should be swallowed with a sufficient amount of liquid.
Warnings
Patients should be advised not to use other paracetamol-containing medicinal products concomitantly. Cases of paracetamol-induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetamol at doses in the therapeutic range. These cases have been reported in patients with one or more risk factors for hepatotoxicity including low body weight (< 50 kg), renal and hepatic insufficiency, chronic alcoholism, concomitant hepatotoxic drugs and acute and chronic malnutrition (low hepatic glutathione reserves). Paracetamol should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, glutathione deficiency, chronic malnutrition, chronic alcoholism, dehydration, the elderly and in patients with mild to moderate hepatic insufficiency and/or renal impairment (see section 4.2). Regular monitoring of liver function tests is recommended in patients with impaired liver function and in those receiving high doses of paracetamol for a long time. The risk of severe hepatotoxic effects increases significantly with increasing dose and duration of treatment. Underlying liver disease increases the risk or liver damage related to paracetamol. The risk of overdose is greater in patients with non-cirrhotic liver damage caused by alcohol. Alcohol intake should be avoided during therapy. Long-term alcohol consumption significantly increases the risk of hepatotoxicity of paracetamol. Measurement of prothrombin time is necessary in concomitant therapy with oral anticoagulants and long-term regular daily intake of paracetamol. The possibility of renal failure cannot be excluded in long-term treatment. Caution is advised if paracetamol is co-administered with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Careful monitoring, including measurement of urinary 5-oxoproline, is recommended.
Conservation
This medicinal product does not require any special storage conditions.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Severe hepatic insufficiency. - Acute hepatitis.
Side effects
The administration of paracetamol may cause the following undesirable effects (classified into groups according to MedDRA terminology with indication of the incidence frequency as follows: very common (≥1/10); common (from: ≥1/100 to: <1/10); uncommon (from: ≥1/1,000 to: <1/100); rare (from: ≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
| MedDRA System Organ Classification | Frequency | Side effects |
| Pathologies of the haemolymphopoietic system | Very rare | Thrombocytopenia |
| Immune system disorders | Rare | Skin hypersensitivity reaction including rash and angioedema |
| Very rare | Anaphylaxis | |
| Respiratory, thoracic and mediastinal pathologies | Very rare | Bronchospasm* |
| Hepatobiliary pathologies | Very rare | Abnormal liver function |
| Skin and subcutaneous tissue disorders | Very rare | Cases of severe skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis |
* In patients sensitive to acetylsalicylic acid or other NSAIDs. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
