Paracetamol - analgesic medicament 20 tablets 500 mg

Product Description

Analgesic drug

Indications

Paracetamol doc generici 500 mg tablets is indicated for the symptomatic treatment of mild to moderate pain and fever.

Composition

Active ingredients

paracetamol 500 mg. For the full list of excipients, see section 6.1.

Excipients

Pregelatinized corn starch; stearic acid; povidone.

Directions for use and Dosage

For children, it is essential to respect the dosage defined based on their body weight. The approximate ages based on body weight are given for information purposes only. Under three months of age, in case of jaundice, it is advisable to reduce the single oral dose. In adults, the maximum oral dosage is 3000 mg of paracetamol per day (see section 4.9). The doctor must evaluate the need for treatment for more than 3 consecutive days. The dosage schedule of PARACETAMOLO DOC Generici 500 mg tablets in relation to body weight:

• Children weighing between 21 and 25 kg (approximately between 6 and 10 years): ½ 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 12 to 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, 2 500 mg tablets to be repeated if necessary after no less than 4 hours. 

Method of administration For oral use only. Taking food and drinks with paracetamol does not influence the efficacy of the medicine.

Special populationsHepatic or renal impairment. In patients with hepatic or renal impairment or Gilbert's syndrome, the dose should be reduced or the time interval between administrations should be prolonged.
Patients with renal impairment. In patients with severe renal impairment (creatinine clearance <10 ml/min.), an interval of at least 8 hours between administrations should be respected.
Chronic alcoholism. Chronic alcohol consumption can lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The dose of 2 g of paracetamol per day should not be exceeded.
Elderly patients
Dose adjustment is not required in the elderly.
Renal insufficiency: In case of renal insufficiency, the dose should be reduced:

Pregnancy and breastfeeding

Pregnancy Epidemiological data obtained on the use of oral therapeutic doses of paracetamol do not indicate any adverse effects on pregnancy or on the health of the fetus or newborn. Prospective data on pregnancies exposed to overdoses have not shown an increased risk of malformation. Reproductive studies with oral administration have not shown any malformation or fetotoxic effect. Consequently, under normal conditions of use, paracetamol can be used throughout pregnancy, after carrying out an assessment of the risks and benefits. During pregnancy, paracetamol should not be taken for long periods, at high doses, or in combination with other drugs, as its safety has not been established in these cases.

Breastfeeding: After oral administration, paracetamol is excreted in breast milk in small amounts. No adverse effects have been reported in breast-fed infants. Therapeutic doses of this medicine can be used during breastfeeding.

Format

20 tablets