“Composition
Active ingredients: paracetamol 500 mg.
Excipients: pregelatinized corn starch; stearic acid; povidone.
Directions
Paracetamol doc generici 500 mg tablets are indicated for the symptomatic treatment of mild to moderate pain and fever.
Method of administration and dosage
For children, it is important to adhere to the dosage determined based on body weight. The approximate age calculated based on body weight is provided for information purposes only. In case of jaundice under three months, it is recommended to reduce the single oral dose. For adults, the maximum oral dose is 3000 mg paracetamol per day (see section 4.9). The doctor should assess the need for treatment for more than 3 consecutive days. Dosage regimen for PARACETAMOLO DOC Generici 500 mg tablets depending on body weight:
• Children weighing 21 to 25 kg (approximately 6 to 10 years): ½ tablet at a time, repeat if necessary after 4 hours, but not more than 6 doses per day (3 tablets). • Children weighing 26 to 40 kg (approximately 8 to 13 years): 1 tablet at a time, repeat if necessary after 6 hours, but not more than 4 doses per day.
• Children weighing 41 to 50 kg (approximately 12 to 15 years): 1 tablet at a time, repeat if necessary after 4 hours, but not more than 6 doses per day.
• Children weighing over 50 kg (approximately over 15 years): 1 tablet at a time, repeat if necessary after 4 hours, but not more than 6 doses per day.
• Adults: 1 tablet at a time, repeat after 4 hours if necessary, not exceeding 6 doses per day. In case of severe pain or high temperature – 2 tablets of 500 mg, repeat at least after 4 hours if necessary.
Method of administration: For oral use only. The effectiveness of the drug is not affected by food or drinks with paracetamol.
Pregnancy and breastfeeding
Pregnancy Epidemiological data on the use of oral therapeutic doses of paracetamol do not indicate any adverse effects on pregnancy or the health of the fetus or newborn. Prospective data on pregnancies exposed to overdoses did not reveal an increased risk of malformations. Reproductive function studies with oral administration did not reveal any malformations or fetotoxic effects. Therefore, under normal conditions of use, paracetamol can be used throughout pregnancy after an assessment of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for a long time, in high doses or in combination with other drugs, as its safety in these cases has not been established.
Breastfeeding After oral administration, paracetamol is excreted in small amounts in breast milk. No side effects have been reported in breastfed children. Therapeutic doses of this drug can be used during breastfeeding.”
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