Pedicetamol 100 mg/ml, oral solution for children and infants from birth, 30 ml

Pedicetamol is an oral solution designed for children and infants from birth up to 32 kg (approximately up to 10 years of age). It provides effective relief from fever lasting no longer than 3 days and mild to moderate pain. Its active ingredient, paracetamol, has proven analgesic and antipyretic properties, making it safe and reliable for infants and children.

Indications

• Fever lasting no longer than 3 days
• Mild to moderate pain in infants and children up to 32 kg

Composition

• Active substance: paracetamol 100 mg per 1 ml of solution
• Excipients: β-macrogol 600, glycerol, raspberry flavour (propylene glycol, ethyl alcohol, benzyl alcohol), sodium saccharin, azorubine (carmoisine, E122), purified water

Dosage

• Recommended daily dose: approximately 60 mg/kg body weight, divided into 4–6 doses per day
• Every 6 hours: 15 mg/kg body weight; every 4 hours if needed: 10 mg/kg body weight
• Total daily dose should not exceed 80 mg/kg in children under 40 kg
• Children under 3 years: use drops (4 mg/drop) with the provided dropper
• Children from 3 years: use milliliters (ml) with the provided syringe

If fever or pain persists beyond 3 days in children, or 5 days in adults (2 days for sore throat), consult your doctor.

Contraindications

• Allergy to paracetamol or any excipients

Warnings and Precautions

• Consult a doctor before use in children under 3 years
• Use with caution in liver, kidney, heart, or lung problems, anemia, or enzyme deficiencies
• Adjust dose in liver disease or in children weighing less than 50 kg with malnutrition, dehydration, or anorexia
• Avoid alcohol consumption during treatment
• Stop treatment and consult a doctor if symptoms worsen or persist beyond recommended duration

Side Effects

Possible side effects include allergic reactions, skin rash, hives, anaphylactic shock, changes in blood cell counts, liver damage with high doses or long-term use, hypoglycemia, kidney effects, and rare serious skin reactions.

Interactions

Tell your doctor or pharmacist if taking antibiotics, anticoagulants, oral contraceptives, antiepileptic drugs, antituberculosis drugs, barbiturates, activated charcoal, cholestyramine, drugs for gout, anticholinergics, metoclopramide, domperidone, propranolol, or zidovudine. Pedicetamol may affect laboratory test results.

Pregnancy, Breastfeeding, and Fertility

Can be used during pregnancy and breastfeeding at the lowest effective dose for the shortest possible time. Consult a doctor if pain or fever persists.

Driving and Operating Machinery

No effects on the ability to drive or operate machinery have been reported.

Important Information

• Contains azorubine (E122), which may cause allergic reactions
• Contains a small amount of ethanol (<0.0012 ml per 1 ml)
• May trigger asthma in sensitive patients

Storage

Keep out of the sight and reach of children. Store in the original packaging.

Package Contents

30 ml bottle of Pedicetamol oral solution with dropper or syringe for accurate dosing

Keywords

Pedicetamol, children's paracetamol, oral solution, infant paracetamol, fever relief, pain relief, analgesic, antipyretic, raspberry flavor, 100 mg/ml, medicine for children