Pedicetamol 100 mg/ml, oral solution for children and infants from birth, 60 ml

Pedicetamol 100 mg/ml is an oral solution intended for infants and children from birth up to 32 kg (approximately up to 10 years). It provides effective relief from fever lasting no longer than 3 days and mild to moderate pain. The active ingredient, paracetamol, has proven analgesic and antipyretic effects, making Pedicetamol a safe and convenient option for 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: macrogol 600, glycerol, raspberry flavour (propylene glycol, ethyl alcohol, benzyl alcohol), sodium saccharin, azorubine (carmoisine, E122), purified water

Dosage

• Calculate dose based on body weight: child’s weight (kg) × 0.15 = ml per dose
• Recommended daily dose: ~60 mg/kg body weight, divided into 4–6 doses per day
• Administer every 6 hours; if needed, may be given every 4 hours (10 mg/kg per dose)
• Total daily dose should not exceed 60 mg/kg body weight
• Use the provided oral syringe for accurate dosing

Pedicetamol can be diluted with water, milk, or fruit juices. If fever or pain persists beyond 3 days in children, or 5 days in adults (2 days for sore throat), consult your doctor.

Contraindications

• Hypersensitivity to paracetamol or excipients
• Acute liver failure, viral hepatitis
• Severe hemolytic anemia, asthma
• Hypersensitivity to acetylsalicylic acid

Warnings and Precautions

• Consult a doctor before use in children under 3 years
• Do not exceed the recommended dose
• Use with caution in kidney, liver, heart, or lung problems, anemia, low glucose-6-phosphate dehydrogenase levels
• Adjust dose in liver disease or in children weighing less than 50 kg with malnutrition, dehydration, or anorexia
• High fever (>39°C) requires medical consultation

Side Effects

Rare: general malaise, hypotension, elevated liver enzymes. Very rare: liver damage with high doses or long-term use, hypoglycemia, kidney effects, skin rash, hives, serious skin reactions, anaphylactic shock, changes in blood cell counts.

Interactions

Consult your doctor if taking antibiotics, anticoagulants, oral contraceptives, antiepileptics, antituberculosis drugs, barbiturates, activated charcoal, cholestyramine, gout medications, anticholinergics, metoclopramide, domperidone, propranolol, or zidovudine. Pedicetamol may affect laboratory tests.

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
• May trigger asthma in sensitive patients
• Contains a small amount of ethanol (<0.0012 ml per 1 ml)

Storage

Keep out of the sight and reach of children. Do not use after the expiry date. Once opened, use within 6 months. Store in the original packaging.

Package Contents

60 ml bottle of Pedicetamol oral solution with child-resistant closure and 5 ml oral syringe

Keywords

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