Indications
Apap Junior is used for the symptomatic treatment of mild to moderate pain and fever.
Active substance: Paracetamol
Composition
One sachet contains 250 mg of paracetamol.
Excipients:
Contains sorbitol (E 420) 600 mg/sachet.
Contains sucrose 0.1 mg/sachet.
Dosage
Doses depend on age and body weight; a single dose is 10 to 15 mg/kg body weight and the total daily dose is 60-75 mg/kg body weight.
The interval between doses depends on symptoms and the maximum daily dose. However, it should not be shorter than 4 hours.
Do not use Apap Junior for more than three days without consulting a doctor.
Body weight (age) | Single dose | Maximum daily dose |
17kg-25kg
(4-8 years) |
250 mg paracetamol
(1 sachet) |
1000 mg paracetamol
(4 sachets) |
26kg-40kg
(8-12 years old) |
500 mg paracetamol
(2 sachets) |
1500 mg paracetamol
(6 sachets) |
Method of administration
For oral use only. The granules should be taken directly into the mouth (on the tongue) and swallowed without water.
Do not take Apap Junior after a meal.
Special patient groups
Liver or kidney dysfunction
In patients with hepatic or renal impairment or Gilbert’s syndrome, the dose should be reduced or the intervals between doses should be extended.
Patients with renal impairment
In patients with severe renal impairment (creatinine clearance < 10 ml/min) an interval of at least 8 hours must be maintained between doses.
Chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The dose of paracetamol should not exceed 2 g per day.
Elderly patients
No dose adjustment is required in elderly patients.
For all indications:
Adults, the elderly and children over 12 years of age: the usual dose is 500-1000 mg every 4 to 6 hours to a maximum of 3 g daily.
There should be at least a 4-hour interval between individual doses.
Renal failure
In case of renal failure the dose should be reduced:
Glomerular filtration rate | Dose |
10 – 50 ml/min | 500 mg every 6 hours |
< 10 ml/min | 500 mg every 8 hours |
An effective daily dose not exceeding 60 mg/kg/day (not exceeding 3 g/day) should be considered in the following situations:
– Adult patients weighing less than 50 kg
– Liver failure (mild to moderate)
– Chronic alcoholism
– Dehydration
– Chronic malnutrition
– Liver or kidney dysfunction
In patients with hepatic or renal impairment or Gilbert’s syndrome, the dose should be reduced or the dose interval extended.
Paracetamol granules in sachets are not recommended for children under 4 years of age; children aged 4-8 years can be given 250 mg every 4-6 hours up to a maximum of 4 doses in 24 hours. Children aged 8-12 years can be given 500 mg every 4-6 hours up to a maximum of 1500 mg in 24 hours.
Contraindications
Hypersensitivity to paracetamol or any of the excipients. Severe hepatic impairment (Child-Pugh score > 9).
Contents: PETP/Aluminium/LDPE foil sachets with white or almost white granulate. Apap Junior is available in a package containing 10 sachets in a cardboard box.
Storage method: below 30°C
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