APAP for children FORTE, 40 mg/ml, oral suspension, 85 ml

APAP for children FORTE is a drug belonging to the group of analgesics and antipyretics, which have an analgesic effect in case of mild to moderate pain and reduce fever.

APAP for children FORTE is a drug intended for short-term, symptomatic treatment of mild to moderate pain (headache, toothache, menstrual pain) and/or fever.APAP for children FORTE is a drug used to treat mild to moderate pain and/or fever in infants (older than 3 months), children, adolescents and adults (including the elderly).

If after 2 days of using the medicine there is no improvement or the patient feels worse, contact your doctor.

• The active substance of the drug is paracetamol.
• Other ingredients: citric acid monohydrate, sodium citrate, sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, purified water, orange flavour [natural flavours, artificial flavours, ethanol, butylhydroxyanisole (E 320)]

Always take this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Instructions for use:

• APAP for children FORTE is intended for oral use;
• Shake well before use;
• The bottle cap is child-proof. To open, press the cap and simultaneously turn clockwise;
• The oral suspension should not be diluted or mixed with other drinks;
• Do not exceed the recommended dose. Please note that higher doses than recommended may pose a risk of very serious liver damage.

The recommended daily dose of paracetamol is approximately 60 mg/kg body weight/day, which is divided into 4 to 6 doses during the day, i.e. 15 mg/kg body weight every 6 hours or 10 mg/kg body weight every 4 hours.

Dosage should be determined primarily based on the patient’s body weight. Information about the child’s age within each weight group is only indicative.

APAP for children FORTE must not be used in children under 3 months of age unless recommended by a doctor.

The exact amount of APAP for children FORTE should be administered using the 5 ml oral syringe (graded every 0.25 ml) included in the package. The oral syringe should be rinsed several times after use up to its outlet (filling it with water).

If you have a high fever (>39ºC), signs of infection, or symptoms that persist for more than 2 days, you must contact your doctor.

Patients with impaired liver or kidney function

In patients with mild to moderate hepatic impairment or patients with Gilbert’s syndrome (familial non-hemolytic jaundice), the effective daily dose should not exceed 60 mg/kg body weight/day (up to a maximum dose of 2 g/day). In patients with renal impairment, the dose must be reduced or
the intervals between subsequent doses must be extended. In patients with severe renal impairment, the intervals between subsequent doses of APAP for children FORTE must be at least 8 hours.

Please ask your doctor or pharmacist for advice.

In infants weighing less than 7 kg (6 months of age), the use of suppositories should be considered if available and the administration of this pharmaceutical form is not
prevented for clinical reasons (e.g. diarrhea).

In children weighing more than 41 kg (older than 12 years of age), adolescents and adults, other pharmaceutical forms of paracetamol may be considered as more appropriate.

Taking a higher dose than recommended for children APAP FORTE

In the event of an overdose, even if you feel well, you should seek immediate medical advice, as there is a risk of delayed, serious liver damage. Take the bottle or empty container with you to help identify the medicine. To avoid possible liver damage, it is important that a doctor gives you the antidote as soon as possible. Symptoms of liver damage do not usually become apparent for several days. Symptoms of overdose may include nausea, vomiting, anorexia (loss of appetite), paleness and abdominal pain, and these symptoms usually occur within 24 hours of taking the medicine.

If you miss a dose of APAP for children FORTE
Do not take a double dose to make up for a missed dose, but take your dose of APAP for children FORTE at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Do not use APAP for children FORTE if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of APAP for children FORTE.