INDICATIONS
PRONTADOL ADULT is indicated for adults and children over 15 years of age for the symptomatic treatment of mild to moderate pain and/or febrile conditions.
FORMATS and DOSAGE FORMS
500 mg/50 mg film-coated tablets: Box of 16, in blister packs.
DOSAGE AND ADMINISTRATION
Dosage
Adults and children ≥ 50 kg
RESTRICTED TO ADULTS AND CHILDREN OVER 50 kg (from 15 years) due to the presence of caffeine.
The usual dosage is 1 to 2 tablets at 500 mg, to be renewed if necessary after a minimum of 4 hours.
It is generally not necessary to exceed 3 grams of paracetamol per day, i.e. 6 tablets.
However, in case of more intense pain, the maximum dosage can be increased up to 4 grams per day or 8 tablets per day.
Always respect an interval of 4 hours between doses.
Maximum recommended doses: see Warnings and Precautions for use.
Method of administration
Take by mouth.
Swallow the tablet without chewing with a large glass of water.
Frequency of administration
Systematic administration avoids oscillations in pain and/or fever.
In adults, they should be taken at least 4 hours apart.
Due to the presence of caffeine, avoid taking at the end of the day.
Renal insufficiency
In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the interval between two doses should be increased to at least 8 hours. The dose of paracetamol should not exceed 3 g per day, or 6 tablets.
The lowest effective daily dose should be considered, not to exceed 60 mg/kg/day (not to exceed 3 g/day) in the following situations
- adults weighing less than 50 kg,
- mild to moderate hepatocellular insufficiency,
- chronic alcoholism,
- chronic malnutrition,
- dehydration.
Duration of treatment
The duration of treatment is limited to 3 days in case of fever and 5 days in case of pain.
COMPOSITION
| |
per scored film-coated tablet |
| Paracetamol |
500 mg |
| Caffeine |
50 mg |
Excipients: corn starch, pregelatinized corn starch, polyvidone, potassium sorbate, talc, stearic acid, croscarmellose sodium, hypromellose, triacetin.
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