PRONTADOL ADULT 16 DRY FILM TABLETS

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

Excipients: corn starch, pregelatinized corn starch, polyvidone, potassium sorbate, talc, stearic acid, croscarmellose sodium, hypromellose, triacetin.