Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
If intercurrent infection occurs, Profiten treatment must be supplemented by specific antimicrobial therapy.
Convulsions have been reported very rarely during Profiten therapy. As Profiten may lower the seizure threshold it should be used with caution in patients with a history of epilepsy.
Thrombocytopenia may occur in patients taking Profiten at the same time as oral antidiabetic drugs (biguanides). The simultaneous administration of these drugs should therefore be avoided (see section 4.3).
In case of reduced attention, possibly due to the sedating effect of Profiten, the dose should be reduced.

Excipients with known effect: Sucrose, sorbitol, sodium benzoate.

Each 5 ml of Profiten syrup contains about: o 3 grams of sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
o 410 mg of sorbitol.
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
o 19.1 mg of sodium benzoate.
This amount is equivalent to 0.95% of the WHO recommended maximum daily intake of 2 g sodium for an adult.Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Effects on Driving

4.7   Effects on ability to drive and use machines
During the first few days of treatment with Profiten reactions may be impaired. Patients should be warned not to take charge of vehicles or machinery until the effect of Profiten treatment on the individual is known.
Patients should be advised to avoid alcoholic drinks.