3501 outpatients with
fever due to respiratory disorders or eruptive diseases or to other causes were included in a post-marketing surveillance study aimed at extending knowledge of
antipyretics and particularly of the
paracetamol-
sobrerol combination. The
antipyretic activity of the
drug under test was comparable to that of the reference molecules.
Paracetamol-
sobrerol combination exerted an extremely valid therapeutic action on
cough and difficult expectoration, parameters which usually are associated with the phlogosis and congestion typical for airway
infections. As already observed in literature, patients receiving
salicylates complained of side effects while patients treated with pyrazolics complained of side effects involving nervous system and cardiovascular apparatus. Side effect incidence in patients treated with the
paracetamol-
sobrerol combination (3.7%) was significantly lower than that observed in subjects treated with
paracetamol (6.1% - P less than 0.01), salicylics (25.1% - P less than 0.001), pyrazolics (12.6% - P less than 0.001), propionics (20.3%, P less than 0.001) or other
antipyretics (17.9% - P less than 0.001). These findings demonstrate that the
paracetamol-
sobrerol combination is a valid therapeutic tool and is particularly suitable in febrile airway pathology. In addition, the low incidence of side effects due to the lower doses of
paracetamol, makes this product well tolerated also by at risk subjects such as children and old patients.