Fenspiride

Cases of cleft palate in fetuses were observed in the animal studies, in two species (rats and rabbits). There are currently no clinical data on the possibility of fenspiride foetotoxicity or fetal malformations when the medicine is administered during pregnancy. For this reason it is not recommended to use the medicine during pregnancy.

There are no data on the excretion of fenspiride into breast milk, however it is not recommended to use the medicine during breast-feeding.

Fenspiride may impair ability to drive, use machines and psychomotor performance, therefore patient should be informed about this when starting therapy.

Adverse reactions listed below are classified according to frequency and system organ class. Frequency categories are defined according to the following convention: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1000 to <1/100, Rare ≥1/10 000 to <1/1000, Very rare <1/10 000, Not known (frequency cannot be estimated from the available data).

Cardiac disorders

Rare: moderate tachycardia, reversible upon reduction of the dose.

Gastrointestinal disorders

Frequency not known: stomach and intestines dysfunction, nausea, upper abdominal pain.

Nervous system disorders

Rare: headache.

Frequency not known: somnolence.

Immune system disorders

Rare: rash, erythema, urticaria, Quincke’s edema, erythema perstans.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.