Butamirate

Concomitant administration of mucolytics should be avoided as it may lead to mucus retention in the respiratory system, which may increase the risk of bronchospasm and airway infection.

No specific studies have been conducted to assess safety of butamirate in pregnant women or during breast-feeding. Therefore butamirate should not be used in the first trimester of pregnancy. During the second and third trimesters of pregnancy, butamirate should be administered only if necessary to use medicines.

It is unknown whether butamirate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from butamirate therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

The medicinal product should be used with caution in drivers and individuals using machines, since the active substance may cause drowsiness in rare cases.

The adverse drug reactions are divided into groups according to MedDRA terminology together with their frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data):

Nervous system disorders

Rare: drowsiness

Gastrointestinal disorders

Rare: nausea, diarrhoea

Skin and subcutaneous tissue disorders

Rare: urticaria