BUTAMIRATE Syrup Ref.[9890] Active ingredients: Butamirate

Butamirate suppresses the cough reflex and therefore the concomitant use with expectorants should be avoided since it may lead to mucus retention in the airways, which increases the risk of bronchospasm and respiratory infections.

If the cough persists for more than 7 days (more than 3 days in children younger than 12 years of age) doctor or pharmacist must be consulted.

Due to the presence of sorbitol in the composition of this product, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect.

Concomitant use with expectorants should be avoided (see section 4.4).

Pregnancy

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.

Breastfeeding

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

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*.

Not applicable.