SINECOD Syrup Ref.[51127] Active ingredients: Butamirate

Because butamirate inhibits the cough reflex simultaneous administration of expectorants should be avoided, because it may lead to the stagnation of mucus in the respiratory tract, which can increase the risk of bronchospasm and airway infection.

You should talk to your doctor if the cough persists for more than 7 days.

Information concerning excipients

Sorbitol (E420): Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Ethanol: This medicinal product contains small amounts of ethanol (11.73 mg/5ml), less than 100 mg per dose.

Simultaneous administration of expectorants should be avoided (see 4.4. Special warnings and precautions for use).

Use during pregnancy

Reproductive studies in animals have shown no risk for the foetus. However, as there are no sufficient studies in pregnant women, the use of SINECOD should be avoided during the first trimester of pregnancy. For the following months of pregnancy, Sinecod should be used according to the doctor’s judgement and instructions.

Use during breast-feeding

Because there is insufficient information on the excretion of butamirate in human milk, for safety reasons SINECOD should be used during breast-feeding only after a careful evaluation of benefits compared with the potential risk.

SINECOD may cause drowsiness in rare cases. It may have a minor influence on the ability to drive and use machines. Therefore it must be taken into account when driving or performing other tasks requiring alertness (e.g. operating machines).

Nervous system disorders

Rare (>1/10,000, <1/1000): drowsiness

Gastrointestinal disorders

Rare (>1/10,000, <1/1000): nausea, diarrhoea

Skin and subcutaneous tissue disorders

Rare: (>1/10,000, <1/1000): 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: http://www.medicinesauthority.gov.mt/adrportal.

Not applicable.