Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
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)
The following undesirable effects were observed:
Immune system disorders:
Not known: anaphylaxis, allergic reaction
Nervous system disorders:
Not known: dizziness, headache
Respiratory, thoracic and mediastinal disorders
Not known: dyspnoea and/or wheezing
Gastrointestinal disorders:
Not known: nausea
Hepatobiliary disorders:
Not known: jaundice due to hepatitis (typically resolves on cessation of alverine), liver function test abnormal
Skin and subcutaneous tissue disorders:
Not known: rash, itching
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 Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.