SPASMONAL Hard capsule Ref.[49655] Active ingredients: Alverine

Additional warnings to be included in the Patient Information Leaflet:

If this is the first time you have had these symptoms, consult your doctor before using any treatment.

If any of the following apply do not use SPASMONAL 60 mg; it may not be the right treatment for you. See your doctor as soon as possible if:

• you are aged 40 years or over
• you have passed blood from the bowel
• you are feeling sick or vomiting
• you have lost your appetite or lost weight
• you are looking pale and feeling tired
• you are suffering from severe constipation
• you have a fever
• you have recently travelled abroad
• you are or may be pregnant
• you have abnormal vaginal bleeding or discharge
• you have difficulty or pain passing urine.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

None stated.

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in Preclinical studies is limited.

May cause dizziness. Do not drive or use machinery if affected.

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 at: www.mhra.gov.uk/yellowcard.

Not applicable.