URISPAS

Posology Adults (elderly included) The recommended adult dosage is one tablet three times a day for as long as required. Pediatric population The safety and efficacy of Urispas in children aged <12 years have not yet been established.

Method of administration Oral administration. The tablets should be taken after a meal in order to prevent nausea.

The source of the below ADRs frequencies is represented by data collected through clinical trials, observational studies, and spontaneous reporting. In the table below, adverse reactions are reported and listed by MedDRA system organ class and 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 available data).

Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness. System Organ Class Frequency Preferred Terms Immune system disorders Not known Hypersensitivity, anaphylactic reaction, anaphylactic shock* Psychiatric disorders Not known Confusional state* Nervous system disorders Uncommon Somnolence Eye disorders Uncommon Not known Visual impairment Glaucoma* Cardiac disorders Not known Palpitations Gastrointestinal disorders Uncommon Common Vomiting, dry mouth, dyspepsia Nausea Hepatobiliary disorders Not known Jaundice, liver disorder, hepatic enzyme abnormal* Skin and subcutaneous tissue disorders Uncommon Rare Not known Rash Urticaria, pruritus Erythema* Renal and urinary disorders Rare Urinary retention General disorders and administration site conditions Rare Fatigue *Adverse reactions from spontaneous reporting in the worldwide post-marketing experience.

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. gov/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The use in children below the age of <12 years is not recommended. Since the renal clearance of the active metabolite accounts more than 50% of the dose, renal impairment may significantly affect the product kinetics. Caution is therefore required in patients with renal impairment.

Urispas contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Urispas contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1; - Gastrointestinal obstructive conditions or ileus - Gastro-intestinal haemorrhage - Achalasia - Urinary retention - Glaucoma - Myasthenia gravis