URISPAS Film-coated tablet Ref.[9722] Active ingredients: Flavoxate

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.

As the tablets contain lactose, its use is not recommended in patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose- galactose malabsorption.

No interaction studies have been performed.

Fertility

There are no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility.

Pregnancy

There are no or limited amount of data from the use of flavoxate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Urispas during pregnancy.

Lactation

It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. Urispas should not be used during breast-feeding.

Patients should be informed that if somnolence or blurred vision occur they should not drive or use machines.

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.

Immune system disorders

Not known: Hypersensitivity, anaphylactic reaction, anaphylactic shock

Psychiatric disorders

Not known: Confusional state

Nervous system disorders

Uncommon: Somnolence

Eye disorders

Uncommon: Visual impairment

Not known: Glaucoma

Cardiac disorders

Not known: Palpitations

Gastrointestinal disorders

Uncommon: Vomiting, dry mouth, dyspepsia

Common: Nausea

Hepatobiliary disorders

Not known: Jaundice, liver disorder, hepatic enzyme abnormal

Skin and subcutaneous tissue disorders

Uncommon: Rash

Rare: Urticaria, pruritus

Not known: Erythema

Renal and urinary disorders

Rare: Urinary retention

General disorders and administration site conditions

Rare: Fatigue

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

Not applicable.