Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, South Africa 0860 ADCOCK (232625)
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.
BLADURIL should be used with caution in patients with suspected glaucoma, especially narrow angle glaucoma and in patients with serious, uncontrolled, obstructive disorders of the lower urinary tract.
In the case of drowsiness, the time between the administration of the doses should be extended. See section 4.7 for effects on ability to drive and use machines.
BLADURIL contains lactose. Patients with the rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take BLADURIL.
No interaction studies have been performed.
There are no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility.
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 BLADURIL during pregnancy.
Safety in pregnancy has therefore not been established.
It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. BLADURIL should therefore not be used during breastfeeding.
BLADURIL may cause drowsiness, blurred vision or vertigo, patients should not drive or operate a motor vehicle or machinery. (see section 4.8).
No data are available.
System Organ Class
Frequency
Adverse Event
Less frequent: Eosinophilia, leukopenia
Less frequent: Angioedema
Frequency unknown: Hypersensitivity, anaphylactic reaction, anaphylactic shock
Frequency unknown: Confusional state
Less frequent: Drowsiness, dizziness, headache, mental confusion (especially in the elderly), nervousness, somnolence, vertigo
Less frequent: Blurred vision, disturbances in eye accommodation, increased ocular tension
Frequency unknown: Glaucoma
Less frequent: Palpitations, tachycardia
Frequent: Nausea
Less frequent: Diarrhoea, dry mouth, dyspepsia, dysphagia, and vomiting
Frequency unknown: Jaundice, liver disorder, hepatic enzyme abnormal
Less frequent: Urticaria, rash, pruritus, and other dermatoses
Frequency unknown: Erythema
Less frequent: Dysuria, urinary retention
Less frequent: Fatigue and hyperpyrexia
Reporting suspected adverse reactions after authorisation of BLADURIL is important. It allows continued monitoring of the benefit/risk balance of BLADURIL. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8.
Not applicable.
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