Bladuril 200 mg Tablet
PDF Leaflet Revision Date: 10 May 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Antispasmodic action in urological disorders.
Dosage (summary)
Adults: 1 tablet three times a day.
Special Populations
- Renal impairment
- Elderly
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established; avoid use during breastfeeding.
Contraindications
- Hypersensitivity to flavoxate
- Pyloric obstruction
- Urinary retention
- Glaucoma
- Myasthenia gravis
Common side effects
- Drowsiness
- Dizziness
- Nausea
- Blurred vision
Counselling Points
- Take with plenty of fluids
- Avoid operating machinery if drowsy
- Report any unusual side effects
Serious warnings
- Caution in renal impairment
- May cause drowsiness affecting ability to drive
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
BLADURIL is indicated for its antispasmodic action in urological disorders.
4.2 Posology and method of administration
Posology
Adults - Take one tablet three times a day (600 mg flavoxate hydrochloride) for as long as required.
Paediatric population
The safety and efficacy of BLADURIL in children aged < 12 years have not been established (see section 4.3).
Method of administration
BLADURIL is for oral use.
4.3 Contraindications
- Hypersensitivity to flavoxate hydrochloride or to any of the excipients of BLADURIL (see section 6.1).
- Pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal haemorrhage and obstructive uropathies of the lower urinary tract.
- Safety in pregnancy and lactation has not been established (see section 4.6).
- BLADURIL is not recommended for use in children under 12 years of age.
- Urinary retention.
- Glaucoma.
- Myasthenia gravis.
4.4 Special warnings and precautions for use
- 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.
- Lactose
BLADURIL contains lactose. Patients with the rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take BLADURIL.
4.5 Interactions with other medicines and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Fertility
There is no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility.
Pregnancy
There is 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.
Breastfeeding
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.
4.7 Effects on ability to drive and use machines
BLADURIL may cause drowsiness, blurred vision or vertigo, thus patients should not drive or operate a motor vehicle or machinery, until they are reasonably certain that BLADURIL does not affect them adversely. (see section 4.8).
4.8 Undesirable effects
a. Summary of the safety profile
No data is available.
b. Tabulated summary of adverse reactions
| System Organ Class | Frequency | Adverse Event |
|---|---|---|
| Blood and lymphatic system disorders | Less frequent | Eosinophilia, leukopenia |
| Immune system disorders | Less frequent | Frequency unknown: Angioedema, Hypersensitivity, anaphylactic reaction, anaphylactic shock |
| Psychiatric disorders | Frequency unknown | Confusional state |
| Nervous system disorders | Less frequent | Drowsiness, dizziness, headache, mental confusion (especially in the elderly), nervousness, somnolence, vertigo |
| Eye disorders | Less frequent | Frequency unknown: Blurred vision, disturbances in eye accommodation, increased ocular tension, Glaucoma |
| Cardiac disorders | Less frequent | Palpitations, tachycardia |
| Gastrointestinal disorders | Frequent | Less frequent: Nausea, Diarrhoea, dry mouth, dyspepsia, dysphagia, and vomiting |
| Hepato-biliary disorders | Frequency unknown | Jaundice, liver disorder, hepatic enzyme abnormalities |
| Skin and subcutaneous tissue disorders | Less frequent | Frequency unknown: Urticaria, rash, pruritus, and other dermatoses, Erythema |
| Renal and urinary disorders | Less frequent | Dysuria, urinary retention |
| General disorders and administration site conditions | Less frequent | Fatigue and hyperpyrexia |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of BLADURIL is important. It allows continued monitoring of the benefit/risk balance of BLADURIL. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: http://www.sahpra.org.za/Publications/Index/8
4.9 Overdose
The most likely symptoms of overdose are blurred vision, dry mouth, drowsiness, and diarrhoea or constipation. Treatment of overdosage is symptomatic and supportive.
