Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Vesoxx should be used with caution in elderly (over 65 years) patients, who may be moresensitive to the effects of centrally acting anticholinergics.

Psychiatric and central nervous system (CNS) anticholinergic events like sleep disorders (e.g.
insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients. Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicines (see also section 4.5). If a patient experiences such events, drug discontinuation should be considered.

Sublingual nitrates may fail to dissolve under the tongue owing to dry mouth, resulting in reduced therapeutic effect (see section 4.5).

The use/administration of oxybutynin products may warrant the following cautionary statements: 
Gastrointestinal disorders
Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
They should also be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux.

Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy or cognitive impairment and in patients with liver or kidney diseases (see section 4.2).

Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.

Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy.
Since oxybutynin may trigger narrow-angle glaucoma the patient should be instructed to immediately contact a physician if they are aware of a sudden loss of visual acuity or ocular pain. Visual acuity and intraocular pressure should be followed during treatment occasionally.

Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.

The risk for anticholinergic adverse events is clearly lower with intravesical use compared to oral administration. This is probably due to oxybutynin being absorbed over a longer period with a delayed peak serum level and a lower degree of metabolism to the active metabolite N-desethyloxybutynin which is the main cause of these side effects.

Paediatric population
In children Vesoxx should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

In children on long term treatment with intravesical oxybutynin an increased frequency of asymptomatic bacteriuria and lower urinary tract infections have been observed. At urinary tract infections during oxybutynin treatment appropriate antibacterial treatment shall be initiated.

This medicinal product contains 3.56 mg sodium per ml, equivalent to 0.18% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Effects on Driving

4.7   Effects on ability to drive and use machines
Because Vesoxx may produce somnolence, or accommodation disorders, patients should be advised to exercise caution when driving or using machinery.