Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

TOVIAZ should be used with caution in patients with:
-       Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) -       Gastrointestinal obstructive disorders (e.g. pyloric stenosis) -       Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis
-       Decreased gastrointestinal motility
-     Autonomic neuropathy
-     Controlled narrow-angle glaucoma

Caution should be exercised when prescribing or uptitrating fesoterodine to patients in whom an increased exposure to the active metabolite (see section 5.1) is expected:

-     Hepatic impairment (see sections 4.2, 4.3 and 5.2)
-     Renal impairment (see sections 4.2, 4.3 and 5.2)
-     Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and 4.5) -     Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).

Dose increases
In patients with a combination of these factors, additional exposure increases are expected. Dose dependent antimuscarinic adverse reactions are likely to occur. In populations where the dose may be increased to 8 mg once daily, the dose increase should be preceded by an evaluation of the individual response and tolerability.

Organic causes must be excluded before any treatment with antimuscarinics is considered. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.

Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed before treatment with fesoterodine. If urinary tract infection is present, an appropriate medical approach should be taken/antibacterial therapy should be started.

Angioedema
Angioedema has been reported with fesoterodine and has occurred after the first dose in some cases. Some cases may be associated with upper airway swelling and may be life-threatening. If angioedema occurs, fesoterodine should be discontinued and appropriate therapy should be promptly provided.

Potent CYP3A4 inducers
The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John’s Wort) is not recommended (see section 4.5).

QT prolongation
TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre- existing cardiac diseases (e.g. myocardial ischaemia, arrhythmia, congestive heart failure), (see section 4.8).
This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).

Lactose
TOVIAZ prolonged-release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines

TOVIAZ has minor influence on the ability to drive and use machines.

Caution should be exercised when driving or using machines due to possible occurrence of side effects such as blurred vision, dizziness, and somnolence (see section 4.8).