Posology : מינונים

4.2   Posology and method of administration
Posology
Swallow YENTREVE whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. ALL of these might affect the enteric coating. YENTREVE should not be administered through a gastric tube either because the pellets may obstruct the tube.

The recommended dose of YENTREVE is 40 mg twice daily without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy. Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.

However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.

The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo- controlled studies. The benefit of treatment should be re-assessed at regular intervals.

Combining YENTREVE with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT.

Hepatic impairment
YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).

Renal impairment:
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). YENTREVE must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).

Paediatric population

The safety and efficacy of duloxetine for the treatment of stress urinary incontinence has not been studied. No data are available.

Special populations

Elderly
Caution should be exercised when treating the elderly.
Discontinuation of treatment
Abrupt discontinuation should be avoided. When stopping treatment with YENTREVE the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Method of administration
For oral use.