Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Loxentia is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Loxentia is indicated in adults.
For further information see section 5.1.
The recommended dose of Loxentia 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.
A 20 mg capsule is also available. However, limited data are available to support the efficacy of Loxentia 20 mg twice daily.
The efficacy of Loxentia 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 Loxentia with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT.
Loxentia must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). Loxentia must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
The safety and efficacy of duloxetine for the treatment of stress urinary incontinence has not been studied. No data are available.
Caution should be exercised when treating the elderly.
Abrupt discontinuation should be avoided. When stopping treatment with Loxentia 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.
For oral use.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. A free airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption. Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
2 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Blisters (OPA/Alu/[HDPE/PE + DES of CaO/HDPE] foil – Alu/PE foil): 7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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