Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Date of authorisation: 20/08/2015, Revision: 12, Status: Authorised

Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being destroyed by the acid in the stomach. The medicine can only be obtained with a prescription.

For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day. A response is usually seen in two to four weeks. In patients who respond to Duloxetine Zentiva, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.

For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day. The response to treatment should be assessed regularly.

For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient’s response. Most patients will need to take 60 mg per day. Patients who also have major depression should start with 60 mg once a day. In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.

The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.