Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
duloxetinhydroklorid
Teva B.V.
N06AX21
duloxetine hydrochloride
30 mg
Enterokapsel, hård
sockersfärer Hjälpämne; duloxetinhydroklorid 33,7 mg Aktiv substans; propylenglykol Hjälpämne
Receptbelagt
Förpacknings: Burk, 100 kapslar; Blister, 7 kapslar; Blister, 100 kapslar; Blister, 98 kapslar; Blister, 56 kapslar; Blister, 30 kapslar; Blister, 28 kapslar; Blister, 14 kapslar
Godkänd
2019-10-18
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT {Product name} 30 mg hard gastro-resistant capsules {Product name} 60 mg hard gastro-resistant capsules [Product name in RMS: Duloxetin Teva B.V.] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine. Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine. Excipient with known effect Each 30 mg capsule contains 101 mg sucrose. Excipient with known effect Each 60 mg capsule contains 201 mg sucrose. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule Opaque grey body imprinted with ‘DLX 30’ and an opaque blue cap imprinted with ‘DLX 30’, length 18 mm. Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap imprinted with ‘DLX 60’, length 20 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. {Product name} is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Major depressive disorder The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 weeks of treatment. 2 After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse. In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. Generalised anxiety disorder The recommended starting dose in patients with generalised anxiety disorder is Läs hela dokumentet