Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
duloxetine (duloxetine hydrochloride)
Lilly S.A.
N06AX21
duloxetine (duloxetine hydrochloride)
60mg
capsules gastro-resistant
(7/1x7/) in blister, (14/2x7/) in blister, (14/1x14/) in blister, (28/4x7/) in blister, (28/2x14/) in blister
Prescription
Registered
2019-06-28
EUSPC 09JULY2015 CYMBALTA* 30 AND 60 MG HARD GASTRO-RESISTANT CAPSULES 1. NAME OF THE MEDICINAL PRODUCT CYMBALTA 30 mg hard gastro-resistant capsules CYMBALTA 60 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 30 mg capsule contains 30 mg of duloxetine (as hydrochloride). Each 60 mg capsule contains 60 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each 30 mg capsule may contain up to 56 mg sucrose. Each 60 mg capsule may contain up to 111 mg sucrose For the full list of excipients, see section 6.1. Not all strengths may be marketed. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. The CYMBALTA 30 mg capsule has an opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. The CYMBALTA 60 mg capsule has an opaque green body, imprinted with ‘60 mg’ and an opaque blue cap, imprinted with ‘9542’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. CYMBALTA 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. 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 reco Les hele dokumentet
_ _ _Page 1 of 19 _ SUMMARY OF PRODUCT CHARACTERISTICS EUSPC09JUL2015 _ _ _Page 2 of 19 _ 1. NAME OF THE MEDICINAL PRODUCT CYMBALTA 30 mg hard gastro-resistant capsules CYMBALTA 60 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 30 mg capsule contains 30 mg of duloxetine (as hydrochloride). Each 60 mg capsule contains 60 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each 30 mg capsule may contain up to 56 mg sucrose. Each 60 mg capsule may contain up to111 mg sucrose For the full list of excipients, see section 6.1. Not all strengths may be marketed. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. The CYMBALTA 30 mg capsule has an opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. The CYMBALTA 60 mg capsule has an opaque green body, imprinted with ‘60 mg’ and an opaque blue cap, imprinted with ‘9542’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. CYMBALTA 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. 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. _ _ _Page 3 of 19 _ _ Les hele dokumentet