Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Duloxetine hydrochloride (equivalent to base)
DKSH SINGAPORE PTE. LTD.
N06AX21
60.0 mg
CAPSULE
Duloxetine hydrochloride (equivalent to base) 60.0 mg
ORAL
Prescription Only
Lilly del Caribe, Inc. (PR01)
ACTIVE
2006-03-07
1 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 capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. The 30 mg capsule has an opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. The 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 generalised anxiety disorder. Treatment of diabetic peripheral neuropathic pain. Management of pain associated with fibromyalgia. Cymbalta is not indicated for use in children and adolescents below 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use, with or without food. Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. _Major Depressive Disorder_ The starting and recommended maintenance dose is 60 mg once daily. Dosages above 60 mg once daily, up to a maximum dose of 120 mg/day administered in evenly divided doses, 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 fro Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Cymbalta capsules 30mg Cymbalta capsules 60mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cymbalta 30mg Each capsule contains 30 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect_ Each capsule may contain up to 56 mg sucrose. Cymbalta 60mg Each capsule contains 60 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect_ Each capsule may contain up to 111 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Cymbalta 30mg Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. Cymbalta 60mg 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 generalised anxiety disorder. Treatment of diabetic peripheral neuropathic pain.Management of pain associated with fibromyalgia. Cymbalta is not indicated for use in children and adolescents below 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use, with or without food. Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. _Major depressive disorder_ The starting and recommended maintenance dose is 60 mg once daily. Dosages above 60 mg once daily, up to a maximum dose of 120 mg/day administered in evenly divided doses, 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 r Les hele dokumentet