Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 67.3 mg (Equivalent: duloxetine, Qty 60 mg)
Eli Lilly Australia Pty Ltd
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: hypromellose; triethyl citrate; indigo carmine; purified talc; sodium lauryl sulfate; Gelatin; iron oxide yellow; sucrose; hypromellose acetate succinate; titanium dioxide; propylene glycol; ethanol; isopropyl alcohol; Shellac; povidone; tert-butyl alcohol; sodium hydroxide; maize starch
Oral
7 capsules, 28 capsules
(S4) Prescription Only Medicine
CYMBALTA is indicated for the treatment of major depressive disorder (MDD).,Treatment of Diabetic Peripheral Neuropathic Pain (DPNP). Treatment of Generalised Anxiety Disorder.
Visual Identification: Opaque green body and opaque blue cap imprinted with "9542" and "60 mg" using white ink; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-03-14
CYMBALTA ® _Duloxetine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYMBALTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about CYMBALTA and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CYMBALTA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CYMBALTA IS USED FOR CYMBALTA is used to treat major depressive disorder (depression), Diabetic Peripheral Neuropathic Pain (nerve pain caused by diabetes) and Generalised Anxiety Disorder (excessive worry) CYMBALTA belongs to a group of medicines called Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs). SNRIs are believed to work by their action on serotonin and noradrenaline in the brain. Serotonin and noradrenaline are the chemical messengers responsible for controlling the psychological and painful physical symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR ANOTHER REASON. This medicine is available only with a doctor's prescription. CYMBALTA is not recommended for use in children and adolescents under the age of 18 years. BEFORE YOU TAKE CYMBALTA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CYMBALTA IF YOU HAVE AN ALLERGY TO: • any medicine containing duloxetine hydrochloride; • any of the ingredients Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION vA12.0_Oct20 SUPERSEDES: vA11.0_Jul19 Page 1 of 28 CYMBALTA (DULOXETINE) TABLETS 1. NAME OF THE MEDICINE CYMBALTA ® (duloxetine hydrochloride). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Duloxetine is available as capsules for oral administration. Each capsule contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include indigo carmine CI73015, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres NF 30/35, purified talc, titanium dioxide CI77891, Chroma-Tone DDB8257-W 609421 and triethyl citrate. The 30mg capsules also contain TekPrint SB-4028 Green Ink (ARTG No. 107268). The 60 mg capsules also contain iron oxide yellow CI77492 and TekPrint SB-0007P White Ink (ARTG No. 2216). 3. PHARMACEUTICAL FORM The 30 mg capsule has an opaque white body and opaque blue cap imprinted with “9543” and “30 mg” using green ink. The 60 mg capsule has an opaque green body and opaque blue cap imprinted with “9542” and “60 mg” using white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CYMBALTA is indicated for the treatment of major depressive disorder (MDD). CYMBALTA is indicated for the treatment of diabetic peripheral neuropathic pain (DPNP). CYMBALTA is indicated for the treatment of generalised anxiety disorder (GAD). 4.2 DOSE AND METHOD OF ADMINISTRATION MAJOR DEPRESSIVE DISORDER CYMBALTA should be administered for the treatment of major depressive disorder at a dose of 60 mg once daily, with or without food. There is no adequate evidence suggesting that patients not responding to 60 mg once daily will benefit from having their dose increased. vA12.0_Oct20 SUPERSEDES: vA11.0_Jul19 Page 2 of 28 DIABETIC PERIPHERAL NEUROPATHIC PAIN The starting and maintenance dose of CYMBALTA in diabetic peripheral neuropathic pain is 60 mg once daily. As the progression of diab Đọc toàn bộ tài liệu