国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 67.32 mg (Equivalent: duloxetine, Qty 60 mg)
Strides Pharma Science Pty Ltd
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: crospovidone; titanium dioxide; hyprolose; hypromellose phthalate; triethyl citrate; hypromellose; purified talc; maize starch; sucrose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; indigo carmine; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
100
(S4) Prescription Only Medicine
Duloxetine is indicated for the treatment of major depressive disorder (MDD).,Duloxetine is indicated for the treatment of generalised anxiety disorder (GAD).
Visual Identification: Blue opaque/Green opaque, size 1 hard capsule filled with white to off-white pellets and imprinted with X on cap & 03 on body with black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-07-01
DEPRETA CONSUMER MEDICINE INFORMATION Ver 1.3 Page 1 of 5 DEPRETA 30 & DEPRETA 60 Duloxetine as hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEPRETA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking DEPRETA 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 DEPRETA USED FOR DEPRETA is used to treat major depressive disorder (depression) and Generalised Anxiety Disorder (excessive worry) DEPRETA 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. DEPRETA is not recommended for use in children and adolescents under the age of 18 years. BEFORE YOU TAKE DEPRETA WHEN YOU MUST NOT TAKE IT DO NOT TAKE DEPRETA IF YOU HAVE AN ALLERGY TO: • any medicine containing duloxetine hydrochloride; • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE DEPRETA IF YOU HAVE LIVER DISEASE. This could increase the chance of you having liver problems during treatment with DEPRETA. DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING ANOTHER MEDICINE FOR D 完全なドキュメントを読む
Product Information: DEPRETA (Duloxetine Gastro-Resistant Capsules 30 mg & 60 mg) Ver 1.3 Page 1 of 21 PRODUCT INFORMATION DEPRETA 30 (DULOXETINE 30 MG PRESENT AS HYDROCHLORIDE) DEPRETA 60 (DULOXETINE 60 MG PRESENT AS HYDROCHLORIDE) NAME OF THE MEDICINE The name of the medicine is Duloxetine (as hydrochloride). CHEMICAL NAME: (+)-( _S_ )- _N_ -methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride MOLECULAR FORMULA: C 18 H 19 NOS · HCl MOLECULAR WEIGHT: 333.88 CAS REGISTRY NUMBER: _[136434-34-9]_ DESCRIPTION Duloxetine hydrochloride is a white to slightly brownish white powder, which is sparingly soluble in water, freely soluble in methanol, soluble in anhydrous ethanol, practically insoluble in hexane. DEPRETA is available as capsules containing 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. _DEPRETA 30 _ Blue opaque/White opaque, size ‘3’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘02’ on white opaque body with black ink. _ _ _DEPRETA 60 _ Blue opaque/Green opaque, size ‘1’ hard gelatin capsule filled with white to off-white pellets and imprinted with ‘X’ on blue opaque cap and ‘03’ on green opaque body with black ink. INACTIVE INGREDIENTS: Each capsule contains hypromellose, hydroxypropylcellulose, crospovidone, sugar spheres, triethyl citrate, titanium dioxide, hypromellose phthalate and purified talc as excipients. Product Information: DEPRETA (Duloxetine Gastro-Resistant Capsules 30 mg & 60 mg) Ver 1.3 Page 2 of 21 The capsule shells (size ‘3’ ARTG # 107904 and size ‘1’ ARTG # 107905) contain indigo carmine, titanium dioxide, gelatin and sodium lauryl sulphate. The 60 mg capsule shells also contain iron oxide yellow. The capsule shells are printed with Tek Print SW-9008 Black Ink (ARTG # 2328). PHARMACOLOGY PHARMACODYNAMICS Duloxetine is a selective serotonin an 完全なドキュメントを読む