Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 67.3 mg
Alphapharm Pty Ltd
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: Gelatin; sucrose; purified talc; hypromellose phthalate; triethyl citrate; indigo carmine; titanium dioxide; hypromellose; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide; maize starch
Oral
28 capsules
(S4) Prescription Only Medicine
Duloxetine capsules are indicated for the treatment of major depressive disorder (MDD).,Treatment of Diabetic Peripheral Neuropathic Pain (DPNP). Treatment of Generalised Anxiety Disorder (GAD).
Visual Identification: Opaque blue/opaque green hard gelatin capsule '158' on body and 'A' on cap with white ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-06-14
TIXOL _duloxetine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tixol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Tixol against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT TIXOL IS USED FOR Tixol belongs to a group of medicines known as 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. Tixol is used to treat: • Major depressive disorder (depression) • Diabetic peripheral neuropathic pain (nerve pain caused by diabetes) • Generalised anxiety disorder (excessive worry) 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. Tixol is available only with a doctor's prescription. Tixol is not recommended for use in children and adolescents under the age of 18 years. BEFORE YOU TAKE TIXOL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE TIXOL 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 TIXOL IF YOU HAVE LIVER DISEASE. This could increase the change of you having liver problems during treatment with Tixol. DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING ANOTHER MEDICINE FOR DEPRESSION CALLED A M Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION TIXOL _Duloxetine (as hydrochloride) _ 1 NAME OF THE MEDICINE 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. Excipients with known effect: sugars, phenylalanine and sulfites. The inactive ingredients also include Sugar Spheres (ARTG 2535), hypromellose, purified talc, purified water, sucrose, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, and indigo carmine. The 30 mg capsules also contain Tekprint SB-4020 Green Ink (ARTG 2652). The 60 mg capsules also contain iron oxide yellow, and TekPrint SW-0012 White Ink (ARTG 13175). The enteric capsules are gluten free. 3 PHARMACEUTICAL FORM The 30 mg enteric capsule has an opaque blue/white hard gelatin capsule ‘157’ on body and ‘A’ on cap with green ink. The 60 mg enteric capsule has an opaque blue/opaque green hard gelatin capsule ‘158’ on body and ‘A’ on cap with white ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TIXOL is indicated for the treatment of: • major depressive disorder (MDD) • diabetic peripheral neuropathic pain (DPNP) • generalised anxiety disorder (GAD). 4.2 DOSE AND METHOD OF ADMINISTRATION MAJOR DEPRESSIVE DISORDER TIXOL 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. DIABETIC PERIPHERAL NEUROPATHIC PAIN The starting and maintenance dose of duloxetine in diabetic peripheral neuropathic pain is 60 mg once daily. As the progression of diabetic neuropathy is highly variable and management of pain is empirical, effectiveness of duloxetine should be assessed on an individual b Прочитать полный документ