Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DULOXETINE HYDROCHLORIDE
UNIMED SDN BHD
DULOXETINE HYDROCHLORIDE
3X10 Capsules
Zydus Lifesciences Limited
DULEVE 30 & DULEVE 60 Duloxetine Delayed Release Capsules USP (60mg and 30mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What DULEVE capsule is used for 2. How DULEVE capsule works 3. Before you use DULEVE capsule 4. How to use DULEVE capsule 5. While you are using it 6. Side effects 7. Storage and Disposal of DULEVE capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT DULEVE CAPSULE IS USED FOR DULEVE is used in adults to treat: • depression • generalised anxiety disorder • diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain) HOW DULEVE CAPSULE WORKS DULEVE contains the active ingredient duloxetine. DULEVE increases the levels of serotonin and noradrenaline in the nervous system. DULEVE starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you DULEVE when you are feeling better to prevent your depression or anxiety from returning. In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months. BEFORE YOU USE DULEVE CAPSULE_ _ _When you must not use it_ _ _ DO NOT take DULEVE if you _: _ • Are allergic to duloxetine or any of the other ingredients of this medicine. • have liver disease • have severe kidney disease • have uncontrolled high blood pressure Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking DULEVE. - _ Before you start to use it _ The following are reasons why DULEVE may not be suitable for you. Talk to your doctor before you take DULEVE if you: • have k Belgenin tamamını okuyun
1. NAME OF THE MEDICINAL PRODUCT DULEVE 30 Duloxetine Delayed Release Capsules USP 30mg DULEVE 60 Duloxetine Delayed Release Capsules USP 60mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DULEVE 30 Duloxetine Delayed Release Capsules USP 30mg Each hard gelatin capsule contains: Duloxetine Hydrochloride USP 33.680mg Equivalent to Duloxetine 30mg (as enteric coated pellets) Approved colours used in capsule shell. DULEVE 60 Duloxetine Delayed Release Capsules USP 60mg Each hard gelatin capsule contains: Duloxetine Hydrochloride USP 67.360mg Equivalent to Duloxetine 60mg (as enteric coated pellets) Approved colours used in capsule shell. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard Gelatin capsule (Delayed Release Capsule) DULOXETINE DELAYED RELEASE CAPSULES USP 30MG: Pink colored free flowing pellets filled in size ‘3’ hard gelatin capsule with opaque blue cap & opaque white body. The Capsule should be free of all physical defects. DULOXETINE DELAYED RELEASE CAPSULES USP 60MG: Pink colored free flowing pellets filled in size ‘1’ capsule with opaque blue cap & opaque green body. The Capsule should be free of all physical defects. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Management of neuropathic pain associated with diabetic peripheral neuropathy in adults. Treatment of generalised anxiety disorder. 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 Belgenin tamamını okuyun