国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DULOXETINE HYDROCHLORIDE
GENPHARMA SDN. BHD
DULOXETINE HYDROCHLORIDE
4 x 7 Capsules
Alembic Pharmaceuticals Limited (Formulation Division)
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ CYMBALOX DELAYED- RELEASE CAPSULES DULOXETINE (30MG, 60MG) _____________________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1.What Cymbalox is used for 2.How Cymbalox works 3.Before you use Cymbalox 4.How to use Cymbalox 5.While you are using it 6.Side effects 7.Storage and Disposal of Cymbalox 8.Product Description 9.Manufacturer and Product Registration Holder 10.Date of revision WHAT CYMBALOX IS USED FOR Cymbalox 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 CYMBALOX WORKS Cymbalox contains the active ingredient duloxetine. Cymbalox increases the levels of serotonin and noradrenaline in the nervous system. Cymbalox 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 Cymbalox 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 CYMBALOX - _When you must not use it_ DO NOT take Cymbalox if you: •are allergic to duloxetine or any of the other ingredients of this medicine (listed in section PRODUCT DESCRIPTION ) •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 Cymbalox. - _Before you start to use it_ The following are reasons why Cymbalox may not be suitable for you. Talk to your docto 阅读完整的文件
CYMBALOX 30MG DELAYED-RELEASE CAPSULES CYMBALOX 60MG DELAYED-RELEASE CAPSULES (Duloxetine Hydrochloride Delayed-Release capsules) 1. NAME OF THE MEDICINAL PRODUCT Cymbalox 30 mg Delayed-Release Capsules Cymbalox 60 mg Delayed-Release Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Hard Gelatin capsule contains: Duloxetine Hydrochloride Ph. Eur Eq. to Duloxetine 30 mg Duloxetine Hydrochloride Ph. Eur Eq. to Duloxetine 60 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM CYMBALOX 30 MG DELAYED-RELEASE CAPSULES Opaque blue/opaque white, hard gelatin capsule size “3”, having imprinting “157” on body with green ink and “A” on cap with green ink and lled with white to off white coloured pellets. CYMBALOX 60 MG DELAYED-RELEASE CAPSULES Opaque blue/opaque green, hard gelatin capsule size “1”, having imprinting “158” on body with white ink and “A” on cap with white ink and lled with white to off white coloured pellets. 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. Doses 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 benet 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 repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. 阅读完整的文件