국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
duloxetine
Boehringer Ingelheim International GmbH
N06AX21
duloxetine
Psychoanaleptics,
Diabetic Neuropathies
Treatment of diabetic peripheral neuropathic pain in adults.
Revision: 2
Withdrawn
2008-10-08
Medicinal product no longer authorised 38 B. PACKAGE LEAFLET Medicinal product no longer authorised 39 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE BOEHRINGER INGELHEIM 30 MG HARD GASTRO-RESISTANT CAPSULES DULOXETINE BOEHRINGER INGELHEIM 60 MG HARD GASTRO-RESISTANT CAPSULES Duloxetine (as hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET : 1. What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for 2. Before you take DULOXETINE BOEHRINGER INGELHEIM 3. How to take DULOXETINE BOEHRINGER INGELHEIM 4. Possible side effects 5 How to store DULOXETINE BOEHRINGER INGELHEIM 6. Further information 1. WHAT DULOXETINE BOEHRINGER INGELHEIM IS AND WHAT IT IS USED FOR DULOXETINE BOEHRINGER INGELHEIM increases the levels of serotonin and noradrenaline in the nervous system. DULOXETINE BOEHRINGER INGELHEIM is used in adults to treat a condition called 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). The effect of DULOXETINE BOEHRINGER INGELHEIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment. 2. BEFORE YOU TAKE DULOXETINE BOEHRINGER INGELHEIM DO NOT TAKE DULOXETINE BOEHRINGER INGELHEIM IF YOU: − are allergic (hypersensitive) to duloxetine or any of the other ingredients of DULOXETINE BOEHRINGER INGELHEIM − have liver disease − have severe kidney disease are taking or have recently taken within the last 14 days, another antidepressan 전체 문서 읽기
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride) Excipients: sucrose 8.6 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetic peripheral neuropathic pain in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. _Adults _ The starting and recommended maintenance dose is 60 mg daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials. The plasma concentration of duloxetine displays large inter-individual variability (see 5.2). Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose. Response to treatment should be evaluated after 2 months. In patients with inadequate initial response, additional response after this time is unlikely. The therapeutic benefit should be reassessed regularly (at least every three months) (see Section 5.1). _Elderly _ No dosage adjustment is recommended for elderly patients solely on the basis of age. However, caution should be exercised when treating the elderly (see section 5.2). _Children and adolescents _ There is no experience in children and adolescents (see section 4.4). _ _ _Hepatic impairment_ DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2). Medicinal product no longer authorised 3 _Renal insufficiency _ No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clear 전체 문서 읽기