Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
duloxetine
Eli Lilly Nederland B.V.
N06AX21
duloxetine
Psychoanaleptics,
Diabetic Neuropathies
Treatment of diabetic peripheral neuropathic pain.Ariclaim is indicated in adults.
Revision: 26
Withdrawn
2004-08-11
40 B. PACKAGE LEAFLET Medicinal product no longer authorised 41 PACKAGE LEAFLET: INFORMATION FOR THE USER ARICLAIM 30 MG HARD GASTRO-RESISTANT CAPSULES ARICLAIM 60 MG HARD GASTRO-RESISTANT CAPSULES Duloxetine (as hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What ARICLAIM is and what it is used for 2. What you need to know before you take ARICLAIM 3. How to take ARICLAIM 4. Possible side effects 5. How to store ARICLAIM 6. Contents of the pack and other information 1. WHAT ARICLAIM IS AND WHAT IT IS USED FOR ARICLAIM contains the active substance duloxetine. ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system. ARICLAIM 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). 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARICLAIM DO NOT TAKE ARICLAIM IF YOU: − are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) − have liver disease − have severe kidney disease − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and ARICLAIM’) − are taking fluvoxamine Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule may contain up to 56 mg sucrose. For the 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. ARICLAIM is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 section 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). _Paediatric population _ The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied. No data are available. _ _ _Special populations _ _Elderly _ No dosage adjustment is recommended for elderly patients solely on the basis of age. However, as with any medicine, caution should be exercised when treating the elderly (see section 5.2). Medicinal product no longer authorised 3 _ _ _Hepatic impairment_ ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4 Pročitajte cijeli dokument