Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
donepezilhydroklorid, vattenfri
Mylan AB
N06DA02
donepezil hydrochloride, anhydrous
10 mg
Munsönderfallande tablett
donepezilhydroklorid, vattenfri 10 mg Aktiv substans; mannitol Hjälpämne
Receptbelagt
Donepezil
Förpacknings: Blister, 7 tabletter (Al); Blister, 10 tabletter (Al); Blister, 14 tabletter (Al); Blister, 28 tabletter (Al); Blister, 30 tabletter (Al); Blister, 50 tabletter (Al); Blister, 56 tabletter (Al); Blister, 60 tabletter (Al); Blister, 84 tabletter (Al); Blister, 98 tabletter (Al); Blister, 100 tabletter (Al); Blister, 120 tabletter (Al); Blister, 180 tabletter (Al)
Avregistrerad
2010-05-21
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DONEPEZIL MYLAN 5 MG ORODISPERSIBLE TABLETS DONEPEZIL MYLAN 10 MG ORODISPERSIBLE TABLETS donepezil 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Donepezil Mylan is and what it is used for 2. What you need to know before you take Donepezil Mylan 3. How to take Donepezil Mylan 4. Possible side effects 5. How to store Donepezil Mylan 6. Contents of the pack and other information 1. WHAT DONEPEZIL MYLAN IS AND WHAT IT IS USED FOR Donepezil Mylan contains the active substance donepezil hydrochloride. Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of that substance. It is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s disease. Symptoms of the illness include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more difficult to carry out their normal daily activities. It is for use in adult patients only. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL MYLAN DO NOT TAKE DONEPEZIL MYLAN: - if you are allergic to donepezil, to piperidine derivative medicines (your doctor or pharmacist can advise on this) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to you Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Donepezil Mylan 5 mg orodispersible tablets Donepezil Mylan 10 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg tablet contains 5 mg donepezil hydrochloride (as monohydrate), equivalent to 4.56 mg of donepezil free base. Each 10 mg tablet contains 10 mg donepezil hydrochloride (as monohydrate), equivalent to 9.12 mg of donepezil free base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. Donepezil Mylan 5 mg are white coloured round flat bevelled edged tablets, debossed with “DL 5” on one side and “M” on the other side. Donepezil Mylan 10 mg are yellow coloured round flat bevelled edged tablets, debossed with “DL 10” on one side and “M” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Mylan is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults/Elderly_ Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose of donepezil hydrochloride can be increased to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil hydrochloride should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the pati Đọc toàn bộ tài liệu