Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
DONEPEZIL HYDROCHLORIDE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
N06DA02
DONEPEZIL HYDROCHLORIDE 10 mg
FILM-COATED TABLET
DONEPEZIL HYDROCHLORIDE 10 mg
POM
PSYCHOANALEPTICS
Withdrawn
2012-02-17
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL 5 MG FILM-COATED TABLETS DONEPEZIL 10 MG FILM-COATED 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 is and what it is used for 2. What you need to know before you take Donepezil 3. How to take Donepezil 4. Possible side effects 5. How to store Donepezil 6. Contents of the pack and other information 1. WHAT DONEPEZIL IS AND WHAT IT IS USED FOR Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities. Donepezil is for use only in adult patients. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL DO NOT TAKE DONEPEZIL • if you are allergic to donepezil hydrochloride, or piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Donepezil . In particular, tell your doctor: • if you have or have had stomach or duodenal ulcers • if you have or have had seizures (fits) or convulsions • if you have or have had a heart condition (irregular or very slow heart beat) • if you have or have had asthma or other long term lung dise Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Donepezil 5 mg Film-coated tablets Donepezil 10 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 5 mg: Each film-coated tablet contains: Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 5 mg Excipient with known effect: Lactose monohydrate 98.00 mg For 10 mg: Each film-coated tablet contains: Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 10 mg Excipient with known effect: Lactose monohydrate 196.00 mg For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 5 mg: White to off-white, round, approximately 7.14 mm in diameter, bevelled edge, biconvex, film coated tablets with inscription "5" on one side and plain on other side. 10 mg: Yellow, round, approximately 8.73 mm in diameter, biconvex, film coated tablets with inscription "10" on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil should be taken orally, in the evening, just prior to retiring. 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 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 should only be started Belgenin tamamını okuyun