מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Donepezil hydrochloride
Bluefish Pharmaceuticals AB
N06DA; N06DA02
Donepezil hydrochloride
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anticholinesterases; donepezil
Marketed
2010-07-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL HYDROCHLORIDE BLUEFISH 5 MG FILM-COATED TABLETS DONEPEZIL HYDROCHLORIDE BLUEFISH 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 or nurse. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Donepezil Hydrochloride Bluefish is and what it is used for 2. What you need to know before you take Donepezil Hydrochloride Bluefish 3. How to take Donepezil Hydrochloride Bluefish 4. Possible side effects 5. How to store Donepezil Hydrochloride Bluefish 6. Contents of the pack and other information 1. WHAT DONEPEZIL HYDROCHLORIDE BLUEFISH IS AND WHAT IT IS USED FOR Donepezil Hydrochloride Bluefish 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 Hydrochloride Bluefish is for use only in adult patients. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE BLUEFISH DO NOT TAKE DONEPEZIL HYDROCHLORIDE BLUEFISH if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients ofthis medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before taking DONEPEZIL Hydroch קרא את המסמך השלם
Health Products Regulatory Authority 20 April 2023 CRN00DDFR Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Hydrochloride Bluefish 10mg Film-coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For 5 mg: Each film-coated tablet contains: Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 5 mg Excipients 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 Excipients with known effect: Lactose monohydrate 196.00 mg For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet 10 mg: Yellow, round, biconvex, approximately 8.73 mm in diameter film coated tablets with inscription 10 on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Bluefish is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults/ elderly people Treatment is initiated at 5 mg/day (once-a-day dosing). In case of sleep disturbances including abnormal dreams, nightmares or insomnia (see section 4.8) intake of Donepezil Bluefish in the morning may be considered. 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 Bluefish 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 if a ca קרא את המסמך השלם