国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Donepezil hydrochloride
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06DA; N06DA02
Donepezil hydrochloride
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anticholinesterases; donepezil
Marketed
2008-10-03
PAGE 2 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARIPIL 5 MG FILM-COATED TABLETS ARIPIL 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 Aripil is and what it is used for 2. What you need to know before you take Aripil 3. How to take Aripil 4. Possible side effects 5. How to store Aripil 6. Contents of the pack and other information 1. WHAT ARIPIL IS AND WHAT IT IS USED FOR Aripil contains the active substance donepezil hydrochloride, which 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 only in adult patients. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIL DO NOT TAKE ARIPIL: - 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 your doctor or pharmacist before taking Aripil if you suffer or have ever suffered from any of the following conditions: 阅读完整的文件
Health Products Regulatory Authority 24 July 2023 CRN00D9RC Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripil 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10 mg donepezil hydrochloride (equivalent to 9.12 mg of donepezil). Excipient with known effect Each 10 mg film-coated tablet contains 174.3 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Aripil 10 mg are white, film-coated, round tablets embossed with “DL” over “10” on one side and “G” on the reverse, approximately 9 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripil 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 patient exists. Therefore, the clinical benefit of donepezil hydrochloride should be reassessed on a regular basis. Discontinuation should be considered when evidence of a ther 阅读完整的文件