国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Teva Pharma B.V.
DONEPEZIL HYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPEZ 5 MG FILM COATED TABLETS ARIPEZ 10 MG FILM COATED TABLETS Donepezil hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Aripez is and what it is used for 2. Before you take Aripez 3. How to take Aripez 4. Possible side effects 5. How to store Aripez 6. Further information 1. WHAT ARIPEZ IS AND WHAT IT IS USED FOR Donepezil belongs to a group of medicines called acetylcholine esterase inhibitors: it increases the levels of the substance acetylcholine in the brain. It is used to relieve the symptoms of mild to moderate Alzheimer’s dementia. 2. BEFORE YOU TAKE ARIPEZ REMEMBER: You must tell your doctor who your carers are. DO NOT TAKE ARIPEZ - if you are allergic (hypersensitive) to donepezil or any of the other ingredients of Aripez Film-coated Tablets. - if you are allergic (hypersensitive) to other medicines containing a PIPERIDINE DERIVATIVE (Aripez is a piperidine derivative) TAKE SPECIAL CARE WITH ARIPEZ Treatment with Aripez should only be started and supervised by a doctor with experience in diagnosing and treating Alzheimer’s dementia. Inform your doctor if you: - have ever had a stomach or intestinal ulcer - frequently take pain-killers or treatment for RHEUMATISM (PAIN OR INFLAMMATION AROUND BONES, JOINTS OR MUSCLES): taking these medicines at the same time as Aripez could put you at greater risk o 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripez 5 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil. Excipient: 128.2 mg lactose / tablet For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-Coated Tablet. White Film-Coated oval shaped tablets, debossed with "93" on one side and "7320" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripez tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. ADULTS/ELDERLY: 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 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 should be reassessed on a re 完全なドキュメントを読む