Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Donepezil hydrochloride
Rowex Ltd
N06DA; N06DA02
Donepezil hydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anticholinesterases; donepezil
Marketed
2008-10-10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOZEPT 5 MG FILM-COATED TABLETS DOZEPT 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dozept is and what it is used for 2. What do you need to know before you take Dozept 3. How to take Dozept 4. Possible side effects 5. How to store Dozept 6. Contents of the pack and other information 1 WHAT DOZEPT IS AND WHAT IT IS USED FOR Dozept belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine. Dozept is used to treat the SYMPTOMS OF DEMENTIA in people diagnosed as having mild to 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 Dozept film-coated tablets are for use in adult patients only. 2 WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE DOZEPT DO NOT TAKE DOZEPT if you are ALLERGIC to donepezil hydrochloride or piperidine derivatives, which are similar substances to donepezil, or soya, peanut or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Dozept. If any of the following concerns you, you or your caregiver sho uld INFORM YOUR DOC Leggi il documento completo
Health Products Regulatory Authority 23 March 2023 CRN00DH3W Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dozept 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of donepezil as (donepezil hydrochloride). Excipient(s) with known effect: 19 mg lactose/film-coated tablet 0.2 mg soya lecithin/film-coated tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round (diameter approx 7 mm) film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil 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 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 regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present. Individual response to donepezil cannot be predicted. Upon discontinuation of treatment, a gradual abatement of the beneficial e Leggi il documento completo