Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Donepezil hydrochloride
Accord Healthcare Ireland Ltd.
N06DA; N06DA02
Donepezil hydrochloride
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anticholinesterases; donepezil
Marketed
2011-08-19
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, if you have or have had: • stomach or duodenal ulcers • seizures (fits) or convulsions • a heart condition (such as irregular or very slow heart beat, heart failure, myocardial infarction) • a heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 12 December 2023 CRN00DPHJ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Donepezil hydrochloride monohydrate equivalent to donepezil hydrochloride 10 mg Excipients: Lactose monohydrate 196.00 mg For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 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 Tablet are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adult and elderly patients 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 Tablet 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 can Διαβάστε το πλήρες έγγραφο