Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Donepezil hydrochloride
Actavis Group PTC ehf
N06DA; N06DA02
Donepezil hydrochloride
10 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anticholinesterases; donepezil
Marketed
2008-11-21
_Continued over page_ DONECEPT 5 MG FILM-COATED TABLETS DONECEPT 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 DONECEPT IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONECEPT 3 HOW TO TAKE DONECEPT 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DONECEPT 6 CONTENTS OF THE PACK AND FURTHER INFORMATION 1 WHAT DONECEPT IS AND WHAT IT IS USED FOR Donecept belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s disease. Donecept is for use in adult patients only. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONECEPT DO NOT TAKE DONECEPT • if you are allergic to donepezil hydrochloride, piperidine derivatives or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Treatment with Donecept should only be started and supervised by a doctor with experience in diagnosing and treating Alzheimer’s dementia. Talk to your doctor or pharmacist before taking Donecept if you: • have ever had stomach or duodenal ulcers, or if you are taking non steroidal anti-inflammatory drugs (NSAIDS) • have ever had a seizure. Donepezil may have the potential to cause fits or seizures. Your doctor will monitor your symptoms. • have a heart condition (especially if you have an irregular heart beat, sick sinus syndrome, or other conditions that affect the rhythm of the heart), as do Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donecept 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg donepezil hydrochloride. Excipients with known effect: Donecept 10 mg film-coated tablet contains 185 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Donecept 10 mg film-coated tablet is pale yellow, round and biconvex engraved with ‘DZ 10’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donecept 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 Donecept 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 medicinal product 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 eff Pročitajte cijeli dokument