البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE
Niche Generics Limited
DONEPEZIL HYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL NICHE 5 MG FILM-COATED TABLETS DONEPEZIL NICHE 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. The name of your medicine is Donepezil Niche 5 mg and 10 mg Film-coated Tablets. It will be called Donepezil Niche for ease from here on. IN THIS LEAFLET: 1. WHAT DONEPEZIL NICHE IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE DONEPEZIL NICHE 3. HOW TO TAKE DONEPEZIL NICHE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DONEPEZIL NICHE 6. FURTHER INFORMATION 1. WHAT DONEPEZIL NICHE IS AND WHAT IT IS USED FOR The active ingredient in your tablets is donepezil hydrochloride. It works by increasing the amount of a substance called acetylcholine in the brain. It is used to treat the symptoms of dementia (changes in the way the brain works) in people with mild to moderately severe Alzheimer’s disease. These symptoms include increasing memory loss, confusion and changes in the way you behave, making it more difficult to carry out normal daily activities. Donepezil Niche is only for use only in adult patients. 2. BEFORE YOU TAKE DONEPEZIL NICHE DO NOT TAKE DONEPEZIL NICHE IF YOU: • know that you are allergic (hypersensitive) to Donepezil hydrochloride (which is a piperidine derivative), or to other piperidine derivatives, or any of the other ingredients of Donepezil Niche listed in section 6 TAKE SPECIAL CARE W اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Niche 10mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains: 10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base. Excipient: 192.0 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Donepezil Niche 10 mg film coated tablets are yellow, round, biconvex tablets debossed ‘D10’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil Niche Tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil Niche tablets 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 Niche tablets 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 th اقرأ الوثيقة كاملة