Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
DONEPEZIL HYDROCHLORIDE
UNIPHARM LTD, ISRAEL
TABLETS
DONEPEZIL HYDROCHLORIDE 10 MG
PER OS
Required
UNIPHARM LTD, ISRAEL
Treatment of mild to moderately severe Alzheimer`s dementia.
2018-05-29
[לוגו מדינת ישראל] [http://www.gov.il/] [http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד הבריאות] [*5400] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] הציבור הרחב עסקים ומוסדות עובדים בבריאות חפש מידע תפריט * [סגירה] סגור * דף הבית [http://www.health.gov.il/] * אודות * אודות המשרד [http://www.health.gov.il/About/Pages/about_us.aspx] * תוכנית עבודה [http://www.health.gov.il/About/Pages/Agenda.aspx] * תקציב המשרד [http://www.health.gov.il/About/Pages/budget.aspx] * תרשים מבנה ארגוני [http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] * בעלי תפקידים [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] * אמנת שירות [http://www.health.gov.il/About/sla/Pages/default.aspx] * אותות ופרסים [http://www.health.gov.il/About/Awards/Pages/mifal.aspx] * פרוייקטים תשתיתיים [http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] * דרושים [http://www.health.gov.il/About/Careers/Pages/default.aspx] * מנכ"לי משרד הבריאות לדורותיהם [http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] * יחידות המשרד * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] * וועדות ומועצות [http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] * נושאים * בריאות הנפש [http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] * בריאות הסביבה [http://www.health.gov.il/Subjects/Environmental_Health/ Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MEMORIT 10 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg donepezil hydrochloride. Excipients with known effect: Each 10 mg tablet contains 80 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Memorit 10 are circular, biconvex, white film-coated tablet with a breakline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Memorit tablets are indicated for the treatment of mild to moderately severe Alzhei mer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults/Elderly people _ 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 Memorit 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 effects of Memorit is seen. _Paediatric population _ Donepezil hydrochloride is not recommended for use in children Soma hati kamili