MEMORIT 10

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

DONEPEZIL HYDROCHLORIDE

Saatavilla:

UNIPHARM LTD, ISRAEL

Lääkemuoto:

TABLETS

Koostumus:

DONEPEZIL HYDROCHLORIDE 10 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

UNIPHARM LTD, ISRAEL

Käyttöaiheet:

Treatment of mild to moderately severe Alzheimer`s dementia.

Valtuutus päivämäärä:

2018-05-29

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Valmisteyhteenveto

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