ARICEPT EVESS 5 mg orodispersible tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Donepezil hydrochloride

Available from:

Pfizer Healthcare Ireland

ATC code:

N06DA; N06DA02

INN (International Name):

Donepezil hydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anticholinesterases; donepezil

Authorization status:

Not marketed

Authorization date:

2006-06-02

Patient Information leaflet

Page 1 of 6
2021-0071509
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARICEPT
® EVESS 5 MG ORODISPERSIBLE TABLETS
ARICEPT
® EVESS 10 MG ORODISPERSIBLE 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 of the 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 ARICEPT EVESS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ARICEPT EVESS
3.
HOW TO TAKE ARICEPT EVESS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ARICEPT EVESS
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
1.
WHAT ARICEPT EVESS IS AND WHAT IT IS USED FOR
ARICEPT EVESS contains the active substance donepezil hydrochloride.
ARICEPT EVESS
(donepezil hydrochloride) belongs to a group of medicines called
acetylcholinesterase
inhibitors. Donepezil increases the levels of a substance
(acetylcholine) in the brain involved
in memory function by slowing down the breakdown of acetylcholine
.
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.
ARICEPT EVESS is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARICEPT EVESS
DO NOT TAKE ARICEPT EVESS
•
if you are allergic to donepezil hydrochloride, or to piperidine
derivatives, or any of
the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmac

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2023
CRN00D7FM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARICEPT EVESS 5 mg orodispersible tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56
mg of donepezil free base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
ARICEPT EVESS 5 mg tablets are white, round tablets, debossed
“ARICEPT” on one side and “5” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT EVESS orodispersible tablets are indicated for the symptomatic
treatment of mild to moderately severe Alzheimer'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 Aricept EVESS
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