ARICEPT 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

Imbat Limited

ATC code:

N06DA02

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Anticholinesterases

Authorization status:

Authorised

Authorization date:

2007-09-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

ARICEPT
® 
10MG FILM-COATED TABLETS 
 (donepezil hydrochloride) 

YOU AND YOUR CAREGIVER SHOULD 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 get serious, or if you notice any
side 
effects not listed in this leaflet, please tell your doctor
or 
pharmacist. 

IN THIS LEAFLET: 

1.  WHAT ARICEPT IS AND WHAT IT IS USED FOR  
2.  BEFORE YOU TAKE ARICEPT  
3.  HOW TO TAKE ARICEPT  
4.  POSSIBLE SIDE EFFECTS  
5.  HOW TO STORE ARICEPT  
6.  FURTHER INFORMATION  

1.  WHAT ARICEPT IS AND WHAT IT IS USED 
FOR

Aricept (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 break 
down 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 is for use in adult patients only. 

2.  BEFORE YOU TAKE ARICEPT 

DO NOT TAKE ARICEPT 

• 
if you are allergic (hypersensitive) to donepezil 
hydrochloride, or to piperidine derivatives, or any of the 
other ingredients of Aricept listed in section 6 

TAKE SPECIAL CARE WITH ARICEPT 

Tell your doctor or pharma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aricept 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg donepezil hydrochloride.
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated tablet
_Product imported from France, Greece, Czech Republic and Poland:_
Yellow round, biconvex tablets embossed 'ARICEPT' on one side and '10' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults/Elderly:
Treatment is initiated at 5 mg/day (once-a-day dosing). ARICEPT 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 ARICEPT 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