Donepezil 5mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Donepezil hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06DA; N06DA02

INN (International Name):

Donepezil hydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Anticholinesterases; donepezil

Authorization status:

Marketed

Authorization date:

2011-08-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL 5 MG FILM-COATED TABLETS
DONEPEZIL 10 MG FILM-COATED 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 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 Donepezil is and what it is used for
2.
What you need to know before you take Donepezil
3.
How to take Donepezil
4.
Possible side effects
5.
How to store Donepezil
6.
Contents of the pack and other information
1. WHAT DONEPEZIL IS AND WHAT IT IS USED FOR
Donepezil belongs to a group of medicines called acetylcholinesterase
inhibitors.
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.
Donepezil is for use only in adult patients.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL
DO NOT TAKE DONEPEZIL
•
if you are allergic to donepezil hydrochloride, or piperidine
derivatives, or to any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Donepezil, if you have
or have had:
•
stomach or duodenal ulcers
•
seizures (fits) or convulsions
•
a heart condition (such as irregular or very slow heart beat, heart
failure, myocardial infarction)
•
a heart condition called ‘prolonged QT interval’ or a history of
certain abnormal heart rhythms called

Summary of Product characteristics

Health Products Regulatory Authority
12 December 2023
CRN00DPHJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: Donepezil hydrochloride monohydrate
equivalent to donepezil hydrochloride 5 mg
Excipient with known effect: Lactose monohydrate 98.00 mg
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, approximately 7.14 mm in diameter,bevelled
edge, biconvex, film coated tablets with inscription "5"
on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Tablet are indicated for the symptomatic treatment of mild
to moderately severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adult and elderly patients
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 Donepezil
Tablet 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 pres