Donepezil Hydrochloride 10mg Film-coated Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Donepezil hydrochloride

Disponible depuis:

Brillpharma (Ireland) Limited

Code ATC:

N06DA; N06DA02

DCI (Dénomination commune internationale):

Donepezil hydrochloride

Dosage:

10 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

Anticholinesterases; donepezil

Statut de autorisation:

Not marketed

Date de l'autorisation:

2013-03-22

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL HYDROCHLORIDE 5MG FILM-COATED TABLETS
DONEPEZIL HYDROCHLORIDE 10MG 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. 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.
THE NAME OF YOUR MEDICINE IS DONEPEZIL HYDROCHLORIDE 5MG FILM-COATED
TABLETS AND
DONEPEZIL
HYDROCHLORIDE
10MG
FILM-COATED
TABLETS.
BUT
IT
WILL
BE
REFERRED
TO
AS
DONEPEZIL TABLETS THROUGHOUT THE LEAFLET.
WHAT IS IN THIS LEAFLET
1. What Donepezil Tablets are and what they are used for
2. What you need to know before you take Donepezil Tablets
3. How to take Donepezil Tablets
4. Possible side effects
5. How to store Donepezil Tablets
6. Contents of the pack and other information
1. WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED FOR
Donepezil
hydrochloride
belongs
to
a
group
of
medicines
called
acetyl
cholinesterase
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.
Donepezil tablets are for use in adult patients only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL TABLETS
DO NOT TAKE DONEPEZIL TABLETS
• if you are allergic (hypersensitive) to donepezil hydrochloride,
or to piperidine derivat

Résumé des caractéristiques du produit

Health Products Regulatory Authority
07 October 2019
CRN008YJ0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Donepezil hydrochloride 10mg.
Also contains 146.80mg of Lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablets)
Yellow coloured, circular, biconvex, film-coated tablets, debossed
with “C” on one side and “6” on other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Hydrochloride Film coated 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). Donepezil
Hydrochloride 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) Donepezil Hydrochloride 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 e