Donepezil Hydrochloride 5mg Film-coated Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Donepezil hydrochloride

Доступна с:

Bristol Laboratories Limited

код АТС:

N06DA; N06DA02

ИНН (Международная Имя):

Donepezil hydrochloride

дозировка:

5 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

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

Терапевтические области:

Anticholinesterases; donepezil

Статус Авторизация:

Not marketed

Дата Авторизация:

2013-03-22

тонкая брошюра

SAME SIZE ARTWORK
420x130 MM
Front
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 hyd

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Donepezil hydrochloride 5mg.
Also contains 73.40mg of Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablets)
White to off white, circular, biconvex, film coated tablet, debossed
with “C” on one side and “7” 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
effect is no longer present. Individual response to donepezil cannot
be predic