Donecept 5mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Donepezil hydrochloride

Dostupno od:

Actavis Group PTC ehf

ATC koda:

N06DA; N06DA02

INN (International ime):

Donepezil hydrochloride

Doziranje:

5 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

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

Područje terapije:

Anticholinesterases; donepezil

Status autorizacije:

Marketed

Datum autorizacije:

2008-11-21

Uputa o lijeku

_Continued over page_
DONECEPT 5 MG FILM-COATED TABLETS
DONECEPT 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 DONECEPT IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONECEPT
3
HOW TO TAKE DONECEPT
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE DONECEPT
6
CONTENTS OF THE PACK AND FURTHER INFORMATION
1
WHAT DONECEPT IS AND WHAT IT IS USED FOR
Donecept belongs to a group of medicines called
acetylcholinesterase inhibitors. It is used to treat the symptoms
of dementia in people diagnosed as having mild to moderately
severe Alzheimer’s disease. Donecept is for use in adult patients
only.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONECEPT
DO NOT TAKE DONECEPT
•
if you are allergic to donepezil hydrochloride, piperidine
derivatives or to any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Treatment with Donecept should only be started and
supervised by a doctor with experience in diagnosing and
treating Alzheimer’s dementia.
Talk to your doctor or pharmacist before taking Donecept if you:
•
have ever had stomach or duodenal ulcers, or if you are
taking non steroidal anti-inflammatory drugs (NSAIDS)
•
have ever had a seizure. Donepezil may have the potential
to cause fits or seizures. Your doctor will monitor your
symptoms.
•
have a heart condition (especially if you have an irregular
heart beat, sick sinus syndrome, or other conditions that
affect the rhythm of the heart), as do

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donecept
5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg donepezil hydrochloride.
Excipients with known effect:
Donecept 5 mg film-coated tablet contains 92.5 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Donecept 5 mg film-coated tablet is white, round and biconvex engraved
with ‘DZ 5’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donecept is indicated for the symptomatic treatment of mild to
moderately severe Alzheimer’s dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS/ELDERLY_
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
Donecept
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 medicinal product 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 gradual abatement of the
beneficial effects of done