ARIPIL OROTAB 5 Milligram Orodispersible Tablet
국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
환자 정보 전단 유효 성분:
DONEPEZIL HYDROCHLORIDE
제공처:
McDermott Laboratories Ltd t/a Gerard Laboratories
ATC 코드:
N06DA02
INN (국제 이름):
DONEPEZIL HYDROCHLORIDE
복용량:
5 Milligram
약제 형태:
Orodispersible Tablet
처방전 유형:
Product subject to prescription which may not be renewed (A)
치료 영역:
Anticholinesterases
승인 상태:
Authorised
승인 날짜:
2010-07-16
환자 정보 전단
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIL OROTAB 5 MG ORODISPERSIBLE TABLETS
ARIPIL OROTAB 10 MG ORODISPERSIBLE 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 Aripil Orotab is and what it is used for
2.
What you need to know before you take Aripil Orotab
3.
How to take Aripil Orotab
4.
Possible side effects
5.
How to store Aripil Orotab
6.
Contents of the pack and other information
1.
WHAT ARIPIL OROTAB IS AND WHAT IT IS USED FOR
Aripil Orotab contains the active substance
donepezil hydrochloride.
Donepezil hydrochloride belongs to a group of medicines called
acetylcholinesterase
inhibitors. Donepezil
hydrochloride increases the levels
of a substance (acetylcholine) in the brain involved in
memory function by slowing down the breakdown
of that substance.
It is used to treat the symptoms dementia in people diagnosed
as having of mild to moderately
severe Alzheimer’s disease. Symptoms of the
illness include increasing memory loss,
confusion and behavioural changes. As a result, sufferers
of Alzheimer’s disease find it more
difficult to carry out their normal daily activities.
It is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIL OROTAB
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제품 특성 요약
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripil Orotab 5 mg Orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains 5 mg donepezil hydrochloride (as monohydrate), equivalent to 4.56 mg of donepezil free
base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
Aripil Orotab 5 mg are white coloured round flat bevelled edged tablets, debossed with “DL 5” on one side and “M” on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripil Orotab 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 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 hydrochloride 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 hydrochloride should b
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