Donepezil 5mg orodispersible tablets sugar free

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Donepezil hydrochloride

から入手可能:

Viatris UK Healthcare Ltd

ATCコード:

N06DA02

INN（国際名）:

Donepezil hydrochloride

投薬量:

5mg

医薬品形態:

Orodispersible tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04110000; GTIN: 5016695004525

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DONEPEZIL HYDROCHLORIDE 5 MG ORODISPERSIBLE TABLETS
DONEPEZIL HYDROCHLORIDE 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 Donepezil Hydrochloride is and what it is used for
2.
What you need to know before you take Donepezil Hydrochloride
3.
How to take Donepezil Hydrochloride
4.
Possible side effects
5.
How to store Donepezil Hydrochloride
6.
Contents of the pack and other information
1.
WHAT DONEPEZIL HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Donepezil Hydrochloride 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 of dementia in people diagnosed as
having 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 DONEPEZIL HYDROCHLORIDE
DO NOT TAKE DONEPEZIL HYDROCHLORIDE
-
if you are allergic to donepezil, to piperidine derivative medicines
(your doctor or
pharmacist can advise on this) or any of the other ingredients of this
med

製品の特徴

OBJECT 1
DONEPEZIL HYDROCHLORIDE 5 MG ORODISPERSIBLE
TABLETS
Summary of Product Characteristics Updated 14-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Donepezil Hydrochloride 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
Donepezil Hydrochloride 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
Donepezil Hydrochloride 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 be
reassessed on a regular basis.
Discontinuation should be considered when evidence of a therapeutic
effe