Donepezil Hydrochloride Bluefish 5mg Film-coated Tablet

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Donepezil hydrochloride

זמין מ:

Bluefish Pharmaceuticals AB

קוד ATC:

N06DA; N06DA02

INN (שם בינלאומי):

Donepezil hydrochloride

כמות:

5 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

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

איזור תרפויטי:

Anticholinesterases; donepezil

מצב אישור:

Marketed

תאריך אישור:

2010-07-09

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DONEPEZIL HYDROCHLORIDE BLUEFISH 5 MG FILM-COATED TABLETS
DONEPEZIL HYDROCHLORIDE BLUEFISH 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 or
nurse.
−
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Donepezil Hydrochloride Bluefish is and what it is used for
2.
What you need to know before you take Donepezil Hydrochloride Bluefish
3.
How to take Donepezil Hydrochloride Bluefish
4.
Possible side effects
5.
How to store Donepezil Hydrochloride Bluefish
6.
Contents of the pack and other information
1. WHAT DONEPEZIL HYDROCHLORIDE BLUEFISH IS AND WHAT IT IS USED FOR
Donepezil Hydrochloride Bluefish contains the active substance
donepezil hydrochloride. Donepezil
Hydrochloride Bluefish 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 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 Hydrochloride Bluefish is for use in adult patients only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
BLUEFISH
DO NOT TAKE DONEPEZIL HYDROCHLORIDE BLUEFISH
•
if you are a

מאפייני מוצר

Health Products Regulatory Authority
20 April 2023
CRN00DDFR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride Bluefish 5mg Film-coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For 5 mg:
Each film-coated tablet contains: Donepezil hydrochloride monohydrate
equivalent to donepezil hydrochloride 5 mg
Excipients with known effect: Lactose monohydrate 98.00 mg
For 10 mg:
Each film-coated tablet contains: Donepezil hydrochloride monohydrate
equivalent to donepezil hydrochloride 10 mg
Excipients with known effect: Lactose monohydrate 196.00 mg
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
5 mg: White to off-white, round, bevelled edge, biconvex,
approximately 7.14 mm in diameter film coated tablets with
inscription 5 on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Bluefish is indicated for the symptomatic treatment of mild
to moderately severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/ elderly people
Treatment is initiated at 5 mg/day (once-a-day dosing). In case of
sleep disturbances including abnormal dreams, nightmares
or insomnia (see section 4.8) intake of Donepezil Bluefish in the
morning may be considered. 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 Bluefish 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 shoul