Aripil 10 mg film-coated tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Donepezil hydrochloride

Pieejams no:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATĶ kods:

N06DA; N06DA02

SNN (starptautisko nepatentēto nosaukumu):

Donepezil hydrochloride

Deva:

10 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

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

Ārstniecības joma:

Anticholinesterases; donepezil

Autorizācija statuss:

Marketed

Autorizācija datums:

2008-10-03

Lietošanas instrukcija

PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIL 5 MG FILM-COATED TABLETS
ARIPIL 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 Aripil is and what it is used for
2.
What you need to know before you take Aripil
3.
How to take Aripil
4.
Possible side effects
5.
How to store Aripil
6.
Contents of the pack and other information
1.
WHAT ARIPIL IS AND WHAT IT IS USED FOR
Aripil contains the active substance donepezil hydrochloride, which
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 only in adult patients.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIL
DO NOT TAKE ARIPIL:
-
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 medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Aripil if you suffer
or have ever suffered from any of the
following conditions:

Produkta apraksts

Health Products Regulatory Authority
24 July 2023
CRN00D9RC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripil 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10 mg donepezil hydrochloride
(equivalent to 9.12 mg of donepezil).
Excipient with known effect
Each 10 mg film-coated tablet contains 174.3 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Aripil 10 mg are white, film-coated, round tablets embossed with
“DL” over “10” on one side and “G” on the reverse,
approximately 9 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripil 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 ther