ARIPEZ 5 Milligram Film Coated Tablet

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

DONEPEZIL HYDROCHLORIDE

Tersedia dari:

Teva Pharma B.V.

INN (Nama Internasional):

DONEPEZIL HYDROCHLORIDE

Dosis:

5 Milligram

Bentuk farmasi:

Film Coated Tablet

Jenis Resep:

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

Status otorisasi:

Authorised

Tanggal Otorisasi:

0000-00-00

Selebaran informasi

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ARIPEZ  5 MG FILM COATED TABLETS 
ARIPEZ  10 MG FILM COATED TABLETS 

Donepezil hydrochloride 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
-  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. Do not pass it on to
others. It may harm them, even if their 
symptoms are the same as yours. 
-  If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell 
your doctor or pharmacist. 

IN THIS LEAFLET:  
1.  What Aripez  is and what it is used for 
2.  Before you take Aripez  
3.  How to take Aripez  
4.  Possible side effects 
5.  How to store Aripez  
6. Further information 

1. 
WHAT ARIPEZ  IS AND WHAT IT IS USED FOR 

Donepezil belongs to a group of medicines called acetylcholine
esterase inhibitors:  it increases the levels of 
the substance acetylcholine in the brain. 

It is used to relieve the symptoms of mild to moderate Alzheimer’s
dementia. 

2. 
BEFORE YOU TAKE ARIPEZ  

REMEMBER: You must tell your doctor who your carers are. 

DO NOT TAKE ARIPEZ  
-  if you are allergic (hypersensitive) to donepezil or any of the
other ingredients of Aripez  Film-coated 
Tablets. 
-  if you are allergic (hypersensitive) to other medicines
containing a PIPERIDINE DERIVATIVE (Aripez  is a 
piperidine derivative) 

TAKE SPECIAL CARE WITH ARIPEZ  
Treatment with Aripez  should only be started and supervised by a
doctor with experience in diagnosing and 
treating Alzheimer’s dementia. 

Inform your doctor if you: 
-  have ever had a stomach or intestinal ulcer 
-  frequently take pain-killers or treatment for RHEUMATISM (PAIN
OR INFLAMMATION AROUND BONES, JOINTS 
OR MUSCLES): taking these medicines at the same time as Aripez  could
put you at greater risk o

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripez 5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil.
Excipient: 128.2 mg lactose / tablet
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
White Film-Coated oval shaped tablets, debossed with "93" on one side and "7320" on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripez tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
ADULTS/ELDERLY:
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil should be taken orally, in the evening, just prior to
retiring. 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 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 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 should be reassessed on a re