Donopez 1mg/ml oral solution

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

donepezil hydrochloride 1 mg/ml

Saadav alates:

Alapis S.A.

ATC kood:

N06DA02

INN (Rahvusvaheline Nimetus):

donepezil hydrochloride

Ravimvorm:

oral solution

Volitamisolek:

Authorised

Loa andmise kuupäev:

2012-05-11

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DONOPEZ 1MG/ML ORAL SOLUTION 
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 get serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist.  

IN THIS LEAFLET: 

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

1. WHAT DONOPEZ IS AND WHAT IT IS USED FOR 

Donopez  belongs to a group of medicines called
acetylcholinesterase inhibitors. 
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. 

Donopez is for use in adult patients only. 

2
. 
BEFORE YOU TAKE DONOPEZ  

DO NOT TAKE DONOPEZ  

  if you are allergic (hypersensitive)
to donepezil hydrochloride, or to piperidine derivatives, or 
any of the other ingredients of Donopez listed in section 6  
  if you are breast feeding  

TAKE SPECIAL CARE WITH DONOPEZ  

Tell your doctor or pharmacist before starting
to take Donopez if you have or have had: 
  stomach or duodenal ulcers  
  seizures (fits) or convulsions  
  a heart condition (irregular or very slow heart beat)  
  asthma or ot

Toote omadused

Page 1 of 10 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Donopez 1mg/ml oral solution 

2 QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 
Each ml of solution contains 1 mg of donepezil hydrochloride. 

Excipients: Methylparahydroxybenzoate, liquid sorbitol non-crystallising,  
sodium metabisulfite. 

For full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Oral solution. 
A clear, colourless to light yellow solution
with strawberry flavour. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Donopez is indicated for the symptomatic treatment of mild
to moderately severe Alzheimer’s 
dementia. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
ADULTS/ELDERLY: 

Treatment is initiated at 5 ml (5mg)/day (once-a-day dosing)
by filling the dosing cup to the 5 
ml line. Donopez should be taken orally, in the evening,
just prior to retiring, and can be taken 
with or without food. 
The 5mg/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
5mg/day, the dose of Donopez can 
be increased to 10 ml (10mg)/day (once – a- day dosing),
by filling the dosing cup to the 10 ml 
line. The maximum recommended daily dose is 10 mg. Doses
greater than 10mg/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 
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