DONEPEZIL HYDROCHLORIDE 1 Mg/Ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

N06DA02

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

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

Therapeutic area:

Anticholinesterases

Authorization status:

Authorised

Authorization date:

2014-04-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
YOU AND YOUR CAREGIVER SHOULD 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 of the 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 1mg/1ml Oral Solution is and what it is
used for
2.
What you need to know before you take Donepezil Hydrochloride 1mg/1ml
Oral
Solution
3.
How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
4.
Possible side effects
5.
How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6.
Contents of the pack and other information
Donepezil belongs to a group of medicines called acetylcholinesterase
inhibitors.
It is used to treat the symptoms of dementia in people diagnosed as
having mild to
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 1mg/1ml Oral Solution is for use in adult
patients only.
DO NOT TAKE DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION:

if you are allergic to (hypersensitive) to donepezil hydrochloride, or
to piperidine
derivatives, or any of the other ingredients of Donepezil
Hydrochloride 1mg/1ml
Oral Solution listed in section 6

if you are breast feeding
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Donepezil
Hydrochloride 1mg/1ml Oral
Solution if you have ever had:

stomach or duodenal ulcers
1.
WHAT DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION IS AND WHAT IT IS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 1mg/1ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1mg donepezil hydrochloride
Excipients with known effect:
D-Sorbitol 70% Solution (E 420) 357mg /ml
Methyl parahydroxybenzoate (E 218) 1mg/ml
Sodium metabisulphite (E223) 0.2mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
A clear colourless liquid with a strawberry odour that is essentially
free from visible foreign matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil 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 ml (5 mg)/day (once-a-day dosing) by
filling the dosing spoon to the line of 5ml. Donepezil
Hydrochloride 1mg/1ml Oral Solution should be taken orally, in the
evening, just prior to retiring, and can be taken
with or without food.
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 1mg/ml Oral Solution
can be increased to 10 ml (10 mg)/day (once-a-day dosing), by filling
the dosing spoon to the line of 10ml. 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