DONEPEZIL KRKA 5 Milligram Orodispersible Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

Krka d.d., Novo mesto

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Dosage:

5 Milligram

Pharmaceutical form:

Orodispersible Tablet

Prescription type:

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

Authorization status:

Withdrawn

Authorization date:

2014-04-22

Patient Information leaflet

Navodila prepognjena na sredini z vidno prvo stranjo (naslovom);
pharma kodi, ki izhajata iz sredine navodila, morata biti vidni!
 smer vlaken
 smer branja kode
70 mm ± 0,5 mm
70 mm ± 0,5 mm
 smer branja kode
_ - PMS-433U-KRKA_
_NA. DONEPEZIL KRKA ODT IE_  prva stran
PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil Krka 5 mg  
orodispersible tablets
Donepezil Krka 10 mg  
orodispersible tablets
Donepezil hydrochloride
YOU AND YOUR CAREGIVER SHOULD 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 Donepezil Krka is and what it is used for
2.  Before you take Donepezil Krka
3.  How to take Donepezil Krka
4.  Possible side effects
5.  How to store Donepezil Krka
6.  Further information
1. What Donepezil Krka is and what it is used for
Donepezil belongs to a group of medicines called
acetylcholinesterase inhibitors.
Donepezil Krka is used to treat the symptoms of dementia in people
diagnosed as having mild to moderately severe Alzheimer’s disease.
2. Before you take Donepezil Krka
DO NOT TAKE DONEPEZIL KRKA
• if you are allergic (hypersensitive) to donepezil hydrochloride or
to piperidine derivatives, or any of the other ingredients of
Donepezil Krka.
TAKE SPECIAL CARE WITH DONEPEZIL KRKA
Tell your doctor or pharmacist before starting to take Donepezil
Krka if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart problem (especially irregular or very slow heart beat)
• asthma or other long term lung disease
• liver problems or hepatitis
• difficulty passing urine or mild kidney disease.
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Krka 5mg Orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg donepezil hydrochloride.
Excipient:
Each orodispersible tablet contains 0.75 mg aspartame (E951), 0.30 mg glucose, 0.25 mg sucrose and 0.02 mg sorbitol
(E420).
For a full list of excipients,see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White round orodispersible tablets, bevel-edged.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Krka 5mg Orodispersible tablets 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 mg/day (once-a-day dosing). Donepezil Krka 5mg Orodispersible tablets should be taken
orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed to disintegrate before
swallowing with or without water, according to patient preference. 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 Krka 5mg Orodispersible tablets 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