DONEPEZIL NICHE 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

Niche Generics Limited

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DONEPEZIL NICHE 5 MG FILM-COATED TABLETS 
DONEPEZIL NICHE 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. 

The name of your medicine is Donepezil Niche 5 mg and 10
mg Film-coated Tablets. It will 
be called Donepezil Niche for ease from here on. 

IN THIS LEAFLET: 
1.  WHAT DONEPEZIL NICHE IS AND WHAT IT IS USED FOR 
2.  BEFORE YOU TAKE DONEPEZIL NICHE 
3.  HOW TO TAKE DONEPEZIL NICHE 
4.  POSSIBLE SIDE EFFECTS 
5.  HOW TO STORE DONEPEZIL NICHE 
6.  FURTHER INFORMATION 

1. 
WHAT DONEPEZIL NICHE IS AND WHAT IT IS USED FOR 

The active ingredient in your tablets is donepezil hydrochloride.
It works by increasing the 
amount of a substance called acetylcholine in the brain. 

It is used to treat the symptoms of dementia (changes in the way the
brain works) in people 
with mild to moderately severe Alzheimer’s disease.  These
symptoms include increasing 
memory loss, confusion and changes in the way you behave, making it
more difficult to carry 
out normal daily activities. 

Donepezil Niche is only for use only in adult patients. 

2. 
BEFORE YOU TAKE DONEPEZIL NICHE 

DO NOT TAKE DONEPEZIL NICHE IF YOU: 
•  know that you are allergic (hypersensitive) to Donepezil
hydrochloride (which is a 
piperidine derivative), or to other piperidine derivatives, or
any of the other 
ingredients of Donepezil Niche listed in section 6 

TAKE SPECIAL CARE W

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Niche 10mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains:
10 mg donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base.
Excipient: 192.0 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Donepezil Niche 10 mg film coated tablets are yellow, round, biconvex tablets debossed ‘D10’ on one side and plain
on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Niche Tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s
dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil Niche tablets 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 Niche 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). 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 th