Donepezil Krka 10 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Donepezil hydrochloride

थमां उपलब्ध:

KRKA, d.d., Novo mesto

ए.टी.सी कोड:

N06DA; N06DA02

INN (इंटरनेशनल नाम):

Donepezil hydrochloride

डोज़:

10 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Anticholinesterases; donepezil

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2011-10-28

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DONEPEZIL KRKA 5 MG FILM-COATED TABLETS
DONEPEZIL KRKA 10 MG FILM-COATED TABLETS
donepezil hydrochloride
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 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 Krka is and what it is used for
2.
What you need to know before you take Donepezil Krka
3.
How to take Donepezil Krka
4.
Possible side effects
5.
How to store Donepezil Krka
6.
Contents of the pack and other information
1.
WHAT DONEPEZIL KRKA IS AND WHAT IT IS USED FOR
Donepezil Krka contains the active substance donepezil hydrochloride.
Donepezil Krka (donepezil
hydrochloride) belongs to a group of medicines called
acetylcholinesterase inhibitors. Donepezil
increases the levels of a substance (acetylcholine) in the brain
involved in memory function by
slowing down the breakdown of acetylcholine.
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.
Donepezil Krka is for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL KRKA
DO NOT TAKE DONEPEZIL KRKA
-
if you are allergic to donepezil hydrochloride, to piperidine
derivatives or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Donepezil Krka if you
hav

उत्पाद विशेषताएं

Health Products Regulatory Authority
18 April 2023
CRN00D7L1
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donepezil Krka 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg donepezil hydrochloride (as
monohydrate) equivalent to 9.12 mg donepezil.
Excipient with known effect:
10 mg
Lactose (mg)
158.35
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellowish-brown, rounded, diameter approx. 9 mm, biconvex, film-coated
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donepezil Krka 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 mg/day (once-a-day dosing). 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
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 regular basis. Discontinuation should be considered
when evidence of a therapeutic effect is no longer present.
Individual response to donepezil cannot be predicted.
Upon discontinuation of treatment,