Dozept 10 mg film-coated-tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Donepezil hydrochloride

थमां उपलब्ध:

Rowex Ltd

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:

2008-10-10

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOZEPT 5 MG FILM-COATED TABLETS
DOZEPT 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dozept
is and what it is used for
2.
What do you need to know before you take Dozept
3.
How to take Dozept
4.
Possible side effects
5.
How to store Dozept
6.
Contents of the pack and other information
1
WHAT DOZEPT IS AND WHAT IT IS USED FOR
Dozept
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.
Dozept
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
Dozept
film-coated tablets are for use in adult patients only.
2
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE DOZEPT
DO NOT TAKE DOZEPT
if you are
ALLERGIC
to

donepezil hydrochloride or

piperidine derivatives, which are similar substances to donepezil, or

soya, peanut or any of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Dozept.
If any of the following concerns you, you or your caregiver sho
uld
INFORM YOUR DOC

उत्पाद विशेषताएं

Health Products Regulatory Authority
23 March 2023
CRN00DH3W
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dozept 10 mg film-coated-tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of donepezil as (donepezil
hydrochloride).
Excipient(s) with known effect:
38 mg lactose/film-coated tablet
0.4 mg soya lecithin/film-coated tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round (diameter approx. 9 mm) film-coated tablet with score
line. The tablet can be divided into equal doses.
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 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 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 disc