Donepezil 10mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Donepezil hydrochloride

Tilgængelig fra:

Accord-UK Ltd

ATC-kode:

N06DA02

INN (International Name):

Donepezil hydrochloride

Dosering:

10mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04110000; GTIN: 5060149318904

Indlægsseddel

1
Actavis Logo
DONEPEZIL HYDROCHLORIDE 5MG AND 10MG ORODISPERSIBLE TABLETS
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.
-
The full name of this medicine is Donepezil hydrochloride
5mg and
10mg Orodispersible
Tablets
but within the leaflet it will be referred to as Donepezil tablets.
WHAT IS IN THIS LEAFLET
:
1.
What Donepezil tablets are and what they are used for
2.
What you need to know before you take Donepezil tablets
3.
How to take Donepezil tablets
4.
Possible side effects
5.
How to store Donepezil tablets
6.
Contents of the pack and other information
1. WHAT DONEPEZIL TABLETS ARE AND WHAT THEY ARE USED FOR
Donepezil tablets belong 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. Donepezil tablets are for use in adult patients only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE DONEPEZIL TABLETS IF YOU ARE
-
ALLERGIC
to donepezil hydrochloride, or to piperidine derivatives, or any of
the other ingredients
of this medicine
(listed in section 6).
.
Warnings and precautions
Treatment with Donepezil tablets should only be started and supervised
by
a doctor with experience in diagnosing and treating Alzheimer's
dementia.
Talk to your doctor or pharmacist before taking Donepezil tablets if
you:
-
have ever had
STOMACH OR DUODENAL ULCERS
, or if you are taking non steroidal anti-
inflammatory drugs (NSAIDS)
-
have ever had a
SEIZURE
. Donepezil may have the potential to cause fits or

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Donepezil hydrochloride 10mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Donepezil hydrochloride10 mg orodispersible tablet contains 10mg
donepezil
hydrochloride.
Excipients with known effect:
Each Donepezil hydrochloride 10 mg orodispersible tablet contains
249.4 mg lactose
(as lactose monohydrate) and 10 mg aspartame (E951).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
Donepezil hydrochloride 10 mg orodispersible tablets are white to
off-white round,
flat tablets with bevelled edges, embossed with ‘10’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil hydrochloride 10mg Orodispersible Tablets 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
hydrochloride
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). Therapy with
donepezil
should only be started if a caregiver is available who will regularly
monitor medicinal
product 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 regula