Donepezil 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Donepezil hydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06DA02

INN (International Name):

Donepezil hydrochloride

Dosage:

10mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5016695003078

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Donepezil Hydrochloride 10 mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg donepezil hydrochloride (as
monohydrate),
equivalent to 9.12 mg of donepezil free base.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet
Donepezil Hydrochloride 10 mg are yellow coloured round flat bevelled
edged
tablets, debossed with “DL 10” on one side and “M” on the
other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Donepezil Hydrochloride 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
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 hydrochloride 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
hydrochloride
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 hydrochloride
cannot be
predicted.
Upon disco