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DONEPEZIL NICHE 5MG FILM COATED TABLETS

Active substance(s): DONEPEZIL HYDROCHLORIDE

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Package Leaflet: Information for the User

Donepezil Niche 5mg and 10mg 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.
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.
What is in this leaflet:
1. What Donepezil Niche is and what
it is used for
2. What you need to know before you
take Donepezil Niche
3. How to take Donepezil Niche
4. Possible side effects
5. How to store Donepezil Niche
6. Contents of the pack and other
information

Donepezil Niche with food, drink and
alcohol
Donepezil Niche can be taken with or
without food.
You should avoid drinking alcohol while you
are taking Donepezil Niche because the
alcohol may change the effect of Donepezil
Niche.
Pregnancy and breast-feeding


If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice
before taking this medicine.



Donepezil Niche should not be taken if
you are pregnant, planning to become or
think you could be pregnant unless your
doctor decides that it is clearly
necessary.



Donepezil Niche must not be used while
breast-feeding.

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.

Driving and using machines

Donepezil Niche is only for use in adult
patients.

Donepezil Niche contains lactose

2. What you need to know
before you take Donepezil
Niche
Do NOT take Donepezil Niche:

if you are allergic to Donepezil
hydrochloride (which is a piperidine
derivative), or to other 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 Niche if you have or have
had:

stomach or duodenal ulcers

seizures (fits) or convulsions
(uncontrollable shaking movements)

problems with your heart such as
irregular or very slow heart beat

asthma or other long term lung disease

liver problems including hepatitis (where
your skin and whites of the eyes go
yellow)

difficulty passing urine or mild kidney
disease

Alzheimer’s disease may impair your ability
to drive or operate machinery and you must
not perform these activities unless your
doctor tells you that it is safe to do so. Also,
your medicine can cause tiredness, dizziness
and muscle cramp. If affected you must not
drive or operate machinery.

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3. How to take Donepezil Niche
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure. Tell your
doctor the name of your caregiver. Your
caregiver will help you take your medicine as
it has been prescribed.


The tablet strength you will take may
change depending on the length of time
you have been taking the medicine and
on what your doctor recommends.



Usually, you will start by taking 5 mg (one
white tablet) every night.



After one month, your doctor may tell
you to take 10 mg (one yellow tablet)
every night.



The maximum recommended dose is
10 mg each night.

Swallow your Donepezil Niche tablet with a
drink of water before you go to bed at night.
DO NOT alter the dose yourself without
your doctor’s advice.
Patients with kidney problems

Children
Donepezil Niche is not recommended for
use in children.

You can take the usual dose as described
above. No dose adjustment is needed.
Patients with liver problems

Other medicines and Donepezil Niche
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. These medicines may alter
the effects of Donepezil Niche if they are
taken together.
In particular, tell your doctor if you are
taking any of the following types of
medicines:

other Alzheimer’s disease medicines,
such as galantamine

pain killers or treatment for arthritis e.g.
aspirin, non-steroidal anti-inflammatory
(NSAID) drugs such as ibuprofen, or
diclofenac sodium

anticholinergics medicines, such as
tolterodine

antibiotics, such as erythromycin,
rifampicin

medicines used to treat fungal infections,
such as ketoconazole, itraconazole

anti-depressants, such as fluoxetine

medicines to control fits or convulsions,
such as phenytoin, carbamazepine

medication for a heart condition, such as
quinidine, beta-blocker (propanolol and
atenolol)

muscle relaxants, such as diazepam,
succinylcholine

general anaesthetic

medicines obtained without a
prescription, such as herbal remedies
If you are going to have an operation that
requires you to have a general anaesthetic,
you should tell your doctor and the
anaesthetist that you are taking Donepezil
Niche. This is because your medicine may
affect the amount of anaesthetic needed.

Your doctor will monitor you before
increasing the dose if you have mild or
moderate liver problems. If you have severe
liver problems, your doctor will decide if
Donepezil Niche is suitable for you.
Your doctor or pharmacist will advise you on
how long you should continue to take your
tablets. You will need to see your doctor
from time to time to review your treatment
and assess your symptoms.
If you take more Donepezil Niche than
you should
DO NOT take more than one tablet each
day. Contact your doctor or nearest hospital
casualty department immediately if you take
more than you should. Take any remaining
tablets, the carton and/or leaflet with you to
the hospital so that the doctor knows what
has been taken.
If you do take more than you should, you
might get symptoms such as feeling and
being sick, drooling, sweating, slow heart
rate, low blood pressure (light-headedness
or dizziness when standing), breathing
problems, losing consciousness and
seizures (fits) or convulsions.
If you forget to take Donepezil Niche
If you forget to take a tablet, just take one
tablet the following day at the usual time.
Do not take a double dose to make up for a
forgotten tablet.
If you forget to take your medicine for more
than one week, call your doctor before
taking any more medicine.
If you stop taking Donepezil Niche
Do not stop taking the tablets unless told to
do so by your doctor. If you stop taking
Donepezil Niche, the benefits of your
treatment will gradually fade away.

4. Possible side effects

Reporting of side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet.

The following side effects have been
reported by people taking Donepezil Niche.
Tell your doctor or pharmacist if you
have any of these effects while you are
taking Donepezil Niche.
Serious side effects:
You must tell your doctor immediately if you
notice these serious side effects mentioned.
You may need urgent medical treatment.

liver damage e.g. hepatitis. The
symptoms of hepatitis are feeling or
being sick, loss of appetite, feeling
generally unwell, fever, itching, yellowing
of the skin and eyes, and dark coloured
urine (may affect up to 1 in 1,000 people)

stomach or duodenal ulcers. The
symptoms of ulcers are stomach pain and
discomfort (indigestion) felt between the
navel and the breast bone (may affect up
to 1 in 100 people)

bleeding in the stomach or intestines.
This may cause you to pass black tar like
stools or visible blood from the rectum
(back passage) (may affect up to 1 in 100
people)

seizures (fits) or convulsions (may affect
up to 1 in 100 people)

fever with muscle stiffness, sweating or a
lowered level of consciousness (a
disorder called “Neuroleptic Malignant
Syndrome”) (may affect up to 1 in 1,000
people)

muscle weakness, tenderness or pain
and particularly, if at the same time, you
feel unwell, have a high temperature or
have dark urine. They may be caused by
an abnormal muscle breakdown which
can be life threatening and lead to kidney
problems (a condition called
rhabdomyolysis).
Other side effects:
Very common: may affect more than 1
in 10 people

diarrhoea

feeling or being sick

headaches

You can also report side effects directly via
the Yellow Card Scheme website
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5. How to store Donepezil Niche
Keep this medicine out of the sight and
reach of children.
Do not store above 30°C.
DO NOT use this medicine after the expiry
date which is stated on the blister and
carton after EXP. The expiry date refers to
the last day of that month.
If your doctor tells you to stop taking your
medicine, you should return any you have
not used to your pharmacist. Do not throw
away any medicines via wastewater or
household waste. Ask your pharmacist how
to throw away medicines you no longer use.
These measures will help protect the
environment.

6. Contents of the pack and
other information
What Donepezil Niche contains

The active substance is Donepezil
hydrochloride. The 5 mg tablet contains
5 mg of Donepezil hydrochloride and the
10 mg tablet contains 10 mg of Donepezil
hydrochloride.

The other ingredients are lactose
monohydrate, cellulose microcrystalline,
magnesium stearate, croscarmellose
sodium, talc, macrogol, polyvinyl alcohol,
titanium dioxide (E171).

Additionally, the 10 mg tablet contains
synthetic iron oxide yellow (E172).
What Donepezil Niche looks like and
contents of the pack

5 mg white tablets marked ‘D5’ on one
side and plain on the other.

10 mg yellow tablets marked ‘D10’ on
one side and plain on the other.
The tablets are supplied in packs of 7, 14,
28, 30, 50, 56, 60, 84, 98, 112 or 120 tablets.

Common: may affect up to 1 in 10
people

muscle cramp

tiredness

difficulty in sleeping (insomnia)

the common cold

loss of appetite

hallucinations (seeing or hearing things
that are not really there)

unusual dreams including nightmares

agitation

aggressive behaviour

fainting

dizziness

stomach feeling uncomfortable

rash

itching

inability to control passing water
(incontinence)

general pain occurring over the body

accidents (patients may be more prone to
falls and accidental injury)

Not all pack sizes may be marketed.

Uncommon: may affect up to 1 in 100
people

slow heart beat

minor increases in blood levels of muscle
enzyme (creatine kinase), as shown by
blood tests

This leaflet was last revised in October
2015.

Rare: may affect up to 1 in 1,000 people
stiffness, shaking or uncontrollable
movement especially of the face and
tongue but also of the limbs

irregular heartbeat, e.g. feeling your
heart beat faster or slower


Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Niche Generics Ltd
1 The Cam Centre
Wilbury Way
Hitchin
Hertfordshire
SG4 0TW
United Kingdom
The Manufacturer is:
Niche Generics Ltd
Unit 5
151 Baldoyle Industrial Estate
Dublin 13
Ireland

This medicinal product is authorised in
the Member States of the EEA under
the following names:
UK: Donepezil Niche 5mg/10mg Film-Coated
Tablets
Ireland: Donepezil Niche 5mg/10mg FilmCoated Tablets

Niche Generics Limited,
Unit 5, 151 Baldoyle Industrial Estate, Baldoyle,
Dublin 13, Ireland
Tel: +353 (0)18167300
e-mail: artwork@nichegenerics.ie
Title:

Donepezil 5mg and 10mg Film-Coated
Tablets Niche UK

MA Number/s:

UK: PL 19611/0107, 19611/0112

Date of Origination:

16/07/2009

Dimensions:

480mm x 145mm

Colours:

Black

Item Code:

N/A

Pharmacode:

TBD

Version Number:

15

Revision Date:

26/11/2015

Reason for Revision:

30/09/15 - addition of risk on
rhabdomyoysis, to align with current
QRD template and to split joint IE/UK
leaflet into 2 separate leaflets.
26/11/15 - updated revision date

Software: QuarkXpress 4.1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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