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RIVASTIGNIME 2MG/ML ORAL SOLUTION

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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Package leaflet: Information for the user

Rivastigmine 2mg/ml oral solution
Rivastigmine

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 Rivastigmine is and what it is used for
2. W
 hat you need to know before you take
Rivastigmine
3. How to take Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Contents of the pack and other information

1. What Rivastigmine is and what
it is used for
The active substance of Rivastigmine is
rivastigmine.
Rivastigmine belongs to a class of substances
called cholinesterase inhibitors. In patients with
Alzheimer’s dementia or dementia due to
Parkinson’s disease, certain nerve cells die in
the brain, resulting in low levels of the
neurotransmitter acetylcholine (a substance
that allows nerve cells to communicate with
each other). Rivastigmine works by blocking the
enzymes that break down acetylcholine:
acetylcholinesterase and butyrylcholinesterase.
By blocking these enzymes, Rivastigmine
allows levels of acetylcholine to be increased in
the brain, helping to reduce the symptoms of
Alzheimer’s disease and dementia associated
with Parkinson’s disease.
Rivastigmine is used for the treatment of adult
patients with mild to moderately severe
Alzheimer’s dementia, a progressive brain
disorder that gradually affects memory,
intellectual ability and behaviour. It can also be
used for the treatment of dementia in adult
patients with Parkinsonʼs disease.

2. What you need to know
before you take Rivastigmine
Do not take Rivastigmine
• if you are allergic to rivastigmine (the active
substance in Rivastigmine) or any of the
other ingredients of this medicine listed in
section 6.
If this applies to you, tell your doctor and do not
take Rivastigmine.

Warnings and precautions
Talk to your doctor before taking Rivastigmine:
• if you have, or have ever had, irregular or
slow heartbeat.
• if you have, or have ever had, an active
stomach ulcer.
• if you have, or have ever had, difficulties in
passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or
severe respiratory disease.
• if you have, or have ever had impaired
kidney function.
• if you have, or have ever had, impaired
liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as
feeling sick (nausea), being sick (vomiting)
and diarrhoea. You may become dehydrated
(losing too much fluid) if vomiting or diarrhoea
are prolonged.
If any of these apply to you, your doctor may
need to monitor you more closely while you are
on this medicine.
If you have not taken Rivastigmine for more
than three days, do not take the next dose until
you have talked to your doctor.
Children and adolescents
There is no relevant use of Rivastigmine in the
paediatric population in the treatment of
Alzheimer’s disease.

Other medicines and Rivastigmine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Rivastigmine should not be given at the same
time as other medicines with similar effects to
Rivastigmine. Rivastigmine might interfere with
anticholinergic medicines (medicines used to
relieve stomach cramps or spasms, to treat
Parkinsonʼs disease or to prevent travel
sickness). Rivastigmine should not be given at
the same time as metoclopromide (a medicine
used to relieve or prevent nausea and
vomiting). Taking the two medicines together
could cause problems such as stiff limbs and
trembling hands.
If you have to undergo surgery whilst taking
Rivastigmine, tell your doctor before you are
given any anaesthetics, because Rivastigmine
may exaggerate the effects of some muscle
relaxants during anaesthesia. Caution when
Rivastigmine is taken together with betablockers (medicines such as atenolol used to

treat hypertension, angina, and other heart
conditions). Taking the two medicines together
could cause problems such as slowing of the
heartbeat (bradycardia) leading to fainting or
loss of consciousness.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
If you are pregnant, the benefits of using
Rivastigmine must be assessed against the
possible effects on your unborn child.
Rivastigmine should not be used during
pregnancy, unless clearly necessary.
You should not breast-feed during treatment
with Rivastigmine.
Driving and using machines
Your doctor will tell you whether your illness
allows you to drive vehicles and use machines
safely. Rivastigmine may cause dizziness and
somnolence, mainly at the start of treatment or
when increasing the dose. If you feel dizzy or
sleepy, do not drive, use machines or perform
any tasks that require your attention.

Important information about some of the
ingredients of Rivastigmine
One of the inactive ingredients in Rivastigmine
oral solution is sodium benzoate. Benzoic acid
is a mild irritant to the skin, eyes and mucous
membranes. Rivastigmine also contains
1.867mg sodium per ml of solution. This should
be taken into account by patients on a
controlled sodium diet.

3. How to take Rivastigmine
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

How to start treatment
Your doctor will tell you what dose of
Rivastigmine to take.
• Treatment usually starts with a low dose.
• Your doctor will slowly increase your dose
depending on how you respond to the
treatment.
• The highest dose that should be taken is
6.0mg twice a day.
Your doctor will regularly check if the medicine
is working for you. Your doctor will also monitor
your weight whilst you are taking this medicine.
If you have not taken Rivastigmine for more
than three days, do not take the next dose until
you have talked to your doctor.

Taking this medicine
• Tell your caregiver that you are taking
Rivastigmine.
• To benefit from your medicine, take it
every day.
• Take Rivastigmine twice a day, in the morning
and evening, with food.
How to use this medicine

1. Preparing the bottle
and syringe

• Take the syringe out
of its protective case.

• Push down and turn the
child resistant cap to
open bottle.











2. Inserting the syringe
adaptor into opening of
white stopper.

3. Attaching the syringe to
the adaptor
• Push the nozzle of the
syringe into the hole in
the adaptor.

4. Filling the syringe
• Pull the plunger
upwards until it reaches
the right mark for the
dose that your doctor
has prescribed.

















5. Removing bubbles
• Push down and pull up
the plunger a few times
to get rid of any large
bubbles.
• A few tiny bubbles are
not important and will
not affect your dose in
any way.
• Check the dose is still
correct.
• Then, remove the
syringe from the bottle.
6. Taking your medicine
• Swallow your medicine
straight from the
syringe.
• You can also mix your
medicine with water in
a small glass. Stir and
drink all of the mixture.
7. After using the syringe
• Wipe the outside of the
syringe and the adaptor
with a clean tissue.
• Then, put the syringe
back in its protective
case.
• Put the child resistant
cap back on the bottle
to close it.

If you take more Rivastigmine than
you should
If you accidentally take more Rivastigmine than
you should, inform your doctor. You may require
medical attention. Some people who have
accidentally taken too much Rivastigmine have
experienced feeling sick (nausea), being sick
(vomiting), diarrhoea, high blood pressure and
hallucinations. Slow heartbeat and fainting may
also occur.
If you forget to take Rivastigmine
If you find you have forgotten to take your dose
of Rivastigmine, wait and take the next dose at
the usual time. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You may have side effects more often when
you start your medicine or when your dose is
increased. Usually, the side effects will slowly
go away as your body gets used to the medicine.

Very common
(may affect more than 1 in 10 people)
• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling sick
(nausea) or being sick (vomiting), diarrhoea
Common
(may affect up to 1 in 10 people)
• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• Decreased appetite
• Nightmares
Uncommon
(may affect up to 1 in 100 people)
• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working
Rare
(may affect up to 1 in 1,000 people)
• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine
Very rare
(may affect up to 1 in 10,000 people)
• High blood pressure
• Urinary tract infection
• Seeing things that are not there
(hallucinations)
• Problems with your heartbeat such as fast or
slow heartbeat
• Bleeding in the gut - shows as blood in stools
or when being sick
• Inflammation of the pancreas – the signs
include serious upper stomach pain, often
with feeling sick (nausea) or being sick
(vomiting)
• The signs of Parkinsonʼs disease get worse
or getting similar signs - such as stiff
muscles, difficulty in carrying out movements
Not known
(frequency cannot be estimated from the
available data)
• Being violently sick (vomiting) that can cause
tearing of the tube that connects your mouth
with your stomach (oesophagus)
• Dehydration (losing too much fluid)
• Liver disorders (yellow skin, yellowing of the
whites of the eyes, abnormal darkening of the
urine or unexplained nausea, vomiting,
tiredness and loss of appetite)

• Aggression, feeling restless
• Uneven heartbeat
Patients with dementia and
Parkinsonʼs disease
These patients have some side effects more
often. They also have some additional side
effects:

Very common
(may affect more than 1 in 10 people)
• Trembling
• Fainting
• Accidentally falling
Common
(may affect up to 1 in 10 people)
• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements
you cannot control
• The signs of Parkinsonʼs disease get worse
or getting similar signs - such as stiff
muscles, difficulty in carrying out movements
and muscle weakness
Uncommon
(may affect up to 1 in 100 people)
• Uneven heartbeat and poor control of
movements
Other side effects seen with rivastigmine
transdermal patches and which may occur
with the oral solution:

Common
(may affect up to 1 in 10 people)
• Fever
• Severe confusion
• Urinary incontinence (inability to retain
adequate urine)
Uncommon
(may affect up to 100 people)
• Hyperactivity (high level of activity, restlessness)
Not Known
(frequency cannot be estimated from the
available data)
• Allergic reaction where the patch was used,
such as blisters or skin inflammation
If you get any of these side effects, contact your
doctor as you may need medical assistance.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: 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 Rivastigmine
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Do not refrigerate or freeze.
Store in an upright position.
Use Rivastigmine oral solution within 1 month
of opening the bottle.
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 Rivastigmine contains
• The active substance is rivastigmine
hydrogen tartrate. Each ml contains
rivastigmine hydrogen tartrate corresponding
to rivastigmine base 2.0mg.
• The other ingredients are sodium benzoate
(E211), citric acid monohydrate (E330),
sodium citrate (E331), quinoline yellow WS
(E104) and purified water.

What Rivastigmine looks like and
contents of the pack
Rivastigmine oral solution is supplied as 50ml
or 120ml of a clear, yellow solution (2.0mg/ml
base) in a type III amber glass bottle closed
with a child resistant tamper-evident screw cap.
The oral solution is packaged with an oral
dosing syringe and a syringe adaptor, in a
plastic tube container.
Marketing Authorisation holder
Aspire Pharma Ltd
Bellamy House, Winton Road, Petersfield,
Hampshire, GU32 3HA, United Kingdom
Manufacturer
One Pharma Industrial Pharmaceutical
Company S.A.
60th km of Athens - Lamia Highway,
GR 320 09, Greece
and
Pharmathen S.A.
Dervenakion 6, Pallini 15351, Attiki, Greece
This leaflet was last revised in:
11/2015

1010065-P5.1

Artwork for:
Aspire Pharma Limited
Product name:
Rivastigmine 2mg/ml
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 400mm x 148mm
Profile supplied: Assumed
Date of first artwork: 12 July 2011
Reason for request: Text revisions
Version no: 5.1
Date of revision:
24 November 2015
Colours:
As swatch(es)
Font(s):
Text: 8pt Helvetica Headings: 9pt Helvetica
Artwork software:
InDesign CS6
BAC ref: S810

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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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