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RIVASTIGMINE 3MG CAPSULES

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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TEVA UK Ref:

231-30-64201-F LEA RIVASTIGMINE A/S CAPS TUK
Rivastigmine 1.5 mg Capsules
Rivastigmine 3 mg Capsules
Rivastigmine 4.5 mg Capsules
Rivastigmine 6 mg Capsules
Rivastigmine

Placement for Pharmacode no.

Package leaflet:
Information for the user

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.
WHAT IS IN THIS LEAFLET:

1. What Rivastigmine is and what it is used for
2. What 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 symptomatic
treatment of in adult patients with mild to
moderately severe Alzheimer’s demetia, a
progression brain disorder that gradually affects
memory, intellectual ability and behaviour. The
capsules can also be used for the symptomatic
treatment of mild to moderately severe dementia
in adult patients with Parkinson’s disease.

Version:

1

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 several
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/using, have recently taken/used or might
take/use any other medicines, including
medicines obtained without a prescription.
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
Parkinson’s disease or to prevent travel
sickness).
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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, thick 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.
Rivastigmin 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.

3

HOW TO TAKE RIVASTIGMINE

Placement for Pharmacode no.

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.
YOU NEED TO KNOW BEFORE
• Your doctor will slowly increase your dose
2 WHAT
YOU TAKE RIVASTIGMINE
depending on how you respond to treatment.
The highest dose that should be taken is 6 mg
Do not take Rivastigmine
• if you are allergic to rivastigmine (the active twice a day.
substance in Rivastigmine), to other
Your doctor will regularly check if the medicine
substances related to rivastigmine or any of is working for you. Your doctor will also monitor
the other ingredients of this medicine (listed your weight whilst you are taking this medicine.
in section 6).
If you have not taken Rivastigmine for several
• if you have had a previous skin reaction
suggestive of allergic contact dermatitis with days, do not take the next dose until you have
talked to your doctor.
rivastigmine patches.
If this applies to you, tell your doctor and do not Taking this medicine
• Tell your caregiver that you are taking
take Rivastigmine.
Rivastigmine.
Warnings and precautions
• To benefit from your medicine, take it every
Talk to your doctor or pharmacist before taking
day.
Rivastigmine.
• Take Rivastigmine twice a day, in the
• if you have, or have ever had, irregular
morning and evening, with food.
heartbeat.
• Swallow the capsules whole with a drink.
• if you have, or have ever had, an active
• Do not open or crush the capsules.
stomach ulcer
If you take more Rivastigmine than you should
• if you have, or have ever had, difficulties in
If you accidentally take more Rivastigmine than
passing urine.
you should, inform your doctor. You may require
• if you have, or have ever had, seizures.
medical attention. Some people who have
• if you have, or have ever had, asthma or
accidentally taken too much Rivastigmine have
severe respiratory disease.
experienced feeling sick (nausea), being sick
• if you have, or have ever had impaired
(vomiting), diarrhoea, high blood pressure and
kidney function
• if you have, or have ever had, impaired liver hallucinations. Slow heart-beat and fainting
may also occur.
function.
• if you suffer from trembling.
If you forget to take Rivastigmine
• if you have a low body weight.
• if you have gastrointestinal reactions such as If you find you have forgotten to take your dose
of Rivastigmine, wait and take the next dose at
feeling sick (nausea), being sick (vomiting)
and diarrhoea. You may become dehydrated the usual time. Do not take a double dose to
make up for a forgotten dose.
(losing too much fluid) if vomiting or
diarrhoea are prolonged.

Size : 160 x 350 mm Front/Back

04 August 2015

TEVA UK Ref:

231-30-64201-F LEA RIVASTIGMINE A/S CAPS TUK
Version:

1

Other side effects seen with
rivastigmine-containing transdermal patches
and which may occur with the hard capsules:
4 POSSIBLE SIDE EFFECTS
Common (may affect up to 1 in 10 people)
Like all medicines, this medicine can cause side • Fever
• Severe confusion
effects, although not everybody gets them.
• Decreased appetite
You may have side effects more often when you • Urinary incontinence (inability to retain
start your medicine or when your dose is
adequate urine)
increased. Usually, the side effects will slowly
Uncommon
(may affect up to 1 in 100 people)
go away as your body gets used to the
• Hyperactivity (high level of activity,
medicine.
restlessness)
Very common (may affect more than 1 in 10
Not
known (frequency cannot be estimated
people)
from the available data)
• Feeling dizzy
• Allergic reaction where the patch was used,
• Loss of appetite
such as blisters or skin inflammation
• Stomach problems such as feeling sick
(nausea) or being sick (vomiting), diarrhoea
If you get any of these side effects, contact your
doctor as you may need medical assistance.
Common (may affect up to 1 in 10 people)
• Anxiety
Reporting of side effects
• Sweating
If you get any side effects, talk to your doctor or
• Headache
pharmacist. This includes any possible side
• Heartburn
effects not listed in this leaflet. You can also
• Weight loss
report side effects directly via the Yellow Card
• Stomach pain
Scheme at: www.mhra.gov.uk/yellowcard.
• Feeling agitated
By reporting side effects you can help provide
• Feeling tired or weak
more information on the safety of this medicine.
• Generally feeling unwell
• Trembling or feeling confused
5 HOW TO STORE RIVASTIGMINE
Uncommon (may affect up to 1 in 100 people)
Keep this medicine out of the reach and sight of
• Depression
children.
• Difficulty in sleeping
Do not use this medicine after the expiry date
• Fainting or accidentally falling
which is stated on the outer carton and the
• Changes in how well your liver is working
blister. The expiry date refers to the last day of
Rare (may affect up to 1 in 1,000 people)
that month.
• Chest pain
This medicinal product does not require any
• Rash, itching
special storage conditions.
• Fits (seizures)
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

• Ulcers in your stomach or intestine
Very rare (may affect up to 1 in 10,000 people)
• High blood pressure
• Urinary tract infection
• Seeing and hearing 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 Parkinson’s 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 Parkinson’s 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
• Depression
• Seeing things that are not there
(hallucinations, visual)
• High blood pressure
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements
you cannot control
• The signs of Parkinson’s 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
• Low blood pressure

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Rivastigmine contains
The active substance is rivastigmine.
Each capsule contains 1.5 mg, 3 mg, 4.5 mg or
6 mg rivastigmine as rivastigmine hydrogen
tartrate.
The other ingredients are:
Capsule shell:
1.5 mg:
Gelatin, Sodium Lauril Sulfate, Titanium Dioxide
(E171), Yellow Iron Oxide (E172)
3 mg, 4.5 mg, 6 mg:
Gelatin, Sodium Lauril Sulfate, Titanium Dioxide
(E171), Yellow Iron Oxide (E172), Red Iron Oxide
(E172)
Contents:
Microcrystalline Cellulose, Hypromellose, Silica
colloidal anhydrous, Magnesium Stearate
What Rivastigmine looks like and contents of
the pack
1.5 mg: Yellow capsules, hard.
3 mg: Orange capsules, hard.
4.5mg: Red capsules, hard.
6 mg: Capsules, hard with orange body and red
cap.
Rivastigmine is available in packs containing 20,
28, 30, 56, 60, 100, 112 or 120 capsules, hard.
Not all pack sizes may be marketed.
Marketing authorisation holder
Teva UK Limited, Eastbourne, BN22 9AG, United
Kingdom
Manufacturer
Merckle GMBH Ludwig-Merckle-Straße 3, 89143
Blaubeuren-weiler, Germany
This leaflet was last revised in July 2015
PL 00289/1688
PL 00289/1689
PL 00289/1690
PL 00289/1691

64201-F

04 August 2015

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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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