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RIVASTIGMINE 6MG CAPSULES

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE / RIVASTIGMINE HYDROGEN TARTRATE

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TEVA UK Ref:

Version:

231-30-64201-G LEA RIVASTIGMINE A/S CAPS TUK Dimensions:
Length:
Width:

1

Colours Used:
350 mm
160 mm

07 April 2016

BLACK

Template

PANTONE® GREEN C

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.
Rivastigmine
If you have not taken Rivastigmine for more
than three days, do not take the next dose until
Package leaflet:
you have talked to your doctor.
Information for the user
Children and adolescents
There is no relevant use of Rivastigmine in the
Read all of this leaflet carefully before you
paediatric population in the treatment of
start taking this medicine because it
Alzheimer’s disease.
contains important information for you.
Other medicines and Rivastigmine
• Keep this leaflet. You may need to read it
again.
Tell your doctor or pharmacist if you are
• If you have any further questions, ask your taking/using, have recently taken/used or might
doctor or pharmacist.
take/use any other medicines.
• This medicine has been prescribed for you
Rivastigmine should not be given at the same
only. Do not pass it on to others. It may
time as other medicines with similar effects to
harm them, even if their signs of illness
Rivastigmine.
are the same as yours.
Rivastigmine might interfere with
• If you get any side effects, talk to your
anticholinergic medicines (medicines used to
doctor or pharmacist. This includes any
relieve stomach cramps or spasms, to treat
possible side effects not listed in this
Parkinson’s disease or to prevent travel
leaflet. See section 4.
sickness).
What is in this leaflet
Rivastigmine should not be given at the same
1. What Rivastigmine is and what it is used for time as metoclopramide (a medicine used to
relieve or prevent nausea and vomiting). Taking
2. What you need to know before you take
the two medicines together could cause
Rivastigmine
problems such as stiff limbs and trembling
3. How to take Rivastigmine
hands.
4. Possible side effects
5. How to store Rivastigmine
If you have to undergo surgery whilst taking
6. Contents of the pack and other information
Rivastigmine, tell your doctor before you are
given any anaesthetics, because Rivastigmine
WHAT
RIVASTIGMINE
IS
AND
WHAT
IT
1 IS USED FOR
may exaggerate the effects of some muscle
relaxants during anaesthesia.
The active substance of Rivastigmine is
Caution when Rivastigmine is taken together
rivastigmine.
with beta-blockers (medicines such as atenolol
used to treat hypertension, angina and other
Rivastigmine belongs to a class of substances
called cholinesterase inhibitors. In patients with heart conditions). Taking the two medicines
together could cause problems such as slowing
Alzheimer’s dementia or dementia due to
of the heartbeat (bradycardia) leading to
Parkinson’s disease, certain nerve cells die in the
fainting or loss of consciousness.
brain, resulting in low levels of the
neurotransmitter acetylcholine (a substance that Pregnancy, breast-feeding and fertility
allows nerve cells to communicate with each
If you are pregnant or breast-feeding, thick you
other). Rivastigmine works by blocking the
may be pregnant or are planning to have a
enzymes that break down acetylcholine:
baby, ask your doctor or pharmacist for advice
acetylcholinesterase and butyrylcholinesterase. before taking this medicine.
By blocking these enzymes, rivastigmine allows
If you are pregnant the benefits of using
levels of acetylcholine to be increased in the
Rivastigmine must be assessed against the
brain, helping to reduce the symptoms of
possible effects on your unborn child.
Alzheimer’s disease and dementia associated
Rivastigmin should not be used during
with Parkinson’s disease.
pregnancy unless clearly necessary. You should
Rivastigmine is used for the symptomatic
not breast-feed during treatment with
treatment of in adult patients with mild to
Rivastigmine
moderately severe Alzheimer’s demetia, a
Driving and using machines
progression brain disorder that gradually affects
memory, intellectual ability and behaviour. The Your doctor will tell you whether your illness
capsules can also be used for the symptomatic allows you to drive vehicles and use machines
treatment of mild to moderately severe dementia safely. Rivastigmine may cause dizziness and
somnolence, mainly at the start of treatment or
in adult patients with Parkinson’s disease.
when increasing the dose. If you feel dizzy or
WHAT
YOU
NEED
TO
KNOW
BEFORE
sleepy, do not drive, use machines or perform
2 YOU TAKE RIVASTIGMINE
any tasks that require your attention.

Placement for Pharmacode no.

Rivastigmine 1.5 mg Capsules
Rivastigmine 3 mg Capsules
Rivastigmine 4.5 mg Capsules
Rivastigmine 6 mg Capsules

3

HOW TO TAKE RIVASTIGMINE

Always take this medicine exactly as your
doctor has told you. Check with your doctor,
pharmacist or nurse 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 treatment.
The highest dose that should be taken is 6 mg
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.
• Swallow the capsules whole with a drink.
• Do not open or crush the capsules.

Size : 160 x 350 mm Front/Back

REG0080388

Version 3.2

Approved

Page 2 of 4

Placement for Pharmacode no.

Do not take Rivastigmine
• if you are allergic to rivastigmine (the active
substance in Rivastigmine), to other
substances related to rivastigmine or any of
the other ingredients of this medicine (listed
in section 6).
• if you have had a previous skin reaction
suggestive of allergic contact dermatitis with
rivastigmine patches.
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)

TEVA UK Ref:

Version:

231-30-64201-G LEA RIVASTIGMINE A/S CAPS TUK Dimensions:
Length:
Width:

1

07 April 2016

Colours Used:
350 mm
160 mm

BLACK

Template

PANTONE® GREEN C

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

• 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 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

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 04/2016
PL 00289/1688
PL 00289/1689
PL 00289/1690
PL 00289/1691

64201-G

REG0080388

Version 3.2

Approved

Page 3 of 4

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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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