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RIVASTIGMINE MYLAN 6 MG HARD CAPSULES

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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Package leaflet: Information for the patient

Rivastigmine 1.5 mg Capsules
Rivastigmine 3 mg Capsules
Rivastigmine 4.5 mg Capsules
Rivastigmine 6 mg Capsules
(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 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 of the 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 this medicine
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.
This medicine 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.
This medicine can also be used for
the treatment of mild to moderately
severe dementia in adult patients with
Parkinson’s disease.

2. What you need to know before you
take Rivastigmine

Before taking this medicine it is important that
you read the following section and discuss any
questions you might have with your doctor.

Do not take Rivastigmine

• if you are allergic to rivastigmine, or to any of
the other ingredients of this medicine (listed
in section 6).
• if you are allergic to medicines known as
‘carbamate derivatives’ such as neostigmine
used in the treatment of myasthenia gravis (a
disease which affects the nerves and muscles)
and darunavir used to treat HIV infection.
• if you have previously used rivastigmine as
a transdermal patch and have had a skin
reaction spreading beyond the patch size,
with a more intense local reaction (such
as blisters, increasing skin inflammation,
swelling) and not improving within 48 hours
after removal of the transdermal patch.
If this applies to you, tell your doctor and do
not take Rivastigmine.

Warnings and precautions

Talk to your doctor or pharmacist 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 have a low body weight, (below 50 kg).
If any of these apply to you, your doctor may
need to monitor you more closely while you are
on this medicine.

During treatment

Contact your doctor if you notice any of
the following:
• If you suffer from trembling.
• 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.
• You develop skin irritation or skin blistering.
• You experience seeing, hearing and feeling
things that are not there or you notice that
you are shaking, especially if this happens
shortly after your doctor has increased
your dose.
• You are constantly sick, especially if you have
just started taking a higher dose than normal.
• You notice that you are losing weight.
If you have not taken Rivastigmine for three
days, do not take the next dose until you have
talked to your doctor.

Description Rivastigmine 1.5, 6, 3, 4.5 mg ALL
Component Type Leaflet
Affiliate Item Code 779838
Superceded Affiliate Item Code 731246
TrackWise PR No. 779838
MA No.

04569/0942,
0943, 0944 & 0945

Packing Site/Printer N/A

Pharma Code 1546
SAP No. N/A
Vendor Job No. 270769
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK

Supplier Code 11300044 MI-10 Keyline/Drawing No. N/A
Barcode Info N/A

Children and adolescents

There is no relevant use of this medicine for
the treatment of Alzheimer’s disease in the
paediatric population.
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 Parkinson’s disease, to relieve bladder
problems (needing to pass water more often or
incontinence) e.g. oxybutynin, tolterodine or to
prevent travel sickness).
If you have to undergo surgery whilst taking
Rivastigmine, you should inform your doctor
before you are given any anaesthetics, because
rivastigmine may exaggerate the effects of
some muscle relaxants during anaesthesia.
Caution should be exercised when rivastigmine
is taken together with medicines known as
beta-blockers e.g. atenolol (used to treat
high blood pressure, angina and other heart
conditions) or timolol (used in eye drops to
treat glaucoma). Caution is also required
with other medicines which may lower heart
rate or rhythm e.g. diltiazem, sotalol, digoxin,
pilocarpine. Taking the two medicines together
could cause problems such as slowing of the
heartbeat (bradycardia) leading to fainting or
loss of consciousness.
If you are taking other medicines known to
affect the normal rhythm of the heart e.g.
chlorpromazine, levomepromazine, sulpiride,
sultopride, amisulpride, tiapride, veralipride,
pimozide, haloperidol, droperidol (used to
treat some mental health conditions), cisapride
(used to treat stomach and gut problems),
citalopram (used to treat depression),
diphemanil (used to treat in stomach
disorders), erythromycin IV, moxifloxacin,
(antibiotics), halofantrine (used to treat
malaria), mizolastine (used to treat allergies),
methadone (used for pain and to treat heroin
addiction) and pentamidine (a medicine used
to treat pneumonia), your doctor may want to
carry out regular checks on your heart.

Pregnancy and breastfeeding

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 this
medicine must be assessed against the possible
effects on your unborn child. This medicine
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 (feeling sleepy), 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
Always take this medicine exactly as your
doctor or pharmacist 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 this
medicine 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 this medicine for 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.

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 a decrease in the size of the
pupils, flushing, stomach pain, difficulty in
breathing and increase in phlegm, increased
sweating, loss of control of bowel movements,
incontinence, increase in production of saliva,
increase in tear production, low blood pressure,
feeling sick (nausea), being sick (vomiting),
diarrhoea, high blood pressure and hearing,
seeing and feeling things that are not there
(hallucinations). Slow heartbeat and fainting
may also occur. In severe cases, muscular
weakness, twitching, fits and stopping
breathing which may be fatal have occurred.
Additionally there have also been reports
of dizziness, shaking, headache, excessive
sleepiness, confusion, and a general feeling of
discomfort (malaise).

779838
11300044 MI-10

Date: 21 Dec 2015
No. of colours 1
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Time: 15:23
Page Count

1/2

Black

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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 stop taking Rivastigmine

Do not stop taking your capsules. It
is important that you carry on taking
Rivastigmine for as long as your doctor tells
you. 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 taking your medicine or when your
dose is increased. Usually, the side effects will
slowly go away as your body gets used to
the medicine.
If any of the following serious side effects
occur, tell your doctor or seek medical
advice immediately:
Rare (may affect up to 1 in 1,000 people):
• Fits (seizures)
• Chest pain that may become worse
when exercising
• Ulcers in your stomach or intestine
Very rare (may affect up to 1 in
10,000 people):
• Inflammation of the pancreas, which shows
as serious upper stomach pain, often with
symptoms such as 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
• Irregular heartbeat, which you may notice as
an uneven heart beat or skipping a beat
• Bleeding in the gut – shows as blood in stools
or when being sick
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)
• 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)

Other possible side effects:

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
• Drowsiness
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• 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,
which may show up in tests
Rare (may affect up to 1 in 1,000 people):
• Rash
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
Not known (frequency cannot be estimated
from the available data):
• Aggression, feeling restless
• Uneven heartbeat
• Losing too much fluid (dehydration)
• Itching
• Widespread skin reaction

Patients with dementia and Parkinson’s
disease

These patients have some side effects more
often. They also have some additional side
effects:

If any of the following serious side effects
occur, tell your doctor or seek medical
advice immediately:

Common (may affect up to 1 in 10 people):
• 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 heart beat
Not known (frequency cannot be estimated
from the available data):
• Yellowing of the skin or whites of the eyes,
which may indicate liver problems

Other possible side effects

Very common (may affect more than 1 in
10 people):
• Trembling
• Accidentally falling

Common (may affect up to 1 in 10 people):
• Diarrhoea
• Dizziness
• Feeling restless
• Slow heartbeat
• High blood pressure
• Difficulty in sleeping
• Seeing things that are not there
(hallucinations)
• Depression
• Too much saliva and dehydration
• Unusually slow movements or movements
you cannot control
Uncommon (may affect up to 1 in
100 people):
• Poor control of movements
• Low blood pressure

Other side effects seen with rivastigmine
transdermal patches and which may occur
with the hard capsules:
Common (may affect up to 1 in 10 people):
• Fever
• Severe confusion
• Decreased appetite
• Inability to retain adequate urine (urinary
incontinence)
Uncommon (may affect up to 1 in
100 people):
• High level of activity, restlessness
(hyperactivity)
Not known (frequency cannot be estimated
from the available data):
• Allergic reaction where the patch was used,
such as blisters, itching or skin inflammation

Reporting of side effects

If you get any side effects, talk to your doctor
or pharmacist. This includes any 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
(EXP) that is stated on the blister/bottle and the
carton. The expiry date refers to the last day of
that month.
This medicinal product does not require any
special storage conditions.
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.
Each Rivastigmine 1.5 mg capsule contains
1.5 mg of rivastigmine.
Each Rivastigmine 3 mg capsule contains 3 mg
of rivastigmine.
Each Rivastigmine 4.5 mg capsule contains
4.5 mg of rivastigmine.
Each Rivastigmine 6 mg capsule contains 6 mg
of rivastigmine.
The other ingredients are:
Contents of Capsule: Cellulose, microcrystalline,
Hypromellose, Magnesium stearate, Silica,
colloidal anhydrous
Capsule Shell: Yellow iron oxide (E172), Red
iron oxide (E172) (3 mg, 4.5 mg, and 6 mg only),
Titanium dioxide (E171), Gelatin
Printing Ink:
Red Ink (1.5 mg, 3 mg and 4.5 mg): Iron oxide
red (E172), Shellac, Propylene glycol (E1520),
Ammonia, Potassium hydroxide.
White Ink (6 mg only): Shellac, Titanium dioxide
(E171), Propylene glycol (E1520).

What Rivastigmine looks like and contents
of the pack

Your medicine comes as a hard capsule
containing a white powder.
The 1.5 mg capsule has a yellow body marked
“RG 15” in red ink, and a yellow cap marked
with “G” in red ink.
The 3 mg capsule has an orange body marked
“RG 30” in red ink, and an orange cap marked
with “G” in red ink.
The 4.5 mg capsule has a reddish-brown body
marked “RG 45” in red ink, and a reddish-brown
cap marked with “G” in red ink.
The 6 mg capsule has an orange body marked
“RG 60” in white ink, and a reddish-brown cap
marked with “G” in white ink, containing a
white powder.
Rivastigmine capsules are available in blister
and bottle packs of 10, 28, 30, 56, 60, 90,
112, 250 and 500. Not all pack sizes will
be marketed.

Marketing Authorisation Holder and
Manufacturer

Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer:
McDermott Laboratories trading as Gerard
Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Mylan Hungary Kft, Mylan utca 1., Komárom,
2900, Hungary
This leaflet was last revised in 01/2016.

779838

Description Rivastigmine 1.5, 6, 3, 4.5 mg ALL
Component Type Leaflet
Affiliate Item Code 779838
Superceded Affiliate Item Code 731246
TrackWise PR No. 779838
MA No.

04569/0942,
0943, 0944 & 0945

Packing Site/Printer N/A

Pharma Code 1546
SAP No. N/A
Vendor Job No. 270769
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK

Supplier Code 11300044 MI-10 Keyline/Drawing No. N/A
Barcode Info N/A

Date: 21 Dec 2015
No. of colours 1
Colours

Time: 15:23
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 150 x 450 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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