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RIVASTIGMINE 3 MG CAPSULES

Active substance(s): RIVASTIGMINE HYDROGEN TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rivastigmine 1.5 mg Capsules, hard
Rivastigmine 3 mg Capsules, hard
Rivastigmine 4.5 mg Capsules, hard
Rivastigmine 6 mg Capsules, hard
Rivastigmine
Read all of this leaflet carefully before you start taking this medicine.
− 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
− If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Rivastigmine is and what it is used for
2. Before you take Rivastigmine
3. How to take Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Further information

Rivastigmine 3 mg capsule contains colouring agents including
Tartrazine (E102) and Sunset yellow FCF (E110), which may cause
allergic reactions.
Rivastigmine 6 mg capsule contains colouring agents including
Tartrazine (E102) and Sunset yellow FCF (E110), which may cause
allergic reactions.

3. HOW TO TAKE RIVASTIGMINE
Always take Rivastigmine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a drink, without opening or crushing
them.
You should take Rivastigmine twice a day with food (in the morning
and evening).
Your doctor will tell you what dosage of Rivastigmine to take, starting
with a low dose and gradually increasing, depending on how you
respond to the treatment. The highest dose that should be taken is
6.0 mg twice a day. If you have not taken Rivastigmine for several
days, do not take the next dose until you have talked to your doctor.
The use of Rivastigmine in children and adolescents (age below
18 years) is not recommended.
To benefit from your medicine you should take it every day.
Tell your caregiver that you are taking Rivastigmine.

1. WHAT RIVASTIGMINE IS AND WHAT IT IS
USED FOR
This medicinal product contains Rivastigmine which belongs to a group
of medicines called cholinesterase inhibitors.
Rivastigmine is used to treat the symptoms of mild to moderately
severe Alzheimer’s dementia.
Rivastigmine is used to treat the symptoms of mild to moderately
severe dementia in patients with Parkinson’s disease.

2. BEFORE YOU TAKE RIVASTIGMINE
Before taking Rivastigmine it is important that you read the following
section and discuss any questions you might have with your doctor.

This medicine should only be prescribed by a specialist and your
doctor should regularly review whether it is having the desired effect.
Your doctor will monitor your weight whilst you are taking this
medicine.
If you take more Rivastigmine than you should
Tell your doctor if you find you have accidentally taken more
Rivastigmine than you are told to. You may require medical attention.
Some people who have accidentally taken too much Rivastigmine
have experienced nausea, 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.

Do not take Rivastigmine if you:
− are allergic (hypersensitive) to Rivastigmine, or any of
the other ingredients of Rivastigmine.
− have severe liver problems

4. POSSIBLE SIDE EFFECTS

Take special care with Rivastigmine if you
− have, or have ever had
− impaired kidney
− impaired liver function
− irregular heartbeat
− an active stomach ulcer
− asthma or severe respiratory disease
− difficulties in passing urine
− seizures (fits or convulsions)
− have not taken Rivastigmine for several days, do not
take the next dose until you have talked to your doctor.
− have experience gastro-intestinal reactions such as
nausea (feeling sick) and vomiting (being sick).
− have a low body weight.
− suffer from trembling.
If any of these apply to you, your doctor may need to monitor you more
closely while you are on this medicine.

You may tend to get side effects most frequently when you start taking
your medicine or increase to a higher dose. Side effects will gradually
disappear most probably as your body becomes used to the medicine.

Children and adolescents
The use of Rivastigmine in children and adolescents (age below
18 years) is not recommended.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
If you have to undergo surgery whilst taking Rivastigmine, you should
inform the doctor before you are given any anaesthetics, because
Rivastigmine may exaggerate the effects of some muscle relaxants
during anaesthesia.
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).
Taking Rivastigmine with food and drink
Rivastigmine should be taken with meals. Capsules should be
swallowed whole with water.
Pregnancy and breast-feeding
It is preferable to avoid the use of Rivastigmine during pregnancy,
unless clearly necessary. Tell your doctor if you become pregnant
during treatment.
Women on Rivastigmine should not breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your illness may impair your ability to drive or operate machinery and
you must not carry out these activities unless your doctor tells you that
it is safe to do so. Rivastigmine may cause dizziness and somnolence,
mainly at the start of treatment or when increasing the dose. If you
experience such effects, you should not drive or operate machinery.
Important information about some of the ingredients of
Rivastigmine
Rivastigmine 1.5 mg capsule contains colouring agents including
Tartrazine (E102), which may cause allergic reactions.

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

The following side effects have also been reported:
Very common side effects (affects more than 1 user in 10 )
include
− dizziness
− vomiting (being sick)
− nausea (feeling sick)
− diarrhoea
− loss of apetite
Common side effects (affects 1 to 10 users in 100 ) include:
− heartburn
− stomach pain
− headache
− agitation
− confusion
− weakness
− fatigue
− sweating
− generally feeling of being unwell
− weight loss
− trembling
Uncommon side effects (affects 1 to 10 users in 1,000) include:
− depression
− difficulty in sleeping
− changes in liver function
− fainting or accidentally falling
Rare side effects (affects 1 to 10 users in 10,000) include:
− chest pain
− fits or convulsions
− rashes
− stomach and intestinal ulcers
Very rare side effects (affect less than 1 user in 10,000) include:
− blood in stools or when vomiting
− urinary tract infection
− inflammation of the pancreas (severe upper stomach
pain, often with nausea and vomiting)
− problems with heart rhythm (both fast and slow)
− high blood pressure
− hallucinations
− worsening of Parkinson’s disease or development of
similar symptoms (muscle stiffness, difficulty in carrying
out movements).
Not known (frequency cannot be estimated from the available data)
− severe vomiting that can lead to a rupture of the oesophagus
(the tube that connects the mouth with the stomach).
− itching
Patients with dementia associated with Parkinson’s disease
experience some side effects more frequently and also some
additional side effects: trembling, (very common), difficulty in sleeping,
anxiety, restlessness, worsening of Parkinson’s disease or
development of similar symptoms (muscle stiffness, difficulty in

carrying out movements), abnormally slow or uncontrollable
movements, slow heart beat, too much saliva, dehydration, (common),
irregular heart beat and poor control of movements (uncommon).
Additional side effects which have been reported with Rivastigmine
transdermal patches: severe confusion, anxiety, fever (common).
Should such symptoms occur, contact your doctor as you may need
medical assistance.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

capsules imprinted ‘RIV 3 mg’ on body with red ink, filled with white to
off white granular powder.
Rivastigmine 4.5 mg Capsules, hard:
Opaque pink cap/ Opaque pink body, “size 3” hard gelatin capsules
imprinted ‘RIV 4.5 mg’ on body with white ink, filled with white to off
white granular powder.
Rivastigmine 6 mg Capsules, hard:
Opaque orange cap/ Opaque pink body, “size 3” hard gelatin capsules
imprinted ‘RIV 6 mg’ on body with white ink, filled with white to off white
granular powder.

5. HOW TO STORE RIVASTIGMINE

Packed in blister of 14 capsules, 28 capsules & 56 capsules and in a
plastic bottle of 250 capsules.

Keep out of the reach and sight of children.
Do not use Rivastigmine after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.

Marketing Authorisation Holder and Manufacturer

Only bottle
Rivastigmine should be used within 125 days of opening the bottle
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Rivastigmine contains:
The active substance is rivastigmine.
Each Rivastigmine 1.5 mg capsule contains Rivastigmine(R,R)-tartrate
corresponding to 1.5 mg rivastigmine.
Each Rivastigmine 3 mg capsule contains Rivastigmine(R,R)-tartrate
corresponding to 3 mg of rivastigmine.
Each Rivastigmine 4.5 mg capsule contains Rivastigmine(R,R)-tartrate
corresponding to 4.5 mg of rivastigmine.
Each Rivastigmine 6 mg capsule contains Rivastigmine(R,R)-tartrate
corresponding to 6 mg of rivastigmine.
Capsule contents
Cellulose Microcrystalline (E460)
Tartaric acid (E334)
Silica Colloidal Anhydrous (E551)
Magnesium Stearate (E470b)
Rivastigmine 1.5 mg:
Capsule Cap & Body:
Tartrazine (E102)
Titanium dioxide (E171)
Sodium lauryl sulphate.
Imprinting ink composition:
Shellac
Propylene Glycol
Sodium Hydroxide
Titanium Dioxide (E171)
Povidone
Allura Red Aluminum Lake (E129)
Rivastigmine 3 mg:
Capsule Cap & Body:
Allura red (E129)
Tartrazine (E102)
Sunset Yellow FCF (E110)
Titanium dioxide (E171)
Sodium lauryl sulphate.
Imprinting ink composition:
Shellac
Propylene Glycol
Sodium Hydroxide
Titanium Dioxide (E171)
Povidone
Allura Red Aluminum Lake (E129)
Rivastigmine 4.5 mg:
Capsule Cap & Body:
Brilliant blue FCF (E133)
Allura red (E129)
Titanium dioxide (E171)
Sodium lauryl sulphate
Imprinting ink composition:
Shellac
Propylene Glycol
Strong Ammonia Solution
Potassium Hydroxide
Titanium Dioxide (E171)
Rivastigmine 6 mg:
Cap: Allura red (E129),Tartrazine (E102), Sunset Yellow
FCF (E110), Titanium dioxide (E171) and Sodium
lauryl sulphate.
Body: Brilliant blue FCF (E133), Allura red (E129), Titanium
dioxide (E171) and Sodium lauryl sulphate.
Imprinting ink composition:
Shellac
Propylene Glycol
Strong Ammonia Solution
Potassium Hydroxide
Titanium Dioxide (E171)
What Rivastigmine looks like and contents of the pack
Capsule, hard
Rivastigmine 1.5 mg Capsules, hard:
Opaque yellow cap/ Opaque yellow body, “size 3” hard gelatin
capsules imprinted ‘RIV 1.5 mg’ on body with red ink, filled with white
to off white granular powder.
Rivastigmine 3 mg Capsules, hard:
Opaque orange cap/ Opaque orange body, “size 3” hard gelatin

Orchid Europe Ltd.
Building 3, Chiswick Park,
566 Chiswick High Road,
Chiswick, London, W4 5YA
United Kingdom
This medicinal product is authorised in the Member States of the
EEA under the following names:
France
- [Rivastigmine] 1.5mg, 3.0mg, 4.5mg & 6.0mg
Capsules, dur
Germany
- Rivastigmin Orchid Europe Ltd 1,5/3/4,5/6 mg
Hartkapseln
Greece
- [Rivastigmine] 1.5mg, 3.0mg, 4.5mg & 6.0mg
Καψάκια, σκληρά
Spain
- [Rivastigmine] 1.5mg, 3.0mg, 4.5mg & 6.0mg
Cápsulas duras
Italy
- “Rivastigmina Orchid Europe” 1.5mg, 3.0mg,
4.5mg & 6.0mg Capsule, rigide
Lithuania
- Rivastigmine Corpus Medica 1,5mg (3,0/4,5/
6,0 mg) kietos kasulės
Netherlands
- [Rivastigmine] 1.5mg, 3.0mg, 4.5mg & 6.0mg
Capsules, hard
United Kingdom
- Rivastigmine 1.5mg, 3mg, 4.5mg & 6mg
Capsules, hard
This leaflet was last approved in 05/2011.

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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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