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RIVASTIGMINE 4.5MG CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivastigmine 1.5 mg, 3mg, 4.5mg and 6mg Capsules
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

1.

WHAT RIVASTIGMINE IS AND WHAT IT IS USED FOR

The name of your medicine is Rivastigmine 1.5mg, 3mg, 4.5mg or 6mg Capsules (called
rivastigmine throughout this leaflet). Rivastigmine belongs to a group of medicines called
‘anti-cholinesterases’.
Rivastigmine is used to treat the signs of:
• Mild to moderately severe Alzheimer’s dementia. Dementia is the gradual loss of mental
abilities such as thinking, remembering, and reasoning.
• Mild to moderately severe dementia in patients with Parkinson’s disease.

2.

BEFORE YOU TAKE RIVASTIGMINE

Do not take rivastigmine and tell your doctor if:
• You have ever had an allergic (hypersensitive) reaction to rivastigmine or other carbamate
derivatives, to the colourings azorubine (E122) and sunset yellow (E110) or any of the
other ingredients in these capsules (listed in Section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• You have severe liver problems.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your
doctor or pharmacist before taking rivastigmine.
Take special care and check with your doctor or pharmacist before taking rivastigmine.
Your doctor may need to monitor you more closely while you are taking this medicine if:
• You have ever had kidney or liver problems
• You have ever had an uneven heartbeat
• You have ever had a stomach ulcer
• You have ever had asthma or severe breathing problems
• You have ever had difficulty passing water (urine)




You have ever had fits (seizures or convulsions).
You have ever experienced reactions such as nausea (feeling sick) and vomiting (being
sick) after taking rivastigmine.
• You have a low body weight
• You have ever suffered from trembling
If any of the above applies (or if you are not sure), talk to your doctor or pharmacist before
taking this medicine.
The use of rivastigmine in children and adolescents (age below 18 years) is not recommended
Regular check-ups or tests
• Your doctor will want to see you regularly to check how well the medicine is working for
you. He will arrange for regular blood tests during your treatment.
• Your doctor will also monitor your weight while you are taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines obtained without a prescription, including herbal
medicines. This is because rivastigmine can affect the way some other medicines work. Also,
some medicines can affect on the way rivastigmine works.
In particular, check with your doctor or pharmacist if you are taking any of the following
medicines:
• Medicines similar to rivastigmine such as donepezil or galantamine
• Medicines for stomach cramps or spasms, Parkinson’s disease or preventing travel
sickness, called anti-cholinergic medicines.
Operations
If you are going to have an operation, tell your doctor or nurse you are taking rivastigmine.
This is because medicines to relax your muscles are sometimes used during an operation or in
an intensive care unit. Rivastigmine can affect the way these medicines work. Also, these
medicines can affect the way rivastigmine works.
If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist
before taking rivastigmine.
Pregnancy and breast-feeding
• Do not take rivastigmine during pregnancy, unless your doctor has told you to.
• Tell your doctor if you become pregnant during treatment with rivastigmine.
• Women taking rivastigmine should not breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or
breast-feeding.
Driving and using machines
• Your illness may affect you being able to drive or use any tools or machines. Do not carry
out these activities unless your doctor tells you that it is safe to do so.
• You may feel dizzy or sleepy while taking rivastigmine. This is more likely to happen at
the start of treatment or when increasing the dose. If this happens, do not drive or use any
tools or machines.

Important information about some of the ingredients of Rivastigmine Capsules
The capsules contain food dyes such as azorubine (E122) and sunset yellow (E110) that may
cause allergic reactions (listed in Section 6). If you have been told by your doctor that you
have an intolerance to some food dyes, talk to your doctor before taking this medicine.

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. This medicine should only be prescribed by a
specialist.
Taking your medicine
• Swallow the capsules whole with a drink of water.
• Do not crush or chew them.
• Take rivastigmine twice a day.
• Take the first dose with your breakfast and the second dose with your evening meal.
• Tell your carer that you are taking rivastigmine.
How much to take
Adults
• Your doctor will tell you what dose of rivastigmine to take. You will probably start with a
low dose. Your doctor may gradually increase the dose, depending on how you respond to
the treatment.
• Do not take more than 6mg each time.
• If you have not taken rivastigmine for several days, do not take the next dose until you
have talked to your doctor
• To benefit from your medicine you should take it every day.
Children
• The use of rivastigmine is not recommended in children.
If you take more rivastigmine than you should
If you take more rivastigmine than you should, talk to a doctor or go to your nearest hospital
straight away. You may need medical attention. Take the medicine pack and any rivastigmine
capsules that are left with you. This is so the doctor knows what you have taken.
The following effects may happen if you take too much rivastigmine:
• Feeling sick (nausea), being sick (vomiting), diarrhoea
• High blood pressure, slow heart beat or feeling faint
• Seeing or hearing things which are not there (hallucinations).
If you forget to take rivastigmine
• If you forget a 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 not taken rivastigmine for several days, do not take the next dose until you
have talked to your doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, rivastigmine can cause side effects, although not everybody gets them.
Side effects are more likely to happen when you start taking rivastigmine or increase the dose.
Side effects may gradually disappear as your body becomes used to the medicine.

Talk to your doctor straight away if:
• You have a fit (seizure or convulsion)
• You get symptoms such as shaking which you cannot control, muscle stiffness or spasms,
slow movement, producing more saliva than usual or feeling restless or you notice a
worsening of your Parkinson’s disease
• You get a burning, aching pain in your stomach, with an empty feeling and hunger. You
may have an ulcer in your stomach or gut
• You pass black tarry stools or notice fresh or clotted blood in your stools (faeces). You
may also notice dark bits that look like coffee grounds in your vomit. These could be a
signs of an ulcer in your stomach or gut which is bleeding
• You get severe upper stomach pain, which may reach through to your back. You may also
feel sick (nausea) or be sick (vomit). These could be signs of pancreatitis
• You have severe vomiting. This can lead to a tear in the food pipe (oesophagus).
If any of the above applies to you, talk to your doctor straight away. These side effects are
rare or very rare (affect less than 1 in 1,000 people)
Other side effects include:
Very common (affects more than 1 in 10 people)
• Feeling sick(nausea), being sick (vomiting), diarrhoea or loss of appetite
• Dizziness.
Common (affects less than 1 in 10 people)
• Headache, feeling sleepy, shaking of your hands, legs or head (tremor)
• Feeling agitated or confused
• Heartburn, stomach ache
• Feeling weak or tired, sweating, a general feeling of being unwell
• Weight loss.
Uncommon (affects less than 1 in 100 people)
• Low mood (depression), difficulty in sleeping
• Changes in the way your liver is working (shown in blood tests)
• Fainting or accidentally falling.
Rare (affects less than 1 in 1,000 people)
• Chest pain (angina pectoris)
• Skin rashes.
Very rare (affects less than 1 in 10,000 people)
• Problems with your heart rhythm (both fast and slow heart beat), high blood pressure
• Seeing or hearing things which are not there (hallucinations).
• Pain, or a burning sensation when passing water (urine), needing to pass water more often
or more urgently than usual, feeling that you are unable to empty your bladder fully. Your
urine may also be cloudy, bloody, or bad-smelling. You may have pain in your lower
abdomen, back or side, have a mild fever and feel or be sick. These may be signs of a
urine infection
If any of the side effects listed above gets serious or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
Patients whose dementia is associated with Parkinson’s disease experience some side effects
more frequently and also some additional side effects such as 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 and dehydration
(common), irregular heart beat and poor control of movements (uncommon).

5.





6.

HOW TO STORE RIVASTIGMINE
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton. The expiry date refers to the
last day of that month.
Do not store above 25°C
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.

FURTHER INFORMATION

What rivastigmine contains:
• Each capsule contains 1.5mg, 3mg, 4.5mg or 6mg of the active substance rivastigmine as
rivastigmine hydrogen tartrate.
• The other ingredients are microcrystalline cellulose, pregelatinized starch, colloidal silicon
dioxide, magnesium stearate, titanium dioxide E171, gelatin.
• Rivastigmine 1.5mg Capsules also contain: Azorubine E122, Sunset yellow E110,
Quinoline yellow E104.
• Rivastigmine 3mg Capsules also contain: Sunset yellow E110, Quinoline yellow E104.
• Rivastigmine 4.5mg Capsules also contain : Azorubine E122.
• Rivastigmine 6mg Capsules also contain: Indigo carmine E132, Sunset yellow E110,
Quinoline yellow E104.
What rivastigmine looks like and contents of the pack
• Rivastigmine 1.5mg Capsules are opaque and red and yellow in colour with ‘1.5’
imprinted on the capsule body. They contain an almost white powder and are size 2
capsules.
• Rivastigmine 3mg Capsules are opaque and yellow in colour with ‘3.0’ imprinted on the
capsule body. They contain an almost white powder and are size 2 capsules.


Rivastigmine 4.5mg Capsules are opaque and red in colour with ‘4.5’ imprinted on the
capsule body. They contain an almost white powder and are size 2 capsules.



Rivastigmine 6mg Capsules are opaque and blue and yellow in colour with ‘6.0’
imprinted on the capsule body. They contain an almost white powder and are size 2
capsules.



Rivastigmine capsules are available in blister packs of 14, 28, 56, 98, 112 capsules.
(Not all pack sizes may be marketed).

The Marketing Authorisation Holder is:
Winthrop Pharmaceuticals
P O Box 611
Guildford
Surrey GU1 4YS.

The Manufacturer is:
Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic
This leaflet was last updated in April 2010.

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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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