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RIVASTIGMINE 2MG/ML ORAL SOLUTION

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

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Package leaflet: Information for the user
Rivastigmin Teva 2mg/ml oral solution
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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Rivastigmin Teva is and what it is used for
2.
What you need to know before you take Rivastigmin Teva
3.
How to take Rivastigmin Teva
4.
Possible side effects
5.
How to store Rivastigmin Teva
6.
Contents of the pack and other information
1.

What Rivastigmine Teva is and what it is used for

The active substance of Rivastigmine Teva 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). Rivastigmin Teva works by blocking the enzymes that break down
acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes,
Rivastigmin Teva 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.
Rivastigmin Teva 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. The capsules and oral solution can also be used for the treatment of dementia in adult
patients with Parkinson’s disease.
2.

What you need to know before you take Rivastigmin Teva

Do not take Rivastigmin Teva
if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in
section 6).
if you have a skin reaction spreading beyond the patch size, if there is a more intense local
reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve
within 48 hours after removal of the transdermal patch.
If this applies to you, tell your doctor and do not take Rivastigmine Teva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rivastigmin Teva.
-

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) and
diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhea are
prolonged.

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 Rivastigmin Teva for more than three days, do not take the next dose until you
have talked to your doctor.
Children and adolescents
There is no relevant use of Rivastigmin Teva in pediatric population in the treatment of Alzheimer’s
disease.
Other medicines and Rivastigmin Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Rivastigmin Teva should not be given at the same time as other medicines with similar effects to
Rivastigmin Teva. Rivastigmin Teva might interfere with anticholinergic medicines (medicines used
to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
Rivastigmin Teva should not be given at the same time as metoclopramide (a medicine used to relieve
or prevent nausea and vomiting). Taking the two medicines together could cause problems such as
stiff limbs and trembling hands.
If you have to undergo surgery whilst taking Rivastigmin Teva, tell your doctor before you are given
any anaesthetics, because Rivastigmin Teva may exaggerate the effects of some muscle relaxants
during anaesthesia.
Caution when Rivastigmin Teva is taken together with beta-blockers (medicines such as atenolol used
to treat hypertension, angina, and other heart conditions). Taking the two medicines together could
cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of
consciousness.
Pregnancy, breast-feeding and fertility
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 Rivastigmin Teva must be assessed against the possible
effects on your unborn child. Rivastigmin Teva should not be used during pregnancy unless clearly
necessary.
You should not breast-feed during treatment with Rivastigmin Teva.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Rivastigmin Teva 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.
Rivastigmin Teva contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
One of the excipients in rivastigmine oral solution is sodium benzoate. Benzoic acid is a mild irritant
to the skin, eyes and mucous membrane.
3.

How to take Rivastigmin Teva

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 Rivastigmin Teva to take.
 Treatment usually starts with a low dose.
 Your doctor will slowly increase your dose depending on how you respond to the treatment.
 The highest dose that should be taken is 6.0 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 Teva 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 Teva.
 To benefit from your medicine, take it every day.
 Take Rivastigmine Teva twice a day, in the morning and evening, with food.
How to use this medicine
1.

Preparing the bottle and syringe
 Take the syringe out of its protective case.
 Push down and turn the child resistant cap to open bottle.

2.

Attaching the syringe to the bottle
 Push the nozzle of the syringe into the hole in the white stopper.

3. Filling the syringe

Pull the plunger upwards until it reaches the right mark for the dose that your
doctor has prescribed.

4.

Removing bubbles

Push down and pull plunger a few times to get rid of any large bubbles.

A few tiny bubbles are not important and will not affect your dose in any way.

Check the dose is still correct.

Then, remove the syringe from the bottle.

5.

Taking your medicine

Swallow your medicine straight from the syringe.

You can also mix your medicine with water in a small glass. Stir and drink all of
the mixture.

6.

After using the syringe

Wipe the outside of the syringe with a clean tissue.

Then, put the syringe back in its protective case.

Put the child resistant cap back on the bottle to close it.

If you take more Rivastigmin Teva than you should
If you accidentally take more Rivastigmine Teva that you should, inform your doctor. You may
require medical attention. Some people who have accidentally taken too much Rivastigmin Teva 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 Rivastigmin Teva
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.
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 your medicine or when your dose is increased.
Usually the side effects will slowly go away as your body gets used to the medicine.

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
 Feeling tired or weak
 Generally feeling unwell
 Trembling or feeling confused
 Decreased appetite
 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
Rare (may affect up to 1 in 1,000 people)
 Chest pain
 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 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 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,
 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
Other side effects seen with Rivastigmine transdermal patches and which may occur with oral
solution:
Common (may affect up to 1 in 10 people)
 Fever
 Severe confusion
 Urinary incontinence (inability to retain adequate urine)
Uncommon (may affect up to 1 in 100 people)
 Hyperactivity (high level of activity, restlessness)
Not known (frequency cannot be estimated from the available data)
 Allergic reaction where the patch was used, such as blisters or skin inflammation
If you get any of these side effects, contact your doctor as you may need medical assistance.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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 Rivastigmin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
The expiry date refers to the last day of that month.
Do not refrigerate or freeze.

Use Rivastigmin Teva within 2 months after first opening of the bottle.
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 Rivastigmin Teva contains
The active substance is rivastigmine. Each ml contains rivastigmine tartrate corresponding to
rivastigmine base 2.0 mg.
The other ingredients are sodium benzoate (E211), calcium hydrogen phosphate, anhydrous,
lemon flavour (containing sucrose), quinoline yellow (E104), phosphoric acid,concentrated and
purified water.
What Rivastigmin Teva looks like and contents of the pack
Rivastigmin Teva Oral solution is supplied as a 120 ml of a clear yellow solution in an amber glass
bottle with a child-resistant closure and dip tube. The oral solution is packaged with a 4 ml oral
syringe graduated to 0.5 ml, 1.0 ml, 1.5 ml, 2.0 ml, 2.5 ml, 3.0 ml, 3.5 ml and 4.0 ml in a plastic tube
container.
Marketing Authorisation Holder and Manufacturer
Marketing Authorsation Holder: TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
Teva Czech Industries s.r.o, Opava-Komarov, Czech Republic
OR*
Teva Operations Poland Sp.z.o.o, ul Mogilska 80. 31-546, Krakow, Poland
OR*
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
OR*
TEVA Pharmaceutical Works Private Limited Company, H-2100 Gödöllő, Táncsics Mihály út 82,
Hungary
OR*
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG
This leaflet was last revised in 03/2016.
PL 00289/1529
* Only the BRS used will be printed on the final leaflet

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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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