Patient leaflet - NIMVASTID 1.5 MG ORODISPERSIBLE TABLETS
1. what nimvastid is and what it is used for
The active substance of Nimvastid 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, Nimvastid 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.
Nimvastid 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 nimvastid
Do not take Nimvastid
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– if you are allergic to rivastigmine (the active substance in Nimvastid) or to any of the
other ingredients of this medicine (listed in section 6).
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– 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 Nimvastid.
Warnings and precautions
Talk to your doctor before taking Nimvastid:
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– if you have, or have ever had, irregular or slow heartbeat.
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– if you have, or have ever had, an active stomach ulcer.
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– if you have, or have ever had, difficulties in passing urine.
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– if you have, or have ever had, seizures.
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– if you have, or have ever had, asthma or severe respiratory disease.
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– if you have, or have ever had impaired kidney function.
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– if you have, or have ever had, impaired liver function.
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– if you suffer from trembling.
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– if you have a low body weight.
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– 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.
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 Nimvastid 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 Nimvastid in the paediatric population in the treatment of Alzheimer’s disease.
Other medicines and Nimvastid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Nimvastid should not be given at the same time as other medicines with similar effects to Nimvastid. Nimvastid might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
Nimvastid 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 Nimvastid, tell your doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution when Nimvastid is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines
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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 Nimvastid must be assessed against the possible effects on your unborn child. Nimvastid should not be used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with Nimvastid.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Nimvastid 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.
Nimvastid contains sorbitol (E420)
This medicine contains 0.00525 mg sorbitol in each 1.5 mg orodispersible tablet.
This medicine contains 0.0105 mg sorbitol in each 3 mg orodispersible tablet.
This medicine contains 0.01575 mg sorbitol in each 4.5 mg orodispersible tablet.
This medicine contains 0.021 mg sorbitol in each 6 mg orodispersible tablets.
3. how to take nimvastid
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 Nimvastid 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 6.0 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 Nimvastid 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 Nimvastid.
- To benefit from your medicine, take it every day.
- Take Nimvastid twice a day, once with your breakfast and once with your evening meal. Your
mouth should be empty before taking the tablet.
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Nimvastid orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a tablet from the package as follows:
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1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it,
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2. Pull up the edge of the foil and peel the foil off completely,
In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed without water. The mouth should be empty before placing the tablet on the tongue.
If you take more Nimvastid than you should
If you accidentally take more Nimvastid than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Nimvastid have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to take Nimvastid
If you find you have forgotten to take your dose of Nimvastid, 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 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
- 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 the orodispersible tablets:
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store nimvastid
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 packaging after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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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 informationwhat nimvastid contains- the active substance is rivastigmine hydrogen tartrate.
Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
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– The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose,
What Nimvastid looks like and contents of the pack
Orodispersible tablets are round and white tablets.
14 × 1 (only for 1.5 mg), 28 × 1, 30 × 1, 56 × 1, 60 × 1 or 112 × 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom (Great Britain)
Consilient Health Limited
Tel.: +44 (0)20 3751 1888
This leaflet was last revised in January 2022.
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