Patient leaflet - Nimvastid 4.5 mg orodispersible tablets

1. What Rivastigmine is and what it is used for

The active substance of Rivastigmine 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.

Rivastigmine 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 Rivastigmine

Do not take Rivastigmine

if you are allergic to rivastigmine (the active substance in Rivastigmine) or to 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.
Warnings and precautions
Talk to your doctor before taking Rivastigmine:
- if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- 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 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 Rivastigmine 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 Rivastigmine in the paediatric population in the treatment of Alzheimer’s disease. 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 or to prevent travel sickness).

Rivastigmine 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 Rivastigmine, tell your doctor before you are given any anaesthetics, because Rivastigmine may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine 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. Caution when Rivastigmine is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

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 Rivastigmine must be assessed against the possible effects on your unborn child. Rivastigmine 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, 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 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 Rivastigmine 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 Rivastigmine 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.
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 feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat 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.

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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
Sleepiness

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
Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)

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

Trembling
Accidentally falling

Common (may affect up to 1 in 1

Anxiety
Feeling restless
Slow and fast heartbeat
Difficulty in sleeping
Too much saliva and dehydratio
Unusually slow movements or m
The signs of Parkinson’s diseas signs – such as stiff muscles, di movements and muscle weakn
Seeing things that are not there
Depression
High blood pressure

Uncommon (may affect up to 1 i

Uneven heartbeat and poor con
Low blood pressure

Not known (frequency cannot be data)

Pisa syndrome (a condition invo contraction with abnormal bend side)
Skin rash

Other side effects seen with riv and which may occur with the Common (may affect up to 1 in 1

Fever
Severe confusion
Urinary incontinence (inability to Uncommon (may affect up to 1 i
Hyperactivity (high level of activ
than 1 in 10 people)
0 people)
n
ovements you cannot control e get worse or getting similar fficulty in carrying out
ess
(hallucinations)
n 100 people)
trol of movements
estimated from the available
lving involuntary muscle ing of the body and head to one
astigmine transdermal patches hard capsules:
0 people)
retain adequate urine)
n 100 people)
ity, 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 Yellow Card Scheme, Website: yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 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.

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 hydrogen tartrate. Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
- The other ingredients for Rivastigmine 1.5 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172) and gelatine in the capsule shell.
- The other ingredients for Rivastigmine 3 mg, 4.5 mg and 6 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content, and titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatine in the capsule shell.

What Rivastigmine looks like and contents of the pack

Rivastigmine 1.5 mg hard capsules, which contain a white to almost white powder, have a yellow cap and yellow body. Rivastigmine 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body. Rivastigmine 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body.

Rivastigmine 6 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and orange body. Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available.

HDPE container: boxes of 200 or 250 hard capsules are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in June 2025.