Nimvastid - patient leaflet, side effects, dosage

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

• – 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).

• – 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:

• – 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 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 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.

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, 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 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 hard capsules:

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.

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 Nimvastid 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 Nimvastid 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 Nimvastid 3 mg, 4.5 mg and 6 mg capsules are microcrystalline

What Nimvastid looks like and contents of the pack

Nimvastid 1.5 mg hard capsules, which contain a white to almost white powder, have a yellow cap and yellow body.

Nimvastid 3 mg hard capsules, which contain a white to almost white powder, have an orange cap and orange body.

Nimvastid 4.5 mg hard capsules, which contain a white to almost white powder, have a brownish red cap and brownish red body.

Nimvastid 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, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

España KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 81	Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25	Portugal KRKA Farmacéutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
Hrvatska KRKA – FARMA d.o.o. Tel: + 385 1 6312 100	Romania KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80	Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
Ísland KRKA Sverige AB Sími: + 46 (0)8 643 67 66 (SE)	Slovenská republika KRKA Slovensko, s.r.o., Tel: + 421 (0) 2 571 04 501
Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841	Suomi/Finland KRKA Finland Oy Puh/Tel: +358 20 754 5330
Kúnpog Kipa Pharmacal Ltd. TnX:+357 24 651 882	Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE)
Latvija KRKA Latvija SIA Tel: + 371 6 733 86 10	United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0) 203 751 1888

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: