Nimvastid
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Rivastigmine
- Made by
- Krka, d.d., Novo mesto
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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 orodispersible tablets can also be used for the treatment of dementia in adult patients with Parkinson’s disease.
From the package leaflet in EMA’s product information, p. 69 · 2025-07-17
How it works
From the US prescribing label for the same active substance (Rivastigmine). It describes the substance, not this exact product.
Although the precise mechanism of action of rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function.
This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase.
Rivastigmine is extensively metabolized primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite NAP226-90.
Less than 1% of the administered dose is excreted in the feces.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-11-14
Do not take it if
- 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.
From the package leaflet in EMA’s product information, p. 69.
Warnings and precautions
- Talk to your doctor before taking Nimvastid:
- 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.
- Children and adolescents
From the package leaflet in EMA’s product information, p. 69–70.
Pregnancy and breastfeeding
- 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.
From the package leaflet in EMA’s product information, p. 70.
Other medicines
- 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.
- Caution when Nimvastid is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).
From the package leaflet in EMA’s product information, p. 70.
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.
- 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.
- 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.
- 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.
- Feeling dizzy Loss of appetite Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea Sweating Headache Heartburn Weight loss Stomach pain Feeling agitated Feeling tired or weak Generally feeling unwell Trembling or feeling confused Decreased appetite Nightmares Sleepiness 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)
- Urinary tract infection 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)
- difficulty in carrying out movements 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:
- Trembling Accidentally falling Feeling restless Slow and fast heartbeat Too much saliva and dehydration Unusually slow movements or movements you cannot control difficulty in carrying out movements and muscle weakness Uneven heartbeat and poor control of movements Low blood pressure Skin rash Other side effects seen with rivastigmine transdermal patches and which may occur with the hard capsules:
- Fever Severe confusion Urinary incontinence (inability to retain adequate urine)
- Hyperactivity (high level of activity, restlessness)
- 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.
- 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 medicine 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.
- 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 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 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.
- Marketing Authorisation Holder and Manufacturer For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
- België/Belgique/Belgien Lietuva KRKA Belgium, SA. UAB KRKA Lietuva Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40 България Luxembourg/Luxemburg КРКА България ЕООД KRKA Belgium, SA.
- Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)
- Česká republika Magyarország KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
- Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490 Danmark Malta KRKA Sverige AB E.J. Busuttil Ltd.
- Tlf.: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885 Deutschland Nederland TAD Pharma GmbH KRKA Belgium, SA.
- Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)
- Eesti Norge KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)
- Ελλάδα Österreich KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien Τηλ: + 30 2100101613 Tel: + 43 (0)1 66 24 300 España Polska KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
- Tel: + 34 911 61 03 80 Tel.: + 48 (0)22 573 7500 France Portugal KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
- Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650 Hrvatska România KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest Tel: + 385 1 6312 101 Tel: + 4 021 310 66 05 Ireland Slovenija KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100 Ísland Slovenská republika LYFIS ehf. KRKA Slovensko, s.r.o., Tel: + 421 (0) 2 571 04 501 Sími: + 354 534 3500 Italia Suomi/Finland KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy Tel: + 39 02 3300 8841 Puh/Tel: +358 20 754 5330 Κύπρος Sverige KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)
- Latvija KRKA Latvija SIA Tel: + 371 6 733 86 10 This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site:
- https://www.ema.europa.eu.
From the package leaflet in EMA’s product information, p. 71–75.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Krka, d.d., Novo mesto |
|---|---|
| Active substance | Rivastigmine |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Classification | N06DA03 · Pain, sleep, mood, epilepsy and the brain |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2009-05-11 |
| Last updated by the regulator | 2025-07-17 |
| EMA product number | EMEA/H/C/001029 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.