Medicine guide
Rivastigmine Actavis
·
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Rivastigmine
- Made by
- Actavis Group PTC ehf
- 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 Rivastigmine Actavis 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 Actavis 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 Actavis 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.
From the package leaflet in EMA’s product information, p. 50 · 2025-06-13
Do not take it if
- 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 Actavis.
From the package leaflet in EMA’s product information, p. 50.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 Actavis 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 Actavis 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 Actavis.
- To benefit from your medicine, take it every day.
- Take Rivastigmine Actavis 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 Actavis than you should If you accidentally take more Rivastigmine Actavis than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine Actavis 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 Actavis If you find you have forgotten to take your dose of Rivastigmine Actavis, 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.
From the package leaflet in EMA’s product information, p. 52.
Warnings and precautions
- Talk to your doctor before taking Rivastigmine Actavis:
- 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 Actavis 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 Actavis in the paediatric population in the treatment of Alzheimer’s disease.
From the package leaflet in EMA’s product information, p. 51.
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 Rivastigmine Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary.
- You should not breast-feed during treatment with Rivastigmine Actavis.
From the package leaflet in EMA’s product information, p. 51–52.
Other medicines
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Rivastigmine Actavis should not be given at the same time as other medicines with similar effects to Rivastigmine Actavis. Rivastigmine Actavis might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
- Rivastigmine Actavis 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 Actavis, tell your doctor before you are given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle relaxants during anaesthesia.
- Caution when Rivastigmine Actavis 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 Actavis 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. 51.
Driving and using machines
- Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
- Rivastigmine Actavis 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.
From the package leaflet in EMA’s product information, p. 52.
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 than 1 in 10 people)
- Trembling
- 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
- Seeing things that are not there (hallucinations)
- Depression
- High blood pressure Uncommon (may affect up to 1 in 100 people)
- Uneven heartbeat and poor control of movements
- Low blood pressure Not known (frequency cannot be estimated from the available data)
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
- Skin rash 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.
From the package leaflet in EMA’s product information, p. 52–54.
How to store it
- 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 carton, blister or capsule container after EXP. The expiry date refers to the last day of that month.
- 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.
From the package leaflet in EMA’s product information, p. 54.
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
BulgariaNo 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 | Actavis Group PTC ehf |
|---|---|
| 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 | 2011-06-16 |
| Last updated by the regulator | 2025-06-13 |
| EMA product number | EMEA/H/C/002036 |
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.
Rivastigmine 1 A PharmaEU authorisation 1 A Pharma GmbH · Rivastigmine · N06DA03Rivastigmine HexalEU authorisation Hexal AG · Rivastigmine · N06DA03Rivastigmine SandozEU authorisation Sandoz GmbH · Rivastigmine · N06DA03ExelonEU authorisation Novartis Europharm Limited · Rivastigmine · N06DA03NimvastidEU authorisation Krka, d.d., Novo mesto · Rivastigmine · N06DA03PrometaxEU authorisation Almirall, S.A. · Rivastigmine · N06DA03