Nimvastid
rivastigmine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Nimvastid is and what it is used for
What you need to know before you take Nimvastid
How to take Nimvastid
Possible side effects
How to store Nimvastid
Contents of the pack and other information
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.
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.
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.
There is no relevant use of Nimvastid in the paediatric population in the treatment of Alzheimer’s disease.
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.
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.
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.
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.
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 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 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
Anxiety
Sweating
Headache
Heartburn
Weight loss
Stomach pain
Feeling agitated
Feeling tired or weak
Generally feeling unwell
Trembling or feeling confused
Decreased appetite
Nightmares
Depression
Difficulty in sleeping
Fainting or accidentally falling
Changes in how well your liver is working
Chest pain
Rash, itching
Fits (seizures)
Ulcers in your stomach or intestine
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
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
These patients have some side effects more often. They also have some additional side effects:
Trembling
Fainting
Accidentally falling
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
Uneven heartbeat and poor control of movements
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.
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 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.
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.
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.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E.J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L.
KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 80 Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
KRKA - FARMA d.o.o. Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841
KRKA Finland Oy Puh/Tel: +358 20 754 5330
KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA Tel: + 371 6 733 86 10
Consilient Health Limited Tel: + 353 (0)1 2057760