1.5 mg, 3 mg, 4.5 mg, 6 mg hard capsules
rivastigmine
What Nimvastid is and what it is used for
The active substance in Nimvastide is rivastigmine.
Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia or dementia caused by Parkinson’s disease, certain nerve cells in the brain die. This leads to 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 increases acetylcholine levels in the brain, thus helping to reduce the symptoms of Alzheimer’s disease and dementia caused by Parkinson’s disease.
Nimvastid is used to treat adult patients with mild to moderate Alzheimer’s dementia, a progressive brain disease that gradually affects memory, intellectual ability, and behavior. The capsules and orodispersible tablets can also be used to treat dementia in adult patients with Parkinson’s disease.
What you need to know before using Nimvastid
Do not use Nimvastid
- if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
- if you get a skin reaction that spreads beyond the size of the patch, if a more intense local reaction occurs (eg 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, talk to your doctor and do not take Nimvastid.
Warnings and cautions
Talk to a 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, difficulty urinating.
- if you have, or have ever had, seizures.
- if you have, or have ever had, asthma or severe respiratory problems.
- if you have, or have ever had, impaired kidney function.
- if you have, or have ever had, impaired liver function.
- if you suffer from tremors.
- if you have low body weight.
- if you get reactions from the stomach or intestines such as. nausea, vomiting and diarrhea. You may become dehydrated (lose too much fluid) if vomiting or diarrhea persists for a long time.
If any of the above applies to you, your doctor may need to check you more closely when you are being treated with 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 young people
There is no relevant use of Nimvastid for a pediatric 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 that have a similar effect to Nimvastid. Nimvastid can affect other anticholinergic medicines (medicines for stomach cramps or seizures, medicines to treat Parkinson’s disease, or medicines to prevent motion sickness).
Nimvastid should not be given concomitantly with metoclopramide (a medicine used to relieve or prevent nausea or vomiting). Taking both medicines at the same time can cause problems such as stiff joints or tremors in the hands.
If you are going to have surgery, tell your doctor that you are taking Nimvastid before you are given anesthesia or anesthesia, as Nimvastid may increase the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Nimvastide concomitantly with beta-blockers (medicines such as atenolol for high blood pressure, angina, and other heart conditions). Taking both medicines at the same time can cause problems such as a slower heartbeat ( bradycardia ), which can lead to fainting or unconsciousness.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 weighed against the possible effects on your unborn baby. Nimvastid should not be used during pregnancy unless necessary.
You should not breastfeed while you are being treated with Nimvastid.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Nimvastid may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you feel dizzy or sleepy, do not drive, use machines or perform any other tasks that require your attention.
How to use Nimvastid
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How to start the treatment
Your doctor will tell you which dose of Nimvastid to take.
- Treatment is usually started with a low dose .
- Your doctor will gradually increase the dose depending on the effect you get from the treatment.
- The maximum dose is 6.0 mg twice daily.
Your doctor will regularly evaluate whether the treatment has the desired effect. Your doctor will also check your weight during treatment with 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.
How to take the medicine
- Tell your healthcare provider that you are taking Nimvastid.
- For the medicine to be useful, take it every day.
- Take Nimvastid twice a day, once in the morning and once in the evening, with food.
- Swallow the capsules whole along with the liquid.
- Do not open or crush the capsules.
If you use more Nimvastid than you should
If you have accidentally taken more Nimvastid than you should, tell your doctor. You may need medical help. Some patients who have accidentally taken too much Nimvastid have developed nausea and vomiting, diarrhea, high blood pressure, and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to use Nimvastid
If you forget to take a dose of Nimvastid, wait until the next dose and then 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You will likely experience some side effects, especially when you start treatment or when your dose is increased. Usually, the side effects gradually disappear when the body gets used to the drug.
Very common (may affect more than 1 user in 10)
- Dizziness
- Decreased appetite
- Problems with the stomach such as nausea, vomiting and diarrhea
Common (may affect up to 1 in 10 people )
- Concern
- Sweating
- Headache
- Heartburn
- Weight loss
- Magont
- Feeling of agitation
- Feeling of tiredness or weakness
- General malaise
- Trembling or feeling of confusion
- Decreased appetite
- Nightmares
Uncommon (may affect up to 1 in 100 people)
- Depression
- Difficulty sleeping
- Fainting and falling unintentionally
- Elevated liver values
Rare (may affect up to 1 in 1,000 people)
- Pain in the chest
- Skin rash, itching
- Cramps (seizures)
- Stomach or intestinal ulcers
Very rare (may affect up to 1 in 10,000 people)
- High blood pressure
- Urinary tract infection
- Seeing things that are not real (hallucinations)
- Cardiac arrhythmias (both fast and slow heart rate)
- Gastrointestinal bleeding (manifests as blood in the stool or on vomiting)
- Inflammation of the pancreas (signs of it include severe pain in the upper abdomen, usually with nausea and vomiting)
- Deterioration of the symptoms of Parkinson’s disease or the onset of similar symptoms – such as stiffness in the muscles, difficulty moving
No known frequency (frequency can not be calculated from available data)
- Severe vomiting that can lead to ruptures of the esophagus
- Dehydration (fluid loss)
- Disorders of liver function (yellowing of the skin, yellowing of the whites of the eyes, abnormal dark urine or unexplained nausea, unexplained vomiting, tiredness and loss of appetite)
- Aggressiveness, feeling of restlessness
- Irregular heartbeat
Patients with dementia with Parkinson’s disease
These patients more often experience certain side effects. They also get some additional side effects:
Very common (may affect more than 1 user in 10)
- Trembling
- Fainting
- Stumble unintentionally
Common (may affect up to 1 in 10 people)
- Concern
- Restlessness
- Slow and fast heartbeat
- Difficulty sleeping
- Too much saliva and dehydration
- Abnormally slow or uncontrolled movements
- Deterioration of the symptoms of Parkinson’s disease or the onset of similar symptoms – such as muscle stiffness, difficulty moving and muscle weakness
Uncommon (may affect up to 1 in 100 people)
- Irregular heartbeat and poor control of movements
Additional side effects that have been seen with rivastigmine transdermal patches and that may occur with the capsules:
Common (may affect up to 1 in 10 people)
- Fever
- Severe confusion
- Urinary incontinence (inability to retain urine)
Uncommon (may affect up to 1 in 100 people)
- Hyperactivity (high activity, restlessness)
No known frequency (frequency can not be calculated from available data)
- Allergic reaction where the patch has been applied, such as blisters or inflammation of the skin
If you get any of these side effects, talk to your doctor as you may need medical attention.
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 carton. The expiration date is the last day of the specified month.
No special warning instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is rivastigmine hydrogen tartrate salt.Each Nimvastide capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
- The other ingredients of Nimvastide 1.5 mg are: Capsule content: microcrystalline cellulose, hypromellose, colloidal silica , anhydrous, magnesium stearate. Capsule shell: titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
- The other ingredients of Nimvastide 3 mg, 4.5 mg and 6 mg are: Capsule content: microcrystalline cellulose, hypromellose, colloidal silica , anhydrous, magnesium stearate. Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and gelatin.
What the medicine looks like and contents of the pack
Nimvastid 1.5 mg hard capsules contain white to off-white powder in a capsule with a yellow upper and lower part.
Nimvastid 3 mg hard capsules contain white to off-white powder in a capsule with an orange top and bottom.
Nimvastid 4.5 mg hard capsules contain white to off-white powder in a capsule with a brownish-red top and bottom.
Nimvastid 6 mg hard capsules contain white to off-white powder in a capsule with a brownish-red top and orange bottom.
Blister pack (PVC / PVDC / Al foil): pack of 14 (1.5 mg only), 28, 30, 56, 60, or 112 hard capsules are available.
HDPE can: pack of 200 or 250 hard capsules available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Contact the representative of the marketing authorization holder to find out more about this medicine:
KRKA Sverige AB
Tel: + 46 (0) 8 643 67 66 (SE)