1.5 mg, 3 mg, 4.5 mg and 6 mg hard capsules
Rivastigmine
What Rivastigmine Stada is and what it is used for
The active substance in Rivastigmine Stada 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, Rivastigmine Stada increases the levels of acetylcholine in the brain, thus helping to reduce the symptoms of Alzheimer’s disease and dementia caused by Parkinson’s disease.
Rivastigmine Stada 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. Rivastigmine Stada can also be used to treat mild to moderate dementia in adult patients with Parkinson’s disease.
Rivastigmine contained in Rivastigmine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Rivastigmine Stada
Do not take Rivastigmine Stada
- if you are allergic to rivastigmine, other carbamate derivatives, or any of the other ingredients of this medicine (listed in section 6).
- if you get a skin reaction that spreads outside the size of the rivastigmine patch, if a more intense local reaction occurs (eg blisters, increased 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 Rivastigmine Stada.
Warnings and cautions
Talk to your doctor before taking Rivastigmine Stada
- 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 Rivastigmine Stada 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 Rivastigmine Stada in children and adolescents in the treatment of Alzheimer’s disease.
Other medicines and Rivastigmine Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastigmine Stada should not be given at the same time as other medicines that have a similar effect to Rivastigmine Stada. Rivastigmine Stada can affect other anticholinergic medicines (medicines for stomach cramps or seizures, medicines to treat Parkinson’s disease or drugs to prevent motion sickness).
Rivastigmine should not be co-administered 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 Rivastigmine Stada before you are given anesthesia or anesthesia, as Rivastigmine Stada may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when rivastigmine is coadministered 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 Rivastigmine Stada must be weighed against the potential effects on your unborn baby. Rivastigmine Stada should not be used during pregnancy unless necessary.
You should not breastfeed while you are being treated with Rivastigmine Stada.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Rivastigmine Stada 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rivastigmine Stada contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, essentially ‘sodium-free’. is next to “sodium-free”.
How to use Rivastigmine Stada
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 Rivastigmine Stada 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 Rivastigmine Stada 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 Rivastigmine Stada.
- For the drug to be useful, take it every day.
- Take Rivastigmine Stada 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 Rivastigmine Stada than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Some patients who have accidentally taken too much Rivastigmine Stada have developed nausea and vomiting, diarrhea, high blood pressure, and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to use Rivastigmine Stada
If you forget to take a dose of Rivastigmine Stada, 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.
4. 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
- loss of 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
- magnet
- feeling of upset
- the 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
- rash, itching
- cramps (seizures)
- gastric or intestinal ulcers
Very rare (may affect up to 1 in 10,000 people)
- high blood pressure
- urinary tract infection
- to see things that are not real (hallucinations)
- heart rhythm disorders (both fast and slow heartbeat)
- gastrointestinal bleeding (manifests as blood in the stool or case of vomiting)
- inflammation of the pancreas (signs of it include severe pain in the upper abdomen, usually with nausea and vomiting)
- worsening of Parkinson’s disease or the onset of similar symptoms – such as stiffness in the muscles, and difficulty moving.
Has been reported (frequency can not be calculated from available data)
- severe vomiting that can lead to ruptures of the esophagus
- dehydration (fluid loss)
- hepatic dysfunction (yellowing of the skin, yellowing of the whites of the eyes, abnormally dark urine or unexplained nausea, unexplained vomiting, fatigue, and loss of appetite)
- aggression, feeling of restlessness
- irregular heartbeat.
Patients with dementia in Parkinson’s disease
These patients more often experience specific side effects. They also get some additional side effects:
Very common (may affect more than 1 user in 10)
- trembling
- fainting
- fall 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
- worsening of the symptoms of Parkinson’s disease or the onset of similar symptoms e.g. 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 transdermal patches containing rivastigmine and that may occur with the capsules:
Common (may affect up to 1 in 10 people)
- fever
- s confusion
- urinary incontinence (inability to hold back urine)
Uncommon (may affect up to 1 in 100 people)
- hyperactivity (high activity, restlessness)
Has been reported (frequency can not be calculated from available data)
- an 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 Rivastigmine Stada
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 blister pack and carton after EXP. The expiration date is the last day of the specified month.
OPA-Al-PVC / Al-blister packs No special storage conditions.
PVC-PVDC / Al blister packs: Do not store above 30 ° C.
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 pack and other information
Content declaration
The active substance is rivastigmine.
Each Rivastigmine Stada 1.5 mg capsule contains 1.5 mg rivastigmine (as rivastigmine hydrogen tartrate).
Each Rivastigmine Stada 3 mg capsule contains 3.0 mg rivastigmine (as rivastigmine hydrogen tartrate).
Each Rivastigmine Stada 4.5 mg capsule contains 4.5 mg rivastigmine (as rivastigmine hydrogen tartrate).
Each Rivastigmine Stada 6 mg capsule contains 6.0 mg of rivastigmine (as rivastigmine hydrogen tartrate).
The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), titanium dioxide (E171), and sodium lauryl sulfate.
Rivastigmine Stada 3 mg, 4.5 mg, and 6 mg capsules also contain red iron oxide (E172).
What the medicine looks like and the contents of the pack
Rivastigmine Stada 1.5 mg hard capsules contain an off-white to slightly yellow powder in a capsule, size 2, with a yellow cap and a yellow base.
Rivastigmine Stada 3 mg hard capsules contain an off-white to slightly yellow capsule powder, size 2, with a light orange cap and a light orange lower part.
Rivastigmine Stada 4.5 mg hard capsules contain an off-white to slightly yellow capsule powder, size 2, with a brown cap and a brown bottom.
Rivastigmine Stada 6 mg hard capsules contain an off-white to slightly yellow capsule powder, size 2, with a brown cap and an orange base.
Rivastigmine Stada is packaged in blister packs of 28, 30, 50, 56, 60, 98, 100, 112, 120, 168, 180 or 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Laboratorios Medicamentos Internacionales SA
Solana 26
28850 Torrejon de Ardoz
Madrid
Spain
Eurogenerics NV
Heizel Esplanade b22
1020 Brussels
Belgium
Centrafarm Services BV
New Donk 9
4879 AC Etten-Leur
Netherlands
Genus Pharmaceuticals Ltd.
Park View House
65 London Road
Newbury, Berkshire, RG14 1JN
UK
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
PharmaCoDane ApS
Marielundvej 46A
2750 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark