1.5 mg, 3 mg, 4.5 mg, 6 mg hard capsules
rivastigmine
What Rivastigmine Sandoz is and what it is used for
The active substance in Rivastigmine Sandoz 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, leading to low levels of the neurotransmitter acetylcholine (a substance that allows the brain cells to communicate with each other). Rivastigmine blocks the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine Sandoz enables the acetylcholine levels in the brain to increase, which helps reduce the symptoms of Alzheimer’s disease and Parkinson’s dementia.
Rivastigmine Sandoz 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. Capsules and oral solutions can also treat dementia in adult patients with Parkinson’s disease.
What you need to know before you take Rivastigmine Sandoz
Do not take Rivastigmine Sandoz
- if you are allergic to rivastigmine (the active ingredient of Rivastigmine Sandoz) or any of the other ingredients of this medicine (listed in section 6).
- if you have previously had reactions that indicate allergic contact dermatitis with rivastigmine.
If this applies to you, talk to your doctor and do not take Rivastigmine Sandoz.
Warnings and cautions
Talk to your doctor before taking Rivastigmine Sandoz
- 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 a 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 used Rivastigmine Sandoz 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 Sandoz for the pediatric treatment of Alzheimer’s disease.
Other medicines and Rivastigmine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastigmine Sandoz should not be given at the same time as other medicines that have a similar effect to Rivastigmine Sandoz. Rivastigmine Sandoz can affect other anticholinergic medicines (medicines for stomach cramps or seizures, medicines to treat Parkinson’s disease or drugs to prevent motion sickness).
Rivastigmine Sandoz should not be given concomitantly with metoclopramide (a medicine used to treat and prevent nausea and vomiting). Taking these two medicines together can cause problems such as stiffness in the legs and arms and trembling hands.
If you are going to have surgery, tell your doctor that you are taking Rivastigmine Sandoz before you are given anesthesia or anesthesia, as Rivastigmine Sandoz may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Rivastigmine Sandoz with beta-blockers (medicines such as atenolol used to treat high blood pressure, angina, and other heart conditions). Taking these two medicines together can cause problems such as slow heart rate ( bradycardia ) and lead to fainting or loss of consciousness.
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 Sandoz must be weighed against the possible effects on your unborn baby. Rivastigmine Sandoz should not be used during pregnancy unless necessary.
You who are taking rivastigmine should not breastfeed while you are being treated with Rivastigmine Sandoz.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Rivastigmine Sandoz 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.
3. How to take Rivastigmine Sandoz
Always take 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 Sandoz 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 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 Sandoz for more than three days, do not take the next dose before talking to your doctor.
How to take the medicine
- Tell your healthcare provider that you are taking Rivastigmine Sandoz.
- For the medicine to be useful, take it every day.
- Take Rivastigmine Sandoz twice a day, once in the morning and once in the evening, with food.
- Swallow the capsules whole with water.
- Do not open or crush the capsules.
If you take more Rivastigmine Sandoz than you should
If you have accidentally taken more Rivastigmine Sandoz then you should tell your doctor. You may need medical help. Some patients who have accidentally taken too much Rivastigmine Sandoz have experienced nausea and vomiting, diarrhea, high blood pressure, and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to take Rivastigmine Sandoz
If you forget to take a dose of Rivastigmine Sandoz, 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 more side effects when you start treatment or when the dose is increased. Usually, the side effects gradually disappear when the body gets used to the medicine.
Very common (may affect more than 1 in 10 people)
- 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
- Magnet
- Feeling of agitation
- 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 1000 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 case of 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 determined from available data)
- Severe vomiting 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, abnormally dark urine or unexplained nausea, unexplained vomiting, fatigue, 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 as well as certain additional side effects:
Very common (may affect more than 1 in 10 people)
- 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
- Exacerbation 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)
- Hyperactivity (high activity level, restlessness)
Additional side effects that have been seen with 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 control urine)
Uncommon (may affect up to 1 in 100 people)
- Hyperactivity (high activity level, restlessness)
Not known (frequency can not be determined using available data)
- Allergic reactions at the patch’s application site, such as blisters or skin inflammation.
If you get any of these side effects, talk to your doctor as you may need medical attention.
How to store Rivastigmine Sandoz
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, bottle, and carton after EXP. The expiration date is the last day of the specified month.
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.
Do not store above 30 ° C.
Contents of the pack and other information
Content declaration
- The active substance is rivastigmine.
- The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide, red iron oxide, titanium dioxide, and shellac.
Each Rivastigmine Sandoz 1.5 mg capsule contains 1.5 mg rivastigmine.
Each Rivastigmine Sandoz 3 mg capsule contains 3 mg rivastigmine.
Each Rivastigmine Sandoz 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine Sandoz 6 mg capsule contains 6 mg rivastigmine.
What the medicine looks like and the contents of the pack
- Rivastigmine Sandoz 1.5 mg hard capsules contain an off-white to slightly yellow powder in a capsule with a yellow cap and a yellow lower part with a red inscription “RIV 1.5 mg” on the lower part.
- Rivastigmine Sandoz 3 mg hard capsules contain an off-white to slightly yellow powder in a capsule with an orange cap and orange saucer with a red inscription “RIV 3 mg” on the saucer.
- Rivastigmine Sandoz 4.5 mg hard capsules contain an off-white to slightly yellow powder in a capsule with a red cap and a red lower part with a white inscription “RIV 4.5 mg” on the lower part.
- Rivastigmine Sandoz 6 mg hard capsules contain an off-white to slightly yellow powder in a capsule with a red cap and an orange base with a red inscription “RIV 6 mg” on the base.
These are packed in blisters, available in three different pack sizes (28, 56, and 112 capsules) and plastic jars with 250 capsules. Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer
Novartis Pharmacéutica, SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sandoz A / S
Edvard Thomsens Vej 14
DK ‑ 2300 Köpenhamn S
Email: info.sverige@sandoz.com