1.5 mg, 3.0 mg, 4.5 mg and 6.0 mg capsules, hard
rivastigmine
What Rivastigmine Actavis is and what it is used for
The active substance in Rivastigmine Actavis 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 Actavis increases acetylcholine levels in the brain, thus helping to reduce the symptoms of Alzheimer’s disease and dementia caused by Parkinson’s disease.
Rivastigmine Actavis 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 the oral solution can also be used to treat dementia in adult patients with Parkinson’s disease.
What you need to know before you take Rivastigmine Actavis
Do not take Rivastigmine Actavis
- 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 Rivastigmine Actavis.
Warnings and cautions
Talk to your doctor before taking Rivastigmine Actavis
- 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 taken Rivastigmine Actavis 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 Actavis for a pediatric population in the treatment of Alzheimer’s disease.
Other medicines and Rivastigmine Actavis
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 that have a similar effect to Rivastigmine Actavis. Rivastigmine Actavis can affect other anticholinergic medicines (medicines for stomach cramps or seizures, medicines to treat Parkinson’s disease, or medicines to prevent motion sickness).
Rivastigmine Actavis 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 Actavis before you are given anesthesia or anesthesia, as Rivastigmine Actavis may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Rivastigmine Actavis 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 Rivastigmine Actavis must be weighed against the potential effects on your unborn baby. Rivastigmine Actavis should not be used during pregnancy unless necessary.
You should not breastfeed while you are being treated with Rivastigmine Actavis.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Rivastigmine Actavis 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 Rivastigmine Actavis
Always take this medicine exactly as your doctor has told you. Consult a doctor, pharmacist, or nurse if you are unsure.
How to start the treatment
Your doctor will tell you which dose of Rivastigmine Actavis 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 Actavis 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 Actavis.
- For the medicine to be useful, take it every day.
- Take Rivastigmine Actavis 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 take more Rivastigmine Actavis than you should
If you have accidentally taken more Rivastigmine Actavis then you should tell your doctor. You may need medical attention. Some patients who have accidentally taken too much Rivastigmine Actavis have experienced malaise (nausea), nausea (vomiting), diarrhea, high blood pressure, and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to take Rivastigmine Actavis
If you forget to take a dose of Rivastigmine Actavis, 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 the 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
- 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 10 users in 1,000)
- 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 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 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. 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)
- An allergic reactions 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 Actavis
Keep this medicine out of the sight and reach of children.
Before the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
The medicine 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.
- Other ingredients are Capsule contents: magnesium stearate, colloidal silica, hypromellose, and microcrystalline cellulose. Capsule shell: Rivastigmine Actavis 1.5 mg hard capsule: titanium dioxide (E171), yellow iron oxide (E172), and gelatin. Rivastigmine Actavis 3 mg, 4.5 mg, and 6 mg hard capsules: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), and gelatin.Ink: shellac, propylene glycol, red iron oxide (E172). The paint may sometimes contain potassium hydroxide.
Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg rivastigmine.
Each Rivastigmine Actavis 3 mg capsule contains 3 mg rivastigmine.
Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
What the medicine looks like and the contents of the pack
- Rivastigmine Actavis 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 1.5mg” on the lower part.
- Rivastigmine Actavis 3 mg hard capsules contain an off-white to slightly yellow powder in a capsule with an orange cap and an orange lower part with a red inscription “RIV 3mg” on the lower part.
- Rivastigmine Actavis 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 Actavis 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 6mg” on the base.
The capsules are packaged in blisters, available in three different pack sizes (28, 56, and 112 capsules) and jars for capsules with 250 capsules. Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76‑78
220 Hafnarfjörður
Iceland
Manufacturer
Pharmapath SA
28is Oktovriou 1
Agia Varvara, 123 51
Greece
Tjoapack Netherlands BV
New Donk 9
4879 AC Etten-Leur
Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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