4.6 mg / 24 hours & 9.5 mg / 24 hours transdermal
patch rivastigmine
What Rivastigmine STADA is and what it is used for
The active substance in Rivastigmine Stada is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia, 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.
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 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 using Rivastigmine STADA
Do not use Rivastigmine STADA
- if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6)
- if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives)
- 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 use Rivastigmine Stada transdermal patch.
Warnings and cautions
Talk to your doctor before using 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 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 you have impaired liver function.
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 a patch for more than three days, do not put on a new patch until you have talked to your doctor.
Children and young people
There is no relevant use of Rivastigmine Stada for a pediatric population 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 may affect other anticholinergic medicines, some of which are medicines for stomach cramps or seizures (eg dicyclomine), medicines to treat Parkinson’s disease (eg amantadine), or medicines to prevent motion sickness (eg diphenhydramine, scopolamine, meclozine).
Rivastigmine Stada 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 while using Rivastigmine Stada transdermal patches, tell your doctor that you are using the medicine, as Rivastigmine Stada transdermal patches may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when Rivastigmine Stada is taken 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.
Rivastigmine STADA with food, drink, and alcohol
Rivastigmine Stada can be used with food, drink, and alcohol.
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 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 transdermal patches.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Rivastigmine Stada transdermal patches may cause fainting spells or you may feel very confused. If you feel dizzy or confused, 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.
How to use Rivastigmine STADA
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
IMPORTANT!
- Remove the previous day’s patch before putting ONE new patch.
- Use only one patch per day.
- Do not cut the patch into pieces.
- The patch should be pressed firmly with the palm of your hand for at least 30 seconds.
How to start the treatment
Your doctor will tell you which Rivastigmine Stada transdermal patch is most suitable for you.
- Treatment is usually started with Rivastigmine Stada 4.6 mg / 24 hours.
- The usual recommended daily dose is Rivastigmine Stada 9.5 mg / 24 hours per day. If this dose is well-tolerated, the doctor may increase the dose one to 13.3 mg / 24 hours.
- Use only one Rivastigmine Stada patch at a time and replace the patch with a new one after 24 hours.
During treatment, your doctor may need to adjust your dose to suit your individual needs.
If you have not used a patch for more than three days, do not put on the next patch until you have talked to your doctor. The treatment with transdermal patches can be resumed with the same dose if the treatment has only been interrupted for a maximum of three days. Otherwise, your doctor will restart your treatment with Rivastigmine Stada 4.6 mg / 24 hours.
Rivastigmine Stada can be used with food, drink, and alcohol.
Where should your Rivastigmine Stada transdermal patch be affixed?
- Before applying the patch, make sure the skin is:
- clean, dry, and hair-free,
- free from powder, oil, moisturizer, or lotion, which may prevent the patch from adhering properly to the skin, and free from scratches, rashes, and/or irritation.
- If you are already using patches, remove what you are wearing before applying a new one. If you have several patches attached to your body at the same time, you may receive an overdose of the medicine, which can be dangerous.
- Apply ONE patch per day in ONLY ONE of the possible locations shown in the following diagram:
- left upper arm or right upper arm
- the left or right side of the upper part of the chest (avoid the breasts themselves)
- the left or right side of the upper back
- the left or right side of the lower back
Remove the previous day’s patch after 24 hours before putting ONE new patch in ONLY ONE of the following possible places.
When changing patches, you must remove the previous day’s patches before applying the new patch to a new spot on the skin each time (eg on the right side of the body one day, on the left side the next day, on the upper part of the body one day, on the lower part of the body the next day). Do not put a new patch on the same skin surface twice within 14 days.
How should your Rivastigmine Stada transdermal patch be attached?
Rivastigmine Stada patches are thin, opaque plastic patches that adhere to the skin. Each patch is sealed in a patch envelope, which protects it until it is put on. Do not open the patch envelope or remove the patch until just before you apply it.
Carefully remove the patch you are wearing before applying a new one.
For patients starting treatment for the first time or starting Rivastigmine Stada again after stopping treatment, please start at the next screen.
Each patch is packaged separately in a sealed patch envelope.
Only open the patch envelope when you are ready to apply the patch.
Cut up the patch envelope along the dotted line and remove the patch from the patch envelope.
A protective film covers the adhesive side of the patch.
Peel off one side of the protective film and do not touch the adhesive part of the patch with your fingers.
Attach the adhesive side of the patch to the upper or lower part of the back, upper arm, or chest, and then pull off the other part of the protective film.
Then press the patch firmly in place for at least 30 seconds with the palm of your hand and make sure that the edges adhere properly.
If it helps you, you can e.g. write down the day of the week on the patch with a thin ballpoint pen.
The patch should be used all the time until it is time to change to a new one. Feel free to try to find different places to attach the patches, places that feel comfortable for you, and where the clothes do not rub against the patch.
How to remove your Rivastigmine Stada transdermal patch ?
Gently grasp one edge of the patch and slowly pull it completely away from the skin. If adhesive remains on the skin, you can moisten the area with warm water and mild soap or use baby oil to remove them. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.
You should wash your hands with soap and water when the patch has been removed. If the patch comes in contact with the eyes, or if the eyes turn red after handling the patch, rinse immediately with plenty of water and consult a physician if symptoms persist.
Can you use your Rivastigmine Stada transdermal patch when bathing, swimming, or sunbathing?
- Bathing, swimming, or showering should not affect the patch. Make sure that the patch does not come off on such occasions.
- Do not expose the patch to external heat sources (eg excessive sunbathing, sauna, solarium) for a long time.
What to do if Rivastigmine Stada transdermal patches fall off?
If a patch falls off, apply a new one for the rest of the day, then change to a new one again at the usual time the next day.
When and for how long should you use your Rivastigmine Stada transdermal patch?
- To benefit from your treatment, you need to put on a new patch every day, preferably at the same time every day.
- Use only one Rivastigmine Stada patch at a time and replace the patch with a new one after 24 hours.
If you use more Rivastigmine STADA than you should
If you inadvertently apply more than one patch, remove all patches from the skin and tell your doctor that you accidentally applied more than one patch. You may need medical attention. Some people who have inadvertently used too much rivastigmine have experienced nausea, vomiting, or diarrhea, high blood pressure, and hallucinations. Slow heart rate and fainting can also occur.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
If you forget to use Rivastigmine STADA
If you find that you have forgotten to apply a patch, apply a new one immediately. You can apply the next patch at the usual time the next day. Do not apply two patches to compensate for a forgotten patch.
If you stop using Rivastigmine STADA
If you stop using the patch, talk to your doctor or pharmacist.
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.
Remove the patch and contact your doctor immediately if you get any of the following side effects that may be serious:
Common (may affect up to 1 in 10 people)
- Loss of appetite
- Dizziness
- The feeling of agitation or fatigue
- Urinary incontinence (inability to retain urine)
Uncommon (may affect up to 1 in 100 people)
- Heart rhythm disorders (both fast and slow heartbeats)
- Seeing things that are not real (hallucinations)
- Gastric ulcer
- Dehydration (fluid loss)
- Hyperactivity (high activity, restlessness)
- Aggressiveness
Rare (may affect up to 1 in 1,000 people)
- Case
Very rare (may affect up to 1 in 10,000 people)
- Stiffness in arms or legs
- Shaking hands
Has been reported (occurs in an unknown number of users)
- An allergic reactions where the patch has been applied, such as blisters or inflammation of the skin
- Worsening of the symptoms of Parkinson’s disease – such as trembling, stiffness, sluggish gait
- Inflammation of the pancreas (symptoms include severe pain in the upper abdomen, usually with nausea and vomiting)
- Fast or irregular heartbeat
- High blood pressure
- Cramps (seizures)
- 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)
- Elevated liver values
- Feeling of restlessness
- Nightmares
Remove the patch and contact your doctor immediately if you get any of the above side effects.
Additional side effects that have been seen with rivastigmine capsules or oral solution and that may occur with the patch:
Common (may affect up to 1 in 10 people)
- Too much saliva
- Decreased appetite
- Restlessness
- General malaise
- Trembling or feeling of confusion
- Increased sweating
Uncommon (may affect up to 1 in 100 people)
- Irregular heartbeat (eg fast heartbeat)
- Difficulty sleeping
- Stumble unintentionally
Rare (may affect up to 1 in 1,000 people)
- Cramps (seizures)
- Intestinal ulcers
- Chest pain – can be caused by a heart attack
Very rare (may affect up to 1 in 10,000 people)
- High blood pressure
- Inflammation of the pancreas (signs of it include severe pain in the upper abdomen, usually with nausea and vomiting)
- Gastrointestinal bleeding (manifests as blood in the stool or case of vomiting)
- Seeing things that are not real (hallucinations)
- Some people who have had severe vomiting have had stretch marks in the esophagus.
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 carton and patch envelope after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Keep the transdermal patch in the patch envelope until use.
No special temperature instructions.
Do not use the patch if you see that it is damaged or if the patch envelope shows signs of opening.
After removing the patch, fold it double with the adhesive side inwards and press it together. Put the used patch back in the patch envelope, and store it securely so that children do not have access to the patch. Do not poke in the eyes with your fingers and wash your hands with soap and water after removing the patch. Return used patches to the pharmacy, preferably in the original packaging.
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.
- Rivastigmine Stada 4.6 mg / 24 h transdermal patch
Each transdermal patch releases 4.6 mg rivastigmine per 24 hours, is 5 cm 2 and contains 9 mg rivastigmine.
- Rivastigmine Stada 9.5 mg / 24 h transdermal patch
Each transdermal patch releases 9.5 mg rivastigmine per 24 hours, is 10 cm 2 and contains 18 mg rivastigmine.
Other ingredients are:
- Support film: Polyester film
- Drug matrix: Acrylate-based adhesive, acrylate-based copolymer containing butyl and methyl methacrylate (80:20)
- Adhesive layer: Silicone-based adhesive
- Protective film: Fluorine-coated polyester film
- Printing: Black ink.
What the medicine looks like and the contents of the pack
Each transdermal patch is a thin patch consisting of three layers. The outside is transparent, white, and marked with the following in black print:
Rivastigmine Stada 4.6 mg / 24 h transdermal patch
“Rivastigmine”, “4.6 mg / 24h”
Rivastigmine Stada 9.5 mg / 24 h transdermal patch
“Rivastigmine”, “9.5 mg / 24h”
A transdermal patch is packaged in a child-resistant, heat-sealed envelope. The transdermal patches are available in packs of 7, 10, 30, 50, 60, or 90 transdermal patches and multiple packs of 60 (2×30), 90 (3×30), or 100 (2×50) transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Eurofins PHAST GmbH
Kardinal-Wendel-Strasse 16
66424 Homburg
Germany
Centrafarm Services BV
New Donk 9
NL-4879 Etten Leurs
Netherlands
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark