4.6 mg / 24 hours, 9.5 mg / 24 hours Depot
patch rivastigmine
What Rivastor is and what it is used for
The active substance in Rivastor 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 increases the levels of acetylcholine in the brain, thus helping to reduce the symptoms of Alzheimer’s disease.
Rivastor 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 Rivastor 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 Rivastor
Do not use Rivastor
- if you are allergic to rivastigmine (the active substance in Rivastor) 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 Rivastor transdermal patches.
Warnings and cautions
Talk to your doctor before using Rivastor
- 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 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 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 one until you have talked to your doctor.
Children and young people
There is no relevant use of Rivastor for a pediatric population in the treatment of Alzheimer’s disease.
Other medicines and Rivastor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rivastor 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).
Rivastor transdermal patches 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 while using Rivastor transdermal patches, tell your doctor that you are using the medicine, as Rivastor transdermal patches may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Rivastor transdermal patches 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 Rivastor must be weighed against the possible effects on your unborn baby. Rivastor should not be used during pregnancy unless necessary.
You should not breastfeed when you are being treated with Rivastor transdermal patches.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Tear transdermal patches can 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.
Rivastor contains lactose
How to use Rivastor
Always use Rivastor transdermal patches 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 Rivastor transdermal patch is most suitable for you.
- Treatment is usually started with Rivastor 4.6 mg / 24 hours.
- The usual recommended daily dose is Rivastor 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. (A strength of 13.3 mg / 24-hour mark is not achieved with this product. For conditions where this strength should be used, refer to other rivastigmine products where transdermal patches of 13.3 mg / 24-hour strength are available.)
- Use only one transdermal 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 apply 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 Rivastor 4.6 mg / 24 hours.
Rivastor can be used with food, drink, and alcohol.
Where should your Rivastor transdermal patch be affixed
- Before applying the patch, make sure that the skin is clean, dry, and hair-free, free of powder, oil, moisturizer, or lotion, which may prevent the patch from adhering properly to the skin, 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 potentially 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 to attach your Rivastor transdermal patch
Rivastor transdermal patches are thin, light brown plastic patches that are attached to the skin. Each patch is sealed in a sachet that protects it until it is put on. Do not open the sachet and do not remove the patch until just before putting it on.
If you are already using a patch, carefully remove it before applying a new one. For patients starting treatment for the first time or resuming rivastigmine after discontinuation of treatment, please start at the next screen.
Each patch is individually packaged in a sealed dope bag.
Only open the sachet when you are ready to apply the patch.
Cut the sachet in both places marked with scissors but not further than the line. Tear open the sachet. Do not cut along the entire edge of the sachet as this may damage the patch.
Remove the patch from the sachet.
Remove the protective paper from the upper, skin-colored side of the patch and discard it.
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 is helpful, you can write e.g. what a weekday it is with a thin ballpoint pen on the patch.
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 Rivastor transdermal patch
Gently grasp one edge of the patch and slowly pull it 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 it. 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 Rivastor 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 Rivastor 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 Rivastor 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 patch at a time and replace the patch with a new one after 24 hours.
If you use more Rivastor 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.
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, diarrhea, high blood pressure, and hallucinations. Slow heart rate and fainting can also occur.
If you forget to use Rivastor
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 Rivastor
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, Rivastor transdermal patch 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 hold back urine)
Uncommon (may affect up to 1 in 100 people)
- heart rhythm disorders (both fast and slow heartbeats)
- to see 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 of hands
No known frequency (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
- 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)
- 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)
- 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 common (may affect up to 1 in 100 people)
- irregular heartbeat (eg fast heartbeat)
- difficulty sleeping
- fall unintentionally are (may affect up to 1 in 1,000 people)
- cramps (seizures)
- intestinal ulcers
- chest pain – can be caused by 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)
- to see things that are not real (hallucinations)
- some people who have had severe vomiting have had stretch marks in the esophagus
How to store Rivastor
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiration date is the last day of the specified month.
- There are no special storage instructions for this medicine.
- Keep the transdermal patch in the sachet until ready to use.
- Do not use the patch if you see that it is damaged or if the sachet 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 sachet and throw it away so that children can not get hold of it. Do not poke in the eyes with your fingers and wash your hands with soap and water after removing the patch. If your home municipality burns household waste, you can dispose of the patch together with the household waste. Otherwise, return used patches to the pharmacy, preferably in the original packaging.
Contents of the pack and other information
Content declaration
- The active substance is rivastigmine.
- Rivastor 4.6 mg / 24 hours: Each patch that emits 4.6 mg rivastigmine per 24 hours is 4.6 cm 2 and contains 6.9 mg rivastigmine.
- Rivastor 9.5 mg / 24 hours: Each patch delivering 9.5 mg rivastigmine per 24 hours is 9.2 cm 2 and contains 13.8 mg rivastigmine.
- Other ingredients are Matrix:
- poly [(2-Ethylhexyl) acrylate, vinyl acetate]
- high molecular weight polyisobutylene
- high molecular weight polyisobutylene
- silica, colloidal, anhydrous
- paraffin, easy-flowing
- Back:
- polyethylene / thermoplastic resin/aluminum coated polyester film
- Protective film:
- polyester film, fluoropolymer coated
Orange ink
What the medicine looks like and the contents of the pack
Each transdermal patch is a thin patch. The outside is light brown and marked with orange ink as follows:
- Rivastor 4.6 mg / 24 h: “RIV-TDS 4.6 mg / 24 h”
- Rivastor 9.5 mg / 24 h: “RIV-TDS 9.5 mg / 24 h”
Each transdermal patch is sealed in a sachet. The patches are available in packs of 7 or 30 transdermal patches and multi-packs of 60 or 90 transdermal patches. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Luye Pharma AG
Am Windfeld 35
83714 Miesbach
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB
medinfo@orionpharma.com