4.6 mg / 24 h, 9.5 mg / 24 h transdermal
patch rivastigmine
What Rigmin is and what it is used for
The active substance in Rigmin transdermal patch 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, Rigmin increases acetylcholine levels in the brain, thus helping to reduce the symptoms of Alzheimer’s disease.
Rigmin 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 Rigmin 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 Rigmin
Do not use Rigmin
- if you are allergic to rivastigmine (the active substance in Rigmin) 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 Rigmin transdermal patches.
Warnings and cautions
Talk to your doctor or pharmacist before using Rigmin transdermal patches:
- if you have or have ever had, an 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 Rigmin for a pediatric population in the treatment of Alzheimer’s disease.
Other drugs and Rigmin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rigmin can 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, or meclozine).
Rigmin patches 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 Rigmin transdermal patches, tell your doctor that you are using the medicine, as Rigmin transdermal patches may intensify the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Rigmin 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 Rigmin must be weighed against the possible effects on your unborn baby. Rigmin should not be used during pregnancy unless necessary.
You should not breastfeed when you are being treated with Rigmin transdermal patches.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Rigmin 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.
How to use Rigmin
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
IMPORTANT:
- Remove the previous day’s patches 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 Rigmin transdermal patch is most suitable for you.
- Treatment is usually started with Rigmin 4.6 mg / 24 hours.
- The usual recommended daily dose is Rigmin 9.5 mg / 24 hours per day. If this dose is well-tolerated, your doctor may increase your dose to Rigmin 13.3 mg / 24 hours.
- Use only one Rigmin 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 in 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 Rigmin 4.6 mg / 24 hours.
Rigmin can be used with food, drink, and alcohol.
Where should your Rigmin 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 patch 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 Rigmin transdermal patch be attached?
Rigmin patches are thin, opaque plastic patches that are attached 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.
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 Rigmin 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 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 Rigmin 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 Rigmin 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 Rigmin 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 Rigmin 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 Rigmin, have felt nauseous, vomited, or had 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. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Rigmin
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 Rigmin
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, and 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, tiredness, 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 (esophagus, the tube that connects the mouth to the stomach)
How to store Rigmin
- 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.
- Do not store above 25 ° C.
- Keep the transdermal patch in the patch envelope until use.
- 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 plaster envelope and throw it away so that children cannot 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. 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 package and other information
Content declaration
- The active substance in Rigmin transdermal patch is rivastigmine.Rigmin 4.6 mg / 24 hours: Each patch that releases 4.6 mg rivastigmine per 24 hours is 5 cm 2 and contains 9 mg rivastigmine.Rigmin 9.5 mg / 24 hours: Each patch that releases 9.5 mg of rivastigmine per 24 hours is 10 cm 2 and contains 18 mg of rivastigmine.
- The other ingredients are lacquered polyethylene terephthalate film, all-rac-α-Tocopherol, poly (butyl methacrylate, methyl methacrylate), copolymer (3: 1), acrylic copolymer, silicone, dimethicone, polyester film coated with fluoropolymer, resin, pigment, organic polymers/resins.
What the medicine looks like and the contents of the pack
Rigmin 4.6 mg / 24 hours transdermal patch is a thin matrix-type transdermal patch and consists of three layers. The outside of the patch film is beige and marked with “RIV” and “4.6 mg / 24 h”.
Rigmin 9.5 mg / 24 hours transdermal patch is a thin matrix-type transdermal patch and consists of three layers. The outside of the patch film is beige and marked with “RIV” and “9.5 mg / 24 h”.
Each transdermal patch is sealed in a patch envelope. Depot patches are available in pack sizes of 7, 30, 60 (2 packs of 30), and 90 (3 packs of 30) depot patches.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany