Description
Rivastigmine transdermal patch is used to treat mild, moderate, and severe dementia (memory loss and mental changes) associated with Alzheimer's disease or mild to moderate dementia associated with Parkinson's disease. Rivastigmine will not cure these diseases and it will not stop these diseases from getting worse. However, rivastigmine can improve thinking ability in some patients with these diseases.
In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is a decrease in a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Rivastigmine is an acetylcholinesterase inhibitor. It slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so rivastigmine may not work as well.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Patch, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rivastigmine transdermal patch in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivastigmine transdermal patch in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bromopride
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Amifampridine
- Atenolol
- Betaxolol
- Bisoprolol
- Bupropion
- Carteolol
- Carvedilol
- Celiprolol
- Donepezil
- Esmolol
- Labetalol
- Levobunolol
- Metipranolol
- Metoclopramide
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Penbutolol
- Pindolol
- Practolol
- Propranolol
- Sotalol
- Timolol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Oxybutynin
- Tolterodine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart problems or
- Lung or breathing problems (eg, asthma or COPD), history of or
- Seizures or
- Stomach ulcers or
- Trouble urinating—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe or
- Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of this medicine from the body. Use of a lower dose may be needed.
- Low body weight (below 50 kilograms)—Use with caution. The side effects of this medicine may be increased. Use of a lower dose may be needed.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use the skin patch:
- Make sure you wash your hands with soap and water before and after applying the patch.
- Do not use this medicine if the pouch seal is broken, or if the patch is cut, damaged, or changed in any way. Do not remove the patch from the sealed pouch until you are ready to apply it.
- This medicine is available in 3 different strengths. Make sure you have the right strength patch that has been prescribed for you.
- Cut the pouch along the dotted line to open and remove the patch. Do not cut or fold the patch. Peel off 1 side of the protective cover. Do not touch the sticky part with your fingers.
- Do not put cream, lotion, or powder on the skin area where the patch will be placed.
- Apply the patch to clean, dry, intact skin on your upper back, lower back, upper arms, or chest that has very little to no hair. Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors. Do not put the patch over burns, cuts, or irritated skin. Avoid putting the patch over skin folds, across the spine, or on areas where it could be rubbed by tight clothing or undergarments.
- Place the sticky side against the skin and peel off the other side of the protective cover. Press down on the patch firmly for 30 seconds to make sure that edges of the patch stick to your skin.
- If the patch falls off, throw it away and apply a new patch in a different area.
- Do not touch your eyes after applying the patch. Rinse it off right away with water if it does get in your eyes or if your eyes become red after touching the patch.
- Choose a different place on your skin to apply the next patch. You may use the same area, but do not use the exact same spot for at least 14 days after your last application.
- Fold the used patch in half and put it back into the pouch you saved.
Keep the patch away from heat, including excessive sunlight, saunas, sun rooms, or heating pads.
Do not stop using this medicine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first. You may need to start the medicine again using a lower dose.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For transdermal dosage form (patch):
- For dementia associated with Alzheimer's disease or Parkinson's disease:
- Adults—At first, one 4.6 milligram (mg) patch once a day. After at least 4 weeks, your doctor may adjust your dose as needed. However, the dose is usually not more than one 13.3 mg patch per day.
- Children—Use and dose must be determined by your doctor.
- For dementia associated with Alzheimer's disease or Parkinson's disease:
Missed Dose
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Storage
Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
This medicine may cause nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns. Call your doctor right away if you have severe diarrhea, dry mouth, thirst, unusual tiredness, and less urine than usual. These could be symptoms of dehydration (loss of too much body fluid). Dehydration is more likely to occur if you have diarrhea or vomiting.
This medicine may cause skin application site reactions, including allergic contact dermatitis. Check with your doctor right away if you have blistering, burning, crusting, dryness, or flaking of the skin or itching, scaling, severe redness, soreness, or swelling of the skin where the patch is applied.
Having more than one patch on your body at the same time can cause you to get too much of this medicine. Make sure you remove the used patch before wearing a new one to decrease your risk of having serious side effects. If you accidentally use more than one patch at a time, call your doctor right away.
This medicine may cause bleeding in your stomach or bowels. Check with your doctor right away if you have bloody or black, tarry stools, constipation, severe stomach pain, or vomiting of blood or material that looks like coffee grounds.
This medicine may also increase your risk of having seizures or tremors. Talk with your doctor before using this medicine if you have any concerns.
This medicine may cause heart problems. Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.
Before you have any kind of surgery or dental treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Using rivastigmine together with medicines that are sometimes used during surgery or dental treatments may increase the effects of these medicines.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
Less common
- Blurred vision
- dizziness
- headache
- loss of bladder control
- nervousness
- pounding in the ears
- slow or fast heartbeat
Rare
- Arm, back, or jaw pain
- chest pain, tightness, heaviness, or discomfort
- confusion
- convulsions
- decreased urine
- difficult or troubled breathing
- dilated neck veins
- false beliefs that cannot be changed by facts
- irregular breathing
- irregular heartbeat
- loss of consciousness
- rapid breathing
- seizures
- severe nausea or vomiting
- stomach pain or tenderness
- sunken eyes
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- unusual tiredness or weakness
- wrinkled skin
Incidence not known
- Blistering, burning, crusting, dryness, or flaking of the skin
- burning, itching, redness, skin rash, swelling, or soreness at the application site
- fast, pounding, or irregular heartbeat or pulse
- hives or welts
- itching, scaling, severe redness, soreness, or swelling of the skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- increasing muscle weakness
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- slow or irregular heartbeat
- sweating
- unusual tiredness or weakness
- watering of mouth
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- discouragement
- fear
- feeling of constant movement of self or surroundings
- feeling sad or empty
- irritability
- lack of appetite
- lack or loss of strength
- loss of interest or pleasure
- nausea
- redness at the application site
- sensation of spinning
- tiredness
- trouble concentrating
- trouble sleeping
- upper stomach pain
- vomiting
- weight loss
Rare
- Blindness
- burning, stinging, or pain at the application site
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased vision
- difficulty with moving
- eye pain
- hearing loss
- itchy skin
- muscle pain or stiffness
- pain in the joints
- pale skin
- tearing
- unusual bleeding or bruising
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
