Patient leaflet - Rivastigmine Brown & Burk 4.6 mg/24 hours transdermal patches
1. What Rivastigmine transdermal patch is and what it is used for
The active substance of Rivastigmine transdermal patch is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in 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 transdermal patch allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease.
Rivastigmine transdermal patch is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
2. What you need to know before you use Rivastigmine transdermal patch
Do not use Rivastigmine transdermal patch
if you are allergic to rivastigmine (the active substance in Rivastigmine transdermal patch) 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 have a skin reaction spreading beyond the patch size, if there is a more intense local
reaction (such as 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, tell your doctor and do not apply Rivastigmine transdermal patches.
Warnings and precautions
Talk to your doctor before using Rivastigmine transdermal patch:
if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc
prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
- if you have, or have ever had, an active stomach ulcer.
- if you have, or have ever had, difficulties in passing urine.
- if you have, or have ever had, seizures.
- if you have, or have ever had, asthma or a severe respiratory disease.
- if you suffer from trembling.
- if you have a low body weight.
if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and
diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
- if you have impaired liver function.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor.
Children and adolescents
There is no relevant use of rivastigmine transdermal patch in the paediatric population in the treatment of Alzheimer's disease.
Other medicines and Rivastigmine transdermal patch
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Rivastigmine might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
Rivastigmine transdermal patch should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
If you have to undergo surgery whilst using Rivastigmine transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution when Rivastigmine Patch is given together with beta-blockers (medicines such as atenolol used to treat hypertension, angina, and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
Caution when Rivastigmine transdermal patch is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 transdermal patch must be assessed against the possible effects on your unborn child. rivastigmine transdermal patch should not be used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with rivastigmine transdermal patches.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. rivastigmine transdermal patches may cause fainting or severe confusion. If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
3. How to use Rivastigmine transdermal patch
Always use Rivastigmine transdermal patches exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
IMPORTANT:
- Take off the previous patch before putting ONE new patch on.
- Only one patch per day.
- Do not cut the patch into pieces.
- Press the patch firmly in place for at least 30 seconds using the palm of the hand.
How to start treatment
Your doctor will tell you which Rivastigmine transdermal patch is most suitable for you. · Treatment usually starts with Rivastigmine transdermal patch 4.6 mg/24 h. · The recommended usual daily dose is Rivastigmine transdermal patch 9.5 mg/24 h. If well
tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h. · Only wear one Rivastigmine patch at a time and replace the patch with a new one after 24
hours.
During the course of the treatment your doctor may adjust the dose to suit your individual needs.
If you have not applied a patch for more than three days, do not apply the next one before you have talked to your doctor. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise your doctor will restart your treatment on Rivastigmine transdermal patch 4.6 mg/24 h.
Rivastigmine transdermal patch can be used with food, drink and alcohol.
Where to apply your Rivastigmine transdermal patch
Before you apply a patch, make sure that your skin is clean, dry and hairless, free of any
powder, oil, moisturiser or lotion that could keep the patch from sticking to your skin properly, free of cuts, rashes and/or irritations.
Carefully remove any existing patch before putting on a new one. Having multiple
patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
Apply ONE patch per day to ONLY ONE of the possible locations shown in the following
diagrams:
- left upper arm or right upper arm
- left upper chest or right upper chest (avoid breast)
- left upper back or right upper back
- left lower back or right lower back
Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.
When changing the patch, you must remove the previous day's patch before you apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day). Do not apply a new patch to the same skin area twice within 14 days.
How to apply your Rivastigmine transdermal patch
Rivastigmine patches are thin, skin-coloured, plastic self-adhesive patches. Each patch is sealed in a sachet that protects it until you are ready to put it on. Do not open the sachet or remove a patch until just before you apply it.
Carefully remove the existing patch before putting on a new one.
For patients starting treatment for the first time and for patients restarting Rivastigmine transdermal patch after treatment interruption, please begin with the second picture.
Each patch is sealed in its own protective sachet. You should only open the sachet when you are ready to apply the patch.
Cut the sachet along the sealed edge with scissors and remove the patch from the sachet.
- The patch can most easily be removed when the sachet is cut on two sides.
- A protective liner covers the sticky side of the patch. Peel off one side of the protective liner and do not touch the sticky part of the patch with your fingers.
- Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.
- Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
The patch should be worn continuously until it is time to replace it with a new one. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
How to remove your Rivastigmine transdermal patch
Gently pull at one edge of the patch to remove it slowly from the skin. In case the adhesive residue is left over on your skin, gently soak 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 after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
Can you wear your Rivastigmine transdermal patch when you are bathing, swimming, or in the sun?
Bathing, swimming or showering should not affect the patch. Make sure the patch does not
loosen during these activities.
Do not expose the patch to any external heat sources (e.g. excessive sunlight, saunas,
solarium) for long periods of time.
What to do if a patch falls off
If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.
When and for how long to apply your Rivastigmine transdermal patch
To benefit from treatment, you must apply a new patch every day, preferably at the same time
of day.
Only wear one Rivastigmine patch at a time and replace the patch with a new one after 24
hours.
If you use more Rivastigmine transdermal patch than you should
If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch. You may require medical attention. Some people who have accidentally taken too much rivastigmine at once have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.
If you forget to use Rivastigmine transdermal patch
If you find you have forgotten to apply a patch, apply one immediately. You may apply the next patch at the usual time the next day. Do not apply two patches to make up for the one that you missed.
If you stop using Rivastigmine transdermal patch
Tell your doctor or pharmacist if you stop using the patch.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Rivastigmine transdermal patches can cause side effects, although not everybody gets them.
You may have side effects more often when you start your medicine or when your dose is increased. Usually, the side effects will slowly go away as your body gets used to the medicine.
Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Common (may affect up to ≥1/100 to <1/10 people)
- Loss of appetite
- Feeling dizzy
- Feeling agitated or sleepy
- Urinary incontinence (inability to retain adequate urine)
- Urine tract infection
- Anxiety
- Depression
- Confusion
- Headache
- Fainting
- Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
- Heartburn
- Stomach pain
- Rash
- Allergic reaction where the patch was used, such as blisters or inflamed skin
- Feeling tired or weak
- Weight loss
- Fever
Uncommon (may affect up to ≥1/1,000 to <1/100 people)
- Problems with your heartbeat such as slow heartbeat
- Seeing things that are not really there (hallucinations)
- Stomach ulcer
- Dehydration (losing too much fluid)
- Hyperactivity (high level of activity, restlessness)
- Aggression
Rare (may affect up to ≥1/10,000 to <1/1,000 people)
- Falling
Very rare (may affect up to <1/10,000 people)
- Stiff arms or legs
- Trembling hands
Not known (frequency cannot be estimated from the available data)
The signs of Parkinson's disease get worse – such as tremor, stiffness and shuffling · Inflammation of the pancreas – signs include serious upper stomach pain, often with feeling
sick (nausea) or being sick (vomiting)
- Fast or uneven heartbeat
- High blood pressure
- Fits (seizures)
Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the
urine or unexplained nausea, vomiting, tiredness and loss of appetite) · Changes in tests which show how well the liver is working
- Feeling restless
- Nightmares
Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of
the body and head to one side)
- Seeing things that are not there (hallunication)
Trembling
- Sleepiness
- Rash, itching,
- Skin reddening
- Blisters
Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Other side effects seen with rivastigmine capsules or oral solution and which may occur with the patch:
Common (may affect up to 1 in 10 people)
- Too much saliva
- Loss of appetite
- Feeling restless
- Generally feeling unwell
- Trembling or feeling confused
- Increased sweating
Uncommon (may affect up to 1 in 100 people)
- Uneven heart rate (e.g. fast heart rate)
- Difficulty sleeping
- Accidental falls
Rare (may affect up to 1 in 1,000 people)
- Fits (Seizures)
- Ulcer in the intestine
- Chest pain this may be caused by heart spasm
Very rare (may affect up to 1 in 10,000 people)
- High blood pressure
Inflammation of the pancreas – the signs include serious upper stomach pain, often with
feeling sick (nausea) or being sick (vomiting)
- Bleeding in the gut – shows as blood in stools or when being sick
- Seeing things that are not there (hallucinations)
Some people who have been violently sick have had tearing of the tube that connects your
mouth with your stomach (oesophagus)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rivastigmine transdermal patch
- 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 sachet after
EXP. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Keep the transdermal patch in the sachet until use.
Do not use any patch that is damaged or shows signs of tampering. · After removing a patch, fold it in half with the sticky sides on the inside and press them
together. Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch. Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Rivastigmine transdermal patches contains
The active substance is rivastigmine.
Rivastigmine Brown & Burk 4.6 mg/24h transdermal patch
2 One transdermal patch in the size of 5.25 cm contains 9 mg of rivastigmine and releases 4.6 mg of rivastigmine per 24 hours.
Rivastigmine Brown & Burk 9.5 mg/24h transdermal patch
2 One transdermal patch in the size of 10.5 cm contains 18 mg of rivastigmine and releases 9.5 mg of rivastigmine per 24 hours.
The other excipients are: Polyethylene terephthalate, polyacrylate, ammonio methacrylate-copolymer (type B) (Ph.Eur.), Polyethylene terephthalate siliconised, black printing ink.
What Rivastigmine transdermal patches looks like and contents of the pack
Each transdermal patch is a thin patch that consists of three layers. The backing layer is translucent and has the following labelling in black colour:
Rivastigmine Brown & Burk 4.6 mg/24h transdermal patch
“Rivastigmine” and “4.6 mg/24h”
Rivastigmine Brown & Burk 9.5 mg/24h transdermal patch
“Rivastigmine” and “9.5 mg/24h”
Each transdermal patch is sealed in a child-proof sachet.
The transdermal patches are available in packs containing 7, 30 or 42 sachets and in multipacks with 60 (2 x 30), 84 (2 x 42) or 90 (3 x 30) sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Brown & Burk UK Limited
Micro House
Bury Street
Ruislip
HA4 7TL
United Kingdom
Manufacturer
AdhexPharma
42-44 rue de longvic
21300 Chenôve
France
This leaflet was last revised in June 2026
Rivastigmine Brown & Burk 4.6 mg/24 hours transdermal patch
Rivastigmine Brown & Burk 9.5 mg/24 hours transdermal patch
rivastigmine Package leaflet: Information for the user 61 mm