Rivastigmine 3M Health Care Ltd
rivastigmine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Rivastigmine 3M Health Care Ltd. is and what it is used for
What you need to know before you use Rivastigmine 3M Health Care Ltd.
How to use Rivastigmine 3M Health Care Ltd.
Possible side effects
How to store Rivastigmine 3M Health Care Ltd.
Contents of the pack and other information
Medicinal product no longer authorised
The active substance of Rivastigmine 3M Health Care Ltd. 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 3M Health Care Ltd. allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease.
Rivastigmine 3M Health Care Ltd. 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.
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 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 3M Health Care Ltd. transdermal patches.
Talk to your doctor before using Rivastigmine 3M Health Care Ltd.:
if you have, or have ever had, an irregular heartbeat.
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 several days, do not apply the next one before you have talked to your doctor.
There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer’s disease.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Rivastigmine 3M Health Care Ltd. 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).
Medicinal product no longer authorised
If you have to undergo surgery whilst using Rivastigmine 3M Health Care Ltd. transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
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 3M Health Care Ltd. transdermal patches must be assessed against the possible effects on your unborn child. Rivastigmine 3M Health Care Ltd. should not be used during pregnancy unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine 3M Health Care Ltd. transdermal patches.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine 3M Health Care Ltd. 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.
Always use this medicine exactly as described in this leaflet and as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Your doctor will tell you which Rivastigmine 3M Health Care Ltd. transdermal patch is most suitable for you.
Treatment usually starts with Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
The recommended daily dose is Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (this high strength is currently not available from 3M but may be available from other Marketing Authorisation Holders).
Only wear one Rivastigmine 3M Health Care Ltd. 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 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 3M Health Care Ltd. 4.6 mg/24 h.
Rivastigmine 3M Health Care Ltd. can be used with food, drink and alcohol.
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.
Medicinal product no longer authorised
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
Medicinal product no longer authorised
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.
Rivastigmine 3M Health Care Ltd. patches are transparent to translucent, plastic patches that stick to the skin. Each patch is sealed in a pouch that protects it until you are ready to put it on. Do not open the pouch 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 3M Health Care Ltd. after treatment interruption, please begin with the second picture.
Each patch is sealed in its own protective pouch.
You should only open the pouch when you are ready to apply the patch.
Tear the pouch open where indicated and remove the patch from the pouch. The pouch can be torn open in two places.
A protective liner covers the sticky side of the patch.
Peel off one half of the protective liner and do not touch the sticky part of the patch with the fingers.
Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second half 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.
Medicinal product no longer authorised
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.
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.
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.
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.
To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Only wear one Rivastigmine 3M Health Care Ltd. patch at a time and replace the patch with a new one after 24 hours.
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 3M Health Care Ltd. have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.
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.
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.
Like all medicines, this medicine 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.
Medicinal product no longer authorised
Loss of appetite
Feeling dizzy
Feeling agitated or sleepy
Urinary incontinence (inability to retain adequate urine)
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
Falling
Stiff arms or legs
Trembling hands
Allergic reaction where the patch was used, such as blisters or inflamed skin
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
Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Too much saliva
Loss of appetite
Feeling restless
Generally feeling unwell
Trembling or feeling confused
Increased sweating
Uneven heart rate (e.g. fast heart rate)
Difficulty sleeping
Accidental falls
Fits (seizures)
Medicinal product no longer authorised
Ulcer in the intestine
Chest pain – this may be caused by heart spasm
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)
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 pouch after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not use this medicine if you see that the patch 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. If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish. Otherwise, return used patches to a pharmacy, preferably in the original packaging.
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.
The active substance is rivastigmine.
Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patches: Each patch releases
4.6 mg of rivastigmine per 24 hours, is 4.15 cm2 and contains 7.17 mg of rivastigmine.
Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patches: Each patch releases
9.5 mg of rivastigmine per 24 hours, is 8.3 cm2 and contains 14.33 mg of rivastigmine.
The other ingredients are polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Medicinal product no longer authorised
Each transdermal patch consists of three layers; a backing layer, an adhesive layer containing the medicine and a transparent, split release liner. The backing layer is transparent to translucent and labelled with “R5” (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or “R10” (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
One transdermal patch is sealed in one pouch. The patches are available in packs containing 7, 30, 60 and 90 pouches. Not all pack sizes may be marketed in your country.
3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire,
LE11 1EP
United Kingdom
3930 Hamont-Achel
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire,
LE11 1EP
United Kingdom
Tel: +44 (0)1509 611611
Medicinal product no longer authorised