Details for: SANDOZ RIVASTIGMINE PATCH
Company: SANDOZ CANADA INCORPORATED
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02426293 | SANDOZ RIVASTIGMINE PATCH 5 | RIVASTIGMINE | 4.6 MG / 24 HOUR | PATCH | TRANSDERMAL |
02426307 | SANDOZ RIVASTIGMINE PATCH 10 | RIVASTIGMINE | 9.5 MG / 24 HOUR | PATCH | TRANSDERMAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Sandoz Rivastigmine Patch is one of a group of drugs known as
“cholinesterase inhibitors” which is used for the treatment of the
symptoms of patients with mild to moderately severe Alzheimer’s
disease.
The symptoms include progressive memory loss, increasing
confusion and behavioural changes, as a result of which it
becomes more and more difficult to carry out activities of daily
living.
This medication should only be taken after proper diagnosis of
your condition has been made by your doctor.
What it does
People with Alzheimer’s disease have decreased levels of acetylcholine, a substance which is found in the brain and which is thought to be necessary for memory and other mental functions. Sandoz Rivastigmine Patch works by inhibiting an enzyme (acetylcholinesterase) which breaks down acetylcholine. This in turn increases the amount of acetylcholine in the brain. Sandoz Rivastigmine Patch is a treatment of symptoms, not a cure of the disease.
When it should not be used
If any of the following conditions apply to you, tell your doctor and do not use Sandoz Rivastigmine Patch.
- If you know that you are allergic (hypersensitive) to rivastigmine (including rivastigmine capsules or oral solution) or to any of the other ingredients listed in this leaflet (see ‘What the nonmedicinal ingredients are’).
- If you have ever had an allergic reaction to a similar type of medicine (e.g. carbamate derivate).
- If you have severe liver disease.
- If you have had a previous allergic skin reaction with Sandoz Rivastigmine Patch that spread beyond the patch size and/or if there was a more severe reaction at the patch site (such as blisters, increasing skin inflammation, swelling) that did not improve within 48 hours after removal of the transdermal patch.
- If you have had severe rash on large areas of your body or blistering of the skin, mouth, eyes, or genitals when taking Sandoz Rivastigmine Patch, Rivastigmine capsules or oral solution.
What the medicinal ingredient is
The active substance of Sandoz Rivastigmine Patch is rivastigmine.
What the non-medicinal ingredients are
Sandoz Rivastigmine Patch contains the following nonmedicinal ingredients: acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicon adhesive applied to a flexible polymer backing film, silicon oil and vitamin E
What dosage form it comes in
Transdermal patch providing continuous smooth delivery of the
medication.
Sandoz Rivastigmine Patch 5: each 5 cm2
transdermal patch
contains 9 mg rivastigmine. The release rate is 4.6mg/24h.
Sandoz Rivastigmine Patch 10: each 10 cm2
transdermal patch
contains 18 mg rivastigmine. The release rate is 9.5mg/24h.
Warnings and precautions
BEFORE you use Sandoz Rivastigmine Patch talk to your doctor or pharmacist if you:
- Have, or ever had an irregular heartbeat;
- Have, or ever had an active stomach ulcer;
- Have, or ever had difficulties in passing urine;
- Have, or ever had seizures;
- Have, or ever had asthma or a severe respiratory disease;
- Suffer from trembling; or are being treated with medications that can cause trembling, such as antipsychotic medications;
- Have a low body weight (for example less than 50 kg);
- Have, or ever had liver or kidney problems;
- Have, or ever had inflammation of the pancreas;
- Are pregnant, planning to become pregnant, or breast-feeding;
- Have fainting episodes.
- Experience gastro-intestinal reactions such as severe nausea (feeling sick), vomiting (being sick) and diarrhea. You may become dehydrated (losing too much fluid) if vomiting or diarrhea are prolonged.
Talk to your doctor right away if you have skin inflammation, blisters or swelling of the skin that are increasing and spreading.
If you have not applied Sandoz Rivastigmine Patch for more than 3 days do not apply the next patch until you have talked to your doctor.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. If you feel dizzy or drowsy, do not drive, use machines or perform any other tasks that require your attention.
Interactions with this medication
Tell your doctor or pharmacist about any other medicines you are
taking or have recently taken, including drugs, or herbal (natural)
products that you have bought without a prescription.
Sandoz Rivastigmine Patch should not be given together with
other medicines that work similar to Sandoz Rivastigmine Patch
(cholinomimetic agents) or with anticholinergic medicines (e.g.
medicines used to relieve stomach cramps or spasms, or to treat
Parkinson’s disease or to prevent travel sickness).
Sandoz Rivastigmine Patch should not be given together with
metoclopramide (a medicine used to alleviate or prevent nausea
and vomiting). There may be additive effects such as stiff limbs
and trembling hands.
If you have to undergo surgery while using Sandoz Rivastigmine
Patch, you should inform your doctor because Sandoz
Rivastigmine Patch may exaggerate the effects of some muscle
relaxants during anesthesia.
Caution when Sandoz Rivastigmine Patch is given together with
beta-blockers (medicines such as atenolol used to treat
hypertension, angina, and other heart conditions). There may be
additive effects such as bradycardia (slow heartbeat) that may
result in syncope (fainting, loss of consciousness).
Proper use of this medication
Follow all instructions given to you by your doctor carefully,
even if they differ from the ones given in this leaflet.
This medicine must not be given to children.
Do not eat Sandoz Rivastigmine Patch.
IMPORTANT:
Usual adult Dose
Your doctor will tell you which Sandoz Rivastigmine Patch is
more suitable for you. Treatment usually starts with Sandoz
Rivastigmine Patch 5 (4.6 mg/24h) applied once a day. The usual
daily dose is Sandoz Rivastigmine Patch 10 (9.5 mg/24h) applied
once a day.
ONLY ONE patch should be worn at a time and the patch
should be replaced by 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 been applying Sandoz Rivastigmine Patch for
more than 3 days do not apply the next patch before you have
talked to your doctor.
Application of Sandoz Rivastigmine Patch
Where to apply Sandoz Rivastigmine Patch
EVERY 24 HOURS, ALWAYS GENTLY REMOVE THE
PREVIOUS DAY’S SANDOZ RIVASTIGMINE PATCH
BEFORE PUTTING ON A NEW ONE.
ONLY ONE PATCH SHOULD BE WORN AT A TIME.
Before you apply Sandoz Rivastigmine 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.
When changing your patch, you must remove the previous day’s patch before you apply your new patch to a different area of skin (for example on the right side of your body one day, then on the left side the next day). Do not apply a new patch to that same spot for at least 14 days.
How to apply Sandoz Rivastigmine Patch
The patch is a thin, opaque, plastic patch that sticks 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 from your skin until just before you apply a new one.
Cut the pouch along the dotted line or at the notch and remove the patch.

A protective liner covers the adhesive side of the patch.
Peel off one side 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, OR upper arm OR chest and then peel off the second side of the protective liner.

Then press the patch firmly in place using the palm of the hand, applying pressure over the entire patch for at least 30 seconds, to make sure that the edges stick well.

If it helps you, you may write (e.g. the day of the week) on the patch with a thin ball point pen.
Sandoz Rivastigmine Patch should be worn continuously until it is time to replace it with a new patch. 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.
Safety and Handling
How to remove Sandoz Rivastigmine Patch
Gently pull at one edge of the Sandoz Rivastigmine Patch to
remove it completely from the skin. In case the adhesive residue
is left over on your skin, gently use mild soap or baby oil to
remove it. Alcohol or other dissolving liquids (nail polish
remover or other solvents) should not be used.
How to dispose of the used Sandoz Rivastigmine Patch
After the patch has been removed, fold it in half with the adhesive
sides on the inside and press them together. Return the used patch
in the pouch from today’s patch and discard safely out of the
reach and sight of children and pets, as there is still drug in the
patch after 24-hour usage. You can dispose of the patch in your
waste container.
Do not touch your eyes with your fingers and wash your hands
with soap and water after handling the patch. In case of contact
with eyes, rinse immediately with plenty of water and seek medical
advice if eyes become red and do not resolve.
Can you wear Sandoz Rivastigmine Patch when bathing,
swimming, or in the sun?
Bathing, swimming, or showering should not affect the patch. To
help ensure that the patch sticks well, do not place on wet or damp
skin. When swimming, you can wear the patch under your bathing
suit. Make sure the patch does not loosen during these activities by
checking it regularly.
While wearing Sandoz Rivastigmine Patch you should not expose
the patch area to external sources of heat as this may increase the
amount of drug that may enter your body through the skin. Such
external heat sources include intensive sunbathing, heat lamps,
heating pads, saunas and hot tubs, etc. This may also occur if you
develop a fever while wearing Sandoz Rivastigmine Patch.
What to do if Sandoz Rivastigmine Patch falls off
If the patch falls off, a new patch should be applied for the rest of
the day, then replace the patch the next day at the same time as
usual.
Accidental transfer of Sandoz Rivastigmine Patch to another
person
If your patch dislodges and accidentally sticks to the skin of
another person, take the patch off immediately and call a doctor.
This is true for both fresh and used patches, as a considerable
amount of drug remains in the patch after use.
When and for how long to apply Sandoz Rivastigmine Patch
To benefit from your medicine a new patch must be applied every
day, after removal of the old patch. Taking Sandoz Rivastigmine
Patch at the same time each day will help you remember when to
take your medicine. Wear ONLY ONE Sandoz Rivastigmine
Patch at a time and replace the patch by a new one after 24 hours.
If you are applying your own patch, tell your caregiver that you are
applying Sandoz Rivastigmine Patch. Also tell your caregiver if
you have not been applying Sandoz Rivastigmine Patch for more
than 3 days.
The prescription of this medicine needs specialized advice before
its initiation and a periodic assessment of therapeutic benefits.
Your doctor will also monitor your weight while you are taking
this medicine.
If you have questions about how long to take Sandoz Rivastigmine
Patch talk to your doctor or your pharmacist
Overdose
- Some people who have accidentally taken too much oral rivastigmine have experienced nausea (feeling sick), vomiting (being sick), and diarrhea. You may become dehydrated (losing too much fluid) if vomiting or diarrhea are prolonged.
- Some people may also experience high blood pressure, hallucinations, slow heart beat and fainting.
Missed Dose
If you find you have forgotten to apply your Sandoz Rivastigmine
Patch, apply a new patch immediately. You may apply the next
patch at the usual time the next day, after removing the previous
day’s patch. Do not apply two patches to make up for the one that
you missed. ONLY ONE patch should be worn at a time.
Do not stop taking Sandoz Rivastigmine Patch or change your
dose without talking with your doctor. If you have not been
applying Sandoz Rivastigmine Patch for more than 3 days do not
apply the next patch before you have talked to your doctor.
Side effects and what to do about them
As with all medicines, patients using Sandoz Rivastigmine Patch may experience side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
You may see side effects more frequently when you start your medication or increase to a higher dose. In most cases side effects will gradually disappear as your body gets used to the medicine.
Nausea and vomiting are the most common side effects (affect between 1 and 10 in every 100 patients). If you experience persistent or severe nausea and/or vomiting, contact your doctor about temporarily stopping your treatment with Sandoz Rivastigmine Patch. Your doctor will decide how you should restart your treatment when you are feeling better.
Other common side effects:
- loss of appetite, weight loss,
- anxiety,
- difficulty in sleeping,
- dizziness,
- trembling,
- accidental falls,
- headache,
- diarrhea, stomach discomfort after meals, stomach pain,
- dehydration,
- inability to adequately retain urine (urinary incontinence),
- redness, itching, irritation, swelling at the application site (skins reactions at the application site),
- tiredness,
- weakness,
- worsening of extrapyramidal symptoms (e.g. stiff limbs and trembling hands) if you take other medications, such as antipsychotics, that cause these symptoms.
- agitation,
- drowsiness (common in Chinese patients),
- unusual high level of activity, restlessness (hyperactivity),
- sweating,
- general feeling of being unwell.
- high blood pressure,
- rash and itching or skin reddening on contact with the patch (very common in Japanese patients),
- itching,
- rash,
- skin reddening,
- blister (at the patch site and/or on other parts of the body),
- skin inflammation with rash,
- fall.
- muscle stiffness, difficulty in carrying out movements (worsening of Parkinson’s disease symptoms).
- changes in blood test results related to liver function,
- restlessness,
- trembling
- heart disorders (alternating heart rhythms),
- skin inflammation, blisters or swelling of the skin that are increasing and spreading.
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate emergency medical assistance |
---|---|---|---|
Common | |||
Depression | ✔ | ||
Urinary tract infection: infection involving the part of the body producing urine | ✔ | ||
Dehydration: losing too much fluid | ✔ | ||
Anemia: fatigue, loss of energy, weakness, shortness of breath |
✔ | ||
Uncommon | |||
Severe confusion | ✔ | ||
Hallucinations: seeing, feeling or hearing things that are not there | ✔ | ||
Chest pain | ✔ | ||
Stroke: loss of coordination, difficulty in speaking and signs of brain disorder | ✔ | ||
Heart attack: crushing chest pain | ✔ | ||
Fainting | ✔ | ||
Problems with heart rhythm (irregular or fast or slow heart beat) | ✔ | ||
Allergic Reaction: rash | ✔ | ||
Stomach ulcer and gastrointestinal hemorrhage: blood in stools or when vomiting | ✔ | ||
Very rare | |||
Inflammation of the pancreas: severe upper stomach pain, often with nausea and vomiting | ✔ | ||
Seizures: fits or convulsions | ✔ | ||
Liver disorders: yellowing of skin and the whites of eyes, darkening of the urine, unexplained nausea, vomiting, loss of appetite, itching, upper stomach pain, tiredness | ✔ | ||
Stevens-Johnson Syndrome: Blistering of the skin, mouth, eyes and genitals | ✔ | ||
Not known | |||
Stiff limbs, trembling hands, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want (extrapyramidal symptoms) | ✔ |
Additional side effects which have been reported with rivastigmine capsules or oral solution that are not listed above for Sandoz Rivastigmine Patch include:
Common: confusion.
Rare: ulcer in the intestines.
Very rare: severe vomiting that can lead to a rupture of the
oesophagus.
If you have any of these effects, if you feel unwell in any other
way, or have symptoms that you do not understand or find
distressing during treatment with Sandoz Rivastigmine Patch, tell
your doctor.
This is not a complete list of side effects. For any unexpected
effects while taking Sandoz Rivastigmine Patch, contact your
doctor or pharmacist.
How to store
- Do not use Sandoz Rivastigmine Patch after the expiry date shown on the carton and pouch.
- Store Sandoz Rivastigmine Patch between 15ºC - 25ºC.
- Do not use any Sandoz Rivastigmine Patch that is damaged or shows signs of tampering.
- Keep Sandoz Rivastigmine Patch out of the reach and sight of children and pets.
- Keep Sandoz Rivastigmine Patch in the individual sealed pouch until just prior to use.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect TM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
What is the most important information I should know about Sandoz Rivastigmine Patch
Sandoz Rivastigmine Patch contains rivastigmine. An overdose with serious and life threatening side effects can happen if you wear more than one patch at a time. An overdose with Sandoz Rivastigmine Patch may cause the following serious side effects:
- severe nausea (feeling sick) and/or vomiting (being sick)
- diarrhea
- high blood pressure
- trouble breathing, or slow or shallow breathing
- slow heart beat and fainting
- seizure
- increasing muscle weakness
- hallucinations
Get medical help right away, if you have been wearing more than one patch at a time, even if you do not have these side effects.
More Information
Please consult your doctor or pharmacist with any questions or
concerns you may have regarding your individual condition.
This document plus the full product monograph, prepared for
health professionals can be obtained by contacting the sponsor,
Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville (QC) Canada
J4B 7K8
or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: November 15, 2016