Apo-Rivastigmine: Uses, Side Effects and Dosage

What is APO-RIVASTIGMINE used for?

APO-RIVASTIGMINE is used in adults to treat symptoms of:

• mild to moderate Alzheimer’s disease
• Parkinson’s disease with an unknown cause
• dementia happening at least 2 years after the diagnosis of Parkinson’s disease

How does APO-RIVASTIGMINE work?

People with Alzheimer’s disease have low amounts of acetylcholine in the brain. It is a substance that is thought to be necessary for memory and other mental functions. APO-RIVASTIGMINE helps stop the break down of acetylcholine. This helps increase the amount of acetylcholine in the brain. APO-RIVASTIGMINE treats the symptoms and does not cure the disease.

What are the ingredients in APO-RIVASTIGMINE?

Medicinal ingredients: Rivastigmine (as rivastigmine hydrogen tartrate).

Non-medicinal ingredients:

Capsules: cornstarch, microcrystalline cellulose and stearic acid. The capsule shell is made of gelatin, red iron oxide (3 mg, 4.5 mg and 6 mg), titanium dioxide and yellow iron oxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

APO-RIVASTIGMINE comes in the following dosage forms:

Capsules: 1.5 mg, 3.0 mg, 4.5 mg or 6.0 mg of rivastigmine (as rivastigmine hydrogen tartrate).

Do not use APO-RIVASTIGMINE if:

• you are allergic to rivastigmine (including rivastigmine patches) or to any of the other ingredients in this medicine
• you are allergic to a similar type of medicine
• you have severe liver problems

• you have had a previous allergic skin reaction with rivastigmine patches. The skin reaction:

  • spread beyond the patch size and/or was more severe at the patch site (such as blisters, increasing skin inflammation, swelling;
  • did not improve within 48 hours after removal of the patch
• you have had severe rash on large areas of your body or blistering of the skin, mouth, eyes, or genitals when taking rivastigmine (patch, capsules or oral solution)
• If you have a history of heart problems including heart rhythm problems

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-RIVASTIGMINE. Talk about any health conditions or problems you may have, including if you:

• have a condition that affects your heart and/or blood vessels (e.g., coronary artery disease, congestive heart failure)
• have fainting episodes
• have or had liver or kidney problems
• are taking any other medicines
• have or have a history of ulcers or bleeding in the stomach or intestines
• have an increased risk of developing ulcers (e.g. you are taking non-steroidal anti-inflammatory drugs (NSAIDS) or high doses of acetylsalicylic acid [ASA])
• have or had problems in passing urine
• have or have had seizures (such as epilepsy)
• have a respiratory disease that affects breathing (e.g., asthma or obstructive pulmonary disease)
• have a low body weight (less than 50 kg)
• are planning to have an operation with general anesthesia (medication that puts you to sleep)
• have uncontrolled involuntary movements of the body, face or limbs (extrapyramidal disorder).

• have an increased risk of developing serious and possibly life-threatening heart rhythm problems. Risk factors include if you:

  • have heart failure.
  • recently had a heart attack.
  • have a slower than usual heartbeat.
  • have been told by a healthcare professional that you have low potassium or magnesium levels in your blood.
  • have or have a family history of heart rhythm problems.
  • take medicines that are known to cause heart rhythm problems.
• are pregnant, think you might be pregnant or plan to become pregnant
• are breast feeding or planning to breast feed
• are older than 85 years of age.

Other warnings you should know about:

APO-RIVASTIGMINE can cause serious side effects, including:

• Gastro-intestinal problems:

  • These include severe nausea, vomiting and diarrhea. You may become dehydrated if these problems happen for a long time. You may become dehydrated if they are not addressed. You or your caregiver should always monitor for these side effects during your treatment. Tell your healthcare professional if these side effects persist. Your dose may need to be changed.
  • Women are more at risk to experience these side effects than men.
  • APO-RIVASTIGMINE can also cause increased acid secretion in the stomach. This can lead to bleeding in the gastrointestinal tract.
• Extrapyramidal symptoms: APO-RIVASTIGMINE can make nervous system problems, like slow or uncontrollable of movements, trembling, seizures and changes in walking patterns worse. Your healthcare professional will monitor these conditions during APO-RIVASTIGMINE treatment.

• Stevens-Johnson Syndrome (SJS) (severe skin rash): This rare serious and life-threatening skin reaction was reported in patients using APO-RIVASTIGMINE. Stop taking APO-RIVASTIGMINE. and get medical help right away if you experience:

  • a severe rash or any other serious skin reaction such as blistering or peeling of the lips, eyes, mouth, nose or genitals.
  • fever, chills, headache, cough, body aches or swollen glands.

• Heart rhythm problems: APO-RIVASTIGMINE may cause serious heart rhythm problems such as:

  • QT Prolongation (a heart rhythm condition where the heart muscle takes longer to contract and relax than usual).
  • Torsade de pointes (a life-threatening irregular heartbeat) in patients with risk factors.
• Pancreatitis (inflammation of the pancreas): It can occur shortly after starting treatment or even after several months or years of treatment with APO-RIVASTIGMINE.

See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.

Driving vehicles and using machines: APO-RIVASTIGMINE may cause you to feel dizzy or drowsy. If you feel dizzy or drowsy, do not drive, use machines or perform any other tasks that require your attention. Your healthcare professional will tell you if you can drive or use machines.

Pregnancy: It is not known if APO-RIVASTIGMINE can harm an unborn baby. Therefore, you should not use it if you can become pregnant unless your healthcare professional has determined the potential benefits outweigh the potential risks to your baby. If you discover that you are pregnant during your treatment with APO-RIVASTIGMINE, tell your healthcare professional right away.

Breastfeeding: It is not known if APO-RIVASTIGMINE can pass into breast milk and harm a breastfed baby. Therefore, APO-RIVASTIGMINE is not recommended during breastfeeding. Talk to your healthcare professional about other ways to feed your baby during your treatment with APO-RIVASTIGMINE.

Surgery: Tell any doctor, dentist, pharmacist, or healthcare professional that you see, that you are taking this medicine. APO-RIVASTIGMINE may exaggerate the effects of some muscle relaxants used during anesthesia.

Check-ups and testing:

• Alzheimer’s disease and cholinesterase inhibitors, such as APO-RIVASTIGMINE, may cause a low appetite and/or significant weight loss. Your healthcare professional will closely monitor your appetite and weight during your treatment with APO-RIVASTIGMINE.
• Your healthcare professional may also monitor your heart rate during this time.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-RIVASTIGMINE:

• Other cholinesterase inhibitors or cholinomimetic medicines (used to treat symptoms of Alzheimer’s disease, dementia, myasthenia gravis, glaucoma and urinary problems). Examples include bethanechol.
• Anticholinergic medicines (used to treat various conditions such as asthma, chronic obstructive pulmonary disease (COPD), bladder problems, gastrointestinal disorders, and symptoms of Parkinson’s disease), Examples include oxybutynin and tolterodine.
• Medicines used to treat nausea and vomiting such as metoclopramide
• Medicines used to treat high blood pressure and chest pain, such as atenolol (beta-blockers)
• Medicines used to prevent pain during surgery

• Medicines that are known to lengthen a part of the heartbeat called “QT interval”. These can include:

  • Medicines that can affect your heart rhythm or the electrical system of your heart such as quinidine, amiodarone, sotalol
  • Medicines used to treat depression like citalopram, escitalopram, amitriptyline
  • Medicines used to treat mental disorders like phenothiazine derivatives, sertindole, pimozide, ziprasidone
  • Medicines used to treat stomach problems like cisapride
  • Medicines used to treat allergies like mizolastin
  • Medicines used to treat bacterial infections such as clarithromycin, erythromycin, levofloxacin, moxifloxacin
  • Medicines used to treat malaria such as halofrantrine
• Medicines used to prevent and control seizures
• Nicotine or tobacco products

How to take APO-RIVASTIGMINE:

• Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• Take APO-RIVASTIGMINE with food. Take APO-RIVASTIGMINE twice a day, once with your breakfast and once with your evening meal.

• Taking APO-RIVASTIGMINE at the same time each day will help you remember when to take your medicine.
• Capsules: Swallow the capsules whole with a drink. Do not open or crush the capsules.

Usual adult dose:

• Your healthcare professional will tell you how much APO-RIVASTIGMINE to take.
• The maximum dose is 6 mg twice a day (12 mg / day).

Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:

• experience serious side effects, or
• your disease gets worse.

Overdose:

• Symptoms of taking too much APO-RIVASTIGMINE can include:

  • nausea, vomiting, or diarrhea. This can lead to dehydration.
  • high or low blood pressure, slow heart beat, slower breaths, muscle weakness
  • headache, dizziness, hallucinations, confusion, fainting, sleepiness
  • stomach pain, shaking, sweating

Missed Dose:

• If you miss a dose of APO-RIVASTIGMINE, take the next dose at the usual time. Do not take two doses at once.
• Do not stop taking APO-RIVASTIGMINE or change your dose without talking with your healthcare professional.
• Your healthcare professional will tell you your new dose if you stop taking APO-RIVASTIGMINE for more than three days.

What are possible side effects from using APO-RIVASTIGMINE?

These are not all the possible side effects you may have when taking APO-RIVASTIGMINE. If you experience any side effects not listed here, tell your healthcare professional.

• nausea, vomiting,
• loss of appetite, weight loss
• dizziness, headache
• accidental falls
• diarrhea, constipation, stomach discomfort after meals, stomach pains, heartburn
• inability to adequately retain urine (urinary incontinence)
• difficulty in sleeping, tiredness, weakness
• agitation, confusion, nightmares, restlessness, anxiety, aggression
• excessive sweating
• a general feeling of being unwell
• fever, stuffy or runny nose
• joint pain, muscle pain or spasms, muscle stiffness
• shortness of breath
• high blood pressure, light-headedness due to low blood pressure
• ringing in the ears
• blurry vision
• trembling
• too much saliva

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Keep APO-RIVASTIGMINE in a safe place and out of the reach and sight of children.

• Do not use APO-RIVASTIGMINE after the expiry date.
• Store APO-RIVASTIGMINE at controlled room temperature 15°C to 30°C.

If you want more information about APO-RIVASTIGMINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: APR 08, 2024