Details for: APO-TETRABENAZINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02407590 | APO-TETRABENAZINE | TETRABENAZINE | 25 MG | TABLET | ORAL |
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
APO-TETRABENAZINE has been prescribed to you by your doctor to treat your symptoms of a movement disorder which causes jerky, irregular, uncontrollable movements, such as those seen in Huntington’s chorea, hemiballismus, senile chorea, tic and Gille de la Tourette’s syndrome, and tardive dyskinesia.
APO-TETRABENAZINE is one of a group of drugs called monoamine depleting agents. APO-TETRABENAZINE is thought to interfere with storage of some chemicals in the brain such as dopamine which is associated with movement disorders.
What it does
Do not take APO-TETRABENAZINE if you:
When it should not be used
- are allergic to tetrabenazine
- are allergic to any of the non-medicinal ingredients listed below
- have symptoms of depression (e.g. feeling sad, crying spells, worthless etc. – see Side Effects table on page 17
- have had depression, in the past or are currently being treated for depression, unless you are under the care of a supervising psychiatrist experienced with your disorder and APO-TETRABENAZINE.
- are taking or have recently taken Monoamine oxidase (MAO) inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide).
- are taking or have recently taken a medication used to treat high blood pressure called reserpine
- have liver problems
What the medicinal ingredient is
Tetrabenazine
What the non-medicinal ingredients are
Anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, yellow ferric oxide
What dosage form it comes in
25 mg tablets
Warnings and precautions
Before you use APO-TETRABENAZINE tell your doctor or pharmacist if you:
- have a history of or current episode of depression or suicidal thoughts
- are taking any prescription or over-the-counter medications or are planning on taking any prescription or over-the-counter medications during your therapy. You should not take APOTETRABENAZINE if you are taking reserpine or if you are taking a monoamine oxidase (MAO) inhibitor.
- have liver problems
- have heart disease including irregular heart beat
- have or have had breast cancer
- have or have had pituitary tumours
- have Parkinson’s disease
- drink alcohol. It is best not to drink alcohol while taking APO-TETRABENAZINE
- are pregnant, or thinking about becoming pregnant, or are breastfeeding
- if you have rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption because APOTETRABENAZINE contains lactose.
Depression
APO-TETRABENAZINE may cause depression, thoughts of suicide or death or suicidal behavior in some patients. You and people close to you should watch for changes in your mood, or if you start to have thoughts about hurting yourself (see table of Serious Side Effects below) and report to your doctor immediately should they occur.
Driving vehicles or using machinery
APO-TETRABENAZINE may cause drowsiness and low blood pressure. Driving, operating machinery, or performing other hazardous tasks should be avoided until you know how APO-TETRABENAZINE affects you.
Trouble swallowing
APO-TETRABENAZINE may increase the chance that you will have trouble swallowing. Contact your doctor if this happens.
Irregular heartbeat
APO-TETRABENAZINE may cause changes in the electrical currents in your heart. These changes may increase the risk of arrhythmias (irregular heartbeats), especially if used in combination with other drugs that have the same effect, or if you already have certain heart conditions. If you feel a change in your heart beat, if you feel dizzy or faint, you should seek immediate medical attention.
Interactions with this medication
You should tell your doctor if you are taking or have recently taken any medications (prescription, nonprescription or natural herbal) especially:
- monoamine oxidase (MAO) inhibitor (e.g. phenelzine sulphate, moclobemide)
- antidepressants such as fluoxetine, paroxetine, quinidine, duloxetine, sertraline
- medicines that treat an irregular heartbeat such as quinidine, procainamide, amiodarone, sotalolantipsychotics or dopamine antagonists such as thioridazine such as thioridazine, chlorpromazine, haloperidol, metoclopramide, olanzapine, risperidone
- medicines for Parkinson’s Disease such as levodopa, amantadine or orphenadrine.
- reserpine
You should consult your doctor before you start any new medicines or before you stop or change doses of any other medicine you are taking while taking APO-TETRABENAZINE.
Proper use of this medication
Usual Dose
How to take APO-TETRABENAZINE:
Adults
Take APO-TETRABENAZINE exactly as prescribed by your doctor.
- An initial starting dose of 12.5 mg two to three times a day is recommended. To obtain a 12.5 mg dose, the scored 25 mg tablet must be split with a pill cutter.
- This can be increased by 12.5 mg a day each week until the maximal tolerated and effective dose is reached.
- In most cases the maximal tolerated dose will be 25 mg three times a day. In some cases, higher doses may be prescribed.
- You should talk to your doctor before you stop taking your medication on your own. If you miss a dose and it is time or almost time for your next dose, take only the next scheduled dose and do not take 2 doses at once. If you miss several days contact your doctor as you may have to start with lower doses.
Geriatric Patient
Reduced initial and maintenance doses should be used. Your doctor will choose the appropriate dose.
Children
Your doctor will decide the best dose.
Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.
Overdose
If you think you have taken too much APOTETRABENAZINE, contact your health care professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
The signs and symptoms of overdose may include drowsiness, sweating, low blood pressure, and feeling cold.
Side effects and what to do about them
Like all medications, APO-TETRABENAZINE may cause some side effects. You may not experience any of them. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose of APO-TETRABENAZINE may have to be adjusted.
The most common side effects of APO-TETRABENAZINE are:
- Signs and symptoms of Parkinsonism, such as tremors, difficulty starting or controlling movement, body stiffness, decrease in facial expressions, difficulty keeping your balance, speech problems, etc.
- Drowsiness, fatigue, weakness
- Depression
- Anxiety, nervousness
- Insomnia
- Restlessness, unable to sit or stand still
- Drooling
- Irritability, agitation
- Nausea, vomiting, stomach pain
- Confusion, disorientation
- Low blood pressure, symptoms may include dizziness when standing up
- Dizziness
- Weight increased
- Increased appetite
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Depression (Symptoms may include: feeling sad, crying spells, sleeping a lot more or a lot less than usual, changes in weight, feelings of worthlessness, guilt, regret, helplessness, or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced sex drive. | ✔ | ||
| Parkinsonism (Symptoms may include: tremors, difficulty starting or controlling movement, body stiffness, decrease in facial expressions, difficulty keeping your balance, speech problems. | ✔ | ||
| Akathisia (feeling restless and unable to sit or stand still) | ✔ | ||
| Trouble swallowing (increased coughing may be the first sign that you are having trouble swallowing) | ✔ | ||
| Frequency unknown | |||
| Allergic reactions [red and lumpy skin rash, hives, swelling, trouble breathing] | ✔* | ||
| A state of confusion, reduced consciousness, high fever, rapid or irregular heartbeat, profuse sweating or pronounced muscle stiffness. | ✔* | ||
| Symptoms of heart beat problems, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures. | ✔* | ||
| Thoughts of death or suicide | ✔* | ||
* If you think you have these side effects, stop taking the drug.
This is not a complete list of side effects. For any unexpected effects while taking APO-TETRABENAZINE, contact your doctor or pharmacist.
How to store
- Keep all medication out of the reach of children.
- Store APO-TETRABENAZINE at controlled room temperature, 15-30°C (59-86°F) in a tightly closed container.
- If your doctor tells you to stop taking APO-TETRABENAZINE please return any leftover medicine to your pharmacist.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APOTETRABENAZINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Date of Preparation: September 1, 2020