Nitoman: Uses, Side Effects and Dosage

What the medication is used for:

NITOMAN 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.

What it does:

NITOMAN is one of a group of drugs called monoamine depleting agents. NITOMAN is thought to interfere with storage of some chemicals in the brain such as dopamine which is associated with movement disorders.

When it should not be used?

Do not take NITOMAN if you:

• 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 15)

• 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 NITOMAN.

• 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:

Corn Starch, Lactose, Talc, Magnesium Stearate and Iron Oxide.

What dosage forms it comes in:

25mg tablets

BEFORE you use NITOMAN 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 NITOMAN 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 tumors
• have Parkinson’s disease

• drink alcohol. It is best not to drink alcohol while taking

  NITOMAN

• 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 NITOMAN contains lactose.

Depression:

NITOMAN 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:

NITOMAN may cause drowsiness and low blood pressure. Driving, operating machinery, or performing other hazardous tasks should be avoided until you know how NITOMAN affects you.

Trouble swallowing:

NITOMAN may increase the chance that you will have trouble swallowing. Contact your doctor if this happens.

Irregular heartbeat:

NITOMAN 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.

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural herbal) especially:

• monoamine oxidase (MAO) inhibitor (e.g. phenelzine sulphate, moclobemide)
• antidepressants such as fluoxetine, paroxetine, duloxetine, sertraline

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

• medicines that treat an irregular heartbeat such as quinidine,

  procainamide, amiodarone, sotalol

• antipsychotics or dopamine antagonists 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 NITOMAN.

Usual dose:

How to take NITOMAN:

Adults

Take NITOMAN 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 Patients

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

The signs and symptoms of overdose may include drowsiness, sweating, low blood pressure, and feeling cold.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Like all medications, NITOMAN 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 NITOMAN may have to be adjusted.

The most common side effects of NITOMAN 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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

PROPER USE OF THIS MEDICATION

* 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 NITOMAN contact your doctor or pharmacist.

• Keep all medication out of the reach of children.
• Store NITOMAN at room temperature (15-30°C).
• Keep container tightly closed.

• If your doctor tells you to stop taking NITOMAN

  please return any leftover medicine to your pharmacist.

HOW TO STORE IT

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/health-canada/news/media-room/advisories-warnings/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

You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor:

Bausch Health, Canada Inc.

2150 St-Elzear Blvd. West,

Laval, Quebec

H7L 4A8

1-800-361-4261

Last Revised: October 1, 2020