Nitoman (Tetrabenazine)

BEFORE you use NITOMAN tell your doctor or pharmacist if you:

• have a 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
• 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 NITOMAN
• are pregnant, or thinking about becoming pregnant, or are breastfeeding

Depression:

NITOMAN may cause depression in some patients. You and people close to you should watch for symptoms of depression (see table Serious Side Effects, How Often They Happen and What to Do About Them 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 the effect of NITOMAN is known.

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. Although these changes may be small, it may increase the risk of arrhythmias (irregular heart beats), 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.

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
• Dizziness

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 antidepressants (e.g. phenelzine sulphate, moclobemide)
• antidepressants such as fluoxetine, paroxetine, quinidine, duloxetine, sertraline
• antipsychotics such as thioridazine, chlorpromazine
• medicines for Parkinson's Disease such as levodopa, amantadine or orphenadrine
• neuroleptic drugs such as haloperidol, chlorpromazine, metoclopramide
• 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 weekly 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.

Elderly and Debilitated Patients:

• Reduced initial and maintenance doses should be used. Your doctor will choose the appropriate dose.

Chlidren:

• 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.