Pitolisant oral tablets

What is this medication?

PITOLISANT (pi TOL i sant) is used to treat excessive sleepiness or cataplexy in patients with narcolepsy. Cataplexy causes a sudden muscle weakness due to a strong emotional response.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Wakix

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• history of irregular heartbeat
• kidney disease
• liver disease
• low levels of potassium in the blood
• low levels of magnesium in the blood
• an unusual or allergic reaction to pitolisant, other foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• antihistamines for allergy, cough and cold
• birth control pills or other hormone-containing birth control devices or implants
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for irregular heart beat like amiodarone, dofetilide, encainide, flecainide, propafenone, quinidine
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cyclosporine
• midazolam
• other medicines that prolong the QT interval (abnormal heart rhythm)
• promethazine
• rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your healthcare professional if the problem does not go away or is severe.

Birth control may not work properly while you are taking this medicine. Talk to your healthcare professional about using an extra method of birth control.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue
• anxious
• changes in emotions or moods
• hallucinations
• seizures
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast, irregular heartbeat; palpitations; feeling faint or lightheaded; falls; breathing problems
• suicidal thoughts, mood changes
• trouble sleeping

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• dry mouth
• headache
• muscle pain
• nausea
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.