Pitolisant Tablets

PITOLISANT (pi TOL i sant) treats narcolepsy. It works by decreasing daytime sleepiness, which can help you sleep better at night. It also reduces the number of episodes of sudden muscle weakness (cataplexy).

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing

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

• Anxiety, nervousness
• Headache
• Nausea
• Trouble sleeping

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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 medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Antihistamines for allergy, cough and cold
• Certain medications for irregular heartbeat, such as amiodarone, dofetilide, encainide, flecainide, propafenone, quinidine
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cyclosporine
• Estrogen or progestin hormones
• Midazolam
• Other medications that cause heart rhythm changes
• Promethazine
• Rifampin
• St. John's wort

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.

Visit your care team for regular checks on your progress. Tell your care team 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 care team if the problem does not go away or is severe.

Estrogen and progestin hormones may not work as well while you are taking this medication. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.