pitolisant
What is the most important information I should know about pitolisant?
You should not use pitolisant if you have severe liver disease.
What is pitolisant?
Pitolisant is used to treat excessive daytime sleepiness or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.
Pitolisant may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking pitolisant?
You should not use pitolisant if you are allergic to it, or if you have:
- severe liver disease.
Tell your doctor if you have ever had:
- liver disease;
- kidney disease;
- a heart rhythm disorder; or
- long QT syndrome (in you or a family member).
Ask a doctor before using this medicine if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pitolisant on the baby.
Pitolisant can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pitolisant, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose of pitolisant.
Pitolisant is not approved for use by anyone younger than 18 years old.
How should I take pitolisant?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Pitolisant is usually taken once daily when you wake up.
It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and use your next dose the following morning at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking pitolisant?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of pitolisant?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast or pounding heartbeats;, fluttering in your chest;
- shortness of breath; or
- sudden dizziness (like you might pass out).
Common side effects may include:
- nausea;
- anxiety; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect pitolisant?
When you start or stop taking pitolisant, your doctor may need to adjust the doses of any other medicines you take on a regular basis.
Pitolisant can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Other drugs may affect pitolisant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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