Igalmi (buccal/sublingual)

Igalmi (buccal/sublingual) is for adults to help treat agitation related to schizophrenia or bipolar disorder.

Igalmi (buccal/sublingual) might also be used for reasons that are not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have ever had:

• diabetes;
• high blood pressure;
• low blood pressure, or if you are dehydrated;
• a serious heart condition such as severe heart block;
• a heart rhythm disorder;
• long QT syndrome; or
• liver disease.

It is not known if Igalmi (buccal/sublingual) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are breastfeeding, tell your doctor if you notice irritability in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Igalmi may cause serious side effects. Call your doctor right away if you have:

• fast, slow, or irregular heartbeats; or
• a feeling of light-headedness, as if you might faint.

Common side effects of Igalmi may include:

• dizziness, drowsiness;
• numbness, tingling, burning pain;
• loss of feeling in the mouth, dry mouth; or
• a feeling like you might faint.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Igalmi (buccal/sublingual) should be administered under the supervision of a healthcare professional.

For sublingual use, place Igalmi under the tongue and allow it to dissolve. Do not swallow or chew.

For buccal use, place Igalmi behind the lower lip and allow it to dissolve. Do not swallow or chew.

Do not eat or drink for at least 15 minutes after sublingual use, or at least one hour after buccal use.

Remain sitting or lying down after using Igalmi (buccal/sublingual).

Your vital signs may be watched during treatment.

You may have withdrawal symptoms after you stop using Igalmi (buccal/sublingual). The most common withdrawal reactions are nausea, vomiting, and agitation.

Store Igalmi in the foil pouch at room temperature away from moisture and heat.

In a medical setting, you are unlikely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid driving or hazardous activity until you know how Igalmi will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Igalmi (buccal/sublingual) can lead to a serious heart issue. Your risk may increase if you are also taking certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Taking Igalmi (buccal/sublingual) together with other medications that make you sleepy can make this effect worse. Consult your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other medications may interact with Igalmi (buccal/sublingual), including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.