Gepirone Extended-Release Tablets

What is this medication?

GEPIRONE (GE pye rone) treats depression. It increases the amount of serotonin in the brain, a substance that helps regulate mood.

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

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
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low levels of electrolytes, such as magnesium or potassium in the blood
• Personal or family history of bipolar disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to gepirone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Keep taking this medication unless your care team tells you to stop. Stopping it too quickly can cause serious side effects. It can also make your condition worse.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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

People 65 years and older may have a stronger reaction and need a smaller dose.

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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine
• MAOIs, such as Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for migraine headache, such as sumatriptan
• Diuretics
• Other medications that cause heart rhythm changes
• Steroid medications, such as prednisone or cortisone

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 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.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Serotonin syndrome is when your body has too much serotonin in it. This happens when this medication is used with other ones that increase serotonin levels. Common medications that increase serotonin levels are antidepressants, some medications for migraines, and some antibiotics. The symptoms of serotonin syndrome include irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, and diarrhea. Contact your care team right away if you think you have serotonin syndrome.

This medication may cause mood and behavior changes, such as anxiety, nervousness, irritability, hostility, restlessness, excitability, hyperactivity, or trouble sleeping. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms.

Discuss this medication with your care team if you may be pregnant. When recommended by your care team, it may be taken during pregnancy. Fetal side effects, such as lung problems, may occur. The risk of side effects increases if it is taken in the third trimester. The benefits of taking this medication may outweigh the risks. It is important to treat and care for physical and mental health conditions during pregnancy.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, contact your care team if the child is unusually sleepy or fussy, has poor feeding, or is not gaining weight.

What side effects may I notice from receiving this medication?

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
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

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

• Dizziness
• Nausea
• Stomach pain
• Trouble sleeping
• Upset stomach

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 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, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.