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Gabapentin enacarbil extended-release tablets

Generic Name: gabapentin enacarbil (GAB-a-PEN-tin EN-a-KAR-bil)
Brand Name: Horizant

Gabapentin enacarbil extended-release tablets is used for:

Treating moderate to severe restless legs syndrome (RLS). It is also used to manage nerve pain caused by shingles. It may also be used for other conditions as determined by your doctor.

Gabapentin enacarbil extended-release tablets is related to the seizure medicine gabapentin. Exactly how it works to treat RLS and nerve pain is not known.

Do NOT use gabapentin enacarbil extended-release tablets if:

  • you are allergic to any ingredient in gabapentin enacarbil extended-release tablets
  • you are taking gabapentin enacarbil extended-release tablets for RLS, and you need to sleep during the day and stay awake at night
  • you are taking another medicine that contains gabapentin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Before using gabapentin enacarbil extended-release tablets:

Some medical conditions may interact with gabapentin enacarbil extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems or are on dialysis
  • if you have a history of seizures, drug abuse, mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with gabapentin enacarbil extended-release tablets. Tell your health care provider if you are taking any medicines.

Ask your health care provider if gabapentin enacarbil extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use gabapentin enacarbil extended-release tablets:

Use gabapentin enacarbil extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Gabapentin enacarbil extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get gabapentin enacarbil extended-release tablets refilled.
  • Take gabapentin enacarbil extended-release tablets by mouth with food.
  • Swallow gabapentin enacarbil extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you are taking gabapentin enacarbil extended-release tablets for RLS, you should take it at about 5 pm, unless your doctor tells you otherwise.
  • Do not suddenly stop taking gabapentin enacarbil extended-release tablets without checking with your doctor. Depending on your dose of gabapentin enacarbil extended-release tablets, your doctor may need to gradually lower your dose to avoid side effects. If you need to stop gabapentin enacarbil extended-release tablets, follow your doctor's instructions.
  • If you miss a dose of gabapentin enacarbil extended-release tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use gabapentin enacarbil extended-release tablets.

Important safety information:

  • Gabapentin enacarbil extended-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Take gabapentin enacarbil extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking gabapentin enacarbil extended-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking gabapentin enacarbil extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Do not switch between gabapentin enacarbil extended-release tablets and other medicines that contain gabapentin without first checking with your doctor.
  • Patients who take gabapentin enacarbil extended-release tablets may be at an increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take gabapentin enacarbil extended-release tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • A serious and sometimes life-threatening or fatal reaction that may affect your skin or other parts of your body (eg, liver, blood cells) has been reported in patients taking medicines for seizures, including gabapentin. A rash may or may not occur along with this reaction. Contact your doctor right away if you develop decreased urination; rash; hives; red, swollen, blistered, or peeling skin; swollen glands or lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; severe tiredness or weakness; unusual muscle pain; or symptoms of infection (eg, fever, chills, sore throat).
  • Lab tests, including kidney function, may be performed while you use gabapentin enacarbil extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use gabapentin enacarbil extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects.
  • Gabapentin enacarbil extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking gabapentin enacarbil extended-release tablets while you are pregnant. Gabapentin enacarbil extended-release tablets is found in breast milk. Do not breast-feed while taking gabapentin enacarbil extended-release tablets.

Possible side effects of gabapentin enacarbil extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; gas; headache; increased appetite; nausea; tiredness; trouble sleeping; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; loss of balance or coordination; new or worsening mental, mood, or behavioral changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening trouble sleeping; suicidal thoughts or actions; swelling of the hands, legs, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness or drowsiness.

Proper storage of gabapentin enacarbil extended-release tablets:

Store gabapentin enacarbil extended-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original bottle. Keep tightly closed. Do not remove any moisture control packs that may come in the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep gabapentin enacarbil extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about gabapentin enacarbil extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Gabapentin enacarbil extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take gabapentin enacarbil extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about gabapentin enacarbil extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to gabapentin enacarbil extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using gabapentin enacarbil extended-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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