Gabapentin Enacarbil (gab-a-PEN-tin en-a-KAR-bil)

Treats restless leg syndrome (RLS) and pain caused by shingles.

Brand Name(s):

Horizant

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip that dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how gabapentin enacarbil works. Tell your doctor if you are also using other medicines that contain gabapentin.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using lorazepam, morphine, oxycodone, or zolpidem.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney problems (including patients receiving dialysis), or a history of depression or mental health problems. Tell your doctor if you need to sleep during daytime and remain awake at night.
• This medicine may cause the following problems:
  • Changes in mood or behavior, including suicidal thoughts or behavior
  • Respiratory depression (serious breathing problem that can be life-threatening), when used with narcotic pain medicines
  • Drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity, which may damage the liver, kidney, blood, heart, or muscles
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Fever, rash, swollen or tender glands in the neck, armpit, or groin
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden mood changes, unusual moods or behavior, including extreme happiness or depression, thoughts or attempts of killing oneself
• Unusual bleeding, bruising, or weakness
• Yellow eyes or skin

If you notice these less serious side effects, talk with your doctor:

• Dizziness, drowsiness, sleepiness, tiredness
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088