IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

GABAPENTIN ENACARBIL SUSTAINED-RELEASE - ORAL

(GAB-a-PEN-tin EN-a-KAR-bil)

COMMON BRAND NAME(S): Horizant

USES: This medication is used to treat moderate to severe restless legs syndrome. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection). This condition is called postherpetic neuralgia. Gabapentin enacarbil is changed by your body to gabapentin. Gabapentin belongs to a class of drugs known as anti-seizure or anticonvulsant drugs.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Gabapentin may also be used to treat seizures and other painful nerve conditions (neuropathic pain).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking gabapentin enacarbil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. The dosage is based on your medical condition and response to treatment. For Restless Legs Syndrome: Take this medication by mouth as directed by your doctor, usually once daily with food at about 5 PM. This dosing schedule is for people who are awake during the day and asleep during the night. If you need to sleep during the daytime and stay awake at night, talk with your doctor about your schedule before using this medication. For Postherpetic Nerve Pain: Take this medication by mouth as directed by your doctor, usually once daily with food for several days, then increase to twice a day with food thereafter. Swallow this medication whole. Do not crush or chew sustained-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split sustained-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. Different forms of gabapentin (such as immediate-release, sustained-release, enacarbil sustained-release) are absorbed in the body differently. Do not switch from one form to the other without consulting your doctor. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Get medical help right away if you have any serious side effects, including: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, change in the amount of urine, chest pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking gabapentin enacarbil, tell your doctor or pharmacist if you are allergic to it; or to gabapentin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood problems (such as depression, thoughts of suicide). This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Gabapentin passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine, morphine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Do not use this medication with other medications that contain gabapentin. This medication may interfere with certain laboratory tests for urine protein. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness and dizziness.

NOTES: Do not share this medication with others.

MISSED DOSE: For Restless Legs Syndrome: If you miss a dose, skip the missed dose and resume your usual dosing schedule the next day. Do not double the dose to catch up. For Postherpetic Nerve Pain: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep this medication in the bottle that it came in and keep the container tightly closed. Do not remove the moisture control packets inside of the bottle. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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