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 SUSTAINED-RELEASE - ORAL

(GAB-a-PEN-tin)

COMMON BRAND NAME(S): Gralise

USES: This medication is used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. This condition is called postherpetic neuralgia. Gabapentin belongs to a class of drugs known as antiseizure drugs (also called anticonvulsant or antiepileptic 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. This drug may also be used for restless legs syndrome and other painful nerve conditions (neuropathic pain).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking gabapentin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once a day with the evening meal. The dosage is based on your medical condition and response to treatment. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. During the first 2 weeks of treatment, your doctor may gradually increase your dose so your body can adjust to the medication. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not take this medication more often or increase your dose without consulting your doctor. 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. Antacids containing aluminum or magnesium may interfere with the absorption of this medication. If you are also taking an antacid, it is best to take gabapentin at least 2 hours after taking the antacid. 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, loss of coordination, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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. Tell your doctor right away if you have any serious side effects, including: swelling of the hands/ankles/feet. A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away 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 very serious side effects, including: slow/shallow breathing. 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: fever, swollen lymph nodes, 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 or at www.fda.gov/medwatch. 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, tell your doctor or pharmacist if you are allergic to it; or to gabapentin enacarbil; 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), use/abuse of drugs/alcohol, breathing problems (such as COPD). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially swelling of the hands/ankles/feet, slow/shallow breathing, dizziness, or loss of coordination. Dizziness and loss of coordination can increase the risk of falling. 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 breastfeeding.

DRUG INTERACTIONS: See also How to Use section. 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. A product that may interact with this drug is: orlistat. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). 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 (including gabapentin enacarbil). This medication may interfere with certain lab tests (such as urine protein), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: vision changes, severe drowsiness, trouble speaking, weakness.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it with food as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. 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 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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