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Generic Name: gabapentin (GAB-a-PEN-tin)
Brand Name: Gralise

Gralise is used for:

Treating nerve pain caused by shingles. It may also be used for other conditions as determined by your doctor.

Gralise is an analgesic for neuropathic (nerve) pain. Exactly how it works to treat nerve pain is not known.

Do NOT use Gralise if:

  • you are allergic to any ingredient in Gralise
  • you have severe kidney problems or are on dialysis

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

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Before using Gralise:

Some medical conditions may interact with Gralise. 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
  • if you have a history of seizures, mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Gralise. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Morphine or naproxen because they may increase the risk of Gralise's side effects, including drowsiness
  • Hydrocodone because its effectiveness may be decreased by Gralise

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gralise 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 Gralise:

Use Gralise as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Gralise comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gralise refilled.
  • Take Gralise by mouth with the evening meal, unless directed otherwise by your doctor.
  • Swallow Gralise whole. Do not break, crush, or chew before swallowing.
  • Do not take an antacid that has aluminum or magnesium in it within 2 hours before you take Gralise.
  • Gralise works best if it is taken at the same time each day.
  • Do not suddenly stop taking Gralise. You may experience side effects such as anxiety, insomnia, nausea, pain, and sweating. Patients with seizure disorder may also experience increased seizures. If you need to stop Gralise or add a new medicine, your doctor will gradually lower your dose.
  • If you miss a dose of Gralise, take it with food as soon as possible. If it is almost time for your next dose, 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 Gralise.

Important safety information:

  • Gralise may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Gralise with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Gralise; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not change your dose of Gralise without checking with your doctor.
  • Do not switch between Gralise and other gabapentin products without first checking with your doctor.
  • Patients who take Gralise may be at 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 Gralise 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; 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).
  • Diabetes patients - Gralise may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Gralise may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gralise.
  • Use Gralise with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the hands, legs, or feet.
  • Gralise 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 Gralise while you are pregnant. Gralise is found in breast milk. If you are or will be breast-feeding while you take Gralise, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gralise:

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:

Diarrhea; dizziness; drowsiness; dry mouth; tiredness.

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; unusual hoarseness); behavior changes; confusion; difficult or painful urination; fever; memory problems; new or worsening mental or mood 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; red, swollen, blistered, or peeling skin; severe headache or dizziness; 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 diarrhea; double vision; drowsiness; sluggishness; slurred speech.

Proper storage of Gralise:

Store Gralise at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gralise out of the reach of children and away from pets.

General information:

  • If you have any questions about Gralise, please talk with your doctor, pharmacist, or other health care provider.
  • Gralise 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 Gralise 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 Gralise. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gralise. 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 Gralise.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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