How Safe Is GRALISE?
GRALISE® may cause side effects. In clinical trials, most side effects were mild to moderate. One of 9 patients experienced dizziness.1
In clinical trials, 1 of 9 patients
taking GRALISE experienced dizziness.1
What can I do to reduce my risk of side effects?
The most important thing you can do to lower your risk of side effects is to take GRALISE exactly as your doctor tells you to. GRALISE has a formulation that is specially designed to help lower the chances of having side effects during the day, but this is only the case if you take GRALISE as prescribed — 3 tablets with the evening meal.1
Do not change your dose or stop taking GRALISE without talking with your healthcare provider. If you stop taking GRALISE suddenly, you may experience side effects. Talk with your healthcare provider about how to stop GRALISE slowly.1
If you miss a dose of GRALISE, take it with food as soon as you remember. If it is almost time for your next dose, just skip the missed dose, and take the next dose at your regular time. Do not take 2 doses at the same time1

Do not drive or operate heavy machines or do other
dangerous activities until you know how GRALISE affects you.
GRALISE can slow your thinking and motor skills.1
The safety and effectiveness of GRALISE in the management of postherpetic neuralgia in patients less than 18 years of age has not been studied.
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Indication and Usage
GRALISE is a prescription medicine used in adults, 18 years and older, to treat pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

Important Safety Information
Do not take GRALISE if you are allergic to gabapentin or any of the ingredients in GRALISE.

Do not change your dose or stop taking GRALISE without talking with your healthcare provider. If you stop taking GRALISE suddenly, you may experience side effects. Talk with your healthcare provider about how to stop GRALISE slowly.

Like other antiepileptic drugs, gabapentin, the active ingredient in GRALISE, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if GRALISE is safe and effective in people with seizure problems (epilepsy). Therefore, GRALISE should not be used in place of other gabapentin products.

It is not known if GRALISE is safe and effective in children under 18 years of age with postherpetic pain.

Before taking GRALISE, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Taking GRALISE with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking GRALISE without first talking to your healthcare provider. Taking GRALISE with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not operate heavy machines or do other dangerous activities until you know how GRALISE affects you. GRALISE can slow your thinking and motor skills.

The most common side effect of GRALISE is dizziness. Tell your healthcare provider about any side effect that bothers you or that does not go away. This is not the only possible side effect of GRALISE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report negative side effects to Depomed at 1-866-458-6389.


References: 1. GRALISE [prescribing information]. Newark, CA: Depomed Inc.; December 2012. 2. Data on file. Depomed Inc. 3. MedlinePlus.com. Gabapentin. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a694007.html. Accessed September 15, 2011.



Please see full Prescribing Information and Medication Guide.
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