AMRIX  (Cyclobenzaprine Hydrochloride Extended-Release Capsules)

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What is AMRIX?

AMRIX ® (cyclobenzaprine hydrochloride extended-release capsules) is a prescription medicine used along with rest and physical therapy to help treat muscle spasm due to acute, painful musculoskeletal problems. AMRIX should only be used for up to 2 or 3 weeks. It is not known if AMRIX is effective when used for longer periods. It is not known if AMRIX is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Who should not take AMRIX?

Do not take AMRIX if you:

Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.

What should I avoid while taking AMRIX?

You should not drink alcohol until you know how AMRIX affects you. Taking AMRIX with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times.

Do not drive, operate machinery, or do other dangerous activities until you know how AMRIX affects you.

What are possible side effects of AMRIX?

AMRIX may cause serious side effects that may lead to heart attack or stroke. Call your healthcare provider immediately or go to the nearest hospital emergency room if you have:

Serotonin syndrome is a serious medical condition that may happen when AMRIX is taken with certain other medicines. Call your healthcare provider right away or go to the nearest hospital emergency room if you become severely ill and have some or all of these symptoms:

The most common side effects of AMRIX include dry mouth, dizziness, fatigue, constipation, nausea, upset stomach, and drowsiness.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the possible side effects of AMRIX. For more information, talk to your healthcare provider or pharmacist.

Please see the Patient Information Leaflet within the Full Prescribing Information.

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