Cyclobenzaprine Hydrochloride
(sye“ kloe ben‘ za preen hye“ droe klor‘ ide)
Extended-Release Capsules
What are cyclobenzaprine hydrochloride extended-release capsules?
Cyclobenzaprine hydrochloride extended-release capsules are a prescription medicine used along with rest and physical therapy to help treat muscle spasm due to acute, painful musculoskeletal problems.
Cyclobenzaprine hydrochloride extended-release capsules should only be used for up to 2 or 3 weeks. It is not known if cyclobenzaprine hydrochloride extended-release capsules are effective when used for longer periods.
It is not known if cyclobenzaprine hydrochloride extended-release capsules are safe and effective in children.
Do not take cyclobenzaprine hydrochloride extended-release capsules if you:
- are allergic to cyclobenzaprine or any of the ingredients in cyclobenzaprine hydrochloride extended-release capsules. See the end of this Patient Information leaflet for a complete list of ingredients in cyclobenzaprine hydrochloride extended-release capsules.
Talk to your healthcare provider or get medical help right away if you have symptoms of an allergic reaction such as:- difficulty breathing
- hives
- swelling of your face or tongue
- itching
- are taking certain antidepressants, known as monoamine oxidase (MAO) inhibitors or it has been 14 days or less since you stopped taking a MAO inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
- have had a recent heart attack
- have heart rhythm problems (arrhythmias)
- have heart failure
- have an overactive thyroid (hyperthyroidism)
Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.
Before taking cyclobenzaprine hydrochloride extended-release capsules, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of eye problems including glaucoma
- have heart problems or have had a heart attack
- have liver problems
- have trouble emptying your bladder (urinary retention)
- are pregnant or plan to become pregnant. It is not known if cyclobenzaprine hydrochloride extended-release capsules will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if cyclobenzaprine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take cyclobenzaprine hydrochloride extended-release capsules.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take:
- a medicine to treat depression, mood, anxiety, psychotic, or thought disorders
- a pain medicine called tramadol or meperidine
- barbiturates or other medicines that depress your central nervous system (CNS depressants)
- a medicine that prevents nerve impulses (anticholinergic medicines)
- a medicine to help quit smoking called bupropion
- a blood pressure medicine called verapamil
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider or pharmacist when you get a new medicine.
How should I take cyclobenzaprine hydrochloride extended-release capsules?
- Take cyclobenzaprine hydrochloride extended-release capsules exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much cyclobenzaprine hydrochloride extended-release capsules to take and when to take it.
- Your healthcare provider may change your cyclobenzaprine hydrochloride extended-release capsules dose if needed.
- Take cyclobenzaprine hydrochloride extended-release capsules around the same time every day.
- Swallow cyclobenzaprine hydrochloride extended-release capsules whole.
- If you have difficulty swallowing cyclobenzaprine hydrochloride extended-release capsules, tell your healthcare provider. Your healthcare provider may recommend opening the cyclobenzaprine hydrochloride extended-release capsule and mixing the contents with applesauce.
- Cyclobenzaprine hydrochloride extended-release capsules should only be taken for short periods (up to two or three weeks).
- If you take too much cyclobenzaprine hydrochloride extended-release capsules, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking cyclobenzaprine hydrochloride extended-release capsules?
You should not drink alcohol until you know how cyclobenzaprine hydrochloride extended-release capsules affect you. Taking cyclobenzaprine hydrochloride extended-release capsules 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 cyclobenzaprine hydrochloride extended-release capsules affect you.
What are the possible side effects of cyclobenzaprine hydrochloride extended-release capsules?
Cyclobenzaprine hydrochloride extended-release capsules may cause serious side effects, including:
- Serotonin syndrome is a serious medical condition that may happen when cyclobenzaprine hydrochloride extended-release capsules is taken with certain other medicines. Call your healthcare provider right away or go to the nearest hospital emergency room if you have some or all of these symptoms suggestive of serotonin syndrome:
- agitation, hallucinations, coma, or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- fast heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle stiffness or tightness
- Cyclobenzaprine hydrochloride extended-release capsules may cause serious side effects that may lead to heart attack or stroke. Call your healthcare provider right away or go to the nearest hospital emergency room if you have:
- irregular or abnormal heartbeats (arrhythmias)
- fast heartbeat (tachycardia)
The most common side effects of cyclobenzaprine hydrochloride extended-release capsules include:
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These are not all the possible side effects of cyclobenzaprine hydrochloride extended-release capsules.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store cyclobenzaprine hydrochloride extended-release capsules?
- Store cyclobenzaprine hydrochloride extended-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep cyclobenzaprine hydrochloride extended-release capsules in a tightly closed container, and keep cyclobenzaprine hydrochloride extended-release capsules out of light.
- Keep cyclobenzaprine hydrochloride extended-release capsules and all medicines out of the reach of children.
General information about the safe and effective use of cyclobenzaprine hydrochloride extended-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cyclobenzaprine hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give cyclobenzaprine hydrochloride extended-release capsules to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about cyclobenzaprine hydrochloride extended-release capsules that is written for healthcare professionals.
What are the ingredients in cyclobenzaprine hydrochloride extended-release capsules?
Active Ingredient: cyclobenzaprine hydrochloride USP
Inactive Ingredients: diethyl phthalate NF, ethylcellulose NF (Ethocel Standard 10 Premium), gelatin, Opadry® Clear YS-1-7006, sugar spheres NF (20-25 mesh), and titanium dioxide.
Cyclobenzaprine hydrochloride 15 mg extended-release capsules also contain: D&C yellow #10, FD&C green #3, and FD&C red #40.
Cyclobenzaprine hydrochloride 30 mg extended-release capsules also contain: FD&C blue #1, FD&C blue #2, FD&C red #40, and FD&C yellow #6.
Distributed by: Manufactured By:
Amneal Pharmaceuticals LLC Adare Pharmaceuticals, Inc.
Bridgewater, NJ 08807 Vandalia, OH 45377
For more information, go to www.amneal.com or call toll-free 1-877-835-5472.
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: 11-2021-03
