Hydrocodone Extended-Release Capsules

• It is used to ease very bad pain.
• It is only to be used when around-the-clock (continuous) care is needed for a long time. It is also only to be used when other pain drugs do not treat your pain well enough or you cannot take them.

Use this medicine (hydrocodone extended-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Take with or without food. Take with food if it causes an upset stomach.
• Swallow whole. Do not crush, chew, or melt the capsule or its contents.
• Take 1 capsule at a time if your dose is more than 1 capsule. Swallow the capsule with lots of water right after putting it in your mouth.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine (hydrocodone extended-release capsules) at the same time of day.
• Do not inject or snort this medicine. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
• Do not use for fast pain relief or on an as needed basis.
• Do not use for pain relief after surgery if you have not been taking drugs like this medicine (hydrocodone extended-release capsules).
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• If you have trouble swallowing, talk with your doctor.
• Do not take more often than every 12 hours unless told to do so by your doctor.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Trouble breathing, slow breathing, or shallow breathing.
• Swelling in the arms or legs.
• A burning, numbness, or tingling feeling that is not normal.
• A fast heartbeat.
• Feeling confused.
• Very hard stools (constipation).
• Very bad belly pain.
• Feeling very tired or weak.
• Mood changes.
• Very bad headache.
• Memory problems or loss.
• Pain when passing urine.
• Seizures.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Taking an opioid drug like this medicine (hydrocodone extended-release capsules) may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Feeling sleepy.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Belly pain.
• Headache.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (hydrocodone extended-release capsules) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017