Avinza Extended-Release Capsules

Avinza Extended-Release Capsules are used for:

Managing moderate to severe pain for more than a few days. It may also be used for other conditions as determined by your doctor.

Avinza Extended-Release Capsules are a narcotic pain reliever. It works in the brain and the nervous system to decrease pain.

Do NOT use Avinza Extended-Release Capsules if:

• you are allergic to any ingredient in Avinza Extended-Release Capsules
• you have known or suspected bowel blockage (eg, paralytic ileus)
• you have severe or persistent diarrhea associated with antibiotic use (pseudomembranous colitis)
• you have slow or difficult breathing, severe asthma, severe hypercarbia or hypercapnia (high blood levels of carbon dioxide), or you are having an asthma attack
• you are taking sodium oxybate (GHB) or you drink alcohol
• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken one within the past 14 days

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

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Before using Avinza Extended-Release Capsules:

Some medical conditions may interact with Avinza Extended-Release Capsules. 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, especially other narcotic pain relievers (eg, codeine, hydromorphone); foods; or other substances
• if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
• if you have increased pressure in the head, a recent head injury, or growths in the brain (eg, tumors, lesions)
• if you have a history of heart problems (eg, cor pulmonale), liver or kidney problems, thyroid problems, stomach or bowel problems (eg, constipation, blockage, inflammation), gallbladder or pancreas problems, prostate problems, trouble urinating, adrenal gland problems (eg, Addison disease), hypoxia (not enough oxygen in your body), hypercapnia or hypercarbia, curvature of the spine, or seizures
• if you have a history of mental or mood problems (eg, depression), hallucinations, suicidal thoughts or actions, or alcohol or other substance abuse or dependence
• if you will be having surgery or you are currently having alcohol withdrawal
• if you have severe drowsiness; low blood volume; stomach pain; very poor health; have had stomach or intestinal surgery; or you are in shock caused by heart problems, blood vessel problems, or severe bleeding

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

• Mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, pentazocine) or naltrexone because they may decrease Avinza Extended-Release Capsules's effectiveness and withdrawal symptoms may occur
• Fluoxetine, rifamycins (eg, rifampin), or risperidone because they may decrease Avinza Extended-Release Capsules's effectiveness
• Cimetidine, ketorolac, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as severe drowsiness, slow or difficulty breathing, confusion, and seizures, may be increased
• Anticholinergics (eg, oxybutynin, scopolamine), antihistamines (eg, diphenhydramine), antinausea medicines (eg, ondansetron), benzodiazepines (eg, lorazepam), MAOIs (eg, phenelzine), other narcotic pain medicines (eg, hydrocodone), phenothiazines (eg, chlorpromazine), quinidine, sleep medicines (eg, zolpidem), or sodium oxybate (GHB) because they may increase the risk of Avinza Extended-Release Capsules's side effects
• Skeletal muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased
• Mexiletine or trovafloxacin because their effectiveness may be decreased by Avinza Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avinza Extended-Release Capsules 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 Avinza Extended-Release Capsules:

Use Avinza Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Avinza Extended-Release Capsules by mouth with or without food.
• Swallow Avinza Extended-Release Capsules whole. Do not dissolve, crush, or chew before swallowing.
• If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
• Take Avinza Extended-Release Capsules on a regular schedule to get the most benefit from it.
• Taking Avinza Extended-Release Capsules at the same time each day will help you remember to take it.
• If Avinza Extended-Release Capsules are no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Avinza Extended-Release Capsules properly.
• If you miss a dose of Avinza Extended-Release Capsules, take it 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 Avinza Extended-Release Capsules.

Important safety information:

• Avinza Extended-Release Capsules may cause dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Avinza Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol, or take any prescription or nonprescription medicines that have alcohol in them while you are taking Avinza Extended-Release Capsules. Ask your pharmacist if you have questions about if any of your medicines have alcohol in them.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Avinza Extended-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Avinza Extended-Release Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Excessive drowsiness usually disappears in 3 to 5 days. Consult your doctor if it continues or is accompanied by unsteadiness or confusion.
• Avinza Extended-Release Capsules may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you use Avinza Extended-Release Capsules.
• The risk of Avinza Extended-Release Capsules becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Do NOT change your dose or use more often than prescribed without checking with your doctor.
• Do NOT suddenly stop taking Avinza Extended-Release Capsules without checking with your doctor. If you have been taking Avinza Extended-Release Capsules for more than a few weeks and your doctor tells you to stop using Avinza Extended-Release Capsules, your dose may need to be gradually lowered as directed by your doctor to avoid side effects.
• Tell your doctor or dentist that you take Avinza Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver, kidney, or lung function, and complete blood cell counts, may be performed while you use Avinza Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Avinza Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially severe drowsiness, or slow or shallow breathing.
• Avinza Extended-Release Capsules should not be used 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 using Avinza Extended-Release Capsules while you are pregnant. Avinza Extended-Release Capsules are found in breast milk. Do not breast-feed while taking Avinza Extended-Release Capsules.

When used for long periods of time or at high doses, Avinza Extended-Release Capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Avinza Extended-Release Capsules stops working well. Do not take more than prescribed

Some people who use Avinza Extended-Release Capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Avinza Extended-Release Capsules suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Avinza Extended-Release Capsules:

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:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; restless mood; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); confusion; disorientation; fainting; fast, irregular, or slow heartbeat; hallucinations; mental or mood changes (eg, agitation, exaggerated sense of well-being); seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or headache; shortness of breath; slow or shallow breathing; sudden chest pain; swelling of the hands, ankles, or feet; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

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.

See also: Avinza side effects (in more detail)

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 bluish skin or nails; cold and clammy skin; coma; confusion; decreased muscle tone; decreased pupil size; loss of consciousness; low body temperature; seizures; severe drowsiness, dizziness, or lightheadedness; severe muscle pain or weakness; shortness of breath; slow heartbeat; slow or shallow breathing.

Store Avinza Extended-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Do not store in the bathroom. Keep Avinza Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Avinza Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Avinza Extended-Release Capsules are 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 is a summary only. It does not contain all information about Avinza Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.