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|Avinza Extended-Release Capsules

Avinza Extended-Release Capsules

Avinza Extended-Release Capsules is 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 is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use Avinza Extended-Release Capsules if:

• you are allergic to any ingredient in Avinza Extended-Release Capsules
• you have known or suspected paralysis of the intestines or antibiotic associated colitis
• you are taking cimetidine, sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
• you have slowed breathing or severe asthma, or you are having an asthma attack

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

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, foods, or other substances
• if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence
• if you have increased pressure in the head, a recent head injury, or lesions in the head
• if you have difficulty urinating; heart, liver, or thyroid disease; hypercapnia (abnormally increased carbon dioxide tension in your arteries); curvature of the spine; seizures; or a history of suicidal thoughts or behaviors
• if you have low blood volume, a stomach blockage or inflammatory bowel disease, have had stomach tract surgery, or are in shock

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:

• Fluoxetine, naltrexone, narcotic agonists/antagonists (eg, pentazocine), rifampin, or risperidone because they may decrease Avinza Extended-Release Capsules"s effectiveness
• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, MAOIs (eg, phenelzine) sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline ) because side effects (eg, disorientation, respiratory depression, seizures) may occur
• Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Avinza Extended-Release Capsules
• 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 you also take trovafloxacin, do not take it within 4 hours before or after taking Avinza Extended-Release Capsules. Check with your doctor if you have questions.
• 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 or drowsiness. 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 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.
• 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.
• 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. Constipation may be avoided by using a stool softener or fiber laxative.
• 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.
• Tell your doctor or dentist that you take Avinza Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Do not take Avinza Extended-Release Capsules if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Avinza Extended-Release Capsules or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.
• Lab tests, including liver function, kidney function, 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.
• 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 is 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; mood changes; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; face or throat swelling; fast, irregular, or slow heartbeat; hallucinations; itching; pounding in the chest; seizures; shock; shortness of breath; sudden chest pain; sweating.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; slowed breathing; slowed heartbeat.

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 is 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.

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.