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|Palladone Extended-Release Capsules

Palladone Extended-Release Capsules

Palladone Extended-Release Capsules is used for:

Treating pain in adults with constant (around-the-clock) moderate to severe pain that is expected to last for an extended period of time. Palladone Extended-Release Capsules should only be started after you have been taking other narcotic (opioid) medicines and your body has gotten used to them (opioid tolerant). Palladone Extended-Release Capsules is not for use as the first narcotic pain medicine prescribed for you, for short-term use, or for occasional ("as-needed") use.

Palladone Extended-Release Capsules is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system used by the body"s natural "pain relievers."

Do NOT use Palladone Extended-Release Capsules if:

• you are allergic to any ingredient in Palladone Extended-Release Capsules or any other morphine-related medicine (eg, morphine, codeine, oxycodone)
• you have diarrhea associated with poisoning, antibiotic use, a bacterial infection (from eating or drinking contaminated food or water); a stomach problem called paralytic ileus (loss of strength in the intestinal muscles)
• you have acute (sudden) or severe asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), shallow breathing, emphysema, right-sided heart failure, or a brain injury or disease with increased pressure in the brain
• you are taking cimetidine or sodium oxybate (GHB)

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

Before using Palladone Extended-Release Capsules:

Some medical conditions may interact with Palladone 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 or have ever had alcoholism, substance abuse, or narcotic dependence; if you consume more than 3 alcoholic drinks per day; or if you have a family history of these problems
• if you have considered or attempted suicide; or if you have major depression or hallucinations (seeing or hearing things that are not there)
• if you have an acute head injury, increased pressure in the head, brain injury or tumor, epilepsy, or seizures (convulsions)
• if you have an acute stomach or intestinal problem; chronic inflammation and ulceration of the bowel; low blood volume; recent abdominal surgery; adrenal gland problems; enlargement of the prostate gland; gallbladder problems; heart failure; lung disease, including shortness of breath; kidney or liver problems; low blood pressure; underactive thyroid; or urinary blockage or problems urinating

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

• Barbiturate anesthetics (eg, thiopental), cimetidine, ketorolac, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, thioridazine), sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur
• Risperidone, rifamycins (eg, rifampin), or certain pain relievers because effectiveness of Palladone Extended-Release Capsules may be decreased
• Naltrexone because the effectiveness of Palladone Extended-Release Capsules will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids
• Mexiletine because effectiveness may be decreased by Palladone Extended-Release Capsules

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

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

• Palladone Extended-Release Capsules comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Palladone Extended-Release Capsules refilled.
• Palladone Extended-Release Capsules may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• This capsule must be swallowed whole with water. If you cannot swallow the capsule whole, contact your doctor. Do not break, chew, dissolve, crush, or open the capsule before swallowing. Taking a broken, chewed, dissolved, or crushed capsule or its contents can release the full 24-hour dose into your body all at once. This is very dangerous. You could die from an overdose of the medicine.
• If you miss a dose of Palladone Extended-Release Capsules, take it as soon as possible. Take your next dose 24 hours later. Do not double your prescribed dose of Palladone Extended-Release Capsules at any time because this increases your chance of an overdose. If you are not sure what to do or you miss more than one dose, contact your doctor.

Ask your health care provider any questions you may have about how to use Palladone Extended-Release Capsules.

Important safety information:

• Palladone Extended-Release Capsules may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Palladone Extended-Release Capsules. Using Palladone Extended-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Palladone Extended-Release Capsules. Palladone Extended-Release Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Palladone Extended-Release Capsules may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit or stand up slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Do not drink alcohol while you are using Palladone Extended-Release Capsules.
• Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.
• If you continue to have pain, your pain worsens, or you have side effects that concern you, contact your health care provider immediately.
• Constipation is a common side effect of Palladone Extended-Release Capsules. Talk to your health care provider about using laxatives or stool softeners to prevent or treat constipation while taking Palladone Extended-Release Capsules.
• Before you have any medical or dental surgery or emergency treatment, tell the doctor or dentist that you are taking Palladone Extended-Release Capsules.
• Use Palladone Extended-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects, especially the possible decreased breathing and drowsiness effects.
• Palladone Extended-Release Capsules is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Palladone Extended-Release Capsules during pregnancy. Palladone Extended-Release Capsules is excreted in breast milk. Do not breast-feed while taking Palladone Extended-Release Capsules.

Use of Palladone Extended-Release Capsules can lead to TOLERANCE. When using for an extended period, Palladone Extended-Release Capsules may not work as well and may require different dosing. Talk with your doctor if Palladone Extended-Release Capsules stops working well.

Long-term use of Palladone Extended-Release Capsules can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness pain where pain comfort is more important. If using Palladone Extended-Release Capsules for an extended period of time, do not suddenly stop taking Palladone Extended-Release Capsules without your doctor"s approval. WITHDRAWAL symptoms have occurred when Palladone Extended-Release Capsules is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact you doctor if you notice any of these symptoms after stopping this medication.

Possible side effects of Palladone 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; drowsiness; dry mouth; general body discomfort; headache; infection; itching; sleepiness; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; feeling faint or dizzy; hallucinations; pounding in the chest; seizure; shallow breathing; urination problems; vomiting.

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 bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure (convulsions).

Store Palladone Extended-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Palladone Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Palladone Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Palladone 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 Palladone 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.