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    Carisoprodol Compound-Codeine Tablet

    GENERIC NAME(S): Carisoprodol-ASA-Codeine

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    WARNINGS:

    Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

    The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works. Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

    Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this medication, get medical help right away.

    Children younger than 12 years should not use products that contain codeine. Children between 12 and 18 years old should not use codeine after certain surgeries (including tonsil/adenoid removal). Also, codeine use is not recommended for children between 12 and 18 years old who are obese or have breathing problems. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.

    Who should not take Carisoprodol Compound-Codeine Tablet?
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    Uses

    See also Warning section.

    This product is used short-term to treat muscle pain and discomfort. It is usually used along with rest, physical therapy, and other treatments. Carisoprodol helps to relax the muscles. Aspirin helps to decrease pain and swelling. Codeine is an opioid (narcotic) pain reliever that works in the brain to change how your body feels and responds to pain.

    How to use Carisoprodol Compound-Codeine Tablet

    Take this medication by mouth with or without food as directed by your doctor, usually 4 times a day. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. If you have stomach upset or nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

    The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Use the smallest effective dose.

    Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

    This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as stomach cramps, trouble sleeping, headache, restlessness, nausea, sweating, diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

    When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

    Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

    Tell your doctor if your condition persists after 2 to 3 weeks or if it worsens.

    Side Effects

    See also Warning section.

    Drowsiness, dizziness, lightheadedness, headache, stomach upset, constipation, nausea/vomiting, or heartburn may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

    To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, dark urine, yellowing eyes/skin, persistent nausea/vomiting, hearing problems (such as ringing in the ears, hearing loss), signs of kidney problems (such as change in the amount of urine), fast/pounding heartbeat, difficulty urinating, mental/mood changes (such as agitation, hallucinations), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

    Get medical help right away if you have any very serious side effects, including: fainting, seizures.

    Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very seriousside effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.

    This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, stop taking this medication and consult your doctor or pharmacist right away: black stool, vomit that looks like coffee grounds, persistent stomach/abdominal pain.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking this medication, tell your doctor or pharmacist if you are allergic to codeine, carisoprodol, or aspirin; or to related medications such as meprobamate, tybamate, or mebutamate; or to other opioid pain medications (such as morphine); or to nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen); or to other salicylates (such as choline salicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), stomach/intestine/esophagus problems (such as ulcers, heartburn, blockage, constipation, diarrhea due to infection, paralytic ileus), a certain blood disorder (acute intermittent porphyria), brain disorders (such as head injury, tumor, seizures), breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, bleeding/clotting disorders (such as hemophilia, von Willebrand disease, thrombocytopenia), certain enzyme deficiencies (such as G6PD or pyruvate kinase deficiency), gout, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders (such as confusion, depression, thoughts of suicide), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis), obesity.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

    This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

    This drug contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

    Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)

    Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and ulcers, dizziness, drowsiness, weakness, confusion, slow/shallow breathing, and difficulty urinating. Dizziness, drowsiness, and confusion can increase the risk of falling.

    Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication is not recommended for use during pregnancy. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. Consult your doctor for more details.

    This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

    Interactions

    See also Warning section.

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug include: corticosteroids (such as prednisone), mifepristone, naltrexone, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol).

    This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel/ticagrelor, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

    Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs if taken together with this medication may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

    The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as cyclobenzaprine, methocarbamol), or antihistamines (such as cetirizine, diphenhydramine).

    Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

    Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

    This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, slow/shallow breathing, seizures, ringing in the ears, mental/mood changes (such as confusion, hallucinations), inability to move your legs/arms, shaky/unsteady movement, vision changes (such as blurred vision), coma.

    Notes

    Do not share this medication with others. It is against the law.

    This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

    Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

    Missed Dose

    If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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