Carisoprodol; Aspirin; Codeine Tablets

What is this medication?

CARISOPRODOL; ASPIRIN; CODEINE (kar eye soe PROE dole; AS pir in; KOE deen) treats muscle pain and stiffness. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by calming overactive nerves in your body, which helps your muscles relax. It also decreases pain and inflammation. It is a combination of a muscle relaxant, an NSAID, and an opioid.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Soma Compound with Codeine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Brain tumor
• Frequently drink alcohol
• Head injury
• Heart disease
• Kidney disease
• Liver disease
• Lung or breathing disease (asthma, COPD)
• Seizures
• Substance use disorder
• Stomach or intestinal problems
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to aspirin, carisoprodol, codeine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. If it upsets your stomach, take it with food or milk. Do not take more medication than you are told to take.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. This medication is not for use in children younger than 12 years. Do not give this medication to a child younger than 18 years after surgery to remove the tonsils and/or adenoids.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Abrocitinib
• Cidofovir
• Defibrotide
• Ketorolac
• Linezolid
• MAOIs such as Marplan, Nardil, and Parnate
• Methylene blue
• Ozanimod
• Probenecid
• Samidorphan

This medication may interact with the following:

• Acetazolamide
• Alcohol
• Atropine
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Certain antibiotics, such as amikacin, bacitracin, clarithromycin, erythromycin, gentamicin, rifampin, tobramycin, vancomycin
• Certain antihistamines
• Certain antivirals for HIV or hepatitis
• Certain medications for bladder problems, such as oxybutynin or tolterodine
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, such as amitriptyline, bupropion, fluoxetine, mirtazapine, paroxetine, sertraline, trazodone
• Certain medications for diabetes, such as glipizide, glyburide, insulin
• Certain medications for fungal infections, such as amphotericin B, ketoconazole, itraconazole, posaconazole
• Certain medications for migraine headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea and vomiting, such as granisetron or ondansetron
• Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin, primidone, valproic acid
• Certain medications for stomach problems, such as dicyclomine or hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
• Cisplatin
• Cyclosporine
• Diuretics
• Foscarnet
• Ipratropium
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Methazolamide
• Methotrexate
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Quinidine
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

If you take other medications that also cause drowsiness like other opioid pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, being unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

Do not take other medications that contain aspirin, ibuprofen, or naproxen with this medication. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medications contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This medication can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Tobacco or alcohol use, older age, and poor health can also increase risks. Call your care team right away if you have stomach pain or blood in your vomit or stool.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Rash, fever, and swollen lymph nodes

Side effects that usually to not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

This medication is a drug that can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and is against the law.

This medication may cause accidental overdose and death if it is taken by other adults, children, or pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and from moisture. Keep container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.