Celecoxib; Tramadol Tablets

What is this medication?

CELECOXIB; TRAMADOL (sell a KOX ib; TRA ma dole) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by decreasing inflammation. It also blocks pain signals in the brain. It is a combination of 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): SEGLENTIS

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

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

• Asthma
• Bleeding problems
• Brain tumor
• Dehydration
• Frequently drink alcohol
• Have had a heart attack, stroke, or mini-stroke
• Head injury
• Heart bypass surgery, or CABG, within the past 2 weeks
• Heart or blood vessel conditions
• Heart failure
• High blood pressure
• Kidney disease
• Liver disease
• Seizures
• Stomach bleeding
• Stomach ulcers, other stomach or intestine problems
• Substance use disorder
• Suicidal thoughts, plans, or attempt
• Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days
• Tobacco use
• An unusual or allergic reaction to celecoxib, tramadol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed.

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. Special care may be needed.

People 65 years and older may have a stronger reaction and need a smaller dose.

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:

• Cidofovir
• Ketorolac
• Linezolid
• MAOIs, such as Marplan, Nardil, and Parnate
• Methylene blue
• Olanzapine; samidorphan
• Safinamide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Aspirin and aspirin-like medications
• Atropine
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Blood thinners
• Cyclosporine
• Digoxin
• Diuretics
• Lithium
• Medications for blood pressure
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Methotrexate
• Other NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Other opioids for pain or cough
• Phenothiazines, such as chlorpromazine or prochlorperazine
• Some antihistamines
• Some medications for bladder problems, such as oxybutynin or tolterodine
• Some medications for depression
• Some medications for Parkinson disease, such as benztropine or trihexyphenidyl
• Some medications for seizures, such as phenobarbital or primidone
• Some medications for stomach problems, such as dicyclomine or hyoscyamine
• Some medications for travel sickness, such as scopolamine
• Steroid medications, such as prednisone or cortisone
• Supplements, such as garlic, ginger, ginkgo, methylsulfonylmethane (MSM)

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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.

Taking this medication with other substances that cause drowsiness, such as alcohol, benzodiazepines, or other opioids can cause serious 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. Call emergency services if you have problems breathing or staying awake.

Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication. If your care team wants you to stop this medication, the dose will be slowly lowered over time to reduce the risk of side effects.

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

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.

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.

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

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.

Do not take aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together.

This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds.

This medication increases the risk of blood clots, heart attack, and stroke. These events can occur at any time. They are more common with long-term use and in those who have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your care team. They can help you find an option that works for you.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have 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 may be pregnant. Taking this medication after 20 weeks of pregnancy may cause serious birth defects. Use of this medication after 30 weeks of pregnancy is not recommended.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

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
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Increase in blood pressure
• 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
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Round red or dark patches on the skin that may itch, burn, and blister
• Seizures
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these 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 this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
• If other options are not available, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. 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.