Seglentis

• Risk factors: Personal or family history of alcohol or substance use disorder | History of depression or other mental health conditions

Seglentis (celecoxib / tramadol) is a controlled substance because it has a risk for addiction and misuse. Because of these risks, you'll be prescribed the lowest amount of medication that's necessary for the shortest period of time possible. Take Seglentis (celecoxib / tramadol) exactly as prescribed. Don't change the dose or how often you take it without talking to your prescriber first.

Misusing Seglentis (celecoxib / tramadol), for example taking it differently than prescribed, might cause the medication to work less well. It can also raise the risk for serious and sometimes life-threatening side effects, such as dangerously slow breathing, extreme sleepiness, and overdose. Misusing the medication can also lead to addiction.

Because of the risk for misuse, addiction, and overdose, the FDA requires Seglentis (celecoxib / tramadol) to be under a restricted program called a Risk Evaluation and Mitigation Strategy (REMS) program. Under this program, your prescriber and pharmacist are required to give you a Medication Guide and go over the proper use, serious risks, and safe storage and disposal of this medication. This helps keep you and your loved ones safe.

• Risk factors: Older age | Being frail | Medical conditions that cause breathing problems | Taking medications that can cause slow breathing (e.g., benzodiazepines, other opioids, sleep medications) | Drinking alcohol | Having certain genes that break down tramadol too quickly | Children | Breastfed babies of mothers who take Seglentis (celecoxib / tramadol)

Seglentis contains tramadol, an opioid that can cause dangerously slow breathing even at recommended doses. This is called respiratory depression and it can be life-threatening. It's important to take the lowest effective dose of Seglentis (celecoxib / tramadol) for the shortest amount of time possible to minimize the risk for slow breathing from the medication. Call 911 if you or a loved one notices that you have slow or shallow breathing.

Respiratory depression can happen to anyone and at any time while you're taking Seglentis (celecoxib / tramadol). The risk is greatest at the start of treatment and is especially high for certain people. For example, taking the medication with alcohol or sedatives can seriously raise your risk. Some people also have certain genetics that raise their risk for respiratory depression after they take Seglentis (celecoxib / tramadol). Additionally, children younger than 12 and those younger than 18 who've just had surgery for tonsil or adenoid removal can't take this medication for pain relief because of the risk for breathing problems. Discuss with your prescriber about your risk for slow breathing with Seglentis (celecoxib / tramadol).

• Risk factors: History of opioid use disorder | Previous opioid overdose | Alcohol use | Taking high doses of Seglentis (celecoxib / tramadol) | Taking more opioids than prescribed

Take Seglentis (celecoxib / tramadol) exactly as prescribed. Taking too much or taking it more often than prescribed can lead to an opioid overdose. Keep your medication out of reach from children, pets, and visitors to prevent accidental exposure or overdose. Symptoms of an opioid overdose include not responding to sound or touch, extremely slow breathing, extreme sleepiness, slow heartbeat, and cold or clammy skin.

Be sure you and your loved ones know how to recognize an opioid overdose. Your prescriber will recommend that you get naloxone (Narcan) — either by prescription or over the counter. Naloxone (Narcan) is a medication that can help treat an opioid overdose. Carry naloxone (Narcan) with you at all times; use it and call 911 right away if an overdose happens.

Seglentis (celecoxib / tramadol) can harm an unborn baby if it's taken during pregnancy. Celecoxib can raise the risk for serious complications, such as heart or kidney problems in your unborn baby or problems during delivery, especially if it's taken in the second half of pregnancy (after week 20). Taking opioids like tramadol long term during pregnancy can also raise the risk of your baby developing a life-threatening condition called neonatal opioid withdrawal syndrome after they're born.

Make sure to tell your prescriber if you're pregnant before you start Seglentis (celecoxib / tramadol) or if you become pregnant while you're taking this medication. Your prescriber can discuss with you about safer options to relieve your pain.

Seglentis is a combination medication that contains celecoxib and tramadol. Both celecoxib and tramadol can interact with many other common medications. These drug interactions can either make Seglentis (celecoxib / tramadol) work less well or put you at risk for serious side effects, like dangerously slow breathing, bleeding, and withdrawal. Let your care team know about all the medications you take or plan to take with Seglentis (celecoxib / tramadol). Your care team can check your medication list to make sure all of your medications are safe to take together.

• Risk factors: Older adults | History of stomach bleeding, stomach ulcers, or other bleeding problems | Liver problems | Taking medications that raise your risk for bleeds | Drinking alcohol | Smoking | Taking Seglentis (celecoxib / tramadol) for a long time

Although rare, the celecoxib in Seglentis can raise your risk for stomach ulcers (sores) and bleeds. Stomach ulcers can feel like a gnawing pain in the stomach area. But people who have stomach bleeds might not have noticeable symptoms, especially if the bleeding is slow and happens over a long period of time. Get medical attention right away, though, if you're feeling faint, vomiting blood, have bloody or dark stools, or have severe stomach pain or discomfort that doesn't go away while you're taking Seglentis (celecoxib / tramadol). These can be common signs of stomach bleeding.

• Risk factors: Heart problems | Taking higher doses of Seglentis (celecoxib / tramadol) | Taking Seglentis (celecoxib / tramadol) for several years | Recent heart attack | Recent or planned heart surgery

Seglentis contains an NSAID called celecoxib. Celecoxib can raise your risk of having blood clots. These blood clots can sometimes lead to a life-threatening heart attack or stroke. Call 911 or get immediate help if you have chest pain that travels to the arms or neck, shortness of breath, sweating, weakness on one side of your body, or trouble speaking or walking. These can be signs of a heart attack or stroke.

Talk to your prescriber before you start taking Seglentis (celecoxib / tramadol) if you have a heart problem, including any heart attacks you've had. Also let your prescriber know if you have a heart surgery scheduled or if you've had a procedure in the past 2 weeks. You can't take this medication after a recent heart surgery because taking NSAIDs too soon afterwards can put you at higher risk for heart attack and stroke.

• Risk factors: Heart failure

Seglentis contains celecoxib, which can cause your body to hold onto extra fluids. This fluid retention can sometimes cause swelling in the hands, ankles, and feet. It can also put you at risk for worsening heart failure if you have this heart condition. Tell your prescriber if you have a history of heart failure before you start Seglentis (celecoxib / tramadol). Contact your healthcare team if you have unexplained fainting, chest pain with physical activity, or irregular heartbeat while you're taking this medication. These can be signs of worsening heart failure from fluid build-up.

Seglentis (celecoxib / tramadol) can cause changes to your blood pressure. Celecoxib can cause your body to hold onto extra fluid, which can raise your blood pressure. On the other hand, tramadol can make your blood pressure drop very low. For example, your blood pressure might suddenly drop when you stand from a sitting or lying down position and make you feel dizzy or off balance. Sit or lie down if you feel dizzy and stand up slowly to avoid falling.

• Risk factors: Older adults | Kidney or liver problems | Heart failure | Taking other medications that can cause kidney damage | Dehydration

Long-term use of NSAIDs like celecoxib (one of the components of Seglentis) can cause kidney damage. Contact your care team if you develop any signs or symptoms of kidney damage, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps. Your care team might need to draw some of your blood to check your kidney health. Seglentis (celecoxib / tramadol) isn't recommended for people with severe kidney problems.

NSAIDs like celecoxib (one of the components of Seglentis) can sometimes raise the liver enzyme levels in the blood. This can be a sign of liver damage. Call your care team right away if you notice right-sided stomach pain; yellowing of the skin or the whites of the eyes; nausea; stool changes (black, tarry, or bloody stools); or dark or brown urine. These can be signs of liver damage, and you might need to stop taking Seglentis (celecoxib / tramadol) to prevent further harm. This medication isn't recommended for people with moderate or severe liver problems.

• Risk factors: Aspirin or NSAID allergy | Sulfa allergy | Aspirin-sensitive asthma | Asthma with rhinitis (runny or stuffy nose), with or without nasal polyps

Severe allergic reactions to Seglentis (celecoxib / tramadol) are possible, including facial swelling, shock, and anaphylaxis. Although rare, the medication can also cause serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking the medication and get medical help right away if you notice swelling of the lips or tongue or difficulty breathing. Also get medical attention as soon as possible if you notice unusual changes in your skin, such as rash, hives, blisters, skin reddening, or skin peeling.

Tell your prescriber if you have an allergy to aspirin, other NSAIDs, or sulfa medications. You might be at higher risk for an allergic reaction to Seglentis (celecoxib / tramadol).

• Risk factors: Taking a monoamine oxidase inhibitor (MAOI) 14 days before starting Seglentis (celecoxib / tramadol) | Taking other medications that raise serotonin levels in your brain (e.g., certain antidepressants, linezolid (Zyvox), certain migraine medications)

Seglentis contains tramadol, which can raise the serotonin levels in your body. This can put you at risk for serotonin syndrome, a rare, but potentially life-threatening condition that happens when there's too much serotonin in the brain. The risk is greater if you're taking other medications that can also make serotonin levels go up. For this reason, it's important to let your care team know what medications, over-the-counter products, and supplements you take or plan to take. Get medical help right away if you have any symptoms of serotonin syndrome, such as fast heart rate, muscle stiffness or spasms, high fever, and confusion.

• Risk factors: Long-term use of Seglentis (celecoxib / tramadol)

If taken regularly for a long time, Seglentis (celecoxib / tramadol) can cause your body to rely on the medication to function (this is called physical dependence). You might experience withdrawal if you stop taking the medication suddenly. Withdrawal symptoms include runny nose, sweating, chills, return of pain, restlessness, anxiety, and irritability.

Don't lower your dose or stop taking Seglentis (celecoxib / tramadol) suddenly without talking to your prescriber first. Your prescriber will slowly lower your dose to prevent withdrawal symptoms. Talk to your prescriber about alternative pain medications if you have concerns about taking Seglentis (celecoxib / tramadol) because of the risk for dependence and withdrawal.

• Risk factors: History of seizures | Medical conditions that raise the risk for seizures | Taking higher than recommended doses of Seglentis (celecoxib / tramadol) | Taking other medications that raise seizure risk

The tramadol in Seglentis can raise your risk for seizures. If you've had a seizure before, discuss with your prescriber about whether Seglentis (celecoxib / tramadol) is safe for you.

• Risk factors: Taking Seglentis (celecoxib / tramadol) for longer than 1 month

Some people taking opioids like the tramadol in Seglentis have had low levels of adrenal hormone. Let your prescriber know if you have symptoms of low adrenal hormone levels, like tiredness, weakness, dizziness, not feeling hungry, nausea, and vomiting. If your adrenal hormone levels drop too low, you might need to stop Seglentis (celecoxib / tramadol) and get treated with corticosteroids.

Some people who've taken medications containing tramadol have had low sodium levels. This drop in sodium levels was mostly reported in females older than 65 years of age and within the first week of starting the medication. Get medical help right away if you experience weakness, dizziness, headache, nausea, muscle cramps, or confusion. These could be signs of low sodium levels, which is a medical emergency.