Celecoxib (sel-e-KOX-ib), Tramadol Hydrochloride (TRAM-a-dol hye-droe-KLOR-ide)

Relieves pain.

Brand Name(s):

Seglentis

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone and other medicines to treat an overdose.
• Use this medicine for the shortest time possible. This will help lower the risk of side effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days. Do not use aspirin or any other NSAID medicine (including diclofenac, diflunisal, ibuprofen, naproxen, salsalate) unless your doctor says it is okay. Do not use this medicine together with other products containing celecoxib or tramadol.
• Some medicines can affect how celecoxib/tramadol works. Tell your doctor if you are using any of the following:
  • Amiodarone, atomoxetine, carbamazepine, cyclosporine, digoxin, erythromycin, fluconazole, ketoconazole, lithium, methotrexate, pemetrexed, phenytoin, quinidine, rifampin, ritonavir
  • Benzodiazepine medicine
  • Blood pressure medicine (including ACE inhibitors, ARBs, beta blockers)
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Medicine to treat anxiety, depression, or mental health problems (including bupropion, fluoxetine, paroxetine, SNRIs, SSRIs, TCAs)
  • Steroid medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of pregnancy, unless your doctor tells you to.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart disease, high blood pressure, adrenal problems, anemia, bleeding problems, lung or breathing problems (including sleep apnea), diabetes, pancreas problems, depression, mental health problems, a history of head injury, seizures, or stomach or bowel problems (including bleeding, ulcers), or you have been addicted to drugs or alcohol.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Increased risk of blood clots, heart attack, stroke, or heart failure
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Worsening of pain
  • Serotonin syndrome (when used with certain medicines)
  • Liver problem
  • Increased risk of seizures
  • Unusual change in mood or behavior
  • Adrenal gland problem
  • Low or high blood pressure
  • Serious skin reactions, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
  • Hypoglycemia (low blood sugar level)
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, muscle spasms or twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Blue lips, fingernails, or skin
• Chest pain, trouble breathing, coughing up blood
• Change in how much or how often you urinate
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness, drowsiness, or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin
• Lightheadedness, dizziness, fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Rapid weight gain, swelling in your hands, ankles, or feet
• Seizures
• Shaking, trembling, sweating, hunger, confusion
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness
• Unusual mood or behavior, thoughts of killing yourself or others
• Worsening of pain, increased sensitivity to pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088