Instructions

Take the medicine with 250 mL (1 cup) of water.

Sit or stand upright for 10 minutes after taking the medicine. Do not lie down.

You may take with food or antacids to prevent stomach upset.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Drink plenty of water while on this medicine.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

Avoid grapefruit and grapefruit juice while on this medicine.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Do not take the medicine more than four times during 24 hours.

Cautions

This medicine has an opioid. Opioids help many people but may cause addiction, especially if used for a long time. The addiction risk is higher if you have a substance use disorder (overuse of or addiction to drugs or alcohol). Ask your doctor about the benefits and risks.

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

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine may cause bleeding from the stomach or bowels. Stop this medicine and call your doctor right away if you have pain in the stomach, red or dark tarry stools, or vomit that looks like coffee grounds.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Speak with your doctor before taking any medicine with aspirin.

Avoid smoking while on this medicine. Smoking may increase your risk for stomach bleeding.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Use medicine with caution if you have breathing problems. Get help right away for slow or shallow breathing.

Call your doctor right away if you notice any unusual bleeding or bruising.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• constipation
• dizziness or drowsiness
• lightheadedness
• nausea and vomiting
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• agitated feeling or trouble sleeping
• decreased appetite
• decreased awareness or responsiveness
• breathing interruption during sleep
• shallow, irregular breathing
• unusual bruising or discoloration on skin
• chest pain
• confusion
• coughing up blood or vomit that looks like coffee grounds
• swelling of the legs, feet, and hands
• fainting
• fever
• hallucinations (unusual thoughts, seeing or hearing things that are not real)
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• ringing in the ears
• shortness of breath
• severe stomach or bowel pain
• dark, tarry stool
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• swelling in the neck or throat
• difficulty or discomfort urinating
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.