Hysingla ER; Zohydro ER
- This drug may be habit-forming with long-term use.
- This drug is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your doctor.
- Swallow whole. Do not chew, break, crush, or melt before swallowing. Doing these things can cause very bad side effects and death.
- Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
- This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- The chance of very bad and sometimes deadly breathing problems may be greater when you first start this drug or anytime your dose is raised.
- Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
- Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
- This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
- Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.
- Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
- It is used to ease very bad pain.
- It is only to be used when around-the-clock (continuous) care is needed for a long time. It is also only to be used when other pain drugs do not treat your pain well enough or you cannot take them.
- If you have an allergy to hydrocodone or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Very bad lung problems like asthma or trouble breathing, high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.
- If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
- If you have a long QT on ECG.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.
- Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor.
- Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
- If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
- Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
- You will be watched closely by your doctor.
- If you are 65 or older, use this drug with care. You could have more side effects.
- This drug is not approved for use in children. Talk with the doctor.
- This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
- Tell your doctor if you are breast-feeding or plan to breast-feed. This drug passes into breast milk and may harm your baby.
- The chance of the tablet getting stuck in the throat, trouble swallowing, and choking may be raised in children. Talk with the doctor.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Chest pain or pressure.
- Trouble breathing, slow breathing, or shallow breathing.
- Swelling in the arms or legs.
- A burning, numbness, or tingling feeling that is not normal.
- A fast heartbeat.
- Feeling confused.
- Very hard stools (constipation).
- Very bad belly pain.
- Feeling very tired or weak.
- Mood changes.
- Very bad headache.
- Memory problems or loss.
- Pain when passing urine.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
- Long-term use of an opioid drug like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
- Trouble swallowing.
- Hard stools (constipation).
- Feeling sleepy.
- Upset stomach or throwing up.
- Feeling tired or weak.
- Belly pain.
- Take by mouth only.
- Take with or without food. Take with food if it causes an upset stomach.
- To gain the most benefit, do not miss doses.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- Take this drug at the same time of day.
- Do not inject or snort this drug. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
- Do not use for fast pain relief or on an as needed basis.
- Do not use for pain relief after surgery if you have not been taking drugs like this drug.
- If you have trouble swallowing, talk with your doctor.
- Swallow whole. Do not crush, chew, or melt the capsule or its contents.
- Take 1 capsule at a time if your dose is more than 1 capsule. Swallow the capsule with lots of water right after putting it in your mouth.
- Do not take more often than every 12 hours unless told to do so by your doctor.
- Swallow whole. Do not chew, break, or crush.
- Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
- Do not take more often than every 24 hours unless told to do so by your doctor.
- Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.