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Tramadol Extended-Release Capsules

Pronunciation

Generic Name: Tramadol Extended-Release Capsules (TRAM a dol)
Brand Name: ConZip

  • This medicine may be habit-forming with long-term use.
  • This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this medicine (tramadol extended-release capsules) can lead to overdose and death. Talk with your doctor.
  • You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine.
  • This medicine 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 medicine (tramadol extended-release capsules) or anytime your dose is raised.
  • Even one dose of this medicine may be deadly if it is taken by someone else or by accident, especially in children. If this medicine (tramadol extended-release capsules) is taken by someone else or by accident, get medical help right away.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • This medicine 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 medicine (tramadol extended-release capsules) 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 medicine with all of your drugs.
  • Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
  • 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.

Uses of Tramadol Extended-Release Capsules:

  • It is used to ease pain.

Children:

  • This medicine is not approved for use in children. However, the doctor may decide the benefits of taking this medicine (tramadol extended-release capsules) outweigh the risks. If your child has been given this medicine, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this medicine (tramadol extended-release capsules) to your child.

What do I need to tell my doctor BEFORE I take Tramadol Extended-Release Capsules?

  • If you have an allergy to tramadol or any other part of this medicine.
  • 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: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have thoughts of suicide or if you have ever had alcohol or other drug abuse or dependence.
  • If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
  • If you are taking carbamazepine.
  • If you are taking another drug that has the same drug in it.
  • 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 medicine (tramadol extended-release capsules) within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with this medicine (tramadol extended-release capsules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tramadol Extended-Release Capsules?

  • Tell all of your health care providers that you take this medicine (tramadol extended-release capsules). 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 medicine 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.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • Do not take this medicine (tramadol extended-release capsules) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • This medicine may raise the chance of seizures. The chance may be higher in people who have certain health problems, use certain other drugs, or drink a lot of alcohol. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
  • If you have been taking this medicine (tramadol extended-release capsules) 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 medicine stops working well. Do not take more than ordered.
  • Do not stop taking this medicine (tramadol extended-release capsules) all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine (tramadol extended-release capsules) with your other drugs.
  • Long-term use of an opioid drug like this medicine 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.
  • Taking an opioid drug like this medicine (tramadol extended-release capsules) 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.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • This medicine 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 medicine (tramadol extended-release capsules), call your doctor right away.

How is this medicine (Tramadol Extended-Release Capsules) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Always take with food or always take on an empty stomach.
  • Swallow whole. Do not chew, break, or crush.
  • Take this medicine (tramadol extended-release capsules) at the same time of day.
  • To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • 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 mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Seizures.
  • Feeling very tired or weak.
  • Chest pain or pressure or a fast heartbeat.
  • Trouble passing urine.
  • Passing urine more often.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Feeling very sleepy.
  • Change in eyesight.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine 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.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Tramadol Extended-Release Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dizziness.
  • Feeling sleepy.
  • Dry mouth.
  • Headache.
  • Itching.
  • Upset stomach or throwing up.
  • Not able to sleep.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

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.

How do I store and/or throw out Tramadol Extended-Release Capsules?

  • 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.

Consumer Information Use and Disclaimer

  • 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.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (tramadol extended-release capsules) is refilled. If you have any questions about this medicine, please talk with the doctor, 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.

This information should not be used to decide whether or not to take this medicine (tramadol extended-release capsules) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (tramadol extended-release capsules). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: September 6, 2017

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