MEDICATION GUIDE
NUCYNTA®
(new-SINN-tah)
(tapentadol)
immediate-release oral tablets C-II
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NUCYNTA® is a federally controlled
substance (C-II) because it can be abused. Keep NUCYNTA®
in a safe place to prevent theft. Selling or giving away NUCYNTA® may harm others, and is against the law.
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Tell your doctor if you (or a family member) have ever
abused or been dependent on alcohol, prescription medicines, or street drugs.
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Read the Medication Guide that comes with NUCYNTA® before you start taking it and each time you get a new
prescription. There may be new information. This Medication Guide does not take
the place of talking to your doctor about your medical condition or your
treatment. Talk to your doctor if you have any questions.
What is the most important information I should know about
NUCYNTA®?
NUCYNTA® is a tablet that contains tapentadol, a
strong medicine that is a pain medicine.
Use NUCYNTA® exactly how your doctor tells you to. Do
not use NUCYNTA® if it has not been prescribed for
you.
You should not take NUCYNTA® if your pain is mild and
can be controlled with other pain medicines such as non-steroidal
anti-inflammatory medicines (NSAIDS) or acetaminophen.
What is NUCYNTA®?
Who should not take NUCYNTA®?
Do not take NUCYNTA® if you:
- have severe lung problems
- have a gastrointestinal problem called paralytic ileus in which the
intestines are not working normally.
- take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI
within the last 14 days. Ask your doctor or pharmacist if any of your medicines
is an MAOI.
What should I tell my doctor before taking NUCYNTA®?
NUCYNTA® may not be right for you.
Tell your doctor about all your medical conditions, including if you
have:
- trouble breathing or lung problems
- or had a head injury
- liver or kidney problems
- convulsions or seizures
- dependency problems with alcohol
- pancreas or gall bladder problems
- past or present substance abuse or drug addiction. There is a risk of abuse
or addiction with narcotic pain medicines. If you have abused drugs in the past,
you may have a higher chance of developing abuse or addiction again while using
NUCYNTA®.
- are pregnant or plan to become pregnant
- are breast-feeding. You should not breast-feed while taking NUCYNTA®.
Tell your doctor about all the medicines you take,
including prescription and nonprescription medicines, vitamins, and herbal
supplements. Using NUCYNTA® with other medicines can
cause serious side effects. The doses of some other medicines may need to be
changed. Your doctor can tell you what medicines can be safely taken with
NUCYNTA®. Especially tell your doctor if you take:
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Monoamine Oxidase Inhibitors (MAOIs). See "Who should not take NUCYNTA®."
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any medicine that makes you sleepy. NUCYNTA® can make you sleepy and affect your breathing. Taking these
medicines together can be dangerous.
How should I take NUCYNTA®?
- Do not take NUCYNTA® unless it has been prescribed
for you by your doctor.
- Take NUCYNTA® exactly as prescribed by your
doctor.
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Do not change the dose of NUCYNTA®
unless your doctor tells you to. Your doctor may change your dose after
seeing how the medicine affects you. Do not use NUCYNTA®
more often than prescribed. Call your doctor if your pain is not well controlled
while taking NUCYNTA®.
- Follow your doctor's instructions about how to slowly stop taking
NUCYNTA® to help lessen withdrawal symptoms.
- NUCYNTA® can be taken with or without food.
What should I avoid while taking NUCYNTA®?
- Do not drive, operate machinery, or participate in any other possibly
dangerous activities until you know how you react to this medicine. NUCYNTA® can make you sleepy.
- You should not drink alcohol while using NUCYNTA®.
Alcohol increases your chance of having dangerous side effects.
What are the possible side effects of NUCYNTA®?
NUCYNTA® can cause serious side
effects including:
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Life-threatening breathing problems. Call your doctor right
away or get emergency medical help if you:
- have trouble breathing, or have slow or shallow breathing
- have a slow heartbeat
- have severe sleepiness
- have cold, clammy skin
- feel faint, dizzy, confused, or can not think, walk or talk normally
- have a seizure
- have hallucinations
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Physical Dependence. NUCYNTA®
can cause physical dependence. Talk to your doctor about slowly stopping
NUCYNTA® to avoid getting sick with withdrawal symptoms.
You could become sick with uncomfortable symptoms because your body has become
used to the medicine. Tell your doctor if you have any of these symptoms of
withdrawal: feeling anxious, sweating, sleep problems, shivering, pain, nausea,
tremors, diarrhea, upper respiratory symptoms, hallucinations, hair "standing on
end." Physical dependence is not the same as drug addiction. Your doctor can
tell you more about the differences between physical dependence and drug
addiction.
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Serotonin syndrome. Serotonin syndrome is a rare,
life-threatening problem that could happen if you take NUCYNTA® with Selective Serotonin Reuptake Inhibitors (SSRIs),
Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Monoamine Oxidase
Inhibitors (MAOIs), triptans or certain other medicines. Call your doctor or get
medical help right away if you have any one or more of the these symptoms: you
feel agitated, have hallucinations, coma, rapid heart beat, feel overheated,
loss of coordination, over active reflexes, nausea, vomiting, or diarrhea.
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Seizures. NUCYNTA® can cause
seizures in people who are at risk for seizures or who have epilepsy. Tell your
doctor right away if you have a seizure and stop taking NUCYNTA®.
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Low blood pressure. This can make you feel dizzy if
you get up too fast from sitting or lying down.
The common side effects with NUCYNTA® are nausea, dizziness, vomiting, sleepiness, and
itching.
Constipation is a common side effect of all opioid medicines. Talk to your
doctor about the use of laxatives and stool softeners to prevent or treat
constipation while taking NUCYNTA®.
Tell your doctor about any side effect that bothers you or that does not go
away. These are not all the possible side effects of NUCYNTA®. For a complete list, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
How should I store NUCYNTA®?
- Store NUCYNTA® at 59ºF to 86ºF (15ºC to 30ºC). Keep
NUCYNTA® tablets dry.
- Dispose of NUCYNTA® tablets you no longer need.
Keep NUCYNTA® in a safe place out of
the reach of children.
General information about NUCYNTA®
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use NUCYNTA® for a condition for
which it was not prescribed. Do not give NUCYNTA® to other people, even if they have the same symptoms you
have. Sharing NUCYNTA® could be harmful and is against
the law.
This Medication Guide summarizes the most important information about
NUCYNTA®. If you would like more information, talk with
your doctor. You can ask your doctor or pharmacist for information about
NUCYNTA® that is written for doctors. For more
information about NUCYNTA® call 1-800-526-7736.
What are the ingredients in NUCYNTA®?
Active Ingredient: tapentadol
Inactive ingredients: microcrystalline cellulose,
lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and
Opadry® II, a proprietary film-coating mixture containing
polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum
lake coloring.
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: June 2010
Manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778
Manufactured for:
PriCara®, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, NJ 08869
© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009
Physicians Total Care, Inc.