September 2, 2014
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Nucynta CR

(tapentadol)

DIN (Drug Identification Number)

02360373 NUCYNTA CR 50MG TABLET
02360381 NUCYNTA CR 100MG TABLET
02360403 NUCYNTA CR 150MG TABLET
02360411 NUCYNTA CR 200MG TABLET
02360438 NUCYNTA CR 250MG TABLET

How does Nucynta CR work? What will it do for me?

Tapentadol belongs to a class of pain relievers known as opioid analgesics (also known as narcotic analgesics) that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

It is used to treat moderate to moderately severe pain for adults who need treatment for several days or more.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Nucynta CR?

The recommended starting dose (for people who are not currently taking opioid pain relievers) is 50 mg every 12 hours. The dose may then be increased to the usual daily dose of 100 mg to 250 mg twice daily, depending on how the medication is tolerated and how well it works for your pain.

If you have been taking another opioid medication, the starting dose of tapentadol may be higher, depending on the dose of the other medication. Your doctor will determine the most appropriate starting dose.

Always swallow the tablet whole. Do not crush, divide, dissolve, or chew tapentadol tablets. Taking broken or crushed tablets may result in too much of the medication being absorbed at one time. This is dangerous, and can be fatal.

You may take the tablets on an empty stomach or with meals.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Stopping the medication suddenly may cause withdrawal symptoms (such as restlessness, irritability, nausea and vomiting, diarrhea, sweating, chills, muscle aches, or watery eyes and nose). Do not stop taking this medication without checking with your doctor first. Your doctor will advise you on how to stop the medication safely.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children and pets. Accidental use by a child is a medical emergency and may result in death.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Nucynta CR come in?

50 mg
Each white, capsule-shaped tablet, engraved with "O-M" on one side and "50" on the other side, contains 50 mg of tapentadol hydrochloride. Nonmedicinal ingredients: silicified microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide.

100 mg
Each light blue, capsule-shaped tablet, engraved with "O-M" on one side and "100" on the other side, contains 100 mg of tapentadol hydrochloride. Nonmedicinal ingredients: silicified microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, and FD&C Blue No. 2 Aluminum Lake.

150 mg
Each blue-green, capsule-shaped tablet, engraved with "O-M" on one side and "150" on the other side, contains 150 mg of tapentadol hydrochloride. Nonmedicinal ingredients: silicified microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, and yellow iron oxide.

200 mg
Each blue, capsule-shaped tablet, engraved with "O-M" on one side and "200" on the other side, contains 200 mg of tapentadol hydrochloride. Nonmedicinal ingredients: silicified microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, and FD&C Blue No. 2 Aluminum Lake.

250 mg
Each dark blue, capsule-shaped tablet, engraved with "O-M" on one side and "250" on the other side, contains 250 mg of tapentadol hydrochloride. Nonmedicinal ingredients: silicified microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, and FD&C Blue No. 2 Aluminum Lake.

Who should NOT take Nucynta CR?

Do not take tapentadol if you:

  • are allergic to tapentadol, or any ingredients of the medication
  • are allergic to opioids
  • are also taking MAO inhibitors (certain medications used for treatment of depression) or have taken them in the last 14 days before treatment with tapentadol
  • are pregnant, in labour, or breast-feeding
  • have a head injury, increased intracranial pressure (pressure inside the head), or severe central nervous system depression (a slowing of the central nervous system leading to decreased heart rate, decreased breathing rate, or loss of consciousness)
  • have asthma or dangerously slow or shallow breathing (respiratory depression, hypercapnia)
  • have convulsions or a seizure disorder
  • have pain that can be controlled by occasional use of painkillers or pain around the time of surgery
  • have paralysis of the gut or a bowel obstruction
  • have severe kidney or liver dysfunction
  • are addicted to alcohol

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