"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(tapentadol) Oral Solution
NUCYNTA oral solution is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults., when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about NUCYNTA oral solution:
- Get emergency help right away if you take too much NUCYNTA oral solution (overdose). When you first start taking NUCYNTA oral solution, when your dose is changed, or if you take too much (overdose), serious or lifethreatening breathing problems that can lead to death may occur.
- Taking NUCYNTA oral solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Never give anyone else your NUCYNTA oral solution. They could die from taking it. Store NUCYNTA oral solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA oral solution is against the law.
Do not take NUCYNTA oral solution if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking NUCYNTA oral solution, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of NUCYNTA oral solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. NUCYNTA oral solution passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA oral solution with certain other medicines can cause serious side effects that could lead to death.
When taking NUCYNTA oral solution:
- Do not change your dose. Take NUCYNTA oral solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- See the detailed Instructions for Use for information about how to take NUCYNTA.
- Always use the syringe that comes with NUCYNTA oral solution to correctly measure your dose. Never use a household teaspoon or tablespoon to measure NUCYNTA oral solution.
- Take your prescribed dose every 4-6 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking NUCYNTA oral solution regularly, do not stop taking NUCYNTA oral solution without talking to your healthcare provider.
- After you stop taking NUCYNTA oral solution, flush any unused tablets down the toilet..
While taking NUCYNTA oral solution DO NOT:
- Drive or operate heavy machinery, until you know how NUCYNTA oral solution affects you. NUCYNTA oral solution can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with NUCYNTA oral solution may cause you to overdose and die.
The possible side effects of NUCYNTA oral solution:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of NUCYNTA oral solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Instructions for Use
(tapentadol) oral solution 20 mg/mL
Read the Instructions for Use before you start taking NUCYNTA® oral solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Important information about measuring NUCYNTA®oral solution
- Always use the oral syringe provided with your NUCYNTA® oral solution to make sure you measure the right amount.
- You will be provided (See Figure A.):
- 1 bottle of NUCYNTA® oral solution
- 1 oral syringe
- 1 adapter
If you do not receive an oral syringe with your NUCYNTA® oral solution, ask your pharmacist to give you one.
Before you use NUCYNTA® oral solution for the first time:
- Remove the child-resistant cap and completely
remove the foil seal (See Figure B).
- Push the ribbed end of the adapter into the neck of
the bottle until it is firmly in place. The bottom
edge of the adapter should fully contact the top rim
of the bottle (See Figure C). Do not remove the
adapter from the bottle after it is inserted.
- Hold the oral syringe in one hand. With your other hand,
fully push down (depress) the plunger (See Figure D).
- Insert the tip of the oral syringe into the
adapter (See Figure E).
- Turn the bottle upside down. Pull back slowly on
the oral syringe plunger to withdraw the dose
prescribed by your healthcare provider (2.5 mL,
3.75 mL, or 5 mL). If you see air bubbles in the
oral syringe, fully push in the plunger so that the
oral solution flows back into the bottle. Then,
withdraw your prescribed dose of oral solution
(See Figure F).
- Leave the oral syringe in the bottle adapter and
turn the bottle right-side up. Place the bottle onto
a flat surface. Remove the oral syringe from the
bottle (See Figure G).
- Place the tip of the oral syringe in your mouth.
Squirt the oral solution into your mouth by
pushing on the plunger until the oral syringe is
empty (See Figure H).
- Leave the adapter in the bottle. Put the childresistant
cap back on the bottle (See Figure I).
- Remove the plunger from the oral syringe barrel.
Rinse the oral syringe with water after each use and
let it air dry. When the oral syringe is dry, put the
plunger back into the oral syringe barrel for the next
use. Do not throw away the oral syringe.
- Talk to your pharmacist if you have questions about how to use the oral syringe, or if you lose or misplace the oral syringe.
To prepare a dose of NUCYNTA® oral solution:
What are the ingredients in NUCYNTA® oral solution?
Active ingredient: tapentadol
Inactive ingredients: citric acid monohydrate, sucralose, raspberry flavor, sodium hydroxide, and purified water.
How should I store NUCYNTA® oral solution?
- Store NUCYNTA® oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
- Store the NUCYNTA® oral solution bottle upright after opening. Keep the oral syringe with your medicine.
- After you stop taking NUCYNTA® oral solution, flush the unused oral solution down the toilet.
Keep NUCYNTA® oral solution out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/3/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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